Betadine Gargle & Mouthwash


1. Name Of The Medicinal Product

Betadine Gargle and Mouthwash.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 1% w/v (equivalent to 0.1% w/v of available iodine).

3. Pharmaceutical Form

Solution.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of acute mucosal infections of the mouth and pharynx, for example gingivitis, and mouth ulcers. For oral hygiene prior to, during and after dental and oral surgery.

4.2 Posology And Method Of Administration

For oral administration, as a gargle and mouthwash. The product should not be swallowed. Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10ml for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as directed.

4.3 Contraindications

Not for use in children under 6 years of age and in patients with a known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days, seek medical or dental advice. Regular use should be avoided in patients on concurrent lithium therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development. The use of Betadine Gargle and Mouthwash in pregnant and lactating women should be limited to a single treatment session only.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Idiosyncratic mucosal irritation and hypersensitivity reactions may occur. Excessive absorption of iodine may produce systemic effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excessive iodine can produce goitre and hypothyroidism or hyperthyroidism. Acute overdose may result in symptoms of metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, difficulty in breathing due to pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea. Metabolic acidosis, hypernatraemia and renal impairment may occur. Treatment: In the cases of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Betadine Gargle and Mouthwash contains povidone iodine, a complex of iodine which shows all the broad spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. Betadine Gargle and Mouthwash kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic Properties

The product is intended for topical application to the mouth and buccal cavity.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol; menthol; methyl salicylate; ethanol 96%; saccharin sodium; purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store in a dry place below 25oC. Protect from light.

6.5 Nature And Contents Of Container

Amber soda-lime-silica glass bottle (USP Type III) fitted with an externally ribbed white urea cap, with a steran faced wad or with a wadless polypropylene cap containing 250ml of product.

6.6 Special Precautions For Disposal And Other Handling

This product should not be swallowed.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0006.

9. Date Of First Authorisation/Renewal Of The Authorisation

30th September 2005.

10. Date Of Revision Of The Text

September 2005.


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Betadine Skin Cleanser (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Skin Cleanser.

2. Qualitative And Quantitative Composition

Povidone Iodine USP 4.00% w/v.

3. Pharmaceutical Form

Topical aqueous solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Acne vulgaris of the face and neck. For general disinfection of the skin (as a liquid soap).

4.2 Posology And Method Of Administration

Route of administration: Topical. Adults, the elderly and children over 2 years: Apply directly or with moistened sponge to the affected areas and work up a rich lather. Allow to remain on the skin for 3-5 minutes then rinse off thoroughly with warm water and dry with a clean or sterile towel or gauze. Repeat twice daily. Infants under 2 years: Limit use to 2-3 days.

4.3 Contraindications

Hypersensitivity to iodine. History of abnormal thyroid function or goitre.

4.4 Special Warnings And Precautions For Use

Do not use on broken skin. Iodine is absorbed through burns and broken skin and, to a lesser extent, through intact skin. Restrict use in infants to 2-3 days.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use in pregnancy and lactation should be limited and although no adverse effects are anticipated from such limited usage, caution is recommended and the therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

If local irritation or sensitivity develops, then discontinue treatment.

4.9 Overdose

Treatment: In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Betadine Skin Cleanser contains povidone iodine, a complex of iodine which shows all the broad-spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of exfoliative debris and infected lesions whilst the colour persists. Betadine Skin Cleanser kills bacteria, viruses, fungi, spores and protozoa.

5.2 Pharmacokinetic Properties

The product is intended for topical application.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water; potassium iodate; NPPE ester; lauric diethanolamide; Natrosol HXR; Vah Floral Perfume No 2; sodium hydroxide.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store at a temperature not exceeding 25oC.

6.5 Nature And Contents Of Container

Polypropylene container with polypropylene lid containing 250ml.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0015.

9. Date Of First Authorisation/Renewal Of The Authorisation

30th March 2005.

10. Date Of Revision Of The Text

May 2006.


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Betadine Dry Powder Spray (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Dry Powder Spray.

2. Qualitative And Quantitative Composition

Povidone Iodine 2.5% w/w.

3. Pharmaceutical Form

Pressurised aerosol spray.

4. Clinical Particulars 4.1 Therapeutic Indications

Antiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.

4.2 Posology And Method Of Administration

For topical use only. Adults and children aged 2 years and over: Shake the can well before use. Spray the required area from a distance of 15-25cm (6-10 inches) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing.

4.3 Contraindications

Hypersensitivity to iodine. Betadine Dry Powder Spray should not be used in serous cavities. Do not use this product regularly if the patient suffers from thyroid disorders or is receiving concurrent lithium therapy. Do not use on children under two years of age.

4.4 Special Warnings And Precautions For Use

Avoid inhaling or spraying into the eyes. Avoid use on patients with renal impairment. Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, a doctor should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects.

4.6 Pregnancy And Lactation

Use in pregnancy or lactation should be limited. Although no adverse effects are anticipated from such limited usage, caution is recommended and therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin. Following prolonged application of Betadine Dry Powder Spray to severe burns or large areas of denuded skin, systemic effects such as metabolic acidosis, parametrical renal impairment and thyroid dysfunction may occur.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.

Treatment: In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Povidone iodine is a complex of iodine which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Isopropyl myristate; n-pentane; butane 40; soya lecithin.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store at or below 25oC.

6.5 Nature And Contents Of Container

Aerosol cans containing 100ml of product.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0005.

9. Date Of First Authorisation/Renewal Of The Authorisation

19th April 2006.

10. Date Of Revision Of The Text

April 2006.


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Vaginal anti-infectives


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.

Vaginal anti-infectives are available as creams, pessaries (tablets), gels or solutions to treat either bacterial or fungal vaginal infections. Vaginal antifungal products are used to treat vaginal thrush. Antibacterial vaginal products are used for bacterial infections such as bacterial vaginosis. Other products are used to manage irritation or minor soreness.

See also

Medical conditions associated with vaginal anti-infectives:

Acne Bacterial Vaginitis Cutaneous Candidiasis Fungal Infection Prophylaxis Oral Thrush Perioral Dermatitis Rosacea Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection Drug List: Gyne-Lotrimin-Cream Zeasorb-Af-Gel Vandazole Lotrimin-Af-Powder Monistat-7-Cream Vagistat-1 Gynazole-1-Cream Clindesse Metrogel-Vaginal-Gel Terazol-Cream Clindamax-Cream Monistat-5 Derma-Gran-Af-Topical Monistat-1 Aloe-Vesta Aloe-Vesta-2-In-1-Antifungal Avc Baza Betadine-Cream Betadine-Spray-Aerosol-Solution Canesten-Topical Cleocin-Cream Clindacin-P Clotrimazole-3 Clotrimazole-7 Cruex-Prescription-Strength Desenex-Spray Desenex-Prescription-Strength Fungicure-Pump-Spray Fungoid Fungoid-Kit Gyne-Lotrimin-3-Cream Gyne-Sulf M-Zole-Dual-Pack Micatin-Cream Micatin-Cooling-Action Micatin-Foot-Powder Micatin-Foot-Powder-Deodorant Micatin-Jock-Itch Micatin-Liquid-Foot Micon-7 Micro-Guard-Topical Minidyne-Solution Miranel-Af-Liquid Mitrazol Monistat-Derm-Cream Monistat-1-Combo-Pack-Cream Monistat-3-Cream Mycelex-Cream Mycelex-Otc Ony-Clear Pharmadine-Aerosol-Solution Polydine-Solution Recuro-Vaginal Secura-Antifungal-Topical Sultrin-Triple-Sulfa Terazol-3-Suppositories Terazol-7 Tetterine-Cream Trimo-San Trysul Vitazol-Topical V-V-S Zazole-Cream
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Betadine Alcoholic Solution (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Alcoholic Solution.

2. Qualitative And Quantitative Composition

Povidone iodine 10.0% w/v.

3. Pharmaceutical Form

Alcoholic solution.

4. Clinical Particulars 4.1 Therapeutic Indications

For use as an antiseptic skin cleanser for major and minor surgical procedures where a quick drying effect is desired.

4.2 Posology And Method Of Administration

For topical administration.

4.3 Contraindications

Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Povidone iodine may produce local skin reactions, although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment. Treatment: In the case of accidental ingestion of large quantities of Betadine symptomatic and supportive treatment should be provided, with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The active ingredient, povidone iodine, slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations: I2? I+ + I- ; I2 + H2O ? H2O I+ + I- ; I2 + I- ? I3-. The microbicidal species H2O I+ preferentially displaces oxygen as the end electron acceptor in the microorganism's respiratory cycle. H2O I+ similarly interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.

5.2 Pharmacokinetic Properties

Betadine Alcoholic Solution is for topical application and therefore a consideration of the absorption, distribution, metabolism and excretion of povidone iodine is largely without relevance.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Nonoxynol 9; dibasic sodium phosphate (anhydrous); citric acid monohydrate; glycerol; industrial methylated spirit; sodium hydroxide; purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

To be stored at or below 25 degrees Celsius and protected from light.

6.5 Nature And Contents Of Container

High-density polyethylene containers fitted with steran lined white polypropylene caps. Pack size: 500ml

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0002.

9. Date Of First Authorisation/Renewal Of The Authorisation

14th March 2005.

10. Date Of Revision Of The Text

March 2005.


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Betadine Surgical Scrub (Molnlycke Health Care )


1. Name Of The Medicinal Product

Betadine Surgical Scrub.

2. Qualitative And Quantitative Composition

Povidone Iodine 7.5% w/v.

3. Pharmaceutical Form

Surgical scrub.

4. Clinical Particulars 4.1 Therapeutic Indications

For use as an antiseptic cleanser for pre-operative scrubbing and washing by surgeons and theatre staff, and pre-operative preparation of patients' skin.

4.2 Posology And Method Of Administration

For topical administration. Adults, the elderly and children: Apply full strength as a pre-operative antiseptic skin cleanser. Povidone iodine is not recommended for regular use in neonates and is contraindicated in very low birth weight infants (below 1500 grams).

4.3 Contraindications

Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

4.4 Special Warnings And Precautions For Use

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

4.6 Pregnancy And Lactation

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

4.9 Overdose

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and impairment of renal function. In the case of accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The active ingredient, povidone iodine, slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations: I2? I+ + I- ; I2 + H2O ? H2O I+ + I- ; I2 + I- ? I3-. The microbicidal species H2O I+ preferentially displaces oxygen as the end electron acceptor in the microorganism's respiratory cycle. H2O I+ similarly interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.

5.2 Pharmacokinetic Properties

Betadine Surgical Scrub is intended for topical application and therefore a consideration of the absorption, distribution, metabolism and elimination of povidone iodine is largely without relevance.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sulphated nonylphenoxypoly(oxyethylene) ethanol ammonium salt; lauric diethanolamide;

ethoxylated lanolin 50%; Natrosol HXR; sodium hydroxide; purified water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Store below 25oC and protect from light.

6.5 Nature And Contents Of Container

High density polyethylene containers fitted with steran lined white polypropylene caps containing 500ml of product.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 21248/0009.

9. Date Of First Authorisation/Renewal Of The Authorisation

6th April 2005.

10. Date Of Revision Of The Text

April 2006.


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Lugols Strong Iodine Solution



Dosage Form: solution
Lugols Strong Iodine Solution CONTENTS      

Iodine 0.05 g/ml, Potassium Iodide 0.105 g/ml.

DESCRIPTION      

LUGOL’S is an aqueous solution containing Iodine 5%, and potassium iodide 10%, w/v (LUGOL’s Solution). LUGOL’s is a transparent liquid with a deep brown color and the odor of iodine.

HOW SUPPLIED      

LUGOL’S is supplied in 8 ml glass single-use bottles.

INDICATIONS AND USAGE      

LUGOL’s is a topical antiseptic. Strong Iodine Solution is a germicide and fungicide. LUGOL’s is preservative-free.

ADMINISTRATION      

LUGOL’S is applied directly to areas needing antiseptic.

WARNINGS      

For External Use Only.

CONTRAINDICATIONS      

Iodide preparations are contraindicated in patients with known sensitivity to the drugs.

CAUTION      

Federal law restricts this device to sale by or on the order of a physician.

STORAGE      

Keep tightly closed. Protect from light.  DO NOT use if seal has been broken. Store at controlled room temperature 15°-30°C (59°-86°F).

DISPOSAL      

Opened containers with unused portions of product and applicator swabs containing residual product should be placed in a suitable, dry container for disposal following local hazardous waste practices. Waste containing LUGOL’S should not be subjected to any thermal process whether intended for destruction or recycling purposes.

PRINCIPAL DISPLAY PANEL

Lugol’s

Strong Iodine Solution USP

Contents      

One Dozen (12)

8ml Vials


LUGOLS STRONG IODINE 
iodine potassium iodide  solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59365-6064 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.05 g  in 1 mL POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 0.105 g  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 59365-6064-1 12 VIAL In 1 CARTON contains a VIAL, SINGLE-USE 1 8 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (59365-6064-1)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 10/01/1992
Labeler - CooperSurgical, Inc. (801895244) Revised: 11/2009CooperSurgical, Inc.
More Lugols Strong Iodine Solution resources Lugols Strong Iodine Solution Drug Interactions Lugols Strong Iodine Solution Support Group 0 Reviews · Be the first to review/rate this drug
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Povidone/Iodine Cream


Pronunciation: POE-vi-done/EYE-oh-dine
Generic Name: Povidone/Iodine
Brand Name: Examples include Betadine and Pharmadine
Povidone/Iodine Cream is used for:

Treating minor wounds and infections, as well as killing bacteria.

Povidone/Iodine Cream is an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Povidone/Iodine Cream if: you are allergic to any ingredient in Povidone/Iodine Cream

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

Before using Povidone/Iodine Cream:

Some medical conditions may interact with Povidone/Iodine Cream. 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 serious burns or deep puncture wounds

Some MEDICINES MAY INTERACT with Povidone/Iodine Cream. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Povidone/Iodine Cream 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 Povidone/Iodine Cream:

Use Povidone/Iodine Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clean the affected area. Apply a small amount of Povidone/Iodine Cream to the affected area. The area may be left uncovered, or you may cover it with a sterile bandage. If you miss a dose of Povidone/Iodine Cream, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Povidone/Iodine Cream.

Important safety information: If you have had a severe allergic reaction to Povidone/Iodine Cream or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Povidone/Iodine Cream or if a certain medicine contains iodine, contact your doctor or pharmacist. If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible. Povidone/Iodine Cream is for external use only. Do not get Povidone/Iodine Cream in your eyes. Do not use Povidone/Iodine Cream over large areas of the body or for more than 1 week unless advised to do so by your doctor. Contact your doctor before using Povidone/Iodine Cream on serious burns, deep wounds, or puncture wounds. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Povidone/Iodine Cream, discuss with your doctor the benefits and risks of using Povidone/Iodine Cream during pregnancy. It is unknown if Povidone/Iodine Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Povidone/Iodine Cream, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Povidone/Iodine Cream:

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:

Skin irritation.

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).

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.

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 Povidone/Iodine Cream:

Store Povidone/Iodine Cream at room temperature, between 68 and 77 degrees F (20 and 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 Povidone/Iodine Cream out of the reach of children and away from pets.

General information: If you have any questions about Povidone/Iodine Cream, please talk with your doctor, pharmacist, or other health care provider. Povidone/Iodine Cream is 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 Povidone/Iodine Cream. 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 Povidone/Iodine resources Povidone/Iodine Use in Pregnancy & Breastfeeding Povidone/Iodine Support Group 0 Reviews · Be the first to review/rate this drug
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Povidone/Iodine Shampoo


Pronunciation: POE-vi-done/EYE-oh-dine
Generic Name: Povidone/Iodine
Brand Name: Betadine
Povidone/Iodine Shampoo is used for:

Cleansing the hair and scalp to reduce the risk of infection.

Povidone/Iodine Shampoo is an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Povidone/Iodine Shampoo if: you are allergic to any ingredient in Povidone/Iodine Shampoo

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

Before using Povidone/Iodine Shampoo:

Some medical conditions may interact with Povidone/Iodine Shampoo. 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 serious burns or deep puncture wounds

Some MEDICINES MAY INTERACT with Povidone/Iodine Shampoo. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Povidone/Iodine Shampoo 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 Povidone/Iodine Shampoo:

Use Povidone/Iodine Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To use Povidone/Iodine Shampoo on the scalp, massage 1 or 2 teaspoonfuls into the wet scalp. Leave on the scalp for up to 10 minutes. Rinse the scalp thoroughly. Wash your hands well after using Povidone/Iodine Shampoo. If you miss a dose of Povidone/Iodine Shampoo, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Povidone/Iodine Shampoo.

Important safety information: If you have had a severe allergic reaction to Povidone/Iodine Shampoo or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Povidone/Iodine Shampoo or if a certain medicine contains iodine, contact your doctor or pharmacist. If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible. Povidone/Iodine Shampoo is for external use only. Do not get Povidone/Iodine Shampoo in your eyes, nose, or mouth. Do not use Povidone/Iodine Shampoo over large areas of the body or for more than 1 week unless advised to do so by your doctor. Contact your doctor before using Povidone/Iodine Shampoo on serious burns, deep wounds, or puncture wounds. Use Povidone/Iodine Shampoo with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Povidone/Iodine Shampoo, discuss with your doctor the benefits and risks of using Povidone/Iodine Shampoo during pregnancy. It is unknown if Povidone/Iodine Shampoo is excreted in breast milk. If you are or will be breast-feeding while you are using Povidone/Iodine Shampoo, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Povidone/Iodine Shampoo:

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:

Skin irritation.

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); worsening of your condition.

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.

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 Povidone/Iodine Shampoo:

Store Povidone/Iodine Shampoo at room temperature, between 68 and 77 degrees F (20 and 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 Povidone/Iodine Shampoo out of the reach of children and away from pets.

General information: If you have any questions about Povidone/Iodine Shampoo, please talk with your doctor, pharmacist, or other health care provider. Povidone/Iodine Shampoo is 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 Povidone/Iodine Shampoo. 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 Povidone/Iodine resources Povidone/Iodine Use in Pregnancy & Breastfeeding Povidone/Iodine Support Group 0 Reviews · Be the first to review/rate this drug
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Pharmadine Gauze Pads


Pronunciation: POE-vi-done/EYE-oh-dine
Generic Name: Povidone/Iodine
Brand Name: Examples include Betadine Swab Aid and Pharmadine Gauze
Pharmadine Gauze Pads are used for:

Treating minor wounds and infections, as well as killing bacteria.

Pharmadine Gauze Pads are an antiseptic combination. It works by killing sensitive bacteria.

Do NOT use Pharmadine Gauze Pads if: you are allergic to any ingredient in Pharmadine Gauze Pads

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

Before using Pharmadine Gauze Pads:

Some medical conditions may interact with Pharmadine Gauze Pads. 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 serious burns or deep puncture wounds

Some MEDICINES MAY INTERACT with Pharmadine Gauze Pads. However, no specific interactions are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pharmadine Gauze Pads 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 Pharmadine Gauze Pads:

Use Pharmadine Gauze Pads as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Clean the affected area with warm water and soap, rinse, and pat dry. Using the pad or swab, apply the medicine by covering the affected and surrounding areas with a thin film of medicine. Allow the medicine to dry. The area may be left uncovered, or you may cover it with a sterile bandage. Wash your hands after using Pharmadine Gauze Pads, unless your hands are part of the treated area. If you miss a dose of Pharmadine Gauze Pads, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Pharmadine Gauze Pads.

Important safety information: If you have had a severe allergic reaction to Pharmadine Gauze Pads or a medicine that contains iodine, contact your doctor or pharmacist immediately. A severe allergic reaction includes a severe rash, hives, difficulty breathing, or dizziness. If you have questions about whether you are allergic to Pharmadine Gauze Pads or if a certain medicine contains iodine, contact your doctor or pharmacist. If you experience a skin rash, hives, or itching, or any other unusual reaction after using this product, discontinue use and contact your doctor as soon as possible. Pharmadine Gauze Pads are for external use only. Do not get Pharmadine Gauze Pads in your eyes, nose, or mouth. Do not use Pharmadine Gauze Pads over large areas of the body or for more than 1 week unless advised to do so by your doctor. Contact your doctor before using Pharmadine Gauze Pads on serious burns, deep wounds, or puncture wounds. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pharmadine Gauze Pads, discuss with your doctor the benefits and risks of using Pharmadine Gauze Pads during pregnancy. It is unknown if Pharmadine Gauze Pads are excreted in breast milk. If you are or will be breast-feeding while you are using Pharmadine Gauze Pads, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Pharmadine Gauze Pads:

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:

Skin irritation.

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).

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: Pharmadine Gauze 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 Pharmadine Gauze Pads:

Store Pharmadine Gauze Pads at room temperature, between 68 and 77 degrees F (20 and 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 Pharmadine Gauze Pads out of the reach of children and away from pets.

General information: If you have any questions about Pharmadine Gauze Pads, please talk with your doctor, pharmacist, or other health care provider. Pharmadine Gauze Pads 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 Pharmadine Gauze Pads. 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 Pharmadine Gauze resources Pharmadine Gauze Side Effects (in more detail) Pharmadine Gauze Use in Pregnancy & Breastfeeding Pharmadine Gauze Support Group 0 Reviews · Be the first to review/rate this drug
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sodium iodide


Generic Name: sodium iodide (SOE dee um EYE oh dide)
Brand names: Iodopen, Iodides

What is sodium iodide?

Sodium iodide is a salt that is formed into an injectable medicine.

Sodium iodide is used to treat or prevent iodine deficiency caused by poor nutrition or poor absorption by the body.

Sodium iodide may also be used to treat a thyroid disorder.

Sodium iodide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about sodium iodide? You should not use this medication if you are allergic to sodium iodide.

Before using sodium iodide, tell your doctor if you have kidney disease, tuberculosis, a blood vessel disorder, a goiter, or a thyroid disorder that is not being treated with sodium iodide.

This medication may cause thyroid problems in an unborn baby, but the medication may sometimes be used during pregnancy. Your doctor should determine whether or not this medication is safe or if it will harm the unborn baby. Before you use sodium iodide, tell your doctor if you are pregnant or plan to become pregnant during treatment. Serious side effects include swollen glands or swelling in your throat, severe headache, fast or pounding heart rate, feeling short of breath, or numbness or tingly feeling in your hands or feet. Sodium iodide may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat to help control your condition. What should I discuss with my health care provider before using sodium iodide? You should not use this medication if you are allergic to sodium iodide.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using sodium iodide, tell your doctor if you have:

kidney disease;

tuberculosis;

a blood vessel disorder such as vasculitis (swelling of your blood vessels);

a goiter; or

a thyroid disorder (unless you are being treated for thyroid disorder with sodium iodide).

This medication may cause thyroid problems in an unborn baby, but the medication may sometimes be used during pregnancy. Your doctor should determine whether or not this medication is safe or if it will harm the unborn baby. Before you use sodium iodide, tell your doctor if you are pregnant or plan to become pregnant during treatment. Sodium iodide 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 use sodium iodide?

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

Sodium iodide injection is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Sodium iodide may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat to help control your condition. Store sodium iodide at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 extreme weakness, burning or metallic taste in your mouth, or fast heart rate.

What should I avoid while using sodium iodide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using sodium iodide.

Sodium iodide 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:

swollen glands or swelling in your throat;

severe headache;

fast, pounding, or uneven heart rate;

feeling short of breath; or

numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

unusual or unpleasant taste or burning in your mouth or throat;

heartburn;

mild skin rash or itching;

tender gums, tooth pain, mouth soreness;

weakness; or

changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sodium iodide?

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

medicines that contain iodine such as Betadine;

lithium (Eskalith, Lithobid);

sodium iodide I-131 (Iodotope); or

medications to treat overactive thyroid, such as methimazole (Tapazole), propylthiouracil ("PTU"), and others.

This list is not complete and there may be other drugs that can interact with sodium iodide. 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 sodium iodide resources Sodium iodide Drug Interactions Sodium iodide Support Group 0 Reviews · Be the first to review/rate this drug sodium iodide Oral, Injection, Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Where can I get more information? Your doctor or pharmacist can provide more information about sodium iodide.
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Iodoshield Active



Dosage Form: FOR ANIMAL USE ONLY
IODOSHIELD
ACTIVE

Iodine based teat sanitizer with Manuka honey from New Zealand
Spray or Dip concentrate
For Commercial Use Only

An aid in reducing the spread of organisms which may cause bovine mastitis.
The product contains the active ingredient at 0.19 pounds per gallon.

USE RATES

FOR ROUTINE SPRAY OR DIP APPLICATIONS
Dilute 1 part FIL Iodoshield Active with 9 parts water.

IN EARLY LACTATION OR INCLEMENT WEATHER CONDITIONS
Dilute 1 part FIL Iodoshield Active with 4 parts water.

GENERAL INSTRUCTIONS

Make up use solutions in clean plastic or stainless steel containers using potable water. Use solutions are reasonably stable if stored in a clean and contamination free environment. However, it is recommended that only sufficient product for a week's use should be made up at one time.

Apply to teats as soon as possible after cup removal. Ensure that the whole teat surface is covered. This product contains a high level of emolliency and generally should not need additional emollient. PRECAUTION: As with any germicide, irritation may occur in sensitive animals. If irritation occurs, discontinue use and consult your veterinarian.

PRECAUTIONARY STATEMENTS HAZARDS TO HUMANS (AND DOMESTIC ANIMALS)

Prolonged or frequently repeated skin contact may cause allergic reaction in some individuals. Remove contaminated clothing and wash before reuse.

CAUTION

Causes moderate eye irritation. Avoid contact with eyes, skin or clothing. Wear protective eyewear (Goggles, face shield or safety glasses). Harmful if swallowed or absorbed through skin or inhaled. Avoid breathing spray mist. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Wear rubber gloves when handling or applying.

FIRST AID

IF IN EYES: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Call a poison control center or doctor for treatment advice.

IF SWALLOWED: Call a poison control center or doctor immediately for treatment advice. Have person sip a glass of water if able to swallow. Do not induce vomiting unless told to by a poison center or doctor.

IF ON SKIN: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. Call a poison control center or doctor for treatment.

IF INHALED: Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth, if possible. Call a poison control center or doctor for further treatment.

Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-800-328-0026 for emergency medical treatment information.

ENVIRONMENTAL HAZARDS

Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NDPES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority.

For guidance contact your State Water Board or Regional Office of the EPA. Do not contaminate water by cleaning of equipment or disposal of waste.

STORAGE AND DISPOSAL

Do not contaminate water, food or feed by storage or disposal. Open dumping is prohibited. Do not reuse empty container. Protect from freezing.

PRODUCT STORAGE: Store the product in a dry and cool place, where it is not reachable by children.

PRODUCT DISPOSAL: Wastes resulting from use of this product may be disposed of on site or at an approved waste disposal facility.

CONTAINER DISPOSAL: Do not reuse containers. Triple rinse containers when empty. Add rinses to use solutions.

GENERAL: Consult federal, state, or local disposal authorities for approved alternative procedures such as limited open burning.

Manufactured by: Farmers Industries (New Zealand) Limited, 72 Portside Drive, PO Box 4144 Mt Maunganui, New Zealand.

TEL +64 7 575 2162 WWW.FIL.CO.NZ

Distributed by FIL Agritech, LLC 5983 US Rte 11 Homer, NY 13077

TOLL FREE 1-800-680-3167 WWW.FILAGRITECH.COM

PRINCIPAL DISPLAY PANEL - 20 L Bottle Label

CAUTION
KEEP OUT OF REACH OF CHILDREN

FIL

FARM INNOVATION / ANIMAL HEALTH

IODOSHIELD
ACTIVE

Contains 2.2% Iodine and 97.8% other ingredients

Iodine based teat sanitizer with
Manuka honey from New Zealand
Spray or Dip concentrate
For Commercial Use Only

An aid in reducing the spread of organisms
which may cause bovine mastitis

WWW.FIL.CO.NZ


Iodoshield Active 
iodine  concentrate Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 51546-001 Route of Administration TOPICAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength iodine (iodine) iodine 86.2 g  in 4.55 L Inactive Ingredients Ingredient Name Strength sorbitol   honey   water   lanolin   alcohol   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 51546-001-02 20 L In 1 BOTTLE None 2 51546-001-20 200 L In 1 DRUM None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/01/2010
Labeler - Farmers Industries (New Zealand) Limited (590180329) Establishment Name Address ID/FEI Operations Farmers Industries (New Zealand) Limited 590180329 MANUFACTURE Revised: 08/2010Farmers Industries (New Zealand) Limited

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Flovent Diskus Powder


Pronunciation: floo-TICK-ah-ZONE
Generic Name: Fluticasone
Brand Name: Examples include Flovent Diskus and Flovent Rotadisk
Flovent Diskus Powder is used for:

Preventing asthma attacks. Flovent Diskus Powder will not stop an asthma attack once one has started. It may also be used to treat other conditions as determined by your doctor.

Flovent Diskus Powder is a corticosteroid. It works by decreasing the irritation and swelling of the breathing tubes (bronchial tubes) of the lung to control or prevent asthma symptoms.

Do NOT use Flovent Diskus Powder if: you are allergic to any ingredient in Flovent Diskus Powder you are having a severe asthma attack

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

Before using Flovent Diskus Powder:

Some medical conditions may interact with Flovent Diskus Powder. 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 glaucoma; cataracts; a bacterial, fungal, parasitic, or viral infection; measles; chicken pox; shingles; tuberculosis (TB); a positive TB skin test; diarrhea; or a herpes infection in the eye; or if you have recently received a vaccination

Some MEDICINES MAY INTERACT with Flovent Diskus Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

Certain medicine that act on the liver (eg, protease inhibitors [eg, ritonavir], ketoconazole) because they may increase the actions and side effects of Flovent Diskus Powder

This may not be a complete list of all interactions that may occur. Ask your health care provider if Flovent Diskus Powder 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 Flovent Diskus Powder:

Use Flovent Diskus Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Flovent Diskus Powder. Talk to your pharmacist if you have questions about this information. Flovent Diskus Powder is for oral inhalation only. If you use 2 inhalations for a dose, use the first and wait at least 30 seconds before using the second inhalation. Do not use Flovent Diskus Powder with a spacer device. Rinse your mouth out or gargle with water after using Flovent Diskus Powder to prevent mouth sores or a bad aftertaste. If you miss a dose of Flovent Diskus Powder, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Flovent Diskus Powder.

Important safety information: Flovent Diskus Powder is used to prevent the occurrence of asthma attacks. It is not to be used for a severe asthma attack that requires quick relief. Ask your doctor to provide you with another medicine that is used to relieve sudden asthma attacks. Avoid exposure to chicken pox and measles. If exposed, contact your doctor at once. If you are also using a bronchodilator inhaler, be sure to always carry the inhaler with you to use during asthma attacks. Always have a spare inhaler available in case the unit malfunctions or is empty. Tell your doctor or dentist that you take Flovent Diskus Powder before you receive any medical or dental care, emergency care, or surgery. Diabetes patients - Flovent Diskus Powder may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. After you begin using Flovent Diskus Powder, a few weeks may pass before the full benefit is obtained. Continue to use it as directed during this time. Use caution if you switch from an oral steroid (eg, prednisone) to Flovent Diskus Powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur. Flovent Diskus Powder should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Flovent Diskus Powder. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Flovent Diskus Powder while you are pregnant. It is not known if Flovent Diskus Powder is found in breast milk. If you are or will be breast-feeding while you use Flovent Diskus Powder, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Flovent Diskus Powder:

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:

Back problems; bronchitis; cough; diarrhea; difficulty speaking; dry mouth; fever; flu; headache; hoarseness; muscle pain; nausea; oral yeast infection; runny nose; sinus inflammation; sore throat; stomach pain or discomfort; stuffy nose; throat irritation; upper respiratory tract infection.

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); cataracts; choking; fainting; growth suppression in children; irregular heartbeat; numbness or tingling in arms or legs; pounding in the chest; severe dizziness; sudden weight loss; swelling of the throat; unusual weakness; vomiting; wheezing; white curd-like patches in the mouth; worsening of asthma.

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: Flovent Diskus 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 Flovent Diskus Powder:

Store Flovent Diskus Powder at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from direct sunlight, heat, and moisture. Do not store in the bathroom. The inhalation device is not reusable. Inhalation devices should be thrown away 2 months after the foil over-wrap is opened or on the expiration date (whichever comes first). Place the sticker provided with the product on the tube and enter the date the foil over-wrap is opened. Do not puncture any of the blisters until you are ready to take a dose. Keep Flovent Diskus Powder out of the reach of children and away from pets.

General information: If you have any questions about Flovent Diskus Powder, please talk with your doctor, pharmacist, or other health care provider. Flovent Diskus Powder is 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 Flovent Diskus Powder. 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 Flovent Diskus resources Flovent Diskus Side Effects (in more detail) Flovent Diskus Use in Pregnancy & Breastfeeding Flovent Diskus Drug Interactions Flovent Diskus Support Group 0 Reviews for Flovent Diskus - Add your own review/rating Compare Flovent Diskus with other medications Asthma, Maintenance Bronchopulmonary Dysplasia Eosinophilic Esophagitis
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Eludril Mouthwash


1. Name Of The Medicinal Product

ELUDRIL mouthwash

2. Qualitative And Quantitative Composition

Actives :

Quantity :

Unit :

Chlorhexidine digluconate

0.100

% W/V

Chlorobutanol

0.500

% W/V

Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine digluconate).

The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22 mg/ml – 0.33 mg/ml.

Each ml contains 5 mg of chlorobutanol.

The content of chlorobutanol per ml when diluted as recommended is 1.11 mg/ml – 1.66 mg/ml.

Excipients:Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Mouthwash.

Clear colourless Oromucosal solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Eludril mouthwash is an antibacterial solution which inhibits dental plaque formation. It is indicated as an aid in the treatment and prevention of gingivitis, and in maintaining oral hygiene, particularly in situations where toothbrushing is difficult to carry out (eg following oral surgery or in physically or mentally-handicapped patients). It is valuable in the management of aphtous ulceration and oral candidal infections (eg denture stomatitis and thrush) and can be used as an adjuvant treatment for minor infections of the throat.

As a disinfectant solution for the cleansing of removable dentures.

4.2 Posology And Method Of Administration

Eludril is contraindicated in infants and children under six years of age: see section 4.3.

1. As a mouthwash, dilute 10 to 15 ml in the measuring-cup provided for this purpose and fill with lukewarm water to the upper line and use as a mouthwash or a gargle two or three times a day.

2. As a disinfectant for removable dentures, prepare a 1 in 3 dilution of Eludril with water. The dentures previously cleansed should be soaked in the solution for one hour.

Route of administration

Oromucosal use. (This product is not intended to be swallowed)

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients.

- Use in infants and children less than 6 years of age.

- Use with anionic agents (see section 4.5).

4.4 Special Warnings And Precautions For Use

Warnings

For oral use only

Do not swallow

Keep out of the eyes and ears. If the mouthwash comes into contact with the eyes or ears, wash out promptly and thoroughly with water.

Discoloration of the tongue, teeth and silicate or composite restorations may occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the mouthwash or, in the case of dentures cleansing with a conventional cleanser: see sections 4.5, 4.8.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional: see section 4.8

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E218) which may cause allergic reactions.

Precautions for use

Chlorhexidine is an irritant and should be used with caution. If there is evidence of irritation or aggravation of the condition, a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents which are usually present in conventional toothpastes. Therefore, thorough rinsing of the mouth with water, after toothbrushing with toothpaste, should be done before using this medicine: see section 4.3. A short time should elapse between using the two products.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects in infants arising from the use of Eludril mouthwash during pregnancy or lactation.

Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable Effects

Body System

Adverse Reactions (frequency not known)

Immune system disorders

Anaphylactic shock, anaphylactic reaction, hypersensitivity

Nervous system disorders

-Dysgeusia: transient disturbance of taste sensation

-Mucosal burning sensation: burning sensation of the tongue.

These effects may occur on initial use of the product and usually diminish with continued use.

Gastrointestinal disorders

-Tongue discoloration: Superficial discoloration of the dorsum of the tongue, reversible after discontinuing treatment: see section 4.4.

-Teeth discoloration: Discoloration of the teeth and silicate or composite restorations: see section 4.4.

-Parotid gland enlargement: swelling of the parotid glands reversible after discontinuing treatment.

- Oral desquamation: In cases where oral desquamation occurs dilution of 10ml of the mouthwash with water to the upper line of the measuring cup will often allow continued use of the mouthwash

4.9 Overdose

Overdose is not expected under normal conditions of use of this solution as a mouthwash (normal dilution conditions for 10 ml is 7.4 %v/v and for 15 ml is 11.1 %v/v.). However, due to the undiluted product alcohol content (33.25 % v/v) accidental ingestion of large amounts by children requires prompt medical attention for appropriate action.

Symptoms

Chlorhexidine when taken orally is poorly absorbed. Most patients will develop very few symptoms. Local effects like burning sensation in the mouth and throat may occur. Systemic effects are unlikely if large volumes are ingested. However, large amounts may cause digestive disorders (epigastric pain, diarrhoea) and if chlorhexidine passes into the general system, signs of neurological toxicity may develop.

Emergency procedures

- Do not attempt to empty the stomach

- Administration of milk, water to drink, raw egg, gelatin or mild soap may be advisable provided the airway can be protected.

- General supportive measures should be instituted as deemed necessary by the physician.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-infectives and antiseptics for local oral treatment.

ATC code: A01AB03.

CHLORHEXIDINE : broad-spectrum antibacterial (gram + and gram -) and anti-fungal product with extended bactericidal activity on buccal mucosa.

CHLOROBUTANOL: local anaesthetic providing a quick relief from pain, bacteriostatic reinforcing the activity of chlorhexidine.

5.2 Pharmacokinetic Properties

CHLORHEXIDINE:

Oral:Very weak systemic absorption, distribution mainly via liver and kidneys; little metabolism (no degradation of the molecule). Elimination mainly in faeces (99.5 % of the ingested dose).

Permucosal absorption: negligible. Distribution, metabolism and elimination same as oral route

CHLOROBUTANOL:

Systemic absorption after oral administration. Half-life of 9 to 10 days.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Poloxamer

Alcohol

Sorbitol solution 70 % (crystallising)

Menthol

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Peppermint spirit

Purified Water

6.2 Incompatibilities

See section 4.5

6.3 Shelf Life

Unopened: 3 years

6.4 Special Precautions For Storage

Store away from light,

Store at a temperature of 25°C maximum.

6.5 Nature And Contents Of Container

Clear glass bottle with aluminium cap and a measuring cup.

Pack sizes: 90ml, 250ml and 500ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 00603/0012R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 9th August 1973

Date of last renewal: 16th April 2007

10. Date Of Revision Of The Text

27/01/2011


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Azmacort Aerosol


Pronunciation: TRYE-am-SIHN-oh lohn
Generic Name: Triamcinolone
Brand Name: Azmacort
Azmacort Aerosol is used for:

Preventing or reducing the frequency and severity of bronchial asthma attacks. It will not stop an asthma attack once it has started. It may also be used for other conditions as determined by your doctor.

Azmacort Aerosol is a corticosteroid. It works by decreasing the irritation and swelling of the airways of the lung. This helps to control or prevent asthma symptoms.

Do NOT use Azmacort Aerosol if: you are allergic to any ingredient in Azmacort Aerosol you are currently taking mifepristone you are having an asthma attack

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

Before using Azmacort Aerosol:

Some medical conditions may interact with Azmacort Aerosol. 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 or have been recently exposed to a bacterial, fungal, parasitic, or viral infection, especially measles, chickenpox, tuberculosis (TB), or herpes simplex of the eye if you have been recently vaccinated with a live or inactivated vaccine, or have had a positive TB skin test if you are having an attack of bronchospasm (tightening of the airway, difficulty breathing), or have diarrhea

Some MEDICINES MAY INTERACT with Azmacort Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, fluconazole, hydantoins (eg, phenytoin), lithium, rifampin, or thioamines (eg, propylthiouracil) because they may decrease Azmacort Aerosol's effectiveness Clarithromycin, itraconazole, oral contraceptives (birth control pills), or midazolam because the risk of side effects, such as nervous system or adrenal gland problems, may be increased Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), mifepristone, nondepolarizing muscle relaxants (eg, vecuronium), ritodrine, sympathomimetics (eg, albuterol, amphetamine, pseudoephedrine), or live vaccines because the risk of their side effects may be increased by Azmacort Aerosol Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), interleukin-2, or nondepolarizing muscle relaxants (eg, vecuronium) because their effectiveness may be decreased by Azmacort Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Azmacort Aerosol 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 Azmacort Aerosol:

Use Azmacort Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Azmacort Aerosol. Talk to your pharmacist if you have questions about this information. Before using Azmacort Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Azmacort Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes. Rinse your mouth or gargle with water after using Azmacort Aerosol to prevent mouth sores or bad taste. Each time a new inhaler is used, turn the canister away from the face and press down into the mouthpiece to release test sprays into the air. This process is called priming and will allow you to be sure the inhaler is working properly and will provide a full dose of medicine. Keep track of the number of sprays you use and subtract this number from the number of doses in the container. This will help you know when the container is becoming empty. If you miss a dose of Azmacort Aerosol, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azmacort Aerosol.

Important safety information: Azmacort Aerosol will not stop an asthma attack once it has started If you are also using a bronchodilator inhaler, be sure to always carry the inhaler with you to use during asthma attacks. After you begin using Azmacort Aerosol, a few weeks may pass before the full benefit is obtained. Continue to use it as directed during this time. Use caution if you switch from an oral steroid (eg, prednisone) to Azmacort Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur. Tell your doctor or dentist that you take Azmacort Aerosol before you receive any medical or dental care, emergency care, or surgery. If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Azmacort Aerosol. Use Azmacort Aerosol with extreme caution in CHILDREN. Azmacort Aerosol should not be used in CHILDREN younger than 6 years 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 Azmacort Aerosol while you are pregnant. It is not known if Azmacort Aerosol is found in breast milk. If you are or will be breast-feeding while you use Azmacort Aerosol, check with your doctor. Discuss any possible risks to your baby.

You may experience WITHDRAWAL when switching from an oral steroid medicine to an inhaled one. Contact your health care provider at once if the following symptoms occur: muscle and joint pain, exhaustion, depression.

Possible side effects of Azmacort Aerosol:

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:

Back pain; dry mouth; flu-like symptoms; headache, hoarseness; irritated or sore throat; sinus inflammation.

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); chest congestion; depression; exhaustion; fainting; muscle and joint pain; severe dizziness; sudden weight loss; unusual weakness; white, curd-like patches in mouth.

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: Azmacort 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 Azmacort Aerosol:

Store Azmacort Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Azmacort Aerosol out of the reach of children and away from pets.

General information: If you have any questions about Azmacort Aerosol, please talk with your doctor, pharmacist, or other health care provider. Azmacort Aerosol is 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 Azmacort Aerosol. 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 Azmacort resources Azmacort Side Effects (in more detail) Azmacort Use in Pregnancy & Breastfeeding Azmacort Drug Interactions Azmacort Support Group 0 Reviews for Azmacort - Add your own review/rating Compare Azmacort with other medications Asthma
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Triamcinolone Aerosol


Pronunciation: TRYE-am-SIHN-oh lohn
Generic Name: Triamcinolone
Brand Name: Azmacort
Triamcinolone Aerosol is used for:

Preventing or reducing the frequency and severity of bronchial asthma attacks. It will not stop an asthma attack once it has started. It may also be used for other conditions as determined by your doctor.

Triamcinolone Aerosol is a corticosteroid. It works by decreasing the irritation and swelling of the airways of the lung. This helps to control or prevent asthma symptoms.

Do NOT use Triamcinolone Aerosol if: you are allergic to any ingredient in Triamcinolone Aerosol you are currently taking mifepristone you are having an asthma attack

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

Before using Triamcinolone Aerosol:

Some medical conditions may interact with Triamcinolone Aerosol. 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 or have been recently exposed to a bacterial, fungal, parasitic, or viral infection, especially measles, chickenpox, tuberculosis (TB), or herpes simplex of the eye if you have been recently vaccinated with a live or inactivated vaccine, or have had a positive TB skin test if you are having an attack of bronchospasm (tightening of the airway, difficulty breathing), or have diarrhea

Some MEDICINES MAY INTERACT with Triamcinolone Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, fluconazole, hydantoins (eg, phenytoin), lithium, rifampin, or thioamines (eg, propylthiouracil) because they may decrease Triamcinolone Aerosol's effectiveness Clarithromycin, itraconazole, oral contraceptives (birth control pills), or midazolam because the risk of side effects, such as nervous system or adrenal gland problems, may be increased Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), mifepristone, nondepolarizing muscle relaxants (eg, vecuronium), ritodrine, sympathomimetics (eg, albuterol, amphetamine, pseudoephedrine), or live vaccines because the risk of their side effects may be increased by Triamcinolone Aerosol Anticholinesterases (eg, pyridostigmine), anticoagulants (eg, warfarin), interleukin-2, or nondepolarizing muscle relaxants (eg, vecuronium) because their effectiveness may be decreased by Triamcinolone Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triamcinolone Aerosol 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 Triamcinolone Aerosol:

Use Triamcinolone Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Triamcinolone Aerosol. Talk to your pharmacist if you have questions about this information. Before using Triamcinolone Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Triamcinolone Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes. Rinse your mouth or gargle with water after using Triamcinolone Aerosol to prevent mouth sores or bad taste. Each time a new inhaler is used, turn the canister away from the face and press down into the mouthpiece to release test sprays into the air. This process is called priming and will allow you to be sure the inhaler is working properly and will provide a full dose of medicine. Keep track of the number of sprays you use and subtract this number from the number of doses in the container. This will help you know when the container is becoming empty. If you miss a dose of Triamcinolone Aerosol, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Triamcinolone Aerosol.

Important safety information: Triamcinolone Aerosol will not stop an asthma attack once it has started If you are also using a bronchodilator inhaler, be sure to always carry the inhaler with you to use during asthma attacks. After you begin using Triamcinolone Aerosol, a few weeks may pass before the full benefit is obtained. Continue to use it as directed during this time. Use caution if you switch from an oral steroid (eg, prednisone) to Triamcinolone Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur. Tell your doctor or dentist that you take Triamcinolone Aerosol before you receive any medical or dental care, emergency care, or surgery. If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Triamcinolone Aerosol. Use Triamcinolone Aerosol with extreme caution in CHILDREN. Triamcinolone Aerosol should not be used in CHILDREN younger than 6 years 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 Triamcinolone Aerosol while you are pregnant. It is not known if Triamcinolone Aerosol is found in breast milk. If you are or will be breast-feeding while you use Triamcinolone Aerosol, check with your doctor. Discuss any possible risks to your baby.

You may experience WITHDRAWAL when switching from an oral steroid medicine to an inhaled one. Contact your health care provider at once if the following symptoms occur: muscle and joint pain, exhaustion, depression.

Possible side effects of Triamcinolone Aerosol:

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:

Back pain; dry mouth; flu-like symptoms; headache, hoarseness; irritated or sore throat; sinus inflammation.

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); chest congestion; depression; exhaustion; fainting; muscle and joint pain; severe dizziness; sudden weight loss; unusual weakness; white, curd-like patches in mouth.

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.

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 Triamcinolone Aerosol:

Store Triamcinolone Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Triamcinolone Aerosol out of the reach of children and away from pets.

General information: If you have any questions about Triamcinolone Aerosol, please talk with your doctor, pharmacist, or other health care provider. Triamcinolone Aerosol is 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 Triamcinolone Aerosol. 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 Triamcinolone resources Triamcinolone Use in Pregnancy & Breastfeeding Drug Images Triamcinolone Drug Interactions Triamcinolone Support Group 24 Reviews for Triamcinolone - Add your own review/rating Compare Triamcinolone with other medications Adrenocortical Insufficiency Allergic Reactions Alopecia Ankylosing Spondylitis Asthma Berylliosis Bursitis Chorioditis Chorioretinitis Conjunctivitis Dermal Necrosis, Prophylaxis Dermatitis Dermatological Disorders Erythroblastopenia Frozen Shoulder Gouty Arthritis Hay Fever Heart Failure Hemolytic Anemia Idiopathic Thrombocytopenic Purpura Iridocyclitis Iritis Keloids Keratitis Leukemia Lichen Planus Lichen Sclerosus Lichen Simplex Chronicus Loeffler's Syndrome Meningitis Nephrotic Syndrome Neuritis Osteoarthritis Pityriasis rubra pilaris Psoriasis Psoriatic Arthritis Rheumatoid Arthritis Sarcoidosis Synovitis Systemic Lupus Erythematosus Thrombocytopenia Idiopathic Uveitis
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Combivent Aerosol


Pronunciation: al-BUE-ter-ol/IP-ra-TROE-pee-um
Generic Name: Albuterol/Ipratropium
Brand Name: Combivent
Combivent Aerosol is used for:

Treating chronic obstructive pulmonary disease (COPD) in patients who require more than 1 bronchodilator.

Combivent Aerosol is a beta-adrenergic (sympathomimetic) and anticholinergic bronchodilator combination. It works by relaxing and widening the air passages, which helps you breathe more easily.

Do NOT use Combivent Aerosol if: you are allergic to any ingredient in Combivent Aerosol, or to atropine or similar medicines you are allergic to soya lecithin or related foods, such as soybean

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

Before using Combivent Aerosol:

Some medical conditions may interact with Combivent Aerosol. 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 (including peanuts) if you have a history of heart problems (eg, fast or irregular heartbeat, chest pain, low blood output), blood vessel problems, high blood pressure, or low blood potassium levels if you have a history of other lung or breathing problems (eg, asthma, hyperactive airway) if you have a history of an overactive thyroid, diabetes, seizures, liver or kidney problems, or an adrenal gland tumor (pheochromocytoma) if you have a history of an enlarged prostate, blockage or narrowing of the bladder, or glaucoma if you have had an unusual reaction to other sympathomimetic medicines (eg, pseudoephedrine) if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Combivent Aerosol. 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 potassium levels may be increased Anticholinergics (eg, bromocriptine, methscopolamine), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), MAOIs (eg, phenelzine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Combivent Aerosol's side effects Beta-blockers (eg, propranolol) because they may decrease Combivent Aerosol's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Combivent Aerosol 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 Combivent Aerosol:

Use Combivent Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Combivent Aerosol. Talk to your pharmacist if you have questions about this information. A health care provider will teach you how to use Combivent Aerosol at home. Be sure you understand how to use Combivent Aerosol. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Insert the metal canister into the clear end of the mouthpiece. Make sure the canister is fully and firmly inserted into the mouthpiece. The canister is only to be used with the mouthpiece provided. Do not use the mouthpiece with other medicines. Test spray Combivent Aerosol 3 times before the first use of a new canister and when the canister has not been used for more than 24 hours. Do NOT spray Combivent Aerosol in the eyes. Remove the orange dust cap from the mouthpiece before using Combivent Aerosol and replace it after you are finished. Shake well for at least 10 seconds before each use. Keep your eyes closed while using Combivent Aerosol to avoid getting it in your eyes. Breathe out slowly and completely through your mouth. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. As your start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Combivent Aerosol. Continue breathing in slowly and deeply and hold for 10 seconds, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait about 2 minutes and repeat the above steps. Keep the mouthpiece clean. Wash it with hot water. If soap is used, rinse well with plain water. Dry completely before using. Keep track of the number of sprays used. Throw the canister away after 200 sprays. After 200 sprays, the canister may not deliver the correct amount of medicine with each spray. Contact your health care provider at once if you feel you have taken too much of Combivent Aerosol. Continue to use Combivent Aerosol even if you feel well. Do not miss any doses. If you miss a dose of Combivent Aerosol, use it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Combivent Aerosol.

Important safety information: Combivent Aerosol is for use in the mouth only. Do not get Combivent Aerosol in your eyes. Getting it in your eyes may cause eye pain, redness, irritation, or discomfort; blurred vision or other vision changes; or worsening of narrow-angle glaucoma. If you get Combivent Aerosol in your eyes, rinse immediately with cool tap water. Check with your doctor if you develop any of these effects. Combivent Aerosol may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you use it with alcohol or certain medicines. Use Combivent Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Combivent Aerosol. If Combivent Aerosol stops working well, if your symptoms become worse, or if you need to use Combivent Aerosol more often than usual, contact your doctor right away. Combivent Aerosol may cause dry mouth or an unpleasant taste in your mouth. To prevent dry mouth, rinse your mouth and gargle after using Combivent Aerosol. If you experience dry mouth, use sugarless gum or candy, or melt bits of ice in your mouth. If you have any of these problems, ask your health care provider if a spacing device may help. Combivent Aerosol may sometimes cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister. If this happens, seek medical care at once. Tell your doctor or dentist that you use Combivent Aerosol before you receive any medical or dental care, emergency care, or surgery. Check with your doctor before using any other inhaled medicines while you are using Combivent Aerosol. Carry an ID card at all times that says you use Combivent Aerosol. Lab tests, including lung function tests, blood pressure, or potassium blood levels, may be performed while you use Combivent Aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. The contents of Combivent Aerosol are under pressure. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Combivent Aerosol should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Combivent Aerosol while you are pregnant. It is not known if Combivent Aerosol is found in breast milk. Do not breast-feed while using Combivent Aerosol. Possible side effects of Combivent Aerosol:

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:

Coughing; dizziness; dry mouth; headache; nausea; nervousness; sinus inflammation; sore throat; trouble sleeping; unusual taste in mouth.

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); burning, numbness, or tingling; clammy skin; difficult or painful urination; fainting; fast or irregular heartbeat; new or worsening breathing problems; numbness of an arm or leg; pain, tightness, or pressure in the jaw, neck, or chest; pounding in the chest; severe headache, nausea, vomiting, or dizziness; severe stomach pain; shortness of breath; swelling of the arms or legs; tremors; vision changes; wheezing.

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: Combivent 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. Symptoms may include chest pain; fast or irregular heartbeat; muscle pain, weakness, or cramping; severe headache or dizziness.

Proper storage of Combivent Aerosol:

Store Combivent Aerosol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid excessive humidity or direct sunlight. Contents are under pressure. Do not puncture. Exposure to heat above 120 degrees F (50 degrees C) may cause bursting. Do not use or store near heat or open flame. Never throw the container into a fire or incinerator. Keep Combivent Aerosol out of the reach of children and away from pets.

General information: If you have any questions about Combivent Aerosol, please talk with your doctor, pharmacist, or other health care provider. Combivent Aerosol is 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. If using Combivent Aerosol for an extended period of time, obtain refills before your supply runs out. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Combivent Aerosol. 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 Combivent resources Combivent Side Effects (in more detail) Combivent Use in Pregnancy & Breastfeeding Combivent Drug Interactions Combivent Support Group 7 Reviews for Combivent - Add your own review/rating Compare Combivent with other medications COPD, Maintenance
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Choletec



Dosage Form: injection, powder, lyophilized, for solution

For Diagnostic Use

Choletec Description

Each reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2•2H2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2•2H2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture.

The pH of the reconstituted product is 4.2 to 5.7.

The structure of mebrofenin (2,2’-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below:

When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection.

PHYSICAL CHARACTERISTICS

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.1 The principal photon that is useful for detection and imaging studies is listed in Table 1.

TABLE 1 Principal Radiation Emission Data Radiation Mean % per
Disintegration Mean Energy
(keV) 1Kocher, David C., “Radioactive Decay Data Tables”, DOE/ TIC-11026, (1981) p.108. Gamma-2 89.07 140.5 External Radiation

The specific gamma ray constant for Tc 99m is 0.78 R/hour-millicurie at 1 cm. The first half value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

TABLE 2 Radiation Attenuation by Lead Shielding Shield Thickness
(Pb) cm Coefficient
of Attenuation   0.017 0.5 0.08 10-1 0.16 10-2 0.25 10-3 0.33 10-4

To correct for physical decay of technetium Tc 99m, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

TABLE 3 Physical Decay Chart: Tc 99m half-life 6.02 hours Hours Fraction
Remaining Hours Fraction
Remaining *Calibration time 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 18 0.126 Choletec - Clinical Pharmacology

Mebrofenin is an iminodiacetic acid (HIDA) derivative with no known pharmacologic action at the recommended doses.

Following intravenous administration in normal subjects, Technetium Tc 99m Mebrofenin was rapidly cleared from the circulation. The mean percent injected dose remaining in the blood at 10 minutes was 17%. The injected activity was cleared through the hepatobiliary system with visualization of the liver by 5 minutes and maximum liver uptake occurring at 11 minutes post-injection. Hepatic duct and gallbladder visualization occurred by 10 to 15 minutes and intestinal activity was visualized by 30 to 60 minutes in subjects with normal hepatobiliary function. The mean percent injected dose excreted in the urine during the first 3 hours was 1% (0.4 to 2.0%).

Elevated serum bilirubin levels increase renal excretion of Tc 99m HIDA agents. In two studies in which Tc 99m Mebrofenin was administered to patients having mean elevated serum bilirubin levels of 9.8 mg/dL (1.7 to 46.3 mg/dL), the mean percent injected dose excreted in the urine during the first 3 hours was 3% (0.2 to 11.5%). The mean percent injected dose excreted in the urine during 3-24 hours was 14.9% (0.4 to 34.8%).

In jaundiced patients, the percent injected dose remaining in the blood at 10 minutes may be twice as high or more than the level in normals. Hepatobiliary transit may be delayed and visualization times increased. As a consequence, the quality of the images obtained frequently diminishes.

Indications and Usage for Choletec

Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

Contraindications

Hypersensitivity to this compound.

Warnings

The theoretical possibility of allergic reactions should be considered in patients who receive multiple doses.

Precautions General

Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Mebrofenin and are not to be administered directly to the patient.

Delayed or non-visualization of the gallbladder may occur in the immediate post-prandial period or after prolonged fasting or parenteral feeding. Functional biliary obstruction may accompany chronic cholecystitis or pancreatitis. In addition, patients with hepatocellular disease may show non-visualization or delayed visualization of the gallbladder. Delayed intestinal transit may also be noted in such patients. Juvenile hepatitis may be associated with gallbladder non-visualization and the failure to visualize activity in the intestine. Administration of meperidine or morphine may delay intestinal transit of the imaging agent and may result in nonvisualization. Septic patients may show absent or delayed hepatobiliary clearance. Thus, a positive finding does not of itself permit a differential diagnosis of any of the above conditions and should be evaluated in the light of the total clinical picture and results of other diagnostic modalities.

The components of the kit are supplied sterile and nonpyrogenic. Aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers should be used during the addition of the pertechnetate solution and the withdrawal of doses for patient administration.

The Technetium Tc 99m labeling reactions involved in preparing the agent depend on maintaining the stannous ion in the reduced state. Any oxidant present in the sodium pertechnetate Tc 99m supply may, thus, adversely affect the quality of the radiopharmaceutical. Hence, sodium pertechnetate Tc 99m containing oxidants should not be employed.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides.

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.

Tc 99m Mebrofenin should be formulated no more than 18 hours prior to clinical use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Mebrofenin may affect fertility in males or females.

Pregnancy Pregnancy Category C

Animal reproduction studies have not been conducted with Technetium Tc 99m Mebrofenin. It is also not known whether Technetium Tc 99m Mebrofenin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Mebrofenin should be given to a pregnant woman only if the expected benefits to be gained clearly outweigh the potential hazards.

Nursing Mothers

Technetium Tc 99m is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

Safety and effectiveness in children below the age of 18 have not be established.

Adverse Reactions

Urticaria and rash have been rarely reported with the use of Technetium Tc 99m Mebrofenin since market introduction. Rare cases of chills and nausea have been reported with related compounds. Infrequently, death has been reported in association with the use of this class of agents.

Choletec Dosage and Administration

The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:

Nonjaundiced patient: 74-185 MBq (2-5 mCi) Patient with serum
   bilirubin level greater
    than 1.5 mg/dL: 111-370 MBq (3-10 mCi)

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.

An interval of at least 24 hours should be allowed before repeat examination.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

RADIATION DOSIMETRY

The estimated absorbed radiation doses 1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4.

TABLE 4 Estimated Absorbed Radiation Doses†                  Normal Subjects*                        Severely
               Jaundiced Patients** Tissue mGy/
370 MBq rads/
10 mCi mGy/
370 MBq rads/
10 mCi †Method of Calculation: (1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S. Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332. (2) Values for S: “S”, Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975). * Bilirubin <1.5 mg/dL
Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. ** Bilirubin >10 mg/dL (mean 21.8 mg/dL)
Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity. Total Body   2.0 0.2   1.7 0.17 Liver   4.7 0.47   8.1 0.81 Gallbladder Wall 13.7 1.37 12.5 1.25 Small Intestine 29.9 2.99 16.0 1.60 Upper Large            Intestine Wall 47.4 4.74 24.8 2.48 Lower Large            Intestine Wall 36.4 3.64 19.7 1.97 Kidney   2.2 0.22   1.9 0.19 Urinary Bladder            Wall   2.9 0.29 24.2 2.42 Ovaries 10.1 1.01   6.4 0.64 Testes   0.5 0.05   1.1 0.11 Red Marrow   3.4 0.34   2.5 0.25 How is Choletec Supplied

Choletec (Kit for the Preparation of Technetium Tc 99m Mebrofenin) is supplied in kits of 10 reaction vials. Each vial contains a sterile, nonpyrogenic lyophilized mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF2•2H2O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF2•2H2O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH has been adjusted with hydrochloric acid or sodium hydroxide prior to lyophilization. The lyophilized vial contents are sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7.

Kit Contents

10 sterile multidose reaction vials.
20 pressure-sensitive labels for Technetium Tc 99m Mebrofenin.
1 package insert.

Preparation

Preparation of Technetium Tc 99m Mebrofenin is done by the following aseptic procedure:

Waterproof gloves should be worn during the preparation procedure. Place reaction vial in an appropriate lead shield. Swab the rubber closure of the reaction vial with a germicide. Inject 1 to 5 mL sterile additive free sodium pertechnetate Tc 99m injection containing up to 3700 MBq (100 mCi) Tc 99m into the reaction vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution.
NOTE: If sodium pertechnetate Tc 99m injection must be diluted for use with Choletec (Kit for the preparation of Technetium Tc 99m Mebrofenin), only preservative free Sodium Chloride Injection USP should be used. Secure the lead shield cover. Swirl the vial gently to mix contents and let stand for 15 minutes. Record the date and time of preparation on pressure-sensitive label. Affix pressure-sensitive label to shield. Examine vial contents. If the solution is not clear and free of particulate matter and discoloration on visual inspection, it should not be used. Measure the radioactivity by a suitable calibration system and record on the shield label prior to patient administration. Withdraw material with a sterile lead shielded syringe for use within 18 hours of preparation. Storage

Store the kit as supplied at 20-25°C (68-77°F) [See USP] prior to and following reconstitution. Use within 18 hours of reconstitution.

The U.S. Nuclear Regulatory Commission has approved this reagent kit for distribution to persons licensed to use byproduct material identified in §35.200 of 10 CFR Part 35, to persons who hold an equivalent license issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.

Manufactured for
Bracco Diagnostics Inc.
Princeton, NJ 08543
by
Hollister-Stier LLC
Spokane, WA 99207

May 2007
875015-H01


Choletec 
mebrofenin  injection, powder, lyophilized, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0270-0083 Route of Administration INTRAVENOUS DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength Mebrofenin (mebrofenin) Active 45 MILLIGRAM  In 1 VIAL Stannous Fluoride Dihydrate Inactive 0.54 MILLIGRAM  In 1 VIAL methylparaben Inactive 5.2 MILLIGRAM  In 1 VIAL propylparaben Inactive 0.58 MILLIGRAM  In 1 VIAL Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0270-0083-20 10 VIAL In 1 CARTON contains a VIAL 1 1 VIAL In 1 VIAL This package is contained within the CARTON (0270-0083-20)
Revised: 03/2008Bracco Diagnostics Inc. More Choletec resources Choletec Side Effects (in more detail) Choletec Support Group 0 Reviews · Be the first to review/rate this drug
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Hydro Ear Drops



Dosage Form: otic solution
Hydro Ear Drops Hydro Ear Drops Description

Each 1 mL for otic administration contains:

Hydrocortisone 10 mg

Pramoxine Hydrochloride 10 mg

Chloroxylenol 1 mg

Benzalkonium Chloride 0.10 mg

In a non-aqueous propylene glycol vehicle with 3% propylene glycol diacetate.

Chloroxylenol:

4-chloro-3.5 dimethylphenol is a broad spectrum bactericidal agent which occurs as white crystals with a phenolic odor. It is soluble in alcohol, ether, and alkali hydroxides.

Hydrocortisone:

11, 17, 21, trihydroxy, (11 b)-Pregn-4-ene-3,20-dione, is an anti-inflammatory and antipruritic agent. It occurs as a white to practically white, odorless, crystalline powder which melts at about 215 °C with decomposition. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform.

Pramoxine hydrochloride:

4[3-(4-butoxyphenoxy) propyl] - Morpholine hydrochloride is a topical anesthetic proven to be safe and effective in hospital tests. It occurs as a white to practically white, crystalline powder, having a numbing taste and it may have a slight aromatic odor. The pH of a solution (1 in 100) is about 4.5, it is freely soluble in water and in alcohol; soluble in chloroform; and very slightly soluble in ether.

Benzalkonium chloride:

Action lowers surface tension permitting greater penetration to meatal skin. It also is a cationic germicide of high bactericidal and bacteriostatic potency.

Hydro Ear Drops - Clinical Pharmacology

This product is effective both as an antibacterial and antifungal agent. The special base is a hydrophilic solution having an acid pH and a low surface tension, exerting a drying effect and allowing the medication to spread quickly to all contiguous surfaces, softening and reducing accumulated cerumen.

Chloroxylenol is a halogenated phenol, non-toxic, non-corrosive, non-staining with a high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood.

Hydrocortisone is a topical corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the corticosteroids is unclear. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membranes of nerve endings with which it comes into contact.

Indications and Usage for Hydro Ear Drops

For the treatment of superficial infections of the external auditory canal complicated by inflammation caused by organisms and susceptible to the action of the antimicrobial. May also be used to control itching in the auditory canal.

Contraindications

Topical steroids are contraindicated in varicella, vaccinia and patients sensitive to any of the components of this preparation. This or any medication should not be applied in the external auditory canal of patients with perforated eardrums.

Warnings

This preparation is not intended for ophthalmic or oral use. If accidental ingestion occurs, seek professional help. If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

Precautions General

If a favorable response does not occur promptly, discontinue the use of this preparation until the infection is controlled by other appropriate measures. Although systemic side effects are not common with topical corticosteroids, the possibility of occurrence must be kept in mind particularly when used for an extended period of time.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glycosuria in some patients. Conditions which augment systemic absorption include the application of more potent steroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental corticosteroids. Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric use).

Information for patients

Patients using topical corticosteroids should receive the following information and instructions:

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. Patients should report any signs of local adverse reactions. Laboratory tests

The urinary free cortisol test and the ACTH stimulation test may be helpful in evaluating the HPA axis suppression.

Carcinogenesis, mutagenesis, impairment of fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect of topical corticosteroids on fertility. Studies to determine mutagenicity with prednisone and hydrocortisone have revealed negative results.

Pregnancy

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients in large amounts, or for prolonged periods of time.

Nursing mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced Hypothalmic-pituitary-adrenal axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface to body weight ratio. HPA axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestation of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Drug Interactions

Interaction of other drugs with the hydrocortisone component of this product is possible. Inform your physician of other medication you are currently taking.

Adverse Reactions

The following adverse reactions with topical corticosteroids have been observed: itching, burning, irritation, dryness, folliculitis, hypertrichosis, acneform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects.

Hydro Ear Drops Dosage and Administration

The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 to 5 drops of the solution should be instilled into the affected ear 3 or 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward to instill the drops and this position maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

How is Hydro Ear Drops Supplied

Hydrocortisone, Pramoxine HCl, Chloroxylenol and Benzalkonium Chloride Ear Drops are supplied in 15ml amber glass bottles with dosage dropper.

Storage

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light. Dispense in original container.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only


Mfg. by

Hi-Tech Pharmacal Co., Inc.,

Amityville, NY 11701


Rev 719:00 07/05

MG #21467


PRINCIPAL DISPLAY PANEL Container Label Carton
Hydro Ear Drops 
hydrocortisone, pramoxine hcl, chloroxylenol and benzalkonium chloride ear drops  solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-719 (50383-719) Route of Administration AURICULAR (OTIC) DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg  in 1 mL PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 mL CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 1 mg  in 1 mL BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.1 mg  in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   PROPYLENE GLYCOL DIACETATE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 50383-719-15 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 15 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (50383-719-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved other 08/01/2002
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749) Revised: 09/2009Hi-Tech Pharmacal Co., Inc.
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Fostair 100 / 6 inhalation solution


Fostair 100/6 micrograms per actuation pressurised inhalation solution

beclometasone dipropionate/formoterol fumarate dihydrate.

For use in adults.

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

1. What Fostair is and what it is used for
2. Before you use Fostair
3. How to use Fostair
4. Possible side effects
5. How to store Fostair
6. Further information

What Fostair is and what it is used for

Fostair is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs.

The two active substances are beclometasone dipropionate and formoterol fumarate dihydrate. Beclometasone dipropionate belongs to a group of medicines called corticosteroids which are often referred to simply as steroids and have an anti-inflammatory action reducing the swelling and irritation in the walls of the small air passages in the lungs. Steroids are used in asthma to help treat symptoms and prevent symptoms.

Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators which relax the muscles in your airways and by doing this widen the airways which makes it easier for you to breathe air in and out of your lungs.

Together these two active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in patients with asthma and also help to prevent the symptoms of asthma.

Fostair is indicated in the regular treatment of people with asthma in whom:

asthma is not adequately controlled by using inhaled corticosteroids and ‘as needed’ short-acting bronchodilators.

or

asthma is responding well to treatment with both corticosteroids and long-acting bronchodilators. Before you use Fostair Do not use Fostair: do NOT use this medicine to treat sudden symptoms of asthma such as shortness of breath, wheezing and cough or for asthma which is getting worse or for sudden acute asthma attacks. It will not help you and it will not provide immediate relief of your symptoms. To relieve your symptoms use your quick acting ‘reliever’ inhaler which you must carry with you at all times. (Your ‘reliever’ inhaler is a quick acting bronchodilator which should provide rapid relief of acute asthma symptoms). if you are allergic or think you are allergic to one or other of the active ingredients of Fostair or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of Fostair (see section 6: Further Information), contact your doctor for advice. Take special care with Fostair

Always tell your doctor before using Fostair:

if you have any heart problems, such as angina (heart pain, pain in the chest), a recent heart attack (myocardial infarction), heart failure, narrowing of the arteries around your heart (coronary heart disease), valvular heart disease or any other known abnormalities of your heart or if you have a condition known as hypertrophic obstructive cardiomyopathy (also known as HOCM, a condition where the heart muscle is abnormal). if you have a narrowing of the arteries (also known as arteriosclerosis), if you have high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall). if you have disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations or if you have been told that your heart trace is abnormal. if you have an overactive thyroid gland if you have low blood levels of potassium if you have any disease of your liver or kidneys if you have diabetes (if you inhale high doses of formoterol your blood glucose may increase and therefore you may need to have some additional blood tests to check your blood sugar when you start using this inhaler and from time to time during treatment). if you have a tumour of the adrenal gland (known as phaeochromocytoma). if you are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Fostair at least 12 hours before the anaesthesia. if you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal infection of your chest. if you must avoid alcohol for any reason.

If any of the above apply to you, always inform your doctor before you use Fostair.

If you have or have had any medical problems or any allergies or if you are not sure as to whether you can use Fostair talk to your doctor, asthma nurse or pharmacist before using the inhaler.

Treatment with a beta-2-agonist like the formoterol contained in Fostair can cause a sharp fall in your serum potassium level (hypokalaemia).

If you have severe asthma, you must take special care. This is because a lack of oxygen in the blood and some other treatments you may be taking together with Fostair, such as medicines for treating heart disease or high blood pressure, known as diuretics or ‘water tablets’ or other medicines used to treat asthma can make the fall in potassium level worse. For this reason your doctor may wish to measure the potassium levels in your blood from time to time.

If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation. In this case, the doctor treating you will decide whether you need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.

Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Fostair and any medicines or tablets bought without a prescription, in their original package, if possible.

Using Fostair with other medicines:

Before starting treatment, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any other inhalers and including medicines obtained without a prescription.

Do not use beta blockers with this medicine. Beta blockers such as atenolol, propranolol and sotalol are used to treat a number of conditions including high blood pressure and heart conditions such as abnormal heart rhythms and heart failure; timolol is used to treat glaucoma. If you need to use beta blockers, and including beta blockers in eye-drops, the effect of formoterol may be reduced or formoterol may not work at all. On the other hand, using other beta adrenergic drugs (drugs which work in the same way as formoterol) may increase the effects of formoterol.

Using Fostair together with:

medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitryptiline and imipramine), phenothiazines, can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias). medicines for treating Parkinson’s Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contractions) and alcohol can lower your heart’s tolerance to beta-2-agonists, such as formoterol. monoamine oxidase inhibitors (MAOIs), including drugs with similar properties like furazolidone and procarbazine, used to treat mental disorders, can cause a rise in blood pressure. medicines for treating heart disease (digoxin) can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms. other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets) may cause a fall in your potassium level. some anaesthetics can increase the risk of abnormal heart rhythms. Pregnancy and breast-feeding:

There are no clinical data on the use of Fostair during pregnancy.

Fostair must not be used if you are pregnant, think that you might be pregnant or are planning to become pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor.

Driving and using machines:

Fostair is unlikely to affect your ability to drive and use machines.

Important information about some of the ingredients of Fostair:

Fostair contains a small amount of alcohol. Each actuation (puff) from your inhaler contains 7mg of ethanol.

How to use Fostair

Fostair is for inhalation use. Fostair should be inhaled via your mouth into your lungs.

Always use Fostair exactly as your doctor has told you to. You must check with your doctor or pharmacist if you are not sure. The pharmacist’s label will tell you how many puffs to take and how often they must be taken.

Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Fostair. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms. Under no circumstances must you change the dose without first speaking to your doctor.

Adults and the elderly:

The usual dose of this medicine is one or two puffs twice daily.

The maximum daily dose is 4 puffs.

Children and adolescents less than 18 years of age:

Children and adolescents aged less than 18 years must NOT take this medicine.

At-risk patients:

Older people do not need to have their dose adjusted. No information is avaliable regarding the use of Fostair in people with liver or kidney problems.

Fostair is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing beclometasone dipropionate. If you have been using a different inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of Fostair you should take for your asthma.

Remember: you must always have your quick-acting ‘reliever’ inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.

Do not increase the dose

If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.

If you use more Fostair than you should: Taking more formoterol than you should can have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels. Taking too much beclometasone dipropionate can lead to short term problems with your adrenal glands. This will get better within a few days however, your doctor may need to carry out some blood tests to check your serum cortisol levels.

Tell your doctor if you have any of the above symptoms.

If you forget to use Fostair:

Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not double the dose.

If you stop using Fostair:

Do not lower the dose or stop using your medication.

Even if you are feeling better, do not stop using Fostair or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Fostair regularly even though you may have no symptoms.

If your breathing gets worse:

If you develop worsening shortness of breath or wheezing (breathing with an audible whistling sound), straight after inhaling your medicine, stop using your Fostair inhaler immediately and use your quick acting ‘reliever’ inhaler straightaway. You should contact your doctor straightaway. Your doctor will assess your symptoms and if necessary may start you on a different course of treatment. You may be told that you should not use Fostair again. You should always carry your ‘reliever’ inhaler with you at all times.

Shortness of breath and wheezing which occurs immediately after using your inhaler is caused by acute narrowing of the airways in your lungs and is known as paradoxical bronchospasm. See also section 4: Possible side effects.

If your asthma gets worse:

If your symptoms get worse or are difficult to control (e.g. if you are using your ‘reliever’ inhaler more frequently or if your ‘reliever’ inhaler does not improve your symptoms), see your doctor immediately. Your asthma may be getting worse and your doctor may need to increase your dose of Fostair or prescribe alternative treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Instructions for use:

Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, release one puff into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an upright position when inhaling.

1. Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. Breathe out as slowly and deeply as possible.
3. Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the mouthpiece.
4. Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down on the top of the inhaler to release one puff.

5. Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler. After use, close with the protective cap.

If you need to take another puff, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5.

Important: Do not perform steps 2 to 5 too quickly.

If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth, this means that Fostair will not be getting into your lungs as it should. Take another puff, carefully following the instructions from Step 2 onwards.

If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.

To lower the risk of a fungal infection in the mouth and throat, rinse your mouth or gargle with water or brush your teeth each time you use the inhaler.

If you think the effect of Fostair is too much or not enough, tell your doctor or pharmacist.

If you find it difficult to operate the inhaler while starting to breathe in you may use the Aero-Chamber Plus spacer device. Ask your doctor, pharmacist or a nurse about this device.

Cleaning:

Remove the cap from the mouthpiece and regularly (once a week) wipe the outside and inside of the mouthpiece with a dry cloth. Do not use water or other liquids to clean the mouthpiece.

It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you follow the instructions on how to use the AeroChamber Plus spacer device and how to clean it carefully.

Possible side effects

Like all medicines Fostair can cause side effects although not everybody gets them. Possible side effects are listed below according to their frequency.

As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using Fostair and this is known as paradoxical bronchospasm. If this occurs you must STOP using Fostair immediately and use your quick acting ‘reliever’ inhaler straightaway to treat the symptoms of shortness of breath and wheezing. You must contact your doctor straight away. Your doctor is likely to assess your asthma and if necessary may start you on another course of treatment. You may be told that you must not use Fostair again.

Common (affecting less than 1 in 10 people):

Headache, hoarseness, sore throat.

Uncommon (affecting less than 1 in 100 people):

palpitations unusual fast heart beat and disorders of heart rhythm some changes in the electrocardiogram (ECG) flu symptoms fungal infections of the mouth and throat fungal infections of the vagina inflammation of the sinuses rhinitis inflammation of the ear throat irritation asthma attack cough and productive cough nausea abnormal or impaired sense of taste burning of the lips dry mouth swallowing difficulties indigestion upset stomach diarrhoea pain in muscle and muscle cramps reddening of the face increased blood flow to some tissues in the body excessive sweating trembling restlessness dizziness

Alterations of some constituents of the blood:

fall in the number of white blood cells increase in the number of blood platelets a fall in the level of potassium in the blood increase in blood sugar level increase in the blood level of insulin, free fatty acid and ketones

Rare (affecting less than 1 in 1,000 people):

tightness in the chest sensation of a missed heartbeat increase or decrease in blood pressure inflammation of the kidney nettle rash or hives swelling of the skin and mucous membrane persisting for several days

Very rare (affecting less than 1 in 10,000 people):

irregular heartbeat shortness of breath worsening of asthma abnormal behaviour sleep disorders and hallucinations a fall in the number of blood platelets swelling of the hands and feet

Using high-dose inhaled corticosteroids over a long time can cause, in very rare cases, systemic effects. These include:

problems with how your adrenal glands work (adrenosuppression) decrease in bone mineral density (thinning of the bones) growth retardation (slowing of growth) in children and adolescents increased pressure in your eyes (glaucoma) cataracts Hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat

If you experience any of the above side effects and they cause you distress, are severe or last for several days, or if you feel unwell or notice anything unusual or a side effect which is not mentioned in this leaflet, or if you are worried in any way or if there is anything you do not understand, you should contact your doctor or pharmacist immediately.

How to store Fostair Keep out of the reach and sight of children. Do not use Fostair beyond five months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label. Do not store the inhaler above 25°C. If the inhaler has been exposed to severe cold, take the canister out of the mouthpiece and warm it with your hands for a few minutes before using. Never warm it by artificial means. Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50°C. Do not pierce the canister. Medicines should not be disposed of via waste water or household waste. Return all used, partially used and unused inhalers to your pharmacist to be disposed of.
These measures will help to protect the environment. Further information What Fostair contains:

The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.

Each actuation/metered dose from the inhaler contains 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.

This corresponds to a delivered dose from the mouthpiece of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoterol fumarate dihydrate.

The other ingredients are: ethanol anhydrous, hydrochloric acid and the CFC-free propellant - Norflurane (HFA-134a). To help protect the environment, the inhaler contains the CFC-free propellant, HFA-134a, which replaces completely the chlorofluorocarbon (CFC) propellants present in some other inhalers and appears to have a less damaging effect on the ozone layer. Fostair does not contain CFCs.

What Fostair looks like and contents of the pack:

Fostair is a pressurised solution contained in an aluminium canister with a metering valve, fitted in a polypropylene plastic actuator with a plastic protective cap.

Each pack contains one canister which provides 120 or 180 actuations (puffs).

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Chiesi Limited Cheadle Royal Business Park Highfield Cheadle SK8 3GY

Manufacturer:

Chiesi Farmaceutici S.p.A. Via Palermo 26/A I-43100 Parma Italy

This medicinal product is authorised in the member states of the EEA under the following names:

Austria FOSTER
France FOSTAIR
Germany KANTOS
Greece FOSTER
Hungary FOSTER
Italy FOSTER
Spain FOSTER
Belgium FOSTER
Czech Republic COMBAIR
Slovakia FOSTER
Poland FOSTEX
Portugal FOSTER
Slovenia FOSTER
The Netherlands FOSTER
UK FOSTAIR
Luxembourg FOSTER

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.

This leaflet was last approved in: 07/2010

CP0029/4

87R78.02/01


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