Proton pump inhibitors


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Proton pump inhibitors act by irreversible inhibition of the H+/K+ ATPase, in the parietal cells of the stomach. It markedly inhibits gastric acid secretion and has a long duration of action. They are used for treatment of gastric and duodenal ulcers, gastroesophageal reflux disease and other excessive gastrointestinal acid secretory disorders.

See also

Medical conditions associated with proton pump inhibitors:

Aspiration Pneumonia Barrett's Esophagus Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis Gastrointestinal Hemorrhage GERD Helicobacter Pylori Infection Indigestion Multiple Endocrine Adenomas NSAID-Induced Gastric Ulcer NSAID-Induced Ulcer Prophylaxis Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Stress Ulcer Prophylaxis Systemic Mastocytosis Zollinger-Ellison Syndrome Drug List: Zegerid Aciphex Nexium_Iv Nexium Prevacid Protonix Kapidex Dexilant-Delayed-Release-Capsules Prilosec Prilosec-Otc-Delayed-Release-Capsules Prevacid-Solutab-Orally-Disintegrating-Tablets Zegerid-Otc Prevacid-I-V Prevacid-Otc Protonix-I-V


More




Aspiration Pneumonia Medications


Definition of Aspiration Pneumonia: Aspiration pneumonia is an inflammation of the lungs and bronchial tubes caused by inhaling foreign material, usually food, drink, vomit, or secretions from the mouth into the lungs. This may progress to form a collection of pus in the lungs (lung abscess).

Drugs associated with Aspiration Pneumonia

The following drugs and medications are in some way related to, or used in the treatment of Aspiration Pneumonia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Aspiration Pneumonia

Medical Encyclopedia:

Aspiration pneumonia
Drug List: Amoclan-Suspension Augmentin Augmentin-Es-600-Suspension Augmentin-Xr-Extended-Release-Tablets Baycadron Beepen-Vk Bicillin-L-A-Suspension Cleocin Cleocin-Hcl Cleocin-Pediatric-Suspension Cleocin-Phosphate-Iv De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Flagyl Flagyl-375 Flagyl-I-V Permapen-Isoject Mefoxin Meticorten Metro Pc-Pen-Vk Pen-V Penicillin-G-Procaine-Injectable-Suspension Penicillin-Vk Pfizerpen Prevacid Prevacid-I-V Prevacid-Otc Prevacid-Solutab-Orally-Disintegrating-Tablets Primaxin-Im Primaxin-Iv Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Timentin Unasyn Veetids Zema-Pak-10-Day Zosyn


More




Prevacid Delayed-Release Capsules


Pronunciation: lan-SOE-pra-zole
Generic Name: Lansoprazole
Brand Name: Prevacid
Prevacid Delayed-Release Capsules are used for:

Preventing or treating certain types of ulcers. It is also used to treat symptoms of gastroesophageal reflux disease (GERD) (eg, heartburn) and irritation of the esophagus. It is also used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Prevacid Delayed-Release Capsules are a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Prevacid Delayed-Release Capsules if: you are allergic to any ingredient in Prevacid Delayed-Release Capsules you are taking an HIV protease inhibitor (eg, atazanavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prevacid Delayed-Release Capsules:

Some medical conditions may interact with Prevacid Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Prevacid Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased Clarithromycin or voriconazole because they may increase the risk of Prevacid Delayed-Release Capsules's side effects Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Prevacid Delayed-Release Capsules Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Prevacid Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prevacid Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prevacid Delayed-Release Capsules:

Use Prevacid Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prevacid Delayed-Release Capsules by mouth on an empty stomach before eating. Swallow Prevacid Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over 1 tablespoon (15 mL) of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. You may also open the capsule and sprinkle the contents into 2 oz (60 mL) apple juice, orange juice, or tomato juice. Mix briefly, then swallow at once. Do not chew or crush the granules. Do not store the mixture for use at a later time. After you take your dose, rinse the glass with at least 4 oz (120 mL) of juice and swallow to be sure you have received all of the medicine. Do NOT mix Prevacid Delayed-Release Capsules with other foods or liquids. You may take antacids while you are using Prevacid Delayed-Release Capsules if you are directed to do so by your doctor. If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Prevacid Delayed-Release Capsules. If you also take sucralfate, take Prevacid Delayed-Release Capsules at least 30 minutes before taking sucralfate. Continue to take Prevacid Delayed-Release Capsules even if you feel well. Do not miss any doses. If you miss a dose of Prevacid Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prevacid Delayed-Release Capsules.

Important safety information: Prevacid Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prevacid Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing. Prevacid Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Prevacid Delayed-Release Capsules in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Prevacid Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures). Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Prevacid Delayed-Release Capsules. Prevacid Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prevacid Delayed-Release Capsules. Prevacid Delayed-Release Capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients. Use Prevacid Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures. Prevacid Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prevacid Delayed-Release Capsules while you are pregnant. It is not known if Prevacid Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Prevacid Delayed-Release Capsules. Possible side effects of Prevacid Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; unusual tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prevacid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prevacid Delayed-Release Capsules:

Store Prevacid Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prevacid Delayed-Release Capsules out of the reach of children and away from pets.

General information: If you have any questions about Prevacid Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider. Prevacid Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prevacid Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prevacid resources Prevacid Side Effects (in more detail) Prevacid Dosage Prevacid Use in Pregnancy & Breastfeeding Drug Images Prevacid Drug Interactions Prevacid Support Group 26 Reviews for Prevacid - Add your own review/rating Compare Prevacid with other medications Aspiration Pneumonia Barrett's Esophagus Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Helicobacter Pylori Infection Multiple Endocrine Adenomas NSAID-Induced Gastric Ulcer NSAID-Induced Ulcer Prophylaxis Stomach Ulcer Systemic Mastocytosis Zollinger-Ellison Syndrome


More




Osteoarthritis Medications


Definition of Osteoarthritis: Osteoarthritis is a chronic disease causing deterioration of the joint cartilage (the softer parts of bones, which cushion their connections to each other) and the formation of new bone (bone spurs) at the margins of the joints.

Drugs associated with Osteoarthritis

The following drugs and medications are in some way related to, or used in the treatment of Osteoarthritis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Osteoarthritis

Medical Encyclopedia:

Osteoarthritis

Harvard Health Guide:

Symptoms and treatment for Osteoarthritis

Drugs.com Health Center:

Osteoarthritis
Drug List: A-G-Profen A-Methapred-Solution Aceta-W-Codeine Actiprofen Actron Addaprin Advil Advil-Liqui-Gels Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Amigesic Amino-Opti-C Anaprox Anaprox-Ds Ansaid Aristocort Aristocort-Forte Arthritis-Pain Arthritis-Pain-Formula Arthrotec Ascriptin Ascriptin-Maximum-Strength Aspercreme-Cream Aspergum-Gum Aspirin-Buffered Aspirin-Lite-Coat Aspiritab Axsain-Cream Bayer Bayer-Plus Bayer-Aspirin-With-Calcium Bextra Buffered-Aspirin Bufferin Bufferin-Arthritis-Strength Bufferin-Extra-Strength Capital-W-Codeine-Suspension Capital-With-Codeine-Suspension Capsicum-Oleoresin Capsin Capzasin-Liquid Capzasin-Back-And-Body Capzasin-Quick-Relief Capzasin-Hp Capzasin-Hp-Arthritis-Formula Capzasin-P-Cream Castiva-Warming-Lotion Cataflam Celebrex Celestone-Solution Celestone-Soluspan Choline-Magnesium-Trisalicylate Clinacort-Injection Clinalog-Injection Clinoril Cocet Cocet-Plus Comfort-Pac-With-Naproxen Cortone-Acetate Cosamin-Ds Cosmegen Cymbalta Daypro Deltasone Depo-Medrol-Suspension Disalcid Dolobid Dolorac Dr-S-Cream Duexis Easprin Ec-Naprosyn-Enteric-Coated-Tablets Ecotrin-Delayed-Release-Tablets Ecotrin-Adult-Low-Strength Ecotrin-Maximum-Strength Empirin Euflexxa Excedrin Excedrin-Extra-Strength Excedrin-Quick-Tab-Peppermint Excedrin-Tension-Headache Ez-Iii Fasprin Feldene Genace Genacote Genpril Glucosamine-Chondroitin-With-Msm Gnp-Capsaicin-Lotion Goodys-Extra-Strength Halfprin Haltran Hyalgan Ibu Ibu-200 Icyhot-Pm-Medicated-Patch Indocin Indocin-Iv Indocin-Sr-Sustained-Release-Capsules Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Leader-Naproxen-Sodium Limbrel Limbrel-250 Limbrel-500 Litecoat-Aspirin Lodine Lodine-Xl Medi-Seltzer-Effervescent-Tablets Medrol Medrol-Dosepak Menthac-Arthritis-Cream-With-Capsaicin Methylprednisolone-Dose-Pack Meticorten Midol-Extended-Relief Midol-Ib Mobic Motrin Motrin-Ib Myoflex-Cream Nalfon Naprelan-Sustained-Release-Tablets Naprosyn Norwich-Aspirin Nuprin Orthovisc Orudis Orudis-Kt Oruvail-Extended-Release-Capsules Osteo-Bi-Flex Osteo-Bi-Flex-Advanced Osteo-Bi-Flex-Double-Strength Osteo-Bi-Flex-Plus-Msm Osteo-Bi-Flex-Triple-Strength P-1000 Pan-C-500 Pennsaid Peridin-C Prevacid_Naprapac Prevacid-Naprapac-375 Prevacid-Naprapac-500 Pryflex Q-Profen Qutenza Relafen Relamine Rt-Capsin Rutin Salflex Salonpas-Gel-Patch Salonpas-Pain-Patch-With-Capsaicin Salsitab Same Schiff-Move-Free Schiff-Move-Free-Caplets Sloan-S-Liniment Solu-Medrol-Solution Span-C Stanback-Analgesic Sterapred Sterapred-Ds Supac Supartz Synvisc Synvisc-One Tac-3-Injection Tolectin Tolectin-600 Tolectin-Ds Tri-Buffered-Aspirin Triam-Forte Triamcot-Injection Triamonide-40-Injection Tricosal Trilisate Trixaicin Trixaicin-Hp Tylenol-W-Codeine Tylenol-With-Codeine-3 Tylenol-With-Codeine-4 U-Tri-Lone-Injection Valorin-Extra Vimovo Vioxx Voltaren Voltaren-Gel Voltaren-Xr-Extended-Release-Tablets Vopac Ysp-Aspirin Zorprin-Controlled-Release-Tablets Zostrix-Cream Zostrix-Diabetic-Foot-Pain Zostrix-Foot-Pain Zostrix-Neuropathy Zostrix-Sports Zostrix-Hp


More




Prevacid


Generic Name: lansoprazole
Dosage Form: capsule, delayed release, tablet, orally disintegrating, delayed release
FULL PRESCRIBING INFORMATION Indications and Usage for Prevacid Short-Term Treatment of Active Duodenal Ulcer

Prevacid is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Prevacid/amoxicillin/clarithromycin

Prevacid in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: Prevacid/amoxicillin

Prevacid in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].

Please refer to the full prescribing information for amoxicillin.

Maintenance of Healed Duodenal Ulcers

Prevacid is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14)].

Short-Term Treatment of Active Benign Gastric Ulcer

Prevacid is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14)].

Healing of NSAID-Associated Gastric Ulcer

Prevacid is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies (14)].

Risk Reduction of NSAID-Associated Gastric Ulcer

Prevacid is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14)].

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

Prevacid is indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14)].

Short-Term Treatment of Erosive Esophagitis

Prevacid is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with Prevacid for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of Prevacid may be considered [see Clinical Studies (14)].

Maintenance of Healing of Erosive Esophagitis (EE)

Prevacid is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies (14)].

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

Prevacid is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14)].

Prevacid Dosage and Administration

Prevacid is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. Prevacid should be taken before eating. Prevacid products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with Prevacid.

Recommended Dose Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with Prevacid for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of Prevacid may be considered. § The Prevacid dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with Prevacid for more than 4 years. Duodenal Ulcers   Short-Term Treatment 15 mg Once daily for 4 weeks   Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*   Triple Therapy:     Prevacid 30 mg Twice daily (q12h) for 10 or 14 days     Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days     Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days   Dual Therapy:     Prevacid 30 mg Three times daily (q8h) for 14 days     Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer   Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer   Healing 30 mg Once daily for 8 weeks†   Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD)   Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks   Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis   ? 30 kg 15 mg Once daily for up to 12 weeks§   > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD   Nonerosive GERD 15 mg Once daily for up to 8 weeks   Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶

Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].

Important Administration Information

Administration Options

Prevacid Delayed-Release Capsules – Oral Administration

Prevacid Delayed-Release Capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, Prevacid Delayed-Release Capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Prevacid Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

Prevacid Delayed-Release Capsules – Nasogastric Tube (?16 French) Administration

For patients who have a nasogastric tube in place, Prevacid Delayed-Release Capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets

Prevacid SoluTab should not be broken or cut. Prevacid SoluTab should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. The tablet typically disintegrates in less than 1 minute. Alternatively, for children or other patients who have difficulty swallowing tablets, Prevacid SoluTab can be delivered in two different ways.   Prevacid SoluTab – Oral Syringe   For administration via oral syringe, Prevacid SoluTab can be administered as follows: Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, administer the contents within 15 minutes. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.   Prevacid SoluTab – Nasogastric Tube (?8 French) Administration   For administration via a nasogastric tube, Prevacid SoluTab can be administered as follows: Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube. Dosage Forms and Strengths 15 mg capsules are opaque, hard gelatin, colored pink and green with the TAP logo and "Prevacid 15" imprinted on the capsule. 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and "Prevacid 30" imprinted on the capsule. 15 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with "15" debossed on one side of the tablet. 30 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with "30" debossed on one side of the tablet. Contraindications

Prevacid is contraindicated in patients with known severe hypersensitivity to any component of the formulation of Prevacid. For information on contraindications for amoxicillin or clarithromycin, refer to their full prescribing information, CONTRAINDICATIONS sections.

Warnings and Precautions Gastric Malignancy

Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.

Bone Fracture

 Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].

For information on warnings and precautions for amoxicillin or clarithromycin, refer to their full prescribing information, WARNINGS and PRECAUTIONS sections.

Hypomagnesemia

 Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

 For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].

Adverse Reactions Clinical

Worldwide, over 10,000 patients have been treated with Prevacid in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, Prevacid treatment has been well-tolerated in both short-term and long-term trials.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of Prevacid-treated patients and occurred at a greater rate in Prevacid-treated patients than placebo-treated patients in Table 1.

Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled Prevacid Studies Body System/Adverse Event Prevacid
(N= 2768)
% Placebo
(N= 1023)
% Body as a Whole   Abdominal Pain 2.1 1.2 Digestive System   Constipation 1.0 0.4   Diarrhea 3.8 2.3   Nausea 1.3 1.2

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of Prevacid, but higher in the patients who received 60 mg of Prevacid (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of Prevacid for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with Prevacid, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with Prevacid included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received Prevacid in domestic trials are shown below:

Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System – diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy

Metabolism and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing Experience

Additional adverse experiences have been reported since Prevacid has been marketed. The majority of these cases are foreign-sourced and a relationship to Prevacid has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole – anaphylactic/anaphylactoid reactions; Digestive System – hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System – agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Metabolism and Nutritional Disorders – hypomagnesemia; Musculoskeletal System – bone fracture, myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses – speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with Prevacid plus amoxicillin and clarithromycin, and Prevacid plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with Prevacid, amoxicillin, or clarithromycin.

Triple Therapy: Prevacid/amoxicillin/clarithromycin

The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Prevacid/amoxicillin

The most frequently reported adverse reactions for patients who received Prevacid three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with Prevacid three times daily plus amoxicillin three times daily dual therapy than with Prevacid alone.

For information on adverse reactions with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Laboratory Values

The following changes in laboratory parameters in patients who received Prevacid were reported as adverse reactions:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and Prevacid, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received Prevacid reported jaundice at any time during the study.

In clinical trials using combination therapy with Prevacid plus amoxicillin and clarithromycin, and Prevacid plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.

For information on laboratory value changes with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Drug Interactions Drugs with pH-Dependent Absorption Kinetics

Prevacid causes long-lasting inhibition of gastric acid secretion. Prevacid and other PPIs are likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, Prevacid and other PPIs should not be co-administered with atazanavir [see Clinical Pharmacology (12.3)].

Prevacid and other PPIs may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole) [see Clinical Pharmacology (12.3)].

Warfarin

In a study of healthy subjects, co-administration of single or multiple 60 mg doses of Prevacid and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time [see Clinical Pharmacology (12.3)]. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [see Clinical Pharmacology (12.3)].

Tacrolimus

Concomitant administration of lansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

Theophylline

A minor increase (10%) in the clearance of theophylline was observed following the administration of Prevacid concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when Prevacid is started or stopped to ensure clinically effective blood levels [see Clinical Pharmacology (12.3)].

Clopidogrel

Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3)]. No dose adjustment of clopidogrel is necessary when administered with an approved dose of Prevacid.

For information on drug interactions for amoxicillin or clarithromycin, refer to their full prescribing information, DRUG INTERACTIONS sections.

USE IN SPECIFIC POPULATIONS Pregnancy

Teratogenic effects

Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology (13.2)].

See full prescribing information for clarithromycin before using in pregnant women.

Nursing Mothers

Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue lansoprazole, taking into account the importance of lansoprazole to the mother.

Pediatric Use

The safety and effectiveness of Prevacid have been established in pediatric patients 1 to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter, double-blind, placebo controlled study.

Neonate to less than 1 year of age

The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than 28 days and 1 to 11 months. Compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based normalized AUC values 2.04- and 1.88-fold higher at doses of 0.5 mg/kg/day and 1 mg/kg/day, respectively). Infants aged ?10 weeks had clearance and exposure values that were similar to neonates. Infants aged greater than 10 weeks who received 1 mg/kg/day had mean AUC values that were similar to adults who received a 30 mg dose.

Lansoprazole was not found to be effective in a U.S. and Polish 4 week multicenter, double-blind, placebo-controlled, parallel-group study of 162 patients between one month and less than 12 months of age with symptomatic GERD based on a medical history of crying/fussing/irritability associated with feedings who had not responded to conservative GERD management (i.e., non-pharmacologic intervention) for 7 to 14 days. Patients received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants ?10 weeks of age or 1.0 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to 4 weeks of double-blind treatment.

The primary efficacy endpoint was assessed by greater than 50% reduction from baseline in either the percent of feedings with a crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding.

There was no difference in the percentage of responders between the lansoprazole pediatric suspension group and placebo group (54% in both groups).

There were no adverse events reported in pediatric clinical studies (1 month to less than 12 months of age) that were not previously observed in adults.

Based on the results of the Phase 3 efficacy study, lansoprazole was not shown to be effective. Therefore, these results do not support the use of lansoprazole in treating symptomatic GERD in infants.

One to 11 years of age

In an uncontrolled, open-label, U.S. multicenter study, 66 pediatric patients (1 to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dose of either Prevacid 15 mg daily if ?30 kg or Prevacid 30 mg daily if greater than 30 kg administered for 8 to 12 weeks. The Prevacid dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after 2 or more weeks of treatment if they remained symptomatic. At baseline 85% of patients had mild to moderate overall GERD symptoms (assessed by investigator interview), 58% had non-erosive GERD and 42% had erosive esophagitis (assessed by endoscopy).

After 8 to 12 weeks of Prevacid treatment, the intent-to-treat analysis demonstrated an approximate 50% reduction in frequency and severity of GERD symptoms.

Twenty-one of 27 erosive esophagitis patients were healed at 8 weeks and 100% of patients were healed at 12 weeks by endoscopy (Table 2).

Table 2: GERD Symptom Improvement and Erosive Esophagitis Healing Rates in Pediatric Patients Age 1 to 11 GERD Final Visit* % (n/N) * At Week 8 or Week 12 † Symptoms assessed by patients diary kept by caregiver. ‡ No data were available for 4 pediatric patients. Symptomatic GERD   Improvement in Overall GERD Symptoms† 76% (47/62‡) Erosive Esophagitis   Improvement in Overall GERD Symptoms† 81% (22/27)   Healing Rate 100% (27/27)

In a study of 66 pediatric patients in the age group 1 year to 11 years old after treatment with Prevacid given orally in doses of 15 mg daily to 30 mg twice daily, increases in serum gastrin levels were similar to those observed in adult studies. Median fasting serum gastrin levels increased 89% from 51 pg/mL at baseline to 97 pg/mL [interquartile range (25th to 75th percentile) of 71 to 130 pg/mL] at the final visit.

The pediatric safety of Prevacid Delayed-Release Capsules has been assessed in 66 pediatric patients aged 1 to 11 years of age. Of the 66 patients with GERD 85% (56/66) took Prevacid for 8 weeks and 15% (10/66) took it for 12 weeks.

The most frequently reported (2 or more patients) treatment-related adverse reactions in patients 1 to 11 years of age (N=66) were constipation (5%) and headache (3%).

Twelve to 17 years of age

In an uncontrolled, open-label, U.S. multicenter study, 87 adolescent patients (12 to 17 years of age) with symptomatic GERD were treated with Prevacid for 8 to 12 weeks. Baseline upper endoscopies classified these patients into two groups: 64 (74%) nonerosive GERD and 23 (26%) erosive esophagitis (EE). The nonerosive GERD patients received Prevacid 15 mg daily for 8 weeks and the EE patients received Prevacid 30 mg daily for 8 to 12 weeks. At baseline, 89% of these patients had mild to moderate overall GERD symptoms (assessed by investigator interviews). During 8 weeks of Prevacid treatment, adolescent patients experienced a 63% reduction in frequency and a 69% reduction in severity of GERD symptoms based on diary results.

Twenty-one of 22 (95.5%) adolescent erosive esophagitis patients were healed after 8 weeks of Prevacid treatment. One patient remained unhealed after 12 weeks of treatment (Table 3).

Table 3: GERD Symptom Improvement and Erosive Esophagitis Healing Rates in Pediatric Patients Age 12 to 17 GERD Final Visit % (n/N) * Symptoms assessed by patient diary (parents/caregivers as necessary). † No data available for 5 patients. ‡ Data from one healed patient was excluded from this analysis due to timing of final endoscopy. Symptomatic GERD (All Patients)   Improvement in Overall GERD Symptoms* 73.2% (60/82)† Nonerosive GERD   Improvement in Overall GERD Symptoms* 71.2% (42/59)† Erosive Esophagitis   Improvement in Overall GERD Symptoms* 78.3% (18/23)     Healing Rate‡ 95.5% (21/22)‡

In these 87 adolescent patients, increases in serum gastrin levels were similar to those observed in adult studies, median fasting serum gastrin levels increased 42% from 45 pg/mL at baseline to 64 pg/mL [interquartile range (25th to 75th percentile) of 44 to 88 pg/mL] at the final visit. (Normal serum gastrin levels are 25 to 111 pg/mL.)

The safety of Prevacid Delayed-Release Capsules has been assessed in these 87 adolescent patients. Of the 87 adolescent patients with GERD, 6% (5/87) took Prevacid for less than 6 weeks, 93% (81/87) for 6 to 10 weeks, and 1% (1/87) for greater than 10 weeks.

The most frequently reported (at least 3%) treatment-related adverse reactions in these patients were headache (7%), abdominal pain (5%), nausea (3%) and dizziness (3%). Treatment-related dizziness, reported in this package insert as occurring in less than 1% of adult patients, was reported in this study by 3 adolescent patients with nonerosive GERD, who had dizziness concurrently with other reactions (such as migraine, dyspnea, and vomiting).

Geriatric Use

No dosage adjustment of Prevacid is necessary in geriatric patients. The incidence rates of Prevacid-associated adverse reactions and laboratory test abnormalities are similar to those seen in younger patients [see Clinical Pharmacology (12.3)].

Renal Impairment

No dosage adjustment of Prevacid is necessary in patients with renal impairment. The pharmacokinetics of lansoprazole in patients with various degrees of renal impairment were not substantially different compared to those in subjects with normal renal function [see Clinical Pharmacology (12.3)].

Hepatic Impairment

In patients with various degrees of chronic hepatic impairment, an increase in the mean AUC of up to 500% was observed at steady state compared to healthy subjects. Consider dose reduction in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

Gender

Over 4,000 women were treated with Prevacid. Ulcer healing rates in females were similar to those in males. The incidence rates of adverse reactions in females were similar to those seen in males [see Clinical Pharmacology (12.3)].

Race

The pooled mean pharmacokinetic parameters of Prevacid from twelve U.S. Phase 1 studies (N=513) were compared to the mean pharmacokinetic parameters from two Asian studies (N=20). The mean AUCs of Prevacid in Asian subjects were approximately twice those seen in pooled U.S. data; however, the inter-individual variability was high. The Cmax values were comparable.

Overdosage

Prevacid is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of Prevacid with no adverse reaction. Oral Prevacid doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.

Prevacid Description

The active ingredient in Prevacid Delayed-Release Capsules and Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Prevacid has the following structure:

Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.

Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.

Prevacid is supplied in delayed-release capsules and in delayed-release orally disintegrating tablets for oral administration.

The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 31, and FD&C Red No. 40.

Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) a


More




lansoprazole and naproxen


Generic Name: lansoprazole and naproxen (lan SOE pra zole and na PROX en)
Brand names: PREVACID NapraPAC 500, PREVACID NapraPAC 375

What is lansoprazole and naproxen?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever.

Lansoprazole is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.

The combination of lansoprazole and naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The lansoprazole in this medication helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

Lansoprazole and naproxen may also be used for purposes not listed in this medication guide.

What is the most important information I should know about lansoprazole and naproxen?

The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking lansoprazole and naproxen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds. Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take lansoprazole and naproxen during pregnancy unless your doctor has told you to. What should I discuss with my healthcare provider before taking lansoprazole and naproxen? You should not use this medication if you are allergic to lansoprazole (Prevacid) or naproxen (Aleve, Anaprox, Naprosyn, and others), or if you have ever had a severe allergic reaction to aspirin or other NSAIDs. Do not use lansoprazole and naproxen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

The naproxen in this medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Naproxen may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking lansoprazole and naproxen, especially in older adults.

To make sure you can safely take lansoprazole and naproxen, tell your doctor if you have any of these other conditions:

liver or kidney disease;

heart disease, high blood pressure, fluid retention, or a history of stroke, heart attack, or congestive heart failure;

low levels of magnesium in your blood;

a bleeding or blood clotting disorder, such as hemophilia;

a history of stomach ulcers or bleeding;

asthma, or a history of allergic reaction to aspirin, especially aspirin triad syndrome; or

if you smoke.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take lansoprazole and naproxen during pregnancy unless your doctor has told you to. Naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while taking lansoprazole and naproxen. How should I take lansoprazole and naproxen?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Each package of this medication contains pills for 7 days of treatment (one lansoprazole capsule and two naproxen tablets per day). In most cases, you will take one lansoprazole (Prevacid) capsule and one naproxen (Naprosyn) tablet each morning before eating. The second naproxen tablet is then taken 12 hours later, without lansoprazole. Follow your doctor's instructions.

Do not crush, chew, break, or open the lansoprazole capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using lansoprazole and naproxen.

Store at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain or discomfort, severe dizziness or drowsiness, confusion, weak or shallow breathing, and urinating less than usual or not at all.

What should I avoid while taking lansoprazole and naproxen?

Avoid taking sucralfate (Carafate) or antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids) at the same time you take lansoprazole and naproxen. These other medications can make it harder for your body to absorb naproxen.

Ask a doctor or pharmacist before using any other pain or arthritis medicine. Many medicines available over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains naproxen or another NSAID.

Ask your doctor before taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with an NSAID may increase your risk of stomach bleeding.

Avoid drinking alcohol. It may increase your risk of stomach bleeding. Lansoprazole and naproxen side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using lansoprazole and naproxen and call your doctor at once if you have a serious side effect such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

urinating less than usual or not at all;

swelling, rapid weight gain, feeling short of breath, even with mild exertion;

low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);

black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

pale skin, easy bruising, feeling very weak or tired.

Less serious side effects may include:

mild stomach pain, heartburn, constipation, diarrhea;

headache, dizziness or drowsiness;

sweating, mild skin rash or itching; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Lansoprazole and naproxen Dosing Information

Usual Adult Dose for Ankylosing Spondylitis:

Initial: 15 mg lansoprazole once daily with naproxen 375 mg twice daily. In the morning before eating take the lansoprazole capsule together with one tablet of naproxen 375 mg with a full glass of water, followed by naproxen 375 mg in the evening with a full glass of water.
The maximum daily naproxen dose is 1000 mg.
The lansoprazole capsule should be swallowed whole. Do not chew or crush.

Usual Adult Dose for Osteoarthritis:

Initial: 15 mg lansoprazole once daily with naproxen 375 mg twice daily. In the morning before eating take the lansoprazole capsule together with one tablet of naproxen 375 mg with a full glass of water, followed by naproxen 375 mg in the evening with a full glass of water.
The maximum daily naproxen dose is 1000 mg.
The lansoprazole capsule should be swallowed whole. Do not chew or crush.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 15 mg lansoprazole once daily with naproxen 375 mg twice daily. In the morning before eating take the lansoprazole capsule together with one tablet of naproxen 375 mg with a full glass of water, followed by naproxen 375 mg in the evening with a full glass of water.
The maximum daily naproxen dose is 1000 mg.
The lansoprazole capsule should be swallowed whole. Do not chew or crush.

What other drugs will affect lansoprazole and naproxen?

Tell your doctor about all other medicines you use, especially:

atazanavir (Reyataz);

cholestyramine (Prevalite);

digoxin (Lanoxin, Lanoxicaps);

lithium (Eskalith, Lithobid);

methotrexate (Rheumatrex, Trexall);

phenytoin (Dilantin);

probenecid (Benemid);

theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

an iron supplement;

a blood thinner such as warfarin (Coumadin, Jantoven);

steroids (prednisone and others);

sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);

medication used to prevent blood clots, such as ticlopidine (Ticlid), and others;

an oral diabetes medication such as glipizide (Glucotrol, Metaglip), glimepiride (Amaryl, Avandaryl, Duetact), or glyburide (DiaBeta, Micronase, Glucovance);

a diuretic (water pill) such as furosemide (Lasix);

an antibiotic such as ampicillin (Principen, Unasyn);

antifungal medication such as ketoconazole (Nizoral);

aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), or piroxicam (Feldene);

an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), or ramipril (Altace); or

a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), or sotalol (Betapace).

This list is not complete and other drugs may interact with lansoprazole and naproxen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More lansoprazole and naproxen resources Lansoprazole and naproxen Use in Pregnancy & Breastfeeding Lansoprazole and naproxen Drug Interactions Lansoprazole and naproxen Support Group 0 Reviews for Lansoprazole and naproxen - Add your own review/rating Compare lansoprazole and naproxen with other medications Ankylosing Spondylitis Osteoarthritis Rheumatoid Arthritis Where can I get more information? Your pharmacist can provide more information about lansoprazole and naproxen.


More




amoxicillin, clarithromycin, and lansoprazole


Generic Name: amoxicillin, clarithromycin, and lansoprazole (a MOX i SIL in, kla RITH roe MYE sin, LAN soe PRA zole)
Brand Names: Prevpac

What is amoxicillin, clarithromycin, and lansoprazole?

Amoxicillin is an antibiotic in the penicillin group of drugs. It fights bacteria in your body.

Clarithromycin is in a group of drugs called macrolide antibiotics. Clarithromycin fights bacteria in your body.

Lansoprazole decreases the amount of acid produced in the stomach.

The combination of amoxicillin, clarithromycin, and lansoprazole is used to prevent stomach ulcer caused by infection with Helicobacter pylori (H. pylori).

Amoxicillin, clarithromycin, and lansoprazole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about amoxicillin, clarithromycin, and lansoprazole? You should not take this medication if you are allergic to amoxicillin (Amoxil, Trimox, Dispermox), clarithromycin (Biaxin), lansoprazole (Prevacid), or to certain other antibiotics.

While you are taking amoxicillin, clarithromycin, and lansoprazole, do not take any of the following medications: cisapride (Propulsid), ergotamine (Ergomar, Cafergot, Ercaf, Migergot), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or pimozide (Orap).

Tell your doctor if you have kidney or liver disease, myasthenia gravis, or if you are allergic to any drugs (especially any antibiotics).

Amoxicillin can make birth control pills less effective, which may result in pregnancy. Before taking amoxicillin, clarithromycin, and lansoprazole, tell your doctor if you use birth control pills.

There are many other medicines that can interact with amoxicillin, clarithromycin, and lansoprazole. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking amoxicillin, clarithromycin, and lansoprazole? You should not take this medication if you are allergic to amoxicillin (Amoxil, Trimox, Dispermox), clarithromycin (Biaxin), lansoprazole (Prevacid), or to any of the following antibiotics:

ampicillin (Omnipen, Principen);

azithromycin (Zithromax);

carbenicillin (Geocillin);

dicloxacillin (Dycill, Dynapen);

erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

oxacillin (Bactocill);

penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids, and others);

telithromycin (Ketek); or

troleandomycin (Tao).

Taking any of the following medicines together with amoxicillin, clarithromycin, and lansoprazole can cause a life-threatening side effect on your heart:

cisapride (Propulsid);

ergotamine (Ergomar, Cafergot, Ercaf, Migergot);

dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate); or

pimozide (Orap).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking amoxicillin, clarithromycin, and lansoprazole, tell your doctor if you have:

kidney disease;

liver disease;

myasthenia gravis; or

if you are allergic to any drugs (especially an antibiotic).

FDA pregnancy category C. Clarithromycin may be harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Amoxicillin can make birth control pills less effective, which may result in pregnancy. Before taking amoxicillin, clarithromycin, and lansoprazole, tell your doctor if you use birth control pills. Amoxicillin, clarithromycin, and lansoprazole can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take amoxicillin, clarithromycin, and lansoprazole?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Each dose of this combination medication contains 4 pills ( 3 capsules and 1 tablet). Take all 4 pills twice daily before you eat, unless your doctor tells you otherwise.

Do not crush, chew, break, or open the pills. Swallow each pill whole. You may swallow the pills one at a time. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Amoxicillin, clarithromycin, and lansoprazole will not treat a viral infection such as the common cold or flu.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using amoxicillin, clarithromycin, and lansoprazole.

Store this medication at room temperature, away from moisture, heat, and light. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include stomach pain, diarrhea, nausea, vomiting, or urinating less than usual.

What should I avoid while taking amoxicillin, clarithromycin, and lansoprazole?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Amoxicillin, clarithromycin, and lansoprazole side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

diarrhea that is watery or bloody;

signs of new infection, such as fever, chills, body aches, flu symptoms, mouth sores;

easy bruising or bleeding, unusual weakness;

agitation, confusion, unusual thoughts or behavior;

dizziness, fainting, fast or pounding heartbeat; or

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

unusual or unpleasant taste in your mouth;

headache;

nausea, vomiting, stomach pain;

constipation, dark colored stools;

dry mouth, increased thirst; or

vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amoxicillin, clarithromycin, and lansoprazole Dosing Information

Usual Adult Dose for Helicobacter pylori Infection:

1000 mg amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, orally two times daily (morning and evening) for 10 to 14 days.

What other drugs will affect amoxicillin, clarithromycin, and lansoprazole?

Many drugs can interact with amoxicillin, clarithromycin, and lansoprazole. Below is just a partial list. Tell your doctor if you are using:

HIV/AIDS medications such as atazanavir (Reyataz), ritonavir (Norvir), or zidovudine (Retrovir);

a blood thinner such as warfarin (Coumadin);

clopidogrel (Plavix);

cyclosporine (Gengraf, Neoral, Sandimmune);

digoxin (Lanoxin, Lanoxicaps);

iron supplements (Feosol, Fergon, Slow Fe, and others);

fluconazole (Diflucan) or ketoconazole (Nizoral);

probenecid (Benemid);

rifabutin (Mycobutin);

sildenafil (Viagra);

tacrolimus (Prograf);

theophylline (Elixophyllin, Theo-24, Uniphyl, and others);

a sulfa drug (such as Bactrim or Septra);

HIV/AIDS medications such as atazanavir (Reyataz), ritonavir (Norvir), or zidovudine (Retrovir);

cholesterol-lowering medicines such as atorvastatin (Lipitor), simvastatin (Zocor), lovastatin (Mevacor), and others;

a heart rhythm medication such as disopyramide (Norpace) or quinidine (Quinaglute, Quinidex, Quin-Release);

a sedative such as alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion);

seizure medication such as carbamazepine (Equetro, Carbatrol, Tegretol), phenytoin (Dilantin), or valproate (Depakote, Depakene); or

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

This list is not complete and there may be other drugs that can interact with amoxicillin, clarithromycin, and lansoprazole. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More amoxicillin, clarithromycin, and lansoprazole resources Amoxicillin, clarithromycin, and lansoprazole Side Effects (in more detail) Amoxicillin, clarithromycin, and lansoprazole Use in Pregnancy & Breastfeeding Amoxicillin, clarithromycin, and lansoprazole Drug Interactions Amoxicillin, clarithromycin, and lansoprazole Support Group 10 Reviews for Amoxicillin, clarithromycin, and lansoprazole - Add your own review/rating Compare amoxicillin, clarithromycin, and lansoprazole with other medications Helicobacter Pylori Infection Where can I get more information? Your pharmacist can provide more information about amoxicillin, clarithromycin, and lansoprazole.

See also: amoxicillin, clarithromycin, and lansoprazole side effects (in more detail)


More




gefitinib


Generic Name: gefitinib (ge FI ti nib)
Brand Names: Iressa

What is gefitinib?

Gefitinib is a cancer chemotherapy medication. Gefitinib interferes with the growth of cancer cells and slows their growth and spread in the body.

Gefitinib is used in the treatment of non-small cell lung cancer.

Gefitinib may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about gefitinib?

Gefitinib should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of gefitinib including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); lung problems; liver problems; eye problems; severe nausea, vomiting, loss of appetite, or diarrhea; and others. Talk to your doctor about the possible side effects from treatment with gefitinib.

What should I discuss with my healthcare provider before taking gefitinib? Do not use gefitinib without first talking to your doctor if you have liver disease; or

lung or breathing problems (other than lung cancer).

You may not be able to take gefitinib, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Gefitinib is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not use gefitinib without first talking to your doctor if you are pregnant or could become pregnant during treatment. Birth control should be used during treatment with gefitinib. It is not known whether gefitinib passes into breast milk. Do not take gefitinib without first talking to your doctor if you are breast-feeding a baby. How should I use gefitinib?

Gefitinib should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Take each dose of gefitinib with a full glass of water.

Gefitinib can be taken with or without food.

Your doctor will determine the correct amount and frequency of treatment with gefitinib depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

It is important to take gefitinib regularly to get the most benefit.

Your doctor may want you to have blood tests and other medical evaluations during treatment with gefitinib to monitor progress and side effects.

Your healthcare provider will store gefitinib as directed by the manufacturer. If you are storing gefitinib at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of gefitinib.

What happens if I overdose? If an overdose of gefitinib is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a gefitinib overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using gefitinib?

There are no restrictions on food, beverages, or activity during treatment with gefitinib unless otherwise directed by your doctor.

Gefitinib side effects

If you experience any of the following serious side effects from gefitinib, contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

lung problems (difficulty breathing, shortness of breath, increased coughing, fever, or chest pain);

severe or persistent nausea, vomiting, loss of appetite, or diarrhea; or

eye pain or irritation.

Other, less serious side effects may be more likely to occur. Continue taking gefitinib and talk to your doctor if you experience:

mild to moderate nausea, vomiting, loss of appetite, or diarrhea;

skin rash, dryness, itching, or acne; or

weakness.

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with gefitinib. You may report side effects to FDA at 1-800-FDA-1088.

Gefitinib Dosing Information

Usual Adult Dose for Non-Small Cell Lung Cancer:

250 mg orally with or without food

What other drugs will affect gefitinib?

Before taking gefitinib, tell your doctor if you are taking any other medicines, especially any of the following:

warfarin (Coumadin);

rifampin (Rifadin, Rimactane);

phenytoin (Dilantin, Phenytek);

ketoconazole (Nizoral);

itraconazole (Sporanox); or

a stomach acid reducer such as cimetidine (Tagamet, Tagamet HB), ranitidine (Zantac, Zantac 75), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and others.

You may not be able to take gefitinib, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Many other drugs may interact with gefitinib. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More gefitinib resources Gefitinib Side Effects (in more detail) Gefitinib Dosage Gefitinib Use in Pregnancy & Breastfeeding Gefitinib Drug Interactions Gefitinib Support Group 3 Reviews for Gefitinib - Add your own review/rating gefitinib Advanced Consumer (Micromedex) - Includes Dosage Information Gefitinib Monograph (AHFS DI) Gefitinib MedFacts Consumer Leaflet (Wolters Kluwer) Iressa Prescribing Information (FDA) Iressa Consumer Overview Compare gefitinib with other medications Non-Small Cell Lung Cancer Where can I get more information? Your healthcare provider may have additional information about gefitinib that you may read.

See also: gefitinib side effects (in more detail)


More




E-400 Clear


Generic Name: vitamin E (VYE ta min E)
Brand Names: Amino-Opti-E, Aqua-E, Aquasol E, Aquavite-E, Aqueous Vitamin E, E Pherol, E-400 Clear, Vita-Plus E Natural

What is E-400 Clear (vitamin E)?

Vitamin E is an antioxidant that occurs naturally in foods such as nuts, seeds, and leafy green vegetables. Vitamin E is important for many processes in the body.

Vitamin E is used to prevent and to treat a deficiency vitamin E. People with certain diseases may need extra vitamin E.

Vitamin E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about E-400 Clear (vitamin E)?

Before using vitamin E, tell your healthcare provider if you have liver disease, diabetes, active bleeding, a vitamin K deficiency, retinitis pigmentosa, chronic diarrhea, if you are being treated for cancer, or if you have a history of heart attack, stroke, blood clot, or recent surgery.

Do not use this product without a doctor's advice your doctor if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing a baby. Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots.

There are many other drugs that can interact with or be made less effective by vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop taking vitamin E and call your doctor at once if you have any unusual bleeding or bruising, or if you feel like you might pass out. What should I discuss with my healthcare provider before taking E-400 Clear (vitamin E)?

Before using vitamin E, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to take vitamin E if you have certain medical conditions.

You may need a dose adjustment or special tests if you have:

liver disease;

diabetes;

active or uncontrolled bleeding;

a vitamin K deficiency;

retinitis pigmentosa;

short bowel syndrome;

chronic diarrhea;

a history of heart attack, stroke, or blood clot;

if you have recently had surgery; or

if you are receiving cancer treatment (chemotherapy or radiation).

It is not known whether vitamin E is harmful to an unborn baby. Your dose needs may be different during pregnancy. Do not use this product without a doctor's advice if you are pregnant or plan to become pregnant while using vitamin E. It is not known whether vitamin E passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this product without a doctor's advice if you are breast-feeding a baby. How should I take E-400 Clear (vitamin E)?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Take vitamin E with a full glass of water.

The chewable tablet must be chewed completely before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take vitamin E with or without food. You do not need to eat extra fat to help your body absorb vitamin E.

The recommended dietary allowance of vitamin E increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include unusual bleeding or bruising.

What should I avoid while taking E-400 Clear (vitamin E)?

Avoid taking other vitamins, mineral supplements, or nutritional products without your doctor's advice.

E-400 Clear (vitamin E) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking vitamin E and call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

easy bruising; or

unusual bleeding (nose, mouth, vagina, or rectum).

Less serious side effects may include:

nausea, diarrhea, stomach cramps;

tired feeling;

headache;

blurred vision; or

mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect E-400 Clear (vitamin E)? Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots, such as:

heparin, warfarin (Coumadin);

alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

The following drugs can interact with or be made less effective by vitamin E. Tell your doctor if you are using any of these:

cyclosporine (Gengraf, Neoral, Sandimmune);

diazepam (Valium) and other sedatives;

fluoxetine (Prozac) and other antidepressants;

mineral oil, orlistat (alli, Xenical);

an antibiotic such as clarithromycin (Biaxin), doxycycline (Doryx, Vibramycin), trimethoprim (Bactrim, Septra, SMX-TMP), and others;

antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), colestipol (Colestid), simvastatin (Zocor, Simcor), lovastatin (Mevacor, Advicor), pravastatin (Pravachol), niacin (Niaspan, Slo-Niacin), and others;

heart or blood pressure medications such as diltiazem (Cartia, Cardizem), losartan (Cozaar), propranolol (Inderal), verapamil (Calan, Covera, Isoptin), and others;

HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir, Kaletra), and others;

narcotic medication such as fentanyl (Actiq, Duragesic, Fentora);

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others; or

stomach acid reducers such as cimetidine (Tagamet), omeprazole (Prilosec), lansoprazole (Prevacid), and others.

This list is not complete and there are many other drugs that can interact with vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More E-400 Clear resources E-400 Clear Side Effects (in more detail) E-400 Clear Use in Pregnancy & Breastfeeding E-400 Clear Drug Interactions E-400 Clear Support Group 0 Reviews for E-400 Clear - Add your own review/rating Aquasol E Advanced Consumer (Micromedex) - Includes Dosage Information Aquasol E Monograph (AHFS DI) Vitamin E Natural MedFacts for Professionals (Wolters Kluwer) Vitamin E Natural MedFacts for Consumers (Wolters Kluwer) Compare E-400 Clear with other medications Alzheimer's Disease Anemia, Sickle Cell Cystic Fibrosis Dietary Supplementation Nocturnal Leg Cramps Retinopathy Prophylaxis Tardive Dyskinesia Vitamin E Deficiency Where can I get more information? Your pharmacist can provide more information about vitamin E.

See also: E-400 Clear side effects (in more detail)


More




Vita-Plus E Natural


Generic Name: vitamin E (VYE ta min E)
Brand Names: Amino-Opti-E, Aqua-E, Aquasol E, Aquavite-E, Aqueous Vitamin E, E Pherol, E-400 Clear, Vita-Plus E Natural

What is Vita-Plus E Natural (vitamin E)?

Vitamin E is an antioxidant that occurs naturally in foods such as nuts, seeds, and leafy green vegetables. Vitamin E is important for many processes in the body.

Vitamin E is used to prevent and to treat a deficiency vitamin E. People with certain diseases may need extra vitamin E.

Vitamin E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Vita-Plus E Natural (vitamin E)?

Before using vitamin E, tell your healthcare provider if you have liver disease, diabetes, active bleeding, a vitamin K deficiency, retinitis pigmentosa, chronic diarrhea, if you are being treated for cancer, or if you have a history of heart attack, stroke, blood clot, or recent surgery.

Do not use this product without a doctor's advice your doctor if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing a baby. Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots.

There are many other drugs that can interact with or be made less effective by vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop taking vitamin E and call your doctor at once if you have any unusual bleeding or bruising, or if you feel like you might pass out. What should I discuss with my healthcare provider before taking Vita-Plus E Natural (vitamin E)?

Before using vitamin E, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to take vitamin E if you have certain medical conditions.

You may need a dose adjustment or special tests if you have:

liver disease;

diabetes;

active or uncontrolled bleeding;

a vitamin K deficiency;

retinitis pigmentosa;

short bowel syndrome;

chronic diarrhea;

a history of heart attack, stroke, or blood clot;

if you have recently had surgery; or

if you are receiving cancer treatment (chemotherapy or radiation).

It is not known whether vitamin E is harmful to an unborn baby. Your dose needs may be different during pregnancy. Do not use this product without a doctor's advice if you are pregnant or plan to become pregnant while using vitamin E. It is not known whether vitamin E passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this product without a doctor's advice if you are breast-feeding a baby. How should I take Vita-Plus E Natural (vitamin E)?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Take vitamin E with a full glass of water.

The chewable tablet must be chewed completely before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take vitamin E with or without food. You do not need to eat extra fat to help your body absorb vitamin E.

The recommended dietary allowance of vitamin E increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include unusual bleeding or bruising.

What should I avoid while taking Vita-Plus E Natural (vitamin E)?

Avoid taking other vitamins, mineral supplements, or nutritional products without your doctor's advice.

Vita-Plus E Natural (vitamin E) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking vitamin E and call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

easy bruising; or

unusual bleeding (nose, mouth, vagina, or rectum).

Less serious side effects may include:

nausea, diarrhea, stomach cramps;

tired feeling;

headache;

blurred vision; or

mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Vita-Plus E Natural (vitamin E)? Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots, such as:

heparin, warfarin (Coumadin);

alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

The following drugs can interact with or be made less effective by vitamin E. Tell your doctor if you are using any of these:

cyclosporine (Gengraf, Neoral, Sandimmune);

diazepam (Valium) and other sedatives;

fluoxetine (Prozac) and other antidepressants;

mineral oil, orlistat (alli, Xenical);

an antibiotic such as clarithromycin (Biaxin), doxycycline (Doryx, Vibramycin), trimethoprim (Bactrim, Septra, SMX-TMP), and others;

antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), colestipol (Colestid), simvastatin (Zocor, Simcor), lovastatin (Mevacor, Advicor), pravastatin (Pravachol), niacin (Niaspan, Slo-Niacin), and others;

heart or blood pressure medications such as diltiazem (Cartia, Cardizem), losartan (Cozaar), propranolol (Inderal), verapamil (Calan, Covera, Isoptin), and others;

HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir, Kaletra), and others;

narcotic medication such as fentanyl (Actiq, Duragesic, Fentora);

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others; or

stomach acid reducers such as cimetidine (Tagamet), omeprazole (Prilosec), lansoprazole (Prevacid), and others.

This list is not complete and there are many other drugs that can interact with vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Vita-Plus E Natural resources Vita-Plus E Natural Side Effects (in more detail) Vita-Plus E Natural Use in Pregnancy & Breastfeeding Vita-Plus E Natural Drug Interactions Vita-Plus E Natural Support Group 0 Reviews for Vita-Plus E Natural - Add your own review/rating Aquasol E Advanced Consumer (Micromedex) - Includes Dosage Information Aquasol E Monograph (AHFS DI) Vitamin E Natural MedFacts for Professionals (Wolters Kluwer) Vitamin E Natural MedFacts for Consumers (Wolters Kluwer) Compare Vita-Plus E Natural with other medications Alzheimer's Disease Anemia, Sickle Cell Cystic Fibrosis Dietary Supplementation Nocturnal Leg Cramps Retinopathy Prophylaxis Tardive Dyskinesia Vitamin E Deficiency Where can I get more information? Your pharmacist can provide more information about vitamin E.

See also: Vita-Plus E Natural side effects (in more detail)


More




Amino-Opti-E


Generic Name: vitamin E (VYE ta min E)
Brand Names: Amino-Opti-E, Aqua-E, Aquasol E, Aquavite-E, Aqueous Vitamin E, E Pherol, E-400 Clear, Vita-Plus E Natural

What is Amino-Opti-E (vitamin E)?

Vitamin E is an antioxidant that occurs naturally in foods such as nuts, seeds, and leafy green vegetables. Vitamin E is important for many processes in the body.

Vitamin E is used to prevent and to treat a deficiency vitamin E. People with certain diseases may need extra vitamin E.

Vitamin E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Amino-Opti-E (vitamin E)?

Before using vitamin E, tell your healthcare provider if you have liver disease, diabetes, active bleeding, a vitamin K deficiency, retinitis pigmentosa, chronic diarrhea, if you are being treated for cancer, or if you have a history of heart attack, stroke, blood clot, or recent surgery.

Do not use this product without a doctor's advice your doctor if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing a baby. Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots.

There are many other drugs that can interact with or be made less effective by vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop taking vitamin E and call your doctor at once if you have any unusual bleeding or bruising, or if you feel like you might pass out. What should I discuss with my healthcare provider before taking Amino-Opti-E (vitamin E)?

Before using vitamin E, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to take vitamin E if you have certain medical conditions.

You may need a dose adjustment or special tests if you have:

liver disease;

diabetes;

active or uncontrolled bleeding;

a vitamin K deficiency;

retinitis pigmentosa;

short bowel syndrome;

chronic diarrhea;

a history of heart attack, stroke, or blood clot;

if you have recently had surgery; or

if you are receiving cancer treatment (chemotherapy or radiation).

It is not known whether vitamin E is harmful to an unborn baby. Your dose needs may be different during pregnancy. Do not use this product without a doctor's advice if you are pregnant or plan to become pregnant while using vitamin E. It is not known whether vitamin E passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this product without a doctor's advice if you are breast-feeding a baby. How should I take Amino-Opti-E (vitamin E)?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Take vitamin E with a full glass of water.

The chewable tablet must be chewed completely before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take vitamin E with or without food. You do not need to eat extra fat to help your body absorb vitamin E.

The recommended dietary allowance of vitamin E increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include unusual bleeding or bruising.

What should I avoid while taking Amino-Opti-E (vitamin E)?

Avoid taking other vitamins, mineral supplements, or nutritional products without your doctor's advice.

Amino-Opti-E (vitamin E) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking vitamin E and call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

easy bruising; or

unusual bleeding (nose, mouth, vagina, or rectum).

Less serious side effects may include:

nausea, diarrhea, stomach cramps;

tired feeling;

headache;

blurred vision; or

mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Amino-Opti-E (vitamin E)? Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots, such as:

heparin, warfarin (Coumadin);

alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

The following drugs can interact with or be made less effective by vitamin E. Tell your doctor if you are using any of these:

cyclosporine (Gengraf, Neoral, Sandimmune);

diazepam (Valium) and other sedatives;

fluoxetine (Prozac) and other antidepressants;

mineral oil, orlistat (alli, Xenical);

an antibiotic such as clarithromycin (Biaxin), doxycycline (Doryx, Vibramycin), trimethoprim (Bactrim, Septra, SMX-TMP), and others;

antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), colestipol (Colestid), simvastatin (Zocor, Simcor), lovastatin (Mevacor, Advicor), pravastatin (Pravachol), niacin (Niaspan, Slo-Niacin), and others;

heart or blood pressure medications such as diltiazem (Cartia, Cardizem), losartan (Cozaar), propranolol (Inderal), verapamil (Calan, Covera, Isoptin), and others;

HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir, Kaletra), and others;

narcotic medication such as fentanyl (Actiq, Duragesic, Fentora);

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others; or

stomach acid reducers such as cimetidine (Tagamet), omeprazole (Prilosec), lansoprazole (Prevacid), and others.

This list is not complete and there are many other drugs that can interact with vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Amino-Opti-E resources Amino-Opti-E Side Effects (in more detail) Amino-Opti-E Use in Pregnancy & Breastfeeding Amino-Opti-E Drug Interactions Amino-Opti-E Support Group 0 Reviews for Amino-Opti-E - Add your own review/rating Aquasol E Advanced Consumer (Micromedex) - Includes Dosage Information Aquasol E Monograph (AHFS DI) Vitamin E Natural MedFacts for Professionals (Wolters Kluwer) Vitamin E Natural MedFacts for Consumers (Wolters Kluwer) Compare Amino-Opti-E with other medications Alzheimer's Disease Anemia, Sickle Cell Cystic Fibrosis Dietary Supplementation Nocturnal Leg Cramps Retinopathy Prophylaxis Tardive Dyskinesia Vitamin E Deficiency Where can I get more information? Your pharmacist can provide more information about vitamin E.

See also: Amino-Opti-E side effects (in more detail)


More




vitamin E


Generic Name: vitamin E (VYE ta min E)
Brand names: Amino-Opti-E, Aqua-E, Aquasol E, Aquavite-E, Aqueous Vitamin E, E Pherol, E-400 Clear, Vita-Plus E Natural, Alpha E, Nutr-E-Sol, Centrum Singles-Vitamin E, TheraTears Nutrition (obsolete)

What is vitamin E?

Vitamin E is an antioxidant that occurs naturally in foods such as nuts, seeds, and leafy green vegetables. Vitamin E is important for many processes in the body.

Vitamin E is used to prevent and to treat a deficiency vitamin E. People with certain diseases may need extra vitamin E.

Vitamin E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vitamin E?

Before using vitamin E, tell your healthcare provider if you have liver disease, diabetes, active bleeding, a vitamin K deficiency, retinitis pigmentosa, chronic diarrhea, if you are being treated for cancer, or if you have a history of heart attack, stroke, blood clot, or recent surgery.

Do not use this product without a doctor's advice your doctor if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing a baby. Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots.

There are many other drugs that can interact with or be made less effective by vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Stop taking vitamin E and call your doctor at once if you have any unusual bleeding or bruising, or if you feel like you might pass out. What should I discuss with my healthcare provider before taking vitamin E?

Before using vitamin E, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to take vitamin E if you have certain medical conditions.

You may need a dose adjustment or special tests if you have:

liver disease;

diabetes;

active or uncontrolled bleeding;

a vitamin K deficiency;

retinitis pigmentosa;

short bowel syndrome;

chronic diarrhea;

a history of heart attack, stroke, or blood clot;

if you have recently had surgery; or

if you are receiving cancer treatment (chemotherapy or radiation).

It is not known whether vitamin E is harmful to an unborn baby. Your dose needs may be different during pregnancy. Do not use this product without a doctor's advice if you are pregnant or plan to become pregnant while using vitamin E. It is not known whether vitamin E passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this product without a doctor's advice if you are breast-feeding a baby. How should I take vitamin E?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

Take vitamin E with a full glass of water.

The chewable tablet must be chewed completely before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take vitamin E with or without food. You do not need to eat extra fat to help your body absorb vitamin E.

The recommended dietary allowance of vitamin E increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat.

See also: Vitamin E dosage (in more detail)

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include unusual bleeding or bruising.

What should I avoid while taking vitamin E?

Avoid taking other vitamins, mineral supplements, or nutritional products without your doctor's advice.

Vitamin E side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking vitamin E and call your doctor at once if you have a serious side effect such as:

feeling like you might pass out;

easy bruising; or

unusual bleeding (nose, mouth, vagina, or rectum).

Less serious side effects may include:

nausea, diarrhea, stomach cramps;

tired feeling;

headache;

blurred vision; or

mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vitamin E Dosing Information

Usual Adult Dose for Vitamin E Deficiency:

Treatment: 60 to 75 units orally once daily.
Prevention: 30 units orally once daily.

Usual Adult Dose for Tardive Dyskinesia:

600 to 1600 units orally per day.

Usual Adult Dose for Sickle Cell Anemia:

450 units orally per day.

Usual Adult Dose for Alzheimer's Disease:

1000 units orally twice daily.

Usual Adult Dose for Dietary Supplement:

Oral liquid formulation (AQUA-E): 200 units (10 mL) orally once daily.

Usual Pediatric Dose for Vitamin E Deficiency:

1 unit/kg/day orally of water-miscible vitamin E.

Usual Pediatric Dose for Retinopathy Prophylaxis:

Prevention of retinopathy of prematurity or Bronchopulmonary dysplasia (BPD) secondary to oxygen therapy: 15 to 30 units/kg/day to maintain plasma levels between 1.5 to 2 mcg/mL (may need as high as 100 units/kg/day). Note: AAP considers this use investigational and routine use is not recommended.

Usual Pediatric Dose for Cystic Fibrosis:

100 to 400 units/day orally.

Usual Pediatric Dose for Dietary Supplement:

Dosing: 1 unit vitamin E = 1 mg dl-alpha-tocopherol acetate.
Oral:
Adequate Intake (AI):
1 to less than 6 months: 4 units daily
6 to less than 12 months: 5 units daily
Recommended Daily Allowance (RDA):
1 to 3 years: 6 units daily
4 to 8 years: 7 units daily
9 to 13 years: 11 units daily
13 years and Older: 15 units daily

What other drugs will affect vitamin E? Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots, such as:

heparin, warfarin (Coumadin);

alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

The following drugs can interact with or be made less effective by vitamin E. Tell your doctor if you are using any of these:

cyclosporine (Gengraf, Neoral, Sandimmune);

diazepam (Valium) and other sedatives;

fluoxetine (Prozac) and other antidepressants;

mineral oil, orlistat (alli, Xenical);

an antibiotic such as clarithromycin (Biaxin), doxycycline (Doryx, Vibramycin), trimethoprim (Bactrim, Septra, SMX-TMP), and others;

antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), colestipol (Colestid), simvastatin (Zocor, Simcor), lovastatin (Mevacor, Advicor), pravastatin (Pravachol), niacin (Niaspan, Slo-Niacin), and others;

heart or blood pressure medications such as diltiazem (Cartia, Cardizem), losartan (Cozaar), propranolol (Inderal), verapamil (Calan, Covera, Isoptin), and others;

HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir, Kaletra), and others;

narcotic medication such as fentanyl (Actiq, Duragesic, Fentora);

seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others; or

stomach acid reducers such as cimetidine (Tagamet), omeprazole (Prilosec), lansoprazole (Prevacid), and others.

This list is not complete and there are many other drugs that can interact with vitamin E. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More vitamin E resources Vitamin E Dosage Vitamin E Use in Pregnancy & Breastfeeding Vitamin E Drug Interactions Vitamin E Support Group 2 Reviews for Vitamin E - Add your own review/rating Vitamin E Natural MedFacts for Professionals (Wolters Kluwer) Vitamin E Natural MedFacts for Consumers (Wolters Kluwer) Vitamin E Monograph (AHFS DI) vitamin e Advanced Consumer (Micromedex) - Includes Dosage Information Compare vitamin E with other medications Alzheimer's Disease Anemia, Sickle Cell Cystic Fibrosis Dietary Supplementation Nocturnal Leg Cramps Retinopathy Prophylaxis Tardive Dyskinesia Vitamin E Deficiency Where can I get more information? Your pharmacist can provide more information about vitamin E.


More




Complera


Generic Name: emtricitabine, rilpivirine, and tenofovir (Oral route)

em-trye-SYE-ta-been, ril-pi-VIR-een hye-droe-KLOR-ide, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Oral route(Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate, a component of emtricitabine/rilpivirine hydrochloride/tenofovir disoproxil fumarate. Not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine/rilpivirine hydrochloride/tenofovir; monitor hepatic function upon discontinuation of therapy .

Commonly used brand name(s)

In the U.S.

Complera

Available Dosage Forms:

Tablet

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Complera

Emtricitabine, rilpivirine, and tenofovir combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have not received any HIV treatment in the past.

This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood. The medicine will also help your immune system. This may help delay problems that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using Complera

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Emtricitabine, rilpivirine, and tenofovir combination is not recommended for children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine, rilpivirine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving emtricitabine, rilpivirine, and tenofovir combination.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Carbamazepine Dexamethasone Esomeprazole Lansoprazole Omeprazole Oxcarbazepine Pantoprazole Phenobarbital Phenytoin Rabeprazole Rifabutin Rifampin Rifapentine St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adefovir Dipivoxil Aluminum Carbonate, Basic Aluminum Hydroxide Aluminum Phosphate Atazanavir Calcium Carbonate Cimetidine Delavirdine Didanosine Dihydroxyaluminum Aminoacetate Dihydroxyaluminum Sodium Carbonate Efavirenz Etravirine Famotidine Magaldrate Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide Magnesium Trisilicate Nevirapine Nizatidine Ranitidine Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ketoconazole Lopinavir Methadone Ritonavir Tipranavir Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Bone problems, history of or Depression, or history of or Fanconi syndrome (type of kidney disease) or Hepatitis B infection or Liver disease or Osteomalacia (soft bones) or Osteoporosis (weak or brittle bones)—Use with caution. May make these conditions worse. Kidney disease—Should not be used in patients with this condition. Proper Use of Complera

Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep taking this medicine for the full time of treatment, even if you begin to feel better. Do not stop taking it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

It is best to take this medicine with food.

If you are taking antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after this medicine.

If you are taking a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, nizatidine, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), take the heartburn medicine at least 12 hours before or 4 hours after this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets): For treatment of HIV infection: Adults—One tablet once a day. Children—Use is not recommended. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use your medicine and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. If you miss a dose or forget to use it, and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Complera

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.

This medicine may cause a rare, but serious, unwanted effect called lactic acidosis. This is a condition where the blood has too much acid. Stop using this medicine and call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort; a decreased appetite; diarrhea; fast, shallow breathing; a general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; or unusual tiredness or weakness.

This medicine may cause rare, but serious, liver problems. This may occur in patients with a history of hepatitis B infection. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: clay-colored stools; dark urine; a decreased appetite; fever; headache; itching; nausea and vomiting; skin rash; stomach pain or tenderness; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.

This medicine may cause your bones to get thin. This could increase your risk for broken bones (fractures). Ask your doctor about this if you have any concerns.

This medicine may cause you to have extra body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from your legs, arms, or face.

When you start taking HIV medicines, your immune system may get stronger. If you already have pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight the infections. If this occurs, be sure to tell your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine should not be used together with adefovir (Hepsera®), dexamethasone (Decadron®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom™, Trizivir®), or certain seizure medicines (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®).

Do not use this medicine together with medicines for tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), certain stomach medicines (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®). or St. John's wort.

The medicines in this combination tablet are also available as Atripla®, Emtriva®, Edurant®, Truvada®, and Viread®. Do not take the emtricitabine, rilpivirine, and tenofovir combination with any of these medicines.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Complera Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common Discouragement feeling sad or empty irritability lack of appetite loss of interest or pleasure mental depression thoughts of killing oneself tiredness trouble concentrating trouble sleeping Less common Body aches or pain burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings chest pain cough difficulty with breathing ear congestion fever or chills headache loss of voice runny or stuffy nose shortness of breath sneezing sore throat tightness in the chest troubled breathing unsteadiness or awkwardness unusual tiredness or weakness weakness in the arms, hands, legs, or feet wheezing Incidence not known Abdominal or stomach discomfort agitation bloating bloody or cloudy urine bone pain broken bones, especially the thigh bone changes in behavior confusion constipation dark urine decreased appetite decrease in amount of urine diarrhea difficulty with swallowing dizziness dry mouth fast heartbeat fast, shallow breathing frequent urination general tiredness and weakness headache hives hostility increased thirst indigestion irritability itching large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs lethargy light-colored stools loss of appetite muscle pain or cramps muscle tenderness, wasting, or weakness nausea or vomiting numbness or tingling in the hands, feet, or lips pain in the stomach, side, or abdomen, possibly radiating to the back rapid weight gain seizures skin rash sleepiness swelling of the face, ankles, hands, feet, or lower legs upper right stomach pain vomiting yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abnormal dreams sleeplessness trouble sleeping unable to sleep Less common Acid or sour stomach back pain belching difficulty with moving heartburn pain in the joints pain or tenderness around the eyes and cheekbones sneezing stomach discomfort or upset Incidence not known Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More




Pantoprazole Sodium


Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
CAS Number: 164579-32-2
Brands: Protonix

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 6 7 8 10

Uses for Pantoprazole Sodium Gastroesophageal Reflux (GERD)

Orally for short-term treatment of erosive esophagitis in patients with GERD.1

Orally to maintain healing and decrease recurrence of erosive esophagitis.1

IV for up to 7–10 days in the treatment of GERD in patients with a history of erosive esophagitis.10 Discontinue IV therapy as soon as patient is able to initiate or resume oral therapy with the drug.10

Pathologic GI Hypersecretory Conditions

Orally for long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.1

IV for up to 6 days in the treatment of pathologic hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions.10

Duodenal Ulcer

Orally for treatment of duodenal ulcer†.2 3 5 6 8

Gastric Ulcer

Orally for treatment of gastric ulcer†.2 3 5 6 8

Crohn's Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal, gastroduodenal, and jejunoileal disease.18 19 20 21 22 23 24

Pantoprazole Sodium Dosage and Administration Administration

Administer orally or IV.1 10 Administer once daily for GERD.1 10 Generally given twice daily for pathologic GI hypersecretory conditions, although may be administered IV every 8 hours if necessary.1 10

Oral Administration Delayed-release Tablets

Administer delayed-release tablets without regard to meals.1

Antacids may be used concomitantly.1

Swallow tablets whole; do not split, crush, or chew.1 May administer two 20-mg tablets if unable to swallow a 40-mg tablet.1

Delayed-release Oral Suspension

Administer delayed-release oral suspension 30 minutes before a meal.1

Mix delayed-release granules for oral suspension with applesauce or apple juice; do not mix with any other foods or liquids (including water).1

Sprinkle the contents of a single-dose packet of pantoprazole sodium delayed-release granules for oral suspension onto 1 teaspoonful of applesauce and administer within 10 minutes of preparation.1

Alternatively, sprinkle the packet contents into 5 mL of apple juice, stir for 5 seconds, and swallow the resulting suspension immediately.1 Rinse the container once or twice with apple juice; swallow the rinsings immediately to ensure complete delivery of the dose.1

Swallow granules in the oral suspension intact; do not crush or chew the granules.1

NG Tube

May administer pantoprazole sodium delayed-release granules for oral suspension via a nasogastric tube (16 French or larger).1

Remove the plunger from a 60-mL syringe and attach the catheter tip of the syringe to the NG tube.1 Empty the contents of a single-dose packet of the granules into the syringe barrel while holding the syringe as high as possible to prevent bending of the tubing.1 Add 10 mL of apple juice to the syringe; gently tap or shake the syringe to facilitate emptying.1 Rinse the syringe and tubing with 10 mL of apple juice at least 2 more times (until no granules remain).1 Verify patency of the tubing to ensure complete delivery of the dose.1

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer through a dedicated IV line or a Y-site.10

Use of spiked IV system adapters may result in breakage of the glass vial, and currently is not recommended by the manufacturer.14 15 (See Glass Vial Breakage under Cautions.)

Administer as reconstituted solution or following further dilution.10

Reconstitution

Reconstitute vial containing 40 mg pantoprazole with 10 mL of 0.9% sodium chloride injection to provide a solution containing 4 mg/mL.10

Dilution

GERD: Dilute one vial of reconstituted solution containing pantoprazole 4 mg/mL with 100 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce a concentration of about 0.4 mg/mL.10

Pathologic hypersecretory conditions: Dilute 2 vials of reconstituted solution containing pantoprazole 4 mg/mL with 80 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce a concentration of 0.8 mg/mL.10

Rate of Administration

GERD: Administer 40-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.4-mg/mL dilution over about 15 minutes (7 mL/minute).10

Pathologic hypersecretory conditions: Administer 80-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.8-mg/mL dilution over about 15 minutes (7 mL/minute).10

Dosage

Available as pantoprazole sodium; dosage expressed in terms of pantoprazole.1 10

Adults GERD IV

40 mg once daily for 7–10 days.10 Discontinue IV therapy when patient is able to initiate or resume oral therapy; safety and efficacy of IV therapy for >10 days not established.10

Treatment of Erosive Esophagitis Oral

40 mg once daily for up to 8 weeks.1 2 If not healed, consider additional 8 weeks of therapy.1 2

Maintenance of Healing of Erosive Esophagitis Oral

40 mg once daily.1 Not studied for >1 year of therapy.1 However, chronic, lifelong therapy with proton-pump inhibitor may be appropriate.12

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome) Oral

40 mg twice daily.1 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 May require dosages of up to 240 mg daily.1 Patients with Zollinger-Ellison syndrome have been treated for >2 years.1

IV

80 mg every 12 hours.10 80 mg every 8 hours is expected to maintain acid output <10 mEq/hour in patients requiring higher dosage.10 Safety and efficacy of dosages exceeding 240 mg daily or use of IV pantoprazole for >6 days not established.10

Special Populations Hepatic Impairment

No dosage adjustment necessary.1 2 3 4 10 Dosage exceeding 40 mg daily not studied in patients with hepatic impairment.1 10

Cautions for Pantoprazole Sodium Contraindications

Known hypersensitivity to pantoprazole, any ingredient in the formulation, or to other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, omeprazole, rabeprazole).1 10 16

Warnings/Precautions Sensitivity Reactions Anaphylaxis

Anaphylaxis reported with IV pantoprazole.10 Immediately discontinue drug and institute appropriate medical intervention.10

General Precautions GI Effects

Response to pantoprazole does not preclude presence of occult gastric neoplasm.1 10

Atrophic gastritis reported occasionally with long-term pantoprazole use, especially in patients infected with Helicobacter pylori.1

Glass Vial Breakage

Breakage of pantoprazole vials reported during attempts to connect the vials to spiked IV system adapters.14 15 Potential safety issue for health-care professionals attempting to connect these system components manually or with mechanical assistance.14 15 Pantoprazole manufacturer does not recommend use of spiked IV system adapters; if such adapters are used, contact manufacturer of the adapter for assistance.14

Injection Site Reactions

Injection site reactions (e.g., thrombophlebitis, abscess) associated with use of IV pantoprazole.10

Hepatic Effects

Mild, transient elevations of serum ALT reported with oral therapy; 0.4% incidence of serum ALT increases >3 times the upper limit of normal with pantoprazole dosage of 40 mg daily in short-term studies.1 10

Edetate Disodium Content

Pantoprazole sodium for injection contains edetate disodium (disodium EDTA), a potent metal ion (e.g., zinc) chelator.10 Consider zinc supplementation in patients prone to zinc deficiency.10 Use caution with other IV products that contain edetate disodium.10

Cyanocobalamin Malabsorption

Deficiency due to malabsorption from prolonged (e.g., >3 years) gastric acid suppression reported rarely.1 Consider possibility if manifestations of cyanocobalamin deficiency occur.1

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).25 26

Hip Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ?1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.27 300 301 302 303 304 305 309 Magnitude of risk is unclear;27 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.27 301 303 305 307 309

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.27 303 305 307 309

Specific Populations Pregnancy

Category B.1 10

Lactation

Distributed into milk.1 10 Discontinue nursing or the drug because of potential risk in nursing infants.1 10

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 9 10

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 10

Common Adverse Effects

Oral: Short-term (up to 8 weeks): Headache,1 diarrhea,1 flatulence,1 abdominal pain,1 rash,1 eructation,1 insomnia,1 hyperglycemia.1 Long-term (up to 12 months): Headache,1 abdominal pain,1 nausea,1 vomiting,1 abnormal liver function test results.1

IV: abdominal pain,10 headache,10 injection site reaction (e.g., thrombophlebitis, abscess),10 constipation,10 dyspepsia,10 nausea,10 diarrhea,10 insomnia,10 dizziness,10 rhinitis.10

Interactions for Pantoprazole Sodium

Extensively metabolized, principally by CYP2C19 and to a minor extent by CYP3A4, 2D6, and 2C9.1 10

Drugs Metabolized by Hepatic Microsomal Enzymes

Unlikely to have clinically important interaction with drugs metabolized by CYP2C19, 3A4, 2D6, 2C9, 1A2.1 10

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Alcohol

Pharmacokinetic interaction unlikely1 10

Amoxicillin

Pharmacokinetic interaction unlikely1 10

Antacids

No clinically important effects on oral pantoprazole absorption1

May be used concomitantly1

Antipyrine

Pharmacokinetic interaction unlikely1 10

Atazanavir

Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response1 10 30

Manufacturer of pantoprazole states that concomitant administration with atazanavir is not recommended1 10

Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir29 30

For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)29 30

Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended29 30

Caffeine

Pharmacokinetic interaction unlikely1 10

Carbamazepine

Pharmacokinetic interaction unlikely1 10

Cisapride

Pharmacokinetic interaction unlikely1 10

Clarithromycin

Pharmacokinetic interaction unlikely1 10

Clopidogrel

Certain CYP2C19 inhibitors (e.g., omeprazole) reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel's clinical efficacy.35 224 225 228 311

Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown31 32 33 224 232

Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250

American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311

If concomitant therapy with a proton-pump inhibitor and clopidogrel is considered necessary, some clinicians prefer pantoprazole (which appears to be the weakest CYP2C19 inhibitor among proton-pump inhibitors)35 36 230 alternatively, consider use of a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)35 36 230 but not cimetidine (also a potent CYP2C19 inhibitor)224 232 233

Diazepam

Pharmacokinetic interaction unlikely1 10

Diclofenac

Pharmacokinetic interaction unlikely1 10

Digoxin

Pharmacokinetic interaction unlikely1 10

Gastric pH-dependent drugs (e.g., ampicillin esters, iron salts, ketoconazole)

Pantoprazole may decrease drug absorption1 10

Glyburide

Pharmacokinetic interaction unlikely1 10

Metoprolol

Pharmacokinetic interaction unlikely1 10

Metronidazole

Pharmacokinetic interaction unlikely1 10

Midazolam

Pharmacokinetic interaction unlikely1 10

Naproxen

Pharmacokinetic interaction unlikely1 10

Nifedipine

Pharmacokinetic interaction unlikely1 10

Oral contraceptives (e.g., levonorgestrel/ethinyl estradiol)

Pharmacokinetic interaction unlikely1 10

Phenytoin

Pharmacokinetic interaction unlikely1 10

Piroxicam

Pharmacokinetic interaction unlikely1 10

Sucralfate

Possible delayed proton-pump inhibitor absorption and decreased bioavailability17

Administer proton-pump inhibitor at least 30 minutes before sucralfate17

Tests for tetrahydrocannabinol (THC)

Possible false-positive results for urine screening tests for THC1 10

Use alternative confirmatory test for verification of positive results1 10

Theophylline

Pharmacokinetic interaction unlikely1 10

Warfarin

Potential increased INR and PT1 10 17

Monitor for INR and PT increases1 10 17

Pantoprazole Sodium Pharmacokinetics Absorption Bioavailability

Well absorbed from GI tract (absolute bioavailability about 77%).1 Peak plasma concentrations attained about 2.5 hours after single or multiple 40-mg oral doses (as delayed-release tablets).1 Time to peak concentration is similar (2–2.5 hours) for delayed-release suspension administered orally or via NG tube.1

Administration of delayed-release oral suspension (in apple juice) via NG tube is bioequivalent to oral administration of the same formulation (in applesauce or apple juice).1 Delayed-release suspension is comparable to delayed-release tablets in degree of inhibition of pentagastrin-stimulated gastric acid secretion.1

Onset

51% mean inhibition of gastric acid secretion within 2.5 hours after a single 40-mg oral dose; 85% after daily administration for 7 days.1

15–30 minutes after single 20- to 120-mg IV infusion.10 About 96% suppression of pentagastrin-stimulated acid output within 2 hours after 80-mg IV infusion.10

Duration

Acid secretion normalized within one week after discontinuance of oral pantoprazole; no apparent rebound hypersecretion.1

24 hours after single IV infusion.10 Median percentage of time gastric pH ?4 similar after 40 mg IV or orally daily for 5 days.10

Food

Food delays absorption of delayed-release tablets but does not affect extent or peak plasma concentrations.1

Special Populations

Pharmacokinetics in patients with severe renal impairment similar to healthy individuals.1 10

Peak plasma concentrations and AUCs increased in patients with mild to severe hepatic impairment, but no more than in slow metabolizers.1 10 (See Hepatic Impairment under Dosage and Administration.)

Distribution Extent

Mainly extracellular.1 10 Prolonged binding to gastric parietal proton pump enzyme.1 10

Distributed into milk.1 10

Plasma Protein Binding

98%, principally albumin.1 10

Elimination Metabolism

Metabolized in the liver, principally by CYP2C19, and to a lesser extent by CYP3A4.1 10 Metabolites appear to be inactive.1 10

Elimination Route

Excreted in urine (about 71%) and feces (18%); no unchanged drug excreted in urine.1 10

Half-life

1 hour.1 10

Special Populations

Hepatic impairment increased plasma half-life to 7–9 hours, but no more than in slow metabolizers, and minimal accumulation occurs.1 10

In patients with poor CYP2C19 metabolizer phenotype, metabolism is slower than those with extensive (or rapid) metabolizer phenotype; elimination half-life is 3.5–10 hours, but minimal accumulation occurs.1 10

Not removed by hemodialysis.1 10

Stability Storage Oral Delayed-release Tablets

20–25°C (may be exposed to 15–30°C).1

Granules for Delayed-release Suspension

20–25°C (may be exposed to 15–30°C).1

Parenteral Powder for Injection

20–25°C (may be exposed to 15–30°C).10 Protect from light.10

Store reconstituted (4 mg/mL) solution at room temperature for up to 24 hours prior to administration as 4-mg/mL solution.10 If reconstituted solution will be further diluted, store reconstituted solution for up to 6 hours before dilution; then store diluted (0.4 or 0.8 mg/mL) solution at room temperature and use within 24 hours of initial reconstitution.10 Do not freeze reconstituted solution.10 Not necessary to protect reconstituted or diluted solution from light.10

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility Y-Site CompatibilityHID

Compatible

Ampicillin sodium

Anidulafungin

Cefazolin sodium

Ceftriaxone sodium

Dimenhydrinate

Dopamine HCl

Epinephrine HCl

Furosemide

Morphine sulfate

Nitroglycerin

Potassium chloride

Vasopressin

Incompatible

Dobutamine HCl

Esmolol HCl

Mannitol

Midazolam HCl

Multivitamins

Variable

Norepinephrine bitartrate

Octreotide acetate

Manufacturer states that pantoprazole sodium may be incompatible with zinc-containing preparations.10

Actions

Inhibits basal and stimulated gastric acid secretion.1 10

Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton- or acid pump), blocking final step in secretion of hydrochloric acid.1 2 3 4 5 6 7 8 9 10 Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.1 2 3 4 5 6 7 8 9 10

Advice to Patients

Importance of swallowing tablets whole, without splitting, crushing, or chewing.1

Delayed-release tablets may be administered without regard to meals.1

Importance of taking delayed-release suspension 30 minutes before a meal.1

Importance of instructing patients regarding proper preparation and administration of the oral suspension.1

Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.305 309

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 10 Antacids may be used concomitantly with delayed-release tablets.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 10

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pantoprazole Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension, delayed-release (containing enteric-coated granules)

40 mg (of pantoprazole) per packet

Protonix

Wyeth

Tablets, delayed-release (enteric-coated)

20 mg (of pantoprazole)

Protonix

Wyeth

40 mg (of pantoprazole)

Protonix

Wyeth

Parenteral

For injection, for IV infusion

40 mg (of pantoprazole)

Protonix I.V.

Wyeth

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Pantoprazole Sodium 20MG Enteric-coated Tablets (WYETH): 30/$109.99 or 90/$319.95

Pantoprazole Sodium 40MG Enteric-coated Tablets (WYETH): 30/$15.99 or 90/$33.99

Protonix 20MG Enteric-coated Tablets (WYETH): 30/$186.38 or 90/$559.13

Protonix 40MG Enteric-coated Tablets (WYETH): 30/$190.00 or 90/$529.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 24, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Wyeth. Protonix (pantoprazole sodium) delayed-release tablets and for delayed-release oral suspension prescribing information. Philadelphia, PA; 2008 May.

2. Anon. Pantoprazole (Protonix). Med Lett Drugs Ther. 2000; 42:65-6. [PubMed 10908422]

3. Fitton A, Wiseman L. Pantoprazole: a review of its pharmacological properties and therapeutic use in acid-related disorders. Drugs. 1996; 51:460-82. [PubMed 8882382]

4. Avner DL. Clinical experience with pantoprazole in gastroesophageal reflux disease. Clin Ther. 2000; 22:1169-85. [IDIS 455520] [PubMed 11110229]

5. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors: pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1998; 56:307-35. [PubMed 9777309]

6. Webb DD. New therapeutic options in the treatment of GERD and other acid-peptic disorders. Am J Managed Care. 2000; 6:S467-75.

7. Berardi RR. A critical evaluation of proton pump inhibitors in the treatment of gastroesophageal reflux disease. Am J Managed Care. 2000; 6:S491-505.

8. Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000; 22:266-80. [IDIS 445669] [PubMed 10963283]

9. Wyeth, St. Davids, PA: Personal communication.

10. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2007 Dec.

11. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2001 Feb.

12. DeVault KR, Castell DO, Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 1999; 94:1434-42. [IDIS 429620] [PubMed 10364004]

13. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2001 Jul 9.

14. Kentrup WA. Dear health care professional letter regarding breakage of Protonix IV glass vials with spiked IV adaptors. Philadelphia, PA: Wyeth; 2004 Aug.

15. Food and Drug Administration. Protonix IV (pantoprazole sodium) injection [September 24, 2004: Wyeth]. MedWatch. Rockville, MD; September 2004. From FDA website.

16. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2003 Mar.

17. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.

18. Freston JW. Review article: role of proton pump inhibitors in non-H. pylori-related ulcers. Aliment Pharmacol Ther. 20001; 15(Suppl 2):2-5.

19. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn's disease in adults: Practice Guidelines. Am J Gastroenterol. 2001; 96:635-43. [IDIS 461432] [PubMed 11280528]

20. Valori RM, Cockel R. Omeprazole for duodenal ulceration in Crohn's disease. Br Med J. 1990; 300:438-9.

21. Bianchi G, Ardizzone S, Petrillo M et al. Omeprazole for peptic ulcer in Crohn's disease. Am J Gastroenterol. 1991; 86: 245-6. [PubMed 1992643]

22. Przemioslo RT, Mee AS. Omeprazole in possible esophageal Crohn's disease. Dig Dis Sci. 1994; 39:1594-5. [IDIS 333053] [PubMed 8026276]

23. Dickinson JB. Is omeprazole helpful in inflammatory bowel disease? J Clin Gastroenterol. 1994; 18:317-9.

24. Abrahao LJ Jr., Abrahao LJ, Vargas C et al. [Gastoduodenal Crohn's disease—report of 4 cases and review of the literature]. (Portuguese; with English abstract.) Arq Gastroenterol. 2001; 38:57-62.

25. Laheij RJF, Sturkenboom MCJM, Hassing RJ et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004;292:1955-60.

26. Gregor JC. Acid suppression and pneumonia.; a clinical indication for rational prescribing. JAMA. 2004;292:2012-3. Editorial.

27. Yang Y-X, Lewis JD, Epstein S et al. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006; 296:2947-53. [PubMed 17190895]

28. Pratha V, Hogan DL, Lynn RB et al. Intravenous pantoprazole as initial treatment in patients with gastroesophageal reflux disease and a history of erosive esophagitis: a randomized clinical trial. Dig Dis Sci. 2006; 51:1595-601. [PubMed 16927137]

29. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (Nov 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

30. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2009 Apr.

31. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 20


More




Protonix


Generic Name: Pantoprazole Sodium
Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
CAS Number: 164579-32-2

Special Alerts:

[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.

BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.

RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 6 7 8 10

Uses for Protonix Gastroesophageal Reflux (GERD)

Orally for short-term treatment of erosive esophagitis in patients with GERD.1

Orally to maintain healing and decrease recurrence of erosive esophagitis.1

IV for up to 7–10 days in the treatment of GERD in patients with a history of erosive esophagitis.10 Discontinue IV therapy as soon as patient is able to initiate or resume oral therapy with the drug.10

Pathologic GI Hypersecretory Conditions

Orally for long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.1

IV for up to 6 days in the treatment of pathologic hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions.10

Duodenal Ulcer

Orally for treatment of duodenal ulcer†.2 3 5 6 8

Gastric Ulcer

Orally for treatment of gastric ulcer†.2 3 5 6 8

Crohn's Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal, gastroduodenal, and jejunoileal disease.18 19 20 21 22 23 24

Protonix Dosage and Administration Administration

Administer orally or IV.1 10 Administer once daily for GERD.1 10 Generally given twice daily for pathologic GI hypersecretory conditions, although may be administered IV every 8 hours if necessary.1 10

Oral Administration Delayed-release Tablets

Administer delayed-release tablets without regard to meals.1

Antacids may be used concomitantly.1

Swallow tablets whole; do not split, crush, or chew.1 May administer two 20-mg tablets if unable to swallow a 40-mg tablet.1

Delayed-release Oral Suspension

Administer delayed-release oral suspension 30 minutes before a meal.1

Mix delayed-release granules for oral suspension with applesauce or apple juice; do not mix with any other foods or liquids (including water).1

Sprinkle the contents of a single-dose packet of pantoprazole sodium delayed-release granules for oral suspension onto 1 teaspoonful of applesauce and administer within 10 minutes of preparation.1

Alternatively, sprinkle the packet contents into 5 mL of apple juice, stir for 5 seconds, and swallow the resulting suspension immediately.1 Rinse the container once or twice with apple juice; swallow the rinsings immediately to ensure complete delivery of the dose.1

Swallow granules in the oral suspension intact; do not crush or chew the granules.1

NG Tube

May administer pantoprazole sodium delayed-release granules for oral suspension via a nasogastric tube (16 French or larger).1

Remove the plunger from a 60-mL syringe and attach the catheter tip of the syringe to the NG tube.1 Empty the contents of a single-dose packet of the granules into the syringe barrel while holding the syringe as high as possible to prevent bending of the tubing.1 Add 10 mL of apple juice to the syringe; gently tap or shake the syringe to facilitate emptying.1 Rinse the syringe and tubing with 10 mL of apple juice at least 2 more times (until no granules remain).1 Verify patency of the tubing to ensure complete delivery of the dose.1

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer through a dedicated IV line or a Y-site.10

Use of spiked IV system adapters may result in breakage of the glass vial, and currently is not recommended by the manufacturer.14 15 (See Glass Vial Breakage under Cautions.)

Administer as reconstituted solution or following further dilution.10

Reconstitution

Reconstitute vial containing 40 mg pantoprazole with 10 mL of 0.9% sodium chloride injection to provide a solution containing 4 mg/mL.10

Dilution

GERD: Dilute one vial of reconstituted solution containing pantoprazole 4 mg/mL with 100 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce a concentration of about 0.4 mg/mL.10

Pathologic hypersecretory conditions: Dilute 2 vials of reconstituted solution containing pantoprazole 4 mg/mL with 80 mL of 5% dextrose injection, 0.9% sodium chloride injection, or lactated Ringer's injection to produce a concentration of 0.8 mg/mL.10

Rate of Administration

GERD: Administer 40-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.4-mg/mL dilution over about 15 minutes (7 mL/minute).10

Pathologic hypersecretory conditions: Administer 80-mg dose IV as the reconstituted (4 mg/mL) solution over not less than 2 minutes10 or as the 0.8-mg/mL dilution over about 15 minutes (7 mL/minute).10

Dosage

Available as pantoprazole sodium; dosage expressed in terms of pantoprazole.1 10

Adults GERD IV

40 mg once daily for 7–10 days.10 Discontinue IV therapy when patient is able to initiate or resume oral therapy; safety and efficacy of IV therapy for >10 days not established.10

Treatment of Erosive Esophagitis Oral

40 mg once daily for up to 8 weeks.1 2 If not healed, consider additional 8 weeks of therapy.1 2

Maintenance of Healing of Erosive Esophagitis Oral

40 mg once daily.1 Not studied for >1 year of therapy.1 However, chronic, lifelong therapy with proton-pump inhibitor may be appropriate.12

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome) Oral

40 mg twice daily.1 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 May require dosages of up to 240 mg daily.1 Patients with Zollinger-Ellison syndrome have been treated for >2 years.1

IV

80 mg every 12 hours.10 80 mg every 8 hours is expected to maintain acid output <10 mEq/hour in patients requiring higher dosage.10 Safety and efficacy of dosages exceeding 240 mg daily or use of IV pantoprazole for >6 days not established.10

Special Populations Hepatic Impairment

No dosage adjustment necessary.1 2 3 4 10 Dosage exceeding 40 mg daily not studied in patients with hepatic impairment.1 10

Cautions for Protonix Contraindications

Known hypersensitivity to pantoprazole, any ingredient in the formulation, or to other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, omeprazole, rabeprazole).1 10 16

Warnings/Precautions Sensitivity Reactions Anaphylaxis

Anaphylaxis reported with IV pantoprazole.10 Immediately discontinue drug and institute appropriate medical intervention.10

General Precautions GI Effects

Response to pantoprazole does not preclude presence of occult gastric neoplasm.1 10

Atrophic gastritis reported occasionally with long-term pantoprazole use, especially in patients infected with Helicobacter pylori.1

Glass Vial Breakage

Breakage of pantoprazole vials reported during attempts to connect the vials to spiked IV system adapters.14 15 Potential safety issue for health-care professionals attempting to connect these system components manually or with mechanical assistance.14 15 Pantoprazole manufacturer does not recommend use of spiked IV system adapters; if such adapters are used, contact manufacturer of the adapter for assistance.14

Injection Site Reactions

Injection site reactions (e.g., thrombophlebitis, abscess) associated with use of IV pantoprazole.10

Hepatic Effects

Mild, transient elevations of serum ALT reported with oral therapy; 0.4% incidence of serum ALT increases >3 times the upper limit of normal with pantoprazole dosage of 40 mg daily in short-term studies.1 10

Edetate Disodium Content

Pantoprazole sodium for injection contains edetate disodium (disodium EDTA), a potent metal ion (e.g., zinc) chelator.10 Consider zinc supplementation in patients prone to zinc deficiency.10 Use caution with other IV products that contain edetate disodium.10

Cyanocobalamin Malabsorption

Deficiency due to malabsorption from prolonged (e.g., >3 years) gastric acid suppression reported rarely.1 Consider possibility if manifestations of cyanocobalamin deficiency occur.1

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).25 26

Hip Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ?1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.27 300 301 302 303 304 305 309 Magnitude of risk is unclear;27 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.27 301 303 305 307 309

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.27 303 305 307 309

Specific Populations Pregnancy

Category B.1 10

Lactation

Distributed into milk.1 10 Discontinue nursing or the drug because of potential risk in nursing infants.1 10

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 9 10

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 10

Common Adverse Effects

Oral: Short-term (up to 8 weeks): Headache,1 diarrhea,1 flatulence,1 abdominal pain,1 rash,1 eructation,1 insomnia,1 hyperglycemia.1 Long-term (up to 12 months): Headache,1 abdominal pain,1 nausea,1 vomiting,1 abnormal liver function test results.1

IV: abdominal pain,10 headache,10 injection site reaction (e.g., thrombophlebitis, abscess),10 constipation,10 dyspepsia,10 nausea,10 diarrhea,10 insomnia,10 dizziness,10 rhinitis.10

Interactions for Protonix

Extensively metabolized, principally by CYP2C19 and to a minor extent by CYP3A4, 2D6, and 2C9.1 10

Drugs Metabolized by Hepatic Microsomal Enzymes

Unlikely to have clinically important interaction with drugs metabolized by CYP2C19, 3A4, 2D6, 2C9, 1A2.1 10

Specific Drugs and Laboratory Tests

Drug or Test

Interaction

Comments

Alcohol

Pharmacokinetic interaction unlikely1 10

Amoxicillin

Pharmacokinetic interaction unlikely1 10

Antacids

No clinically important effects on oral pantoprazole absorption1

May be used concomitantly1

Antipyrine

Pharmacokinetic interaction unlikely1 10

Atazanavir

Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response1 10 30

Manufacturer of pantoprazole states that concomitant administration with atazanavir is not recommended1 10

Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir29 30

For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)29 30

Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended29 30

Caffeine

Pharmacokinetic interaction unlikely1 10

Carbamazepine

Pharmacokinetic interaction unlikely1 10

Cisapride

Pharmacokinetic interaction unlikely1 10

Clarithromycin

Pharmacokinetic interaction unlikely1 10

Clopidogrel

Certain CYP2C19 inhibitors (e.g., omeprazole) reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel's clinical efficacy.35 224 225 228 311

Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown31 32 33 224 232

Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250

American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311

If concomitant therapy with a proton-pump inhibitor and clopidogrel is considered necessary, some clinicians prefer pantoprazole (which appears to be the weakest CYP2C19 inhibitor among proton-pump inhibitors)35 36 230 alternatively, consider use of a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)35 36 230 but not cimetidine (also a potent CYP2C19 inhibitor)224 232 233

Diazepam

Pharmacokinetic interaction unlikely1 10

Diclofenac

Pharmacokinetic interaction unlikely1 10

Digoxin

Pharmacokinetic interaction unlikely1 10

Gastric pH-dependent drugs (e.g., ampicillin esters, iron salts, ketoconazole)

Pantoprazole may decrease drug absorption1 10

Glyburide

Pharmacokinetic interaction unlikely1 10

Metoprolol

Pharmacokinetic interaction unlikely1 10

Metronidazole

Pharmacokinetic interaction unlikely1 10

Midazolam

Pharmacokinetic interaction unlikely1 10

Naproxen

Pharmacokinetic interaction unlikely1 10

Nifedipine

Pharmacokinetic interaction unlikely1 10

Oral contraceptives (e.g., levonorgestrel/ethinyl estradiol)

Pharmacokinetic interaction unlikely1 10

Phenytoin

Pharmacokinetic interaction unlikely1 10

Piroxicam

Pharmacokinetic interaction unlikely1 10

Sucralfate

Possible delayed proton-pump inhibitor absorption and decreased bioavailability17

Administer proton-pump inhibitor at least 30 minutes before sucralfate17

Tests for tetrahydrocannabinol (THC)

Possible false-positive results for urine screening tests for THC1 10

Use alternative confirmatory test for verification of positive results1 10

Theophylline

Pharmacokinetic interaction unlikely1 10

Warfarin

Potential increased INR and PT1 10 17

Monitor for INR and PT increases1 10 17

Protonix Pharmacokinetics Absorption Bioavailability

Well absorbed from GI tract (absolute bioavailability about 77%).1 Peak plasma concentrations attained about 2.5 hours after single or multiple 40-mg oral doses (as delayed-release tablets).1 Time to peak concentration is similar (2–2.5 hours) for delayed-release suspension administered orally or via NG tube.1

Administration of delayed-release oral suspension (in apple juice) via NG tube is bioequivalent to oral administration of the same formulation (in applesauce or apple juice).1 Delayed-release suspension is comparable to delayed-release tablets in degree of inhibition of pentagastrin-stimulated gastric acid secretion.1

Onset

51% mean inhibition of gastric acid secretion within 2.5 hours after a single 40-mg oral dose; 85% after daily administration for 7 days.1

15–30 minutes after single 20- to 120-mg IV infusion.10 About 96% suppression of pentagastrin-stimulated acid output within 2 hours after 80-mg IV infusion.10

Duration

Acid secretion normalized within one week after discontinuance of oral pantoprazole; no apparent rebound hypersecretion.1

24 hours after single IV infusion.10 Median percentage of time gastric pH ?4 similar after 40 mg IV or orally daily for 5 days.10

Food

Food delays absorption of delayed-release tablets but does not affect extent or peak plasma concentrations.1

Special Populations

Pharmacokinetics in patients with severe renal impairment similar to healthy individuals.1 10

Peak plasma concentrations and AUCs increased in patients with mild to severe hepatic impairment, but no more than in slow metabolizers.1 10 (See Hepatic Impairment under Dosage and Administration.)

Distribution Extent

Mainly extracellular.1 10 Prolonged binding to gastric parietal proton pump enzyme.1 10

Distributed into milk.1 10

Plasma Protein Binding

98%, principally albumin.1 10

Elimination Metabolism

Metabolized in the liver, principally by CYP2C19, and to a lesser extent by CYP3A4.1 10 Metabolites appear to be inactive.1 10

Elimination Route

Excreted in urine (about 71%) and feces (18%); no unchanged drug excreted in urine.1 10

Half-life

1 hour.1 10

Special Populations

Hepatic impairment increased plasma half-life to 7–9 hours, but no more than in slow metabolizers, and minimal accumulation occurs.1 10

In patients with poor CYP2C19 metabolizer phenotype, metabolism is slower than those with extensive (or rapid) metabolizer phenotype; elimination half-life is 3.5–10 hours, but minimal accumulation occurs.1 10

Not removed by hemodialysis.1 10

Stability Storage Oral Delayed-release Tablets

20–25°C (may be exposed to 15–30°C).1

Granules for Delayed-release Suspension

20–25°C (may be exposed to 15–30°C).1

Parenteral Powder for Injection

20–25°C (may be exposed to 15–30°C).10 Protect from light.10

Store reconstituted (4 mg/mL) solution at room temperature for up to 24 hours prior to administration as 4-mg/mL solution.10 If reconstituted solution will be further diluted, store reconstituted solution for up to 6 hours before dilution; then store diluted (0.4 or 0.8 mg/mL) solution at room temperature and use within 24 hours of initial reconstitution.10 Do not freeze reconstituted solution.10 Not necessary to protect reconstituted or diluted solution from light.10

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral Solution CompatibilityHID

Compatible

Dextrose 5% in water

Sodium chloride 0.9%

Drug Compatibility Y-Site CompatibilityHID

Compatible

Ampicillin sodium

Anidulafungin

Cefazolin sodium

Ceftriaxone sodium

Dimenhydrinate

Dopamine HCl

Epinephrine HCl

Furosemide

Morphine sulfate

Nitroglycerin

Potassium chloride

Vasopressin

Incompatible

Dobutamine HCl

Esmolol HCl

Mannitol

Midazolam HCl

Multivitamins

Variable

Norepinephrine bitartrate

Octreotide acetate

Manufacturer states that pantoprazole sodium may be incompatible with zinc-containing preparations.10

Actions

Inhibits basal and stimulated gastric acid secretion.1 10

Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton- or acid pump), blocking final step in secretion of hydrochloric acid.1 2 3 4 5 6 7 8 9 10 Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.1 2 3 4 5 6 7 8 9 10

Advice to Patients

Importance of swallowing tablets whole, without splitting, crushing, or chewing.1

Delayed-release tablets may be administered without regard to meals.1

Importance of taking delayed-release suspension 30 minutes before a meal.1

Importance of instructing patients regarding proper preparation and administration of the oral suspension.1

Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.305 309

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 10 Antacids may be used concomitantly with delayed-release tablets.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 10

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Pantoprazole Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For suspension, delayed-release (containing enteric-coated granules)

40 mg (of pantoprazole) per packet

Protonix

Wyeth

Tablets, delayed-release (enteric-coated)

20 mg (of pantoprazole)

Protonix

Wyeth

40 mg (of pantoprazole)

Protonix

Wyeth

Parenteral

For injection, for IV infusion

40 mg (of pantoprazole)

Protonix I.V.

Wyeth

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Pantoprazole Sodium 20MG Enteric-coated Tablets (WYETH): 30/$109.99 or 90/$319.95

Pantoprazole Sodium 40MG Enteric-coated Tablets (WYETH): 30/$15.99 or 90/$33.99

Protonix 20MG Enteric-coated Tablets (WYETH): 30/$186.38 or 90/$559.13

Protonix 40MG Enteric-coated Tablets (WYETH): 30/$190.00 or 90/$529.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 24, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Wyeth. Protonix (pantoprazole sodium) delayed-release tablets and for delayed-release oral suspension prescribing information. Philadelphia, PA; 2008 May.

2. Anon. Pantoprazole (Protonix). Med Lett Drugs Ther. 2000; 42:65-6. [PubMed 10908422]

3. Fitton A, Wiseman L. Pantoprazole: a review of its pharmacological properties and therapeutic use in acid-related disorders. Drugs. 1996; 51:460-82. [PubMed 8882382]

4. Avner DL. Clinical experience with pantoprazole in gastroesophageal reflux disease. Clin Ther. 2000; 22:1169-85. [IDIS 455520] [PubMed 11110229]

5. Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors: pharmacology and rationale for use in gastrointestinal disorders. Drugs. 1998; 56:307-35. [PubMed 9777309]

6. Webb DD. New therapeutic options in the treatment of GERD and other acid-peptic disorders. Am J Managed Care. 2000; 6:S467-75.

7. Berardi RR. A critical evaluation of proton pump inhibitors in the treatment of gastroesophageal reflux disease. Am J Managed Care. 2000; 6:S491-505.

8. Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000; 22:266-80. [IDIS 445669] [PubMed 10963283]

9. Wyeth, St. Davids, PA: Personal communication.

10. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2007 Dec.

11. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2001 Feb.

12. DeVault KR, Castell DO, Practice Parameters Committee of the American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 1999; 94:1434-42. [IDIS 429620] [PubMed 10364004]

13. Wyeth. Protonix (pantoprazole sodium) I.V. for injection prescribing information. Philadelphia, PA; 2001 Jul 9.

14. Kentrup WA. Dear health care professional letter regarding breakage of Protonix IV glass vials with spiked IV adaptors. Philadelphia, PA: Wyeth; 2004 Aug.

15. Food and Drug Administration. Protonix IV (pantoprazole sodium) injection [September 24, 2004: Wyeth]. MedWatch. Rockville, MD; September 2004. From FDA website.

16. AstraZeneca. Nexium (esomeprazole magnesium) delayed-release capsules prescribing information. Wilmington, DE; 2003 Mar.

17. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.

18. Freston JW. Review article: role of proton pump inhibitors in non-H. pylori-related ulcers. Aliment Pharmacol Ther. 20001; 15(Suppl 2):2-5.

19. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn's disease in adults: Practice Guidelines. Am J Gastroenterol. 2001; 96:635-43. [IDIS 461432] [PubMed 11280528]

20. Valori RM, Cockel R. Omeprazole for duodenal ulceration in Crohn's disease. Br Med J. 1990; 300:438-9.

21. Bianchi G, Ardizzone S, Petrillo M et al. Omeprazole for peptic ulcer in Crohn's disease. Am J Gastroenterol. 1991; 86: 245-6. [PubMed 1992643]

22. Przemioslo RT, Mee AS. Omeprazole in possible esophageal Crohn's disease. Dig Dis Sci. 1994; 39:1594-5. [IDIS 333053] [PubMed 8026276]

23. Dickinson JB. Is omeprazole helpful in inflammatory bowel disease? J Clin Gastroenterol. 1994; 18:317-9.

24. Abrahao LJ Jr., Abrahao LJ, Vargas C et al. [Gastoduodenal Crohn's disease—report of 4 cases and review of the literature]. (Portuguese; with English abstract.) Arq Gastroenterol. 2001; 38:57-62.

25. Laheij RJF, Sturkenboom MCJM, Hassing RJ et al. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004;292:1955-60.

26. Gregor JC. Acid suppression and pneumonia.; a clinical indication for rational prescribing. JAMA. 2004;292:2012-3. Editorial.

27. Yang Y-X, Lewis JD, Epstein S et al. Long-term proton pump inhibitor therapy and risk of hip fracture. JAMA. 2006; 296:2947-53. [PubMed 17190895]

28. Pratha V, Hogan DL, Lynn RB et al. Intravenous pantoprazole as initial treatment in patients with gastroesophageal reflux disease and a history of erosive esophagitis: a randomized clinical trial. Dig Dis Sci. 2006; 51:1595-601. [PubMed 16927137]

29. Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (Nov 3, 2008). From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

30. Bristol-Myers Squibb. Reyataz (atazanavir sulfate) capsules prescribing information. Princeton, NJ; 2009 Apr.

31. Gilard M, Arnaud B, Cornily JC et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin. JACC. 2008; 51:256-60, doi


More




Protonix


Related Posts Prevacid: