Provera Tablets 100 mg, Provera Tablets 200 mg & Provera Tablets 400 mg


1. Name Of The Medicinal Product

Provera Tablets 100 mg or Medroxyprogesterone Acetate Tablets 100 mg.

Provera Tablets 200 mg or Medroxyprogesterone Acetate Tablets 200 mg.

Provera® Tablets 400 mg

2. Qualitative And Quantitative Composition

1 tablet contains 100mg medroxyprogesterone acetate.

1 tablet contains 200 mg medroxyprogesterone acetate.

1 tablet contains 400 mg medroxyprogesterone acetate.

For excipients, see 6.1.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars 4.1 Therapeutic Indications

Progestogen indicated for the treatment of certain hormone dependant neoplasms, such as:

1. Endometrial carcinoma.

2. Renal cell carcinoma.

3. Carcinoma of breast in post menopausal women.

4.2 Posology And Method Of Administration

Route of administration: Oral.

Adults

Endometrial and renal cell carcinoma

200 - 600 mg daily

Breast carcinoma

400 - 1500 mg daily

The incidence of minor side-effects, such as indigestion and weight gain, increase with the increase in dose.

Response to hormonal therapy may not be evident until after at least 8-10 weeks of therapy.

Elderly patients : This product has been used primarily in the older age group for the treatment of malignancies. There is no evidence to suggest that the older age group is any less prepared to handle the drug metabolically than is the younger patient. Therefore the same dosage, contra-indications, and precautions would apply to either age group.

Children:The product is not anticipated for paediatric use in the indications recommended.

4.3 Contraindications

Medroxyprogesterone acetate is contraindicated in the following conditions:

• thrombophlebitis, thrombo-embolic disorders, and where there is a high risk of developing such manifestations [presence or history of atrial fibrillation, valvular disorders, endocarditis, heart failure, pulmonary embolism; thrombo-embolic ischaemic attack (TIA), cerebral infarction; atherosclerosis; immediate post surgery period]

• hypercalcaemia in patients with osseous metastases

• known sensitivity to medroxyprogesterone acetate or any component of the drug.

• impaired liver function or active liver disease.

• missed abortion, metrorrhagia, known or suspected pregnancy.

• undiagnosed vaginal bleeding.

• previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism).

active or recent arterial thromboembolic disease (e.g., angina, myocardial infarction).

• suspected or early breast carcinoma

Progestogens are known to be porphyrogenic. Patients with a history of attacks or aged under 30 are at greatest risk of an acute attack while on progesterone treatment. A careful assessment of potential benefit should be made where this risk is present.

4.4 Special Warnings And Precautions For Use

Warnings:

In the treatment of carcinoma of breast occasional cases of hypercalcaemia have been reported.

Unexpected vaginal bleeding during therapy with medroxyprogesterone acetate should be investigated.

Medication should not be readministered pending examination if there is sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilloedema or retinal vascular lesions, medication should not be readministered.

Medroxyprogesterone acetate may produce Cushingoid symptoms.

Some patients receiving medroxyprogesterone acetate may exhibit suppressed adrenal function. Medroxyprogesterone acetate may decrease ACTH and hydrocortisone blood levels.

Treatment with medroxyprogesterone acetate should be discontinued in the event of:

• jaundice or deterioration in liver function

• significant increase in blood pressure

• new onset of migraine-type headache

Precautions:

Animal studies show that Provera possesses adrenocorticoid activity. This has also been reported in man, therefore patients receiving large doses continuously and for long periods should be observed closely for signs normally associated with adrenocorticoid therapy, such as hypertension, sodium retention, oedema, etc. Care is needed in treating patients with diabetes and/or arterial hypertension.

Before using Provera the general medical condition of the patient should be carefully evaluated.

This product should be used under the supervision of a specialist and the patient kept under regular surveillance.

Patients with the following conditions should be carefully monitored while taking progestogens:

• Conditions which may be influenced by potential fluid retention

o Epilepsy

o Migraine

o Asthma

o Cardiac dysfunction

o Renal dysfunction

• History of mental depression

• Diabetes (a decrease in glucose tolerance has been observed in some patients).

• Hyperlipidaemia

The pathologist (laboratory) should be informed of the patient's use of medroxyprogesterone acetate if endometrial or endocervical tissue is submitted for examination.

The physician/laboratory should be informed that medroxyprogesterone acetate may decrease the levels of the following endocrine biomarkers:

• Plasma/urinary steroids (e.g., cortisol, oestrogen, pregnanediol, progesterone, testosterone)

• Plasma/urinary gonadotrophins (e.g., LH and FSH)

• Sex-hormone-binding-globulin

The use of medroxyprogesterone acetate in oncology indications may also cause partial adrenal insufficiency (decrease in pituitary-adrenal axis response) during Metyrapone testing. Thus the ability of adrenal cortex to respond to ACTH should be demonstrated before metyrapone is administered.

Although medroxyprogesterone acetate has not been causally associated with the induction of thromboembolic disorders, any patient with a history or who develops this kind of event while undergoing therapy with medroxyprogesterone acetate should have her status and need for treatment carefully assessed before continuing therapy.

Risk of venous thromboembolism (VTE)

The risk of VTE has not been assessed for progesterone alone. However, VTE is a known risk factor of oestrogen-only and combined hormone replacement therapy. When prescribing medroxyprogesterone acetate for oncology indications the following precautions and risk factors should be considered in the light of the patient's condition, the dose of medroxyprogesterone acetate and the duration of therapy:

• Generally recognised risk factors for VTE include a personal or family history of VTE or known thromboembolic states, severe obesity (BMI > 30 kg/m2) and systemic lupus erythematosus

• The risk of VTE may be temporarily increased with prolonged immobilisation, major trauma or major surgery.

• If VTE develops after initiating therapy, medroxyprogesterone acetate should be discontinued. Patients should be told to contact their doctor immediately if they become aware of a symptom suggestive of potential thromboembolism (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction with other medicaments

The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz,).

Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore be reduced.

Aminoglutethimide has been reported to decrease plasma levels of some progestogens.

Concurrent administration of ciclosporin and MPA has been reported to lead to increased plasma ciclosporin levels and/or decreased plasma MPA levels.

Interactions with oral anti-coagulants have been reported rarely, but causality has not been established.

When used in combination with cytotoxic drugs, it is possible that progestogens may reduce the haematological toxicity of chemotherapy.

Special care should be taken when progestogens are administered with other drugs which also cause fluid retention, such as NSAIDs and vasodilators.

Other forms of interaction

Progestogens can influence certain laboratory tests (e.g., tests for hepatic function, thyroid function and coagulation).

4.6 Pregnancy And Lactation

Pregnancy

Medroxyprogesterone acetate is contraindicated in women who are pregnant. If medroxyprogesterone acetate is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the foetus.

Some reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female foetuses.

Infants from unintentional pregnancies that occur 1 to 2 months after injection of medroxyprogesterone acetate injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because pregnancies while on medroxyprogesterone acetate are uncommon.

Lactation

Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk. Therefore, the use of Provera whilst breast-feeding is not recommended.

4.7 Effects On Ability To Drive And Use Machines

No adverse effect has been reported.

4.8 Undesirable Effects

Reactions occasionally associated with the use of progestogens, particularly in high doses, are:

Breast: Tenderness, mastodynia or galactorrhoea.

Genitourinary: Abnormal uterine bleeding (irregular, increase, decrease), amenorrhoea, alterations of cervical secretions, cervical erosions, prolonged anovulation.

Central nervous system: Confusion, euphoria, loss of concentration, nervousness, insomnia, somnolence, fatigue, dizziness, depression, vision disorders and headache.

Skin and mucous membranes: Sensitivity reactions ranging from pruritus, urticaria, angioneurotic oedema, to generalised rash and anaphylaxis have occasionally been reported. Acne, alopecia or hirsutism have been reported in a few cases.

Allergy: Hypersensitivity reactions (e.g., anaphylaxis or anaphylactoid reactions, angioedema).

Gastro-intestinal/hepatobiliary: Constipation, diarrhoea, dry mouth, disturbed liver function, jaundice, vomiting, nausea and indigestion .

Metabolic and nutritional: Adrenergic-like effects (e.g., fine hand tremors, sweating, tremors, cramps in calves at night), corticoid-like effects (e.g., Cushingoid Syndrome), decreased glucose tolerance, diabetic cataract, exacerbation of diabetes mellitus, glycosuria.

Cardiovascular: Cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitations, pulmonary embolism, retinal thrombosis, tachycardia, thromboembolic disorders, thrombophlebitis.

Haematological: Elevation of white blood cells and platelet count.

Miscellaneous: Change in appetite, change in libido, oedema/fluid retention, hypercalcaemia, malaise, hyperpyrexia, weight gain, moon facies.

4.9 Overdose

No action required other than cessation of therapy.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Progestogens. ATC Code: L02A B

Medroxyprogesterone acetate has the pharmacological action of a progestogen.

5.2 Pharmacokinetic Properties

Medroxyprogesterone acetate is absorbed from the gastro intestinal tract with a single oral dose of 10-250 mg. The time taken to reach the peak serum concentration (Tmax) was 2-6 hours and the average peak serum concentration (Cmax) was 13-46.89 mg/ml.

Unmetabolised medroxyprogesterone acetate is highly plasma protein bound. Medroxyprogesterone acetate is metabolised in the liver.

Medroxyprogesterone acetate is primarily metabolised by faecal excretion as glucuronide conjugated metabolite.

Metabolised medroxyprogesterone acetate is excreted more rapidly and in a greater percentage following oral doses than after aqueous intramuscular injection

400 mg only:

The comparative bioavailability of medroxyprogesterone acetate (MPA) in sixteen healthy male volunteers was determined following the oral ingestion of 400 mg MPA as two Provera 200 mg tablets or as one Provera 400mg tablet. It is concluded that the bioavailability appeared to be equivalent in this group of volunteers.

5.3 Preclinical Safety Data

No further preclinical safety data available.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose

Maize Starch

Byco C

Macrogol 400

Sodium starch glycollate

Docusate sodium

Sodium benzoate

Magnesium stearate

Isopropyl alcohol

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Provera 100mg: 36 months if stored in glass/HDPE bottles, or 24 month in blister packs.

Provera 200mg: 36 months if stored in glass/HDPE bottles, or 24 month in blister packs.

Provera 400mg: The shelf-life for Provera Tablets 400 mg is 36 months

6.4 Special Precautions For Storage

Provera 100mg: Store below 25°C. Bottle packs only: keep in a well closed container.

Provera 200mg: Store below 25°C.Bottle packs only: keep in a well closed container.

Provera 400mg: Store at controlled room temperature (15 - 30?C).Bottle packs only: keep in a well closed container.

6.5 Nature And Contents Of Container

Provera 100mg: Amber glass bottle with screw cap containing 100 tablets. HDPE bottle with tamper evident cap containing 100 tablets. PVC/aluminium strip containing 30, 60 or 100 tablets.

Provera 200mg: Amber glass bottle with screw cap containing 100 tablets. HDPE bottle with tamper evident cap containing 100 tablets. PVC/aluminium strip containing 30, 60 or 100 tablets.

Provera 400mg: Glass/HDPE bottles of 60 tablets. PVC aluminium blisters of 30 tablets

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

8. Marketing Authorisation Number(S)

Provera 100mg: PL 0032/0111

Provera 200mg: PL 0032/0112

Provera 400mg: PL 0032/0131

9. Date Of First Authorisation/Renewal Of The Authorisation

Provera 100mg: 7 November 1983/30 January 1996

Provera 200mg: 7 November 1983/30 January 1996

Provera 400mg: Date of first authorisation: 29 April 1986. Date of renewal of authorisation: 21 May 1998

10. Date Of Revision Of The Text

August 2007

LEGAL CATEGORY

POM

Company Reference: PVB1_0


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Birth Control (Contraception) Medications


Definition of Birth Control: The prevention of conception or impregnation. More...

Drugs associated with Birth Control

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

See sub-topics

Topics under Birth Control Emergency Contraception (14 drugs) Learn more about Birth Control (Contraception)

Medical Encyclopedia:

Birth control and family planning Emergency contraception Over-the-counter birth control
Drug List: Alesse Altavera Amethia Amethia-Lo Amethyst Apri Aranelle Aviane Balziva Beyaz Brevicon Briellyn Camila Camrese Caziant Cesia Cryselle-28 Cyclafem-1-35 Cyclafem-7-7-7 Cyclessa Demulen Depo-Provera Depo-Provera-Contraceptive-Injectable Depo-Subq-Provera-104-Injectable-Suspension-Subcutaneous Desogen Ella Emoquette Enpresse Errin Estrostep-Fe Femcon-Fe-Chewable-Tablets Femhrt Generess-Fe Genora-1-35 Gianvi Gildess-Fe-1-5-0-03 Gildess-Fe-1-0-2 Implanon Jenest Jevantique Jolessa Jolivette Junel-1-5-30 Junel-1-20 Junel-Fe-1-5-30 Junel-Fe-1-20 Kariva Kelnor Leena Lessina Levlen Levlite Levonest Levora Lo-Loestrin-Fe Lo-Ovral Lo-Ovral-28 Loestrin-1-20 Loestrin-21-1-5-30 Loestrin-21-1-20 Loestrin_24_Fe Loestrin-Fe-1-5-30 Loestrin-Fe-1-20 Loryna Loseasonique Low-Ogestrel Low-Ogestrel-28 Lunelle Lutera Lybrel Microgestin-1-5-30 Microgestin-1-20 Microgestin-Fe-1-5-30 Microgestin-Fe-1-20 Mircette Mirena Modicon Mononessa Natazia Necon-0-5-35 Necon-1-35 Necon-1-50 Necon-10-11 Necon-7-7-7 Nelova-0-5-35 Nexplanon Nor-Qd Nora-Be Nordette Norethin-1-35-E Norinyl-1-35 Norinyl-1-50 Norplant-System Nortrel-0-5-35 Nortrel-1-35 Nortrel-7-7-7 Nuvaring Ocella Ogestrel Ogestrel-28 Orsythia Ortho_Cyclen Ortho_Evra Ortho-Micronor Ortho-Tri-Cyclen Ortho-Tri-Cyclen-Lo Ortho-Cept Ortho-Novum-1-35 Ortho-Novum-1-50 Ortho-Novum-7-7-7 Ovcon-35 Ovcon-35-Fe Ovcon-50 Portia Previfem Provera Quasense-Extended-Cycle Reclipsen Safyral Seasonale Seasonique Solia Sprintec Sronyx Syeda Tilia-Fe Tri-Legest Tri-Legest-Fe Tri-Levlen Tri-Lo-Sprintec Tri-Norinyl Tri-Previfem Tri-Sprintec Trinessa Trinessa-Lo Triphasil Triphasil-21 Triphasil-28 Trivora Trivora-28 Velivet Vestura Yasmin Yaz Zarah Zenchent Zenchent-Fe Zeosa Zovia Zovia-1-35 Zovia-1-50
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Contraceptives


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.

Contraceptives are used to prevent unwanted pregnancy. Hormonal contraceptives consist of one or more synthetic female sex hormones (estrogen and progestin or progestin only). These sex hormones prevent pregnancy by blocking the normal process of ovulation. They may also alter the lining of the uterus (endometrium) so that it is unable to support a fertilized egg and they change the mucus in the cervix so that it is hard for the sperm to travel hence conception is less likely should ovulation occur.

These hormones are either taken as regular doses in pill form (oral contraceptives), or are administered through the skin by means of a patch impregnated with hormones. They can also be given by three monthly injections of a long acting progestin, or by subcutaneous implants of progestin. They are also available as hormonal intrauterine devices and vaginal rings.

See also

Medical conditions associated with contraceptives:

Abnormal Uterine Bleeding Acne Amenorrhea Birth Control Emergency Contraception Endometrial Cancer Endometrial Hyperplasia, Prophylaxis Endometriosis Gonadotropin Inhibition Menstrual Disorders Ovarian Cysts Polycystic Ovary Syndrome Postmenopausal Symptoms Premenstrual Dysphoric Disorder Premenstrual Syndrome Prevention of Osteoporosis Renal Cell Carcinoma Drug List: Junel-1-5-30 Nordette Norinyl-1-35 Zeosa Plan-B Triphasil Ortho-Novum-1-35 Loestrin-1-20 Plan-B-One-Step Demulen Zarah Ovcon-35 Trivora Lybrel Low-Ogestrel-28 Necon-1-35 Ortho-Novum-7-7-7 Aranelle Gildess-Fe-1-5-0-03 Modicon Nexplanon Next-Choice Tri-Legest-Fe Ortho_Cyclen Lutera Ortho_Evra Junel-1-20 Seasonale Yasmin Femcon-Fe-Chewable-Tablets Lo-Ovral Mircette Desogen Lo-Loestrin-Fe Low-Ogestrel Nora-Be Microgestin-1-20 Camila Kelnor Mirena Nuvaring Portia Provera Aviane Quasense-Extended-Cycle Trinessa Jolessa Lo-Ovral-28 Mononessa Yaz Alesse Beyaz Cryselle-28 Kariva Levlen Ocella Depo-Provera-Contraceptive-Injectable Loestrin_24_Fe Microgestin-Fe-1-5-30 Apri Aygestin Implanon Zovia-1-35 Depo-Provera Femhrt Ortho-Tri-Cyclen Ortho-Tri-Cyclen-Lo Tri-Lo-Sprintec Levora Natazia Sronyx Junel-Fe-1-5-30 Junel-Fe-1-20 Tri-Sprintec Seasonique Sprintec Cyclessa Microgestin-Fe-1-20 Safyral Necon-7-7-7 Ortho-Cept Loseasonique Ortho-Micronor Gianvi Jolivette Reclipsen Errin Lessina Zovia Tri-Previfem Briellyn Nortrel-7-7-7 Velivet Ogestrel-28 Loestrin-Fe-1-20 Nortrel-1-35 Loestrin-21-1-20 Orsythia Triphasil-28 Altavera Amethia Amethia-Lo Amethyst Balziva Brevicon Camrese Caziant Cesia Cyclafem-1-35 Cyclafem-7-7-7 Depo-Subq-Provera-104-Injectable-Suspension-Subcutaneous Emoquette Enpresse Estrostep-Fe Generess-Fe Genora-1-35 Gildess-Fe-1-0-2 Jenest Jevantique Jinteli Leena Levlite Levonest Loestrin-21-1-5-30 Loestrin-Fe-1-5-30 Loryna Lunelle Microgestin-1-5-30 Necon-0-5-35 Necon-1-50 Necon-10-11 Nelova-0-5-35 Nor-Qd Norethin-1-35-E Norinyl-1-50 Norplant-System Nortrel-0-5-35 Ogestrel Ortho-Novum-1-50 Ovcon-35-Fe Ovcon-50 Preven-Ec Previfem Solia Syeda Tilia-Fe Tri-Legest Tri-Levlen Tri-Norinyl Trinessa-Lo Triphasil-21 Trivora-28 Vestura Zenchent Zenchent-Fe Zovia-1-50
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Thera-Tabs


Generic Name: Multivitamins (MUL-ti-VYE-ta-mins)
Brand Name: Examples include Stress-600 and Thera-Tabs
Thera-Tabs is used for:

Treating or preventing low levels of vitamins in the body. It may also be used for other conditions as determined by your doctor.

Thera-Tabs is a vitamin supplement. It works by providing extra vitamins to the body.

Do NOT use Thera-Tabs if: you are allergic to any ingredient in Thera-Tabs

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

Before using Thera-Tabs:

Some medical conditions may interact with Thera-Tabs. 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

Some MEDICINES MAY INTERACT with Thera-Tabs.

Ask your health care provider if Thera-Tabs 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 Thera-Tabs:

Use Thera-Tabs as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Thera-Tabs by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. If you miss a dose of Thera-Tabs, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Thera-Tabs.

Important safety information: Do not take large doses of vitamins while you use Thera-Tabs unless your doctor tells you to. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Thera-Tabs while you are pregnant. It is not known if Thera-Tabs is found in breast milk. If you are or will be breast-feeding while you use Thera-Tabs, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Thera-Tabs:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Thera-Tabs. 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: Thera-Tabs 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 nausea; vomiting.

Proper storage of Thera-Tabs:

Store Thera-Tabs at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Thera-Tabs out of the reach of children and away from pets.

General information: If you have any questions about Thera-Tabs, please talk with your doctor, pharmacist, or other health care provider. Thera-Tabs 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.

This information is a summary only. It does not contain all information about Thera-Tabs. 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 Thera-Tabs resources Thera-Tabs Side Effects (in more detail) Thera-Tabs Use in Pregnancy & Breastfeeding Thera-Tabs Drug Interactions Thera-Tabs Support Group 0 Reviews for Thera-Tabs - Add your own review/rating Compare Thera-Tabs with other medications Dietary Supplementation
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Premphase


Generic Name: conjugated estrogens and medroxyprogesterone (KON joo GAY ted ES troe jenz and me DOX ee proe JES ter one)
Brand Names: Premphase, Prempro

What are Premphase (conjugated estrogens and medroxyprogesterone)?

Conjugated estrogens are a mixture of estrogen hormones. Estrogen is a female sex hormone produced by the ovaries that is necessary for many processes in the body.

Medroxyprogesterone is also a female hormone, usually called "progesterone." It is important for the regulation of ovulation and menstruation.

Together, conjugated estrogens and medroxyprogesterone are used to treat the symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation, and to prevent thinning of the bones (osteoporosis).

Conjugated estrogens and medroxyprogesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

Conjugated estrogens and medroxyprogesterone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Premphase (conjugated estrogens and medroxyprogesterone)? Do not use this medication if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer. This medication can harm an unborn baby or cause birth defects. Do not use conjugated estrogens and medroxyprogesterone if you are pregnant.

Long-term treatment with conjugated estrogens and medroxyprogesterone may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using this medication long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens and medroxyprogesterone.

Conjugated estrogens and medroxyprogesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions. What should I discuss with my healthcare provider before taking Premphase (conjugated estrogens and medroxyprogesterone)? Do not use this medication if you have:

a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

abnormal vaginal bleeding that a doctor has not checked;

liver disease; or

any type of breast, uterine, or hormone-dependent cancer.

If you have any of these other conditions, you may need a dose adjustment or special tests:

high blood pressure, heart disease, or circulation problems;

a personal or family history of stroke;

endometriosis;

liver or kidney disease;

asthma;

epilepsy or other seizure disorder;

migraines;

diabetes;

underactive thyroid;

high cholesterol or triglycerides;

high or low levels of calcium in your blood;

porphyria;

systemic lupus erythematosus (SLE);

gallbladder disease; or

if you have had your uterus removed (hysterectomy).

Conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using conjugated estrogens and medroxyprogesterone.

Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use conjugated estrogens and medroxyprogesterone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Conjugated estrogens and medroxyprogesterone can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without the advice of a doctor. How should I take Premphase (conjugated estrogens and medroxyprogesterone)?

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

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The 28-day Premphase treatment consists of two differently colored pills, 14 of each color. Carefully follow the patient instructions about which pills to take on days 1 through 14 and which pills to take on days 15 through 28.

You may take this medication with or without food. Try to take the medicine at the same time each day.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens and medroxyprogesterone.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you need surgery, tell the surgeon ahead of time that you are using conjugated estrogens and medroxyprogesterone. You may need to stop using the medicine for a short time.

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

Store at room temperature away from moisture and heat. Keep the medicine container tightly closed. What happens if I miss a dose?

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

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding. What should I avoid while taking Premphase (conjugated estrogens and medroxyprogesterone)? Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by conjugated estrogens and medroxyprogesterone. Premphase (conjugated estrogens and medroxyprogesterone) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

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

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

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

pain or swelling in your lower leg;

abnormal vaginal bleeding;

migraine headache;

pain, swelling, or tenderness in your stomach;

confusion, problems with memory or concentration;

jaundice (yellowing of the skin or eyes);

swelling in your hands, ankles, or feet; or

a breast lump.

Less serious side effects may include:

mild nausea, vomiting, bloating, stomach pain;

breast pain, tenderness, or swelling;

freckles or darkening of facial skin;

acne, increased hair growth, loss of scalp hair;

changes in weight or appetite;

problems with contact lenses;

vaginal itching or discharge;

changes in your menstrual periods, decreased sex drive; or

headache, nervousness, dizziness, tired feeling.

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

What other drugs will affect Premphase (conjugated estrogens and medroxyprogesterone)?

The following drugs can interact with conjugated estrogens and medroxyprogesterone. Tell your doctor if you are using any of these:

St. John's wort;

carbamazepine (Carbatrol, Tegretol);

phenobarbital (Luminal, Solfoton);

rifampin (Rifadin, Rifater, Rifamate, Rimactane);

ritonavir (Norvir);

ketoconazole (Nizoral) or itraconazole (Sporanox); or

an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin, E-Mycin), itraconazole (Sporanox) or ketoconazole (Nizoral).

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

More Premphase resources Premphase Side Effects (in more detail) Premphase Use in Pregnancy & Breastfeeding Premphase Drug Interactions Premphase Support Group 0 Reviews for Premphase - Add your own review/rating Premphase Advanced Consumer (Micromedex) - Includes Dosage Information Premphase MedFacts Consumer Leaflet (Wolters Kluwer) Prempro Consumer Overview Compare Premphase with other medications Atrophic Urethritis Atrophic Vaginitis Oophorectomy Osteoporosis Postmenopausal Symptoms Primary Ovarian Failure Where can I get more information? Your pharmacist can provide more information about conjugated estrogens and medroxyprogesterone.

See also: Premphase side effects (in more detail)


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Temp Tabs


Pronunciation: e-LECK-troe-lite
Generic Name: Electrolyte
Brand Name: Examples include Medi-Lyte and Temp Tabs
Temp Tabs is used for:

Decreasing fatigue, muscle cramps, or heat exhaustion due to excessive sweating. The use of Temp Tabs for these conditions has not been evaluated or approved by the Food and Drug Administration. It may also be used for other conditions as determined by your doctor.

Temp Tabs is an electrolyte combination. It works by replacing electrolytes in the body.

Do NOT use Temp Tabs if: you are allergic to any ingredient in Temp Tabs you have high blood potassium levels

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

Before using Temp Tabs:

Some medical conditions may interact with Temp Tabs. 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 heart disease, high blood pressure, fluid retention (eg, swelling of the hands, ankles, or feet), intestinal holes or punctures, difficulty urinating, kidney problems, or unexplained rectal bleeding if you have severe or persistent vomiting or severe diarrhea, or you are dehydrated if you have high levels of sodium in the blood if you are unable to properly absorb glucose from food

Some MEDICINES MAY INTERACT with Temp Tabs. However, no specific interactions with Temp Tabs are known at this time.

Ask your health care provider if Temp Tabs 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 Temp Tabs:

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

Take Temp Tabs with a full glass of water (8 oz/240 mL). If you miss a dose of Temp Tabs, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Temp Tabs.

Important safety information: If vomiting, fever, or stomach pain or bloating occurs, or if you have diarrhea that continues for longer than 24 hours, check with your doctor. Temp Tabs 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 Temp Tabs while you are pregnant. It is not known if Temp Tabs is found in breast milk. If you are or will be breast-feeding while you use Temp Tabs, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Temp Tabs:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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: Temp Tabs 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 Temp Tabs:

Store Temp Tabs at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Temp Tabs out of the reach of children and away from pets.

General information: If you have any questions about Temp Tabs, please talk with your doctor, pharmacist, or other health care provider. Temp Tabs 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 Temp Tabs. 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 Temp Tabs resources Temp Tabs Side Effects (in more detail) Temp Tabs Support Group 0 Reviews · Be the first to review/rate this drug
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Farlutal 500 for Injection


1. Name Of The Medicinal Product

Farlutal 500 suspension for injection

2. Qualitative And Quantitative Composition

Medroxyprogesterone Acetate, 20.0 % W/V

Farlutal 500 for injection contains 500 mg medroxyprogesterone acetate in 2.5 ml.

For excipients see section 6.1.

3. Pharmaceutical Form

Suspension for injection.

White sterile suspension for injection which settles on standing but readily disperses on shaking.

4. Clinical Particulars 4.1 Therapeutic Indications

Palliative treatment of hormone-sensitive malignancies. Farlutal has been successfully used to produce regressions in breast, endometrial, prostatic and renal cell carcinoma. High dose Farlutal therapy has proved especially useful in breast carcinoma and in achieving subjective improvements in terminally ill patients, notably pain relief and improved performance status.

4.2 Posology And Method Of Administration

Route of administration: Intramuscular injection

The suspension should be well shaken before use and injected deeply into healthy gluteal muscle.

Suggested dosage schemes are as follows:

Recurrent and/or Metastatic Breast Cancer:

Initial dose: 500 - 1000 mg/day i.m. for 4 weeks

Maintenance: 500 mg i.m. twice a week

Recurrent and/or Metastatic Endometrial or Renal Cancer:

The recommended initial dose is 400-1000 mg per week. If improvement is noted within a few weeks or months and the disease appears to be stabilised, it may be possible to maintain improvement with as little as 400 mg per month.

Metastatic Prostate Cancer:

Initial dose: 500 mg i.m. twice weekly for 3 months

Maintenance: 500 mg i.m. weekly

Children and Elderly:

None stated.

4.3 Contraindications

Medroxyprogesterone acetate is contraindicated in the following conditions:

• thrombophlebitis, thrombo-embolic disorders, and where there is a high risk of developing such manifestations [presence or history of atrial fibrillation, valvular disorders, endocarditis, heart failure, pulmonary embolism; transitory ischaemic attack (TIA), cerebral infarction; atherosclerosis; immediate post surgery period]

• previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism)

active or recent arterial thrombo-embolic disease (e.g., angina, myocardial infarction)

• severe hepatic insufficiency

• hypercalcaemia in patients with osseous metastases

• suspected or early breast carcinoma,

• missed abortion, metrorrhagia, known or suspected pregnancy

• undiagnosed vaginal bleeding

• known hypersensitivity to medroxyprogesterone acetate or any other component of Farlutal Injection.

Progestogens are known to be porphyrogenic. Patients with a history of attacks or aged under 30 are at greatest risk of an acute attack while on progesterone treatment. A careful assessment of potential benefit should be made where this risk is present.

4.4 Special Warnings And Precautions For Use

Farlutal should be used under the direction of those experienced in cancer chemotherapy.

Warnings

Although medroxyprogesterone acetate has not been causally associated with thrombotic or thrombo-embolic disorders, patients with a relevant history or who develop this kind of event while undergoing therapy with medroxyprogesterone acetate should have their status and need for treatment carefully assessed before continuing therapy.

In the event of a sudden partial or complete loss of vision, or sudden onset of proptosis, diplopia or migraine, administration of medroxyprogesterone acetate should be halted. If examination reveals papilloedema or retinal vascular lesions, medication should not be re-instated.

Treatment with medroxyprogesterone acetate should be discontinued in the event of:

• jaundice or deterioration in liver function

• significant increase in blood pressure

• new onset of migraine-type headache

In the event of vaginal bleeding occurring, an accurate diagnosis should be made. If endometrial or endocervical tissue is submitted for histological examination, the pathologist (laboratory) should be informed that the patient has been receiving a progestogen.

The pathologist or laboratory should be advised that the patient is receiving medroxyprogesterone acetate as this can decrease the levels of the following endocrine biomarkers:

• Plasma/urinary steroids (e.g., cortisol, oestrogen, pregnanediol, progesterone, testosterone)

• Plasma/urinary gonadotrophins (e.g., LH and FSH)

• Sex-hormone-binding-globulin

Precautions

Animal studies have shown that medroxyprogesterone acetate possesses adrenocorticoid activity and this effect has also been observed in humans.

Some patients receiving medroxyprogesterone acetate may exhibit suppressed adrenal function. Medroxyprogesterone acetate may also decrease ACTH and hydrocortisone blood levels.

When used in oncology indications, medroxyprogesterone acetate may cause partial adrenal insufficiency (decrease in pituitary-adrenal axis response) during metyrapone testing. Thus the ability of the adrenal cortex to respond to ACTH should be demonstrated before metyrapone is administered. The pathologist/laboratory should be made aware that the patient is being treated with medroxyprogesterone acetate.

Medroxyprogesterone acetate may produce Cushingoid symptoms.

Patients with the following conditions should be carefully monitored while taking progestogens:

• Conditions which may be influenced by potential fluid retention

o Epilepsy

o Migraine

o Asthma

o Cardiac dysfunction

o Renal dysfunction

• Hyperlipidaemia

• History of mental depression

• Diabetes (a decrease in glucose tolerance has been observed in some patients)

Farlutal may raise plasma calcium levels; some cases of hypercalcaemia have been reported in the treatment of breast carcinoma.

Risk of venous thromboembolism (VTE)

The risk of VTE has not been assessed for progesterone alone. However, VTE is a known risk factor of oestrogen-only and combined hormone replacement therapy. When prescribing medroxyprogesterone acetate for oncology indications the following precautions and risk factors should be considered in the light of the patient's condition, the dose of medroxyprogesterone acetate and the duration of therapy:

• Generally recognised risk factors for VTE include a personal or family history of VTE or known thrombo-embolic states, severe obesity (BMI> 30 kg/m2) and systemic lupus erythematosus

• The risk of VTE may be temporarily increased with prolonged immobilisation, trauma or surgery or acute illnesses.

If VTE develops after initiating therapy, medroxyprogesterone acetate should be discontinued. Patients should be told to contact their doctor immediately if they become aware of a symptom suggestive of potential thromboembolism (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction with other medicaments

The metabolism of progestogens may be increased by concomitant administration of compounds known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes. These compounds include anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g., rifampicin, rifabutin, nevirapine, efavirenz,).

Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.

Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of progestogens. Progestogen levels may therefore be reduced.

Aminoglutethimide administered cocurrently may decrease medroxyprogesterone acetate availability.

Medroxyprogesterone acetate may be used in combination with cytotoxic drugs. In these circumstances it has been reported that the haematological toxicity of chemotherapy might be reduced.

Special care should be taken in the concomitant use of medroxyprogesterone acetate (particularly at higher doses) and drugs which also cause oedema, such as NSAIDs and vasodilators.

Concurrent administration of ciclosporin and MPA has been reported to lead to increased plasma ciclosporin levels and/or decreased plasma MPA levels.

Interactions with oral anti-coagulants have been reported rarely, but causality has not been established.

Other forms of interaction

Medroxyprogesterone acetate can influence certain laboratory tests (e.g., hepatic function tests, coagulation tests and thyroid function tests).

4.6 Pregnancy And Lactation

Pregnancy

Farlutal is contra-indicated during pregnancy.

Administration of progesterone during the first months of pregnancy may possibly be associated with the occurrence of congenital cardiac malformations in the neonate. In addition, instances of masculinisation of female foetuses have been reported following high dose therapy during pregnancy.

It should be noted that long term administration of medroxyprogesterone acetate to beagle dogs has resulted in the development of mammary nodules which were occasionally found to be malignant. The relevance of these findings to humans has, however, not been established.

Lactation

Medroxyprogesterone acetate and its metabolites are excreted in breast milk. Therefore, the use of Farlutal in breast-feeding is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Genitourinary

Abnormal uterine bleeding (irregular, increase, decrease), amenorrhoea, alterations of cervical secretions, cervical erosions, prolonged anovulation

Breast

Galactorrhoea, mastodynia, tenderness

Central Nervous System

Confusion, depression, dizziness, euphoria, fatigue, headache, insomnia, loss of concentration, nervousness, somnolence, vision disorders

Gastrointestinal/

Hepatobiliary

Constipation, diarrhoea, dry mouth, disturbed liver function, jaundice, nausea, vomiting

Metabolic & Nutritional

Adrenergic-like effects (e.g., fine-hand tremors, sweating, cramps in calves at night), corticoid-like effects (e.g., facies lunaris, Cushingoid syndrome), decreased glucose tolerance, diabetic cataract, exacerbation of diabetes mellitus, glycosuria

Cardiovascular

Cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitations, pulmonary embolism, retinal thrombosis, tachycardia, thrombo-embolic disorders, thrombophlebitis

 

Haematological

Elevation of white blood cells and platelet counts

Skin & Mucous Membranes

Acne, alopecia, hirsutism, pruritus, rash, urticaria

 

Musculoskeletal

Injection site reactions such as sterile abscesses or inflammatory infiltrates.

Allergy

Hypersensitivity reactions (e.g., anaphylaxis & anaphylactoid reactions, angioedema)

Miscellaneous

Changes in appetite, changes in libido, oedema/fluid retention, hypocalcaemia, malaise, pyrexia, weight change

4.9 Overdose

No positive action is required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Progestogens. ATC Code: L02AB02.

MPA has an antigonadotrophic effect, it blocks the pre-ovulatory intermenstrual oestrogen peak by direct action on the ovary. Its effects at low doses include contraceptive action, secretion by the endometrium, delay in the menstrual flow, a decrease in the viscosity of cervical mucus and a reduction in the vaginal karyopycnotic index.

At higher doses, oncological actions are evident. There is a direct cytotoxic action on tumour cells manifested by a decrease in DNA and RNA synthesis.

5.2 Pharmacokinetic Properties

The absorption and metabolism of the MPA are affected by both the administration route used and the type of pharmaceutical preparation.

After i.m. administration of MPA in an aqueous solution, absorption is slow. The highest blood levels are found during the first 2 days, measurable amounts being found up to 100 days after treatment. Variations in plasma concentrations are interpreted as being due to irregular release from the injection site.

Only 3-6% of the administered dose is recovered in urine after 24 hours. After 6 days approximately 11% is found in the urine and 3% in the faeces, hence elimination is slow after i.m. administration. Traces of metabolites have been found in the urine up to 6 months after high doses of MPA. Only a slight increase in porter-silber steroids is found in the urine of patients treated by the i.m. route.

5.3 Preclinical Safety Data

No further preclinical safety data available.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Polysorbate 80

Sodium Chloride

Carbowax 400

Methyl Hydroxybenzoate

Propyl Hydroxybenzoate

Water for Injections

6.2 Incompatibilities

Farlutal injection should not be mixed with other agents.

6.3 Shelf Life

48 months

6.4 Special Precautions For Storage

The vials should be stored between 15° - 30°C and should not be frozen.

6.5 Nature And Contents Of Container

Colourless siliconised glass vial (Type I) with grey chlorobutyl rubber stopper and aluminium seal containing 2.5 ml of suspension.

6.6 Special Precautions For Disposal And Other Handling

Farlutal should be well shaken before use and should not be mixed with other agents. It should be administered using a long wide-bore needle. Narrow-bore or short needles must not be used.

The vials are for single dose administration only. Discard any remaining solution.

7. Marketing Authorisation Holder

Farmitalia Carlo Erba Limited

Davy Avenue

Milton Keynes

MK5 8PH

UK

8. Marketing Authorisation Number(S)

PL 03433/0045

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation: 14 August 1981

10. Date Of Revision Of The Text

December 2004


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Estrogens, Conjugated


Class: Estrogens
VA Class: GU500
Brands: Cenestin, Enjuvia, Premarin, Premphase, Prempro

Estrogens increase the risk of endometrial cancer in postmenopausal women.101 104 105 106 107 121 (See Endometrial Cancer under Cautions.)

Do not use estrogens with or without progestins for prevention of cardiovascular disease101 104 105 106 107 121 (see Cardiovascular Risk Reduction under Uses and Cardiovascular Disorders under Cautions) or dementia (see Alzheimer’s Disease under Uses).101 104 105 107

The Women’s Health Initiative (WHI) study of estrogen alone reported increased risks of stroke and DVT in postmenopausal women receiving approximately 7 years of therapy with conjugated estrogens 0.625 mg daily.101 104 105 107

The WHI study of estrogen plus progestin reported increased risks of MI, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women receiving ?5 years of therapy with conjugated estrogens 0.625 mg in conjunction with medroxyprogesterone acetate 2.5 mg daily.101 104 105 106 107

The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women ?65 years of age receiving long-term therapy (4–5 years) with conjugated estrogens in conjunction with medroxyprogesterone acetate or conjugated estrogens alone.101 104 105 107 Not known whether this finding also applies to younger postmenopausal women.101 104 105 107

Other dosages of conjugated estrogens with medroxyprogesterone and other combinations or dosage forms of estrogens with progestin not studied in WHI trials; in the absence of comparable data, assume risks are similar.101 104 105 107

Prescribe estrogens (with or without progestins) at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.101 104 105 106 107

Introduction

Mixture of estrogens available either as preparations that meet current official USP standards (i.e., conjugated estrogens USP)101 105 107 108 109 or as nonofficial preparations (i.e., synthetic conjugated estrogens A and synthetic conjugated estrogens B, which are prepared synthetically from plant sources).106 108 109 121 122

Uses for Estrogens, Conjugated

Use of estrogens alone in postmenopausal women generally is referred to as estrogen replacement therapy (ERT); use of estrogens in combination with progestins usually is referred to as hormone replacement therapy (HRT) or postmenopausal hormone therapy.b

ERT

Management of moderate to severe vasomotor symptoms associated with menopause.101 106 107 121

Management of vulvar and vaginal atrophy associated with menopause.101 105 106 107 If used solely for this indication, consider use of topical vaginal preparations.101 105 106 107

Osteoporosis

Prevention of postmenopausal osteoporosis.100 101 107 Used adjunctively with other measures (e.g., diet, calcium, vitamin D, weight-bearing exercise, physical therapy) to retard further bone loss and progression of osteoporosis in postmenopausal women.100 101 107

Estrogens are effective for prevention of osteoporosis but are associated with a number of adverse effects.100 101 107 If prevention of postmenopausal osteoporosis is the sole indication for therapy, consider alternative therapy (e.g., alendronate, raloxifene, risedronate).101 107 112

Has been effective in the treatment of osteoporosis in postmenopausal women. Formerly recommended as first-line therapy; however, recommendations on appropriate use of HRT have been revised based on WHI study findings. (See Boxed Warning.) Evaluate risks and benefits of long-term HRT use in the management of osteoporosis, taking into account the increased risk of breast cancer and cardiovascular disease, availability of other pharmacologic modalities (e.g., alendronate, calcitonin, calcium, raloxifene, risedronate, vitamin D), and life-style factors that can be modified.101 107

Has been used in a limited number of anorexic women with chronic amenorrhea to reduce calcium loss† and, thereby, reduce risk of osteoporosis.

Corticosteroid-induced Osteoporosis

Has been used to prevent bone loss in postmenopausal women receiving low- to moderate-dose corticosteroid therapy†.

Hypoestrogenism

Treatment of hypoestrogenism secondary to hypogonadism, castration, or primary ovarian failure.101 Used for induction of puberty in adolescents with pubertal delay due to hypogonadism.101

Metastatic Breast Carcinoma

Palliative treatment of metastatic breast cancer in selected women and men.101 One of several second-line agents.a

Prostate Carcinoma

Palliative treatment of advanced androgen-dependent prostate carcinoma.101

Abnormal Uterine Bleeding

Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.104

Cardiovascular Risk Reduction†

ERT or HRT does not decrease the incidence of cardiovascular disease.101 105 106 107 AHA, American College of Obstetricians and Gynecologists, FDA, and manufacturers recommend that hormone therapy not be used to prevent heart disease in healthy women (primary prevention) or to protect women with preexisting heart disease (secondary prevention).

Alzheimer’s Disease

Prior use of HRT, but not current HRT unless such use exceeds 10 years, associated with reduced risk of Alzheimer’s disease†. Estrogens have not been shown to prevent progression of Alzheimer’s disease; American Academy of Neurology recommends that estrogens not be used for treatment of Alzheimer’s disease.

Initiation of ERT or HRT in women ?65 years of age not associated with an improvement in cognitive function. Some women receiving ERT or HRT experience detrimental effects. Incidence of probable dementia in women receiving ERT or HRT was higher than that in women receiving placebo. (See Boxed Warning.) Use of ERT or HRT to prevent dementia or cognitive decline in women ?65 years of age is not recommended.

Postpartum Breast Engorgement

Used in the past for prevention of postpartum breast engorgement†; FDA has withdrawn approval of estrogen-containing drugs for this indication, since estrogens have not been shown to be safe for this use.110 (See Lactation under Cautions.)

Pregnancy

Not effective for any purpose during pregnancy; use contraindicated in pregnant women.101 104 105 106 107 121 (See Pregnancy under Cautions.)

Estrogens, Conjugated Dosage and Administration General

A progestin generally is added to estrogen therapy (HRT) in women with an intact uterus.101 104 105 107 121 Addition of a progestin for ?10 days per cycle of estrogen or daily with estrogen reduces incidence of endometrial hyperplasia and attendant risk of endometrial carcinoma in women with an intact uterus.101 104 105 107 121

ERT is appropriate in women who have undergone a hysterectomy (to avoid unnecessary exposure to progestins).101 104 105 107 121

Administration

Conjugated estrogens USP usually administered orally; may also administer intravaginally or by deep IM or slow IV injection.101 104 105 107

Administer synthetic conjugated estrogens A and synthetic conjugated estrogens B orally.106 121

Estrogen therapy generally is administered in a continuous daily dosage regimen or, alternatively, in a cyclic regimen.101 105 107 When administered cyclically, estrogen usually is given once daily for 3 weeks followed by 1 week without the drug or once daily for 25 days followed by 5 days off; regimen is repeated as necessary.101 105

When parenteral administration of conjugated estrogens USP is required, IV injection is preferred because of the more rapid response compared with IM injection.104

Oral Administration

Oral preparations containing medroxyprogesterone acetate in combination with conjugated estrogens USP as monophasic or biphasic regimens are commercially available in a mnemonic dispensing package to aid user in complying with the prescribed dosage schedule.107

IV Administration

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

Administer by direct IV injection.104

Reconstitution

Reconstitute vial containing 25 mg of conjugated estrogens USP with 5 mL of sterile water for injection.104 Do not shake vigorously.104 Administer immediately after reconstitution.104

Rate of Administration

Administer slowly (to avoid flushing reaction).104

IM Administration

Administer by deep IM injection.104

Reconstitution

Reconstitute vial containing 25 mg of conjugated estrogens USP with 5 mL of sterile water for injection.104 Do not shake vigorously.104 Administer immediately after reconstitution.104

Vaginal Administration

Administer intravaginally as a vaginal cream.105

Dosage

Individualize dosage according to the condition being treated and the tolerance and therapeutic response of the patient.101 104 105 106 107 121

To minimize risk of adverse effects, use the lowest possible effective dosage.101 104 105 106 107 121 Because of the potential increased risk of cardiovascular events, breast cancer, and venous thromboembolic events, limit estrogen and estrogen/progestin therapy to the lowest effective doses and shortest duration of therapy consistent with treatment goals and risks for the individual woman.101 104 105 107 121

Periodically reevaluate estrogen and estrogen/progestin therapy (i.e., at 3- to 6-month intervals).101 104 105 107 121

Pediatric Patients Hypoestrogenism Oral

Conjugated estrogens USP: 0.15 mg daily may induce breast development.101 Increase dosage at 6- to 12-month intervals to achieve appropriate bone age advancement and epiphyseal closure.101

Conjugated estrogens USP: 0.625 mg daily (with progestins) sufficient to induce artificial cyclic menses and to maintain bone mineral density (BMD) after skeletal maturity.101

Adults Estrogen Replacement Therapy Vasomotor Symptoms Oral

Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off).101 Adjust dosage based on patient response.101

Synthetic conjugated estrogens A: Initially, 0.45 mg daily.106 May increase dosage up to 1.25 mg daily.106

Synthetic conjugated estrogens B: Initially, 0.3 mg daily.121 Adjust dosage based on patient response.121

Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily.107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily.107

Conjugated estrogens USP with medroxyprogesterone acetate (Premphase), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15–28 of the cycle.107

Vulvar and Vaginal Atrophy Oral

Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off).101 Adjust dosage based on patient response.101

Synthetic conjugated estrogens A: 0.3 mg daily.106

Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily.107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily.107

Conjugated estrogens USP with medroxyprogesterone acetate (Premphase), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15–28 of the cycle.107

Vaginal

Conjugated estrogens USP: 0.5–2 g daily in cyclic regimen (3 weeks on, 1 week off).105

Osteoporosis Prevention in Postmenopausal Women Oral

Conjugated estrogens USP: Initially, 0.3 mg daily continuously or in cyclic regimen (25 days on, 5 days off).101 Adjust dosage based on clinical and BMD response.101

Conjugated estrogens USP in fixed combination with medroxyprogesterone acetate (Prempro), monophasic regimen: Initially, conjugated estrogens USP 0.3 mg with medroxyprogesterone acetate 1.5 mg daily.107 Alternatively, conjugated estrogens USP 0.45 mg with medroxyprogesterone acetate 1.5 mg daily, conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 2.5 mg daily, or conjugated estrogens USP 0.625 mg with medroxyprogesterone acetate 5 mg daily.107 Adjust dosage based on clinical and BMD response.107

Conjugated estrogens USP with medroxyprogesterone acetate (Premphase), biphasic regimen: Conjugated estrogens USP 0.625 mg daily; medroxyprogesterone acetate 5 mg daily on days 15–28 of the cycle.107

Hypoestrogenism Female Hypogonadism Oral

Conjugated estrogens USP: 0.3–0.625 mg daily in a cyclic regimen (3 weeks on, 1 week off).101 Adjust dosage based on symptom severity and endometrial responsiveness.101

Female Castration or Primary Ovarian Failure Oral

Conjugated estrogens USP: 1.25 mg daily in a cyclic regimen.101 Adjust dosage based on symptom severity and clinical response.101

Metastatic Breast Carcinoma Oral

Conjugated estrogens USP: 10 mg 3 times daily for ?3 months.101

Prostate Carcinoma Oral

Conjugated estrogens USP: 1.25–2.5 mg 3 times daily.101

Abnormal Uterine Bleeding IV or IM

Conjugated estrogens USP: 25 mg; can repeat dose in 6–12 hours.104

Cautions for Estrogens, Conjugated Contraindications

Undiagnosed abnormal genital bleeding.101 104 105 106 107 121

Known or suspected breast cancer or history of breast cancer (except when used for palliative treatment of metastatic disease in appropriately selected individuals).101 104 105 106 107 121

Known or suspected estrogen-dependent neoplasia.101 104 105 106 107 121

Active DVT or pulmonary embolism; history of DVT or pulmonary embolism.101 104 105 106 107 121

Active or recent (within past year) arterial thromboembolic disease (e.g., stroke, MI).101 104 105 106 107 121

Liver disease or impairment.101 104 105 107 121

Known or suspected pregnancy.101 104 105 106 107 121

Known hypersensitivity to estrogen or any ingredient in the formulation.101 104 105 106 107 121

Warnings/Precautions Warnings Cardiovascular Disorders

Estrogen/progestin therapy associated with increased risk of MI, stroke, DVT, and pulmonary embolism.101 104 105 106 107 112 113 114 121 Estrogen therapy associated with increased risk of stroke and DVT.101 104 105 107 (See Boxed Warning.) Discontinue estrogens immediately if any of these events occur or are suspected.101 104 105 106 107 121 Use of ERT or HRT is not advised in women with a history of stroke or transient ischemic attacks. (See Contraindications under Cautions.)

Appropriately manage risk factors for cardiovascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, obesity) and/or venous thromboembolism (personal or family history of venous thromboembolism, obesity, systemic lupus erythematosus).101 104 105 106 107 121 (See Contraindications under Cautions.)

Discontinue estrogens, whenever feasible, at least 4–6 weeks prior to surgery that is associated with an increased risk of thromboembolism or during prolonged immobilization.101 104 105 106 107 121

Endometrial Cancer

Use of unopposed estrogen therapy in women who have a uterus is associated with increased risk of endometrial cancer.101 104 105 106 107 121 Clinical surveillance and evaluation are essential.101 104 105 106 107 121 Perform diagnostic tests to rule out malignancy in women with undiagnosed, persistent or recurring abnormal vaginal bleeding.101 104 105 106 107 121

Incidence of endometrial hyperplasia is reduced substantially when progestins are used concomitantly.101 104 105 106 107 121

Breast Cancer

HRTassociated with increased risk of breast cancer.101 104 105 106 107 112 113 114 121

All postmenopausal women should receive yearly breast examinations by a clinician and perform monthly self-examinations.101 104 105 106 107 121 Schedule periodic mammography based on patient age and risk factors.101 104 105 106 107 121

Dementia

ERT or HRT in women ?65 years of age has been associated with increased risk of developing probable dementia.101 104 105 107 121 Whether these findings apply to younger women is unknown.101 104 105 107 121 (See Alzheimer’s Disease under Uses.)

Gallbladder Disease

ERT associated with increased risk of gallbladder disease requiring surgery.101 104 105 106 107 121

Hypercalcemia

Estrogens may cause severe hypercalcemia in patients with breast cancer and bone metastases.101 104 105 106 107 121 Discontinue the drug and initiate appropriate therapy to reduce serum calcium concentrations if hypercalcemia occurs.101 104 105 106 107 121

Ocular Effects

Retinal thrombosis reported.101 104 105 106 107 121 Discontinue pending examination if sudden partial or complete loss of vision or sudden onset of proptosis, diplopia, or migraine occurs.101 104 105 107 121 Discontinue estrogens if papilledema or retinal vascular lesions noted on examination.101 104 105 106 107 104 105 121

General Precautions Elevated BP

Rarely, substantial increases in BP attributed to idiosyncratic reactions to estrogen.101 104 105 106 107 121 ERT generally is not associated with elevated BP.101 104 105 107 121 Monitor BP at regular intervals.101 104 105 106 107 121

Hypertriglyceridemia

Estrogen therapy may be associated with increases in plasma triglyceride concentrations resulting in pancreatitis in women with increased serum lipids.101 104 105 106 107 121

Fluid Retention

Estrogens may cause some degree of fluid retention; use with caution and careful monitoring in patients with conditions that might be aggravated by fluid retention (e.g., cardiac or renal impairment).101 104 105 106 107 121

Hypocalcemia

Use with caution in patients with severe hypocalcemia.101 104 105 106 107 121

Ovarian Cancer

Long-term estrogen therapy associated with increased incidence of ovarian cancer in some epidemiologic studies.101 104 105 106 107 121 Other studies did not show a clinically important association.101 104 105 106 107 121

Endometriosis

Estrogens may exacerbate endometriosis.101 104 105 106 107 121

Malignant transformation of residual endometrial implants reported rarely in women receiving unopposed estrogen following hysterectomy.101 104 105 107 Consider the addition of progestin in women with residual endometriosis following hysterectomy.101 104 105 107 121

Other Conditions

Estrogens may exacerbate asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas; use with caution in patients with these conditions.101 104 105 107 121

Precautions Specific to Vaginal Administration

Exposure to conjugated estrogens USP vaginal cream may weaken latex condoms.105 Consider the potential for the cream to weaken and contribute to protective failure of latex or rubber condoms, diaphragms, or cervical caps.105

Estrogen-Progestin Combinations

When a progestin is used in conjunction with estrogen therapy, consider the cautions, precautions, and contraindications associated with progestin therapy.107 a

Specific Populations Pregnancy

Category X.101 104 105 106 107 121 (See Contraindications under Cautions.)

In utero exposure of females to diethylstilbestrol (DES [no longer commercially available in US]) is associated with increased risk of vaginal adenosis, squamous cell dysplasia of the cervix, and clear-cell vaginal cancer in later life.b

In utero exposure of males to DES is associated with an increased risk of genital abnormalities and possibly testicular cancer later in life.b

Women who receive DES during pregnancy may be at increased risk of breast cancer; causal relationship unproven.b

Lactation

Administration of estrogens to nursing women has been associated with decreased amounts and lower quality of milk.101 104 105 106 107 121 Detectable amounts of estrogens have been identified in milk of women receiving these drugs.101 104 105 106 107 121 Caution advised.101 104 105 106 107 121

Pediatric Use

Estrogen therapy has been used for induction of puberty in adolescents with some forms of pubertal delay.101 Safety and efficacy of estrogens in children not otherwise established.101 104 105 107 121

Use estrogen therapy with caution and careful monitoring if bone growth is not yet complete, since estrogens may cause premature epiphyseal closure.101

Estrogen therapy in prepubertal girls induces premature breast development and vaginal cornification and may induce vaginal bleeding.101 Estrogen therapy in boys may modify the normal pubertal process.101

Geriatric Use

No substantial differences in safety in women ?65 years of age compared with younger women; increased incidence of stroke and invasive breast cancer reported in women?75 years of age compared with younger women.101 104 105 107

Possible increased risk of developing probable dementia in women ?65 years of age. (See Dementia under Cautions.)101 104 105 107

Clinical studies of estrogens alone or in combination with a progestin did not include sufficient numbers of patients ?65 years of age to determine whether geriatric patients respond differently than younger patients.101 104 105 107

Hepatic Impairment

Estrogens may be poorly metabolized in patients with hepatic impairment.101 104 105 106 107 121 (See Contraindications under Cautions.)

Caution advised in patients with a history of cholestatic jaundice associated with previous estrogen use or with pregnancy; discontinue if jaundice recurs.101 104 105 106 107 121

Renal Impairment

Use with caution.101 104 105 107 121 (See Fluid Retention under Cautions.)

Common Adverse Effects

Abdominal pain, asthenia, flatulence, leg cramps, pruritus, vaginal hemorrhage, vaginitis, vaginal moniliasis.101 107

Interactions for Estrogens, Conjugated

Appears to be metabolized partially by CYP3A4.101 104 105 106 107 121

Drugs Affecting Hepatic Microsomal Enzymes

CYP3A4 inhibitors: Potential pharmacokinetic interaction (increased plasma estrogen concentrations).101 104 105 106 107 121

CYP3A4 inducers: Potential pharmacokinetic interaction (decreased plasma estrogen concentrations).101 104 105 106 107 121

Specific Drugs and Foods

Drug or Food

Interaction

Comments

Anticoagulants, oral

Possible decreased anticoagulant actionb

Monitor; increase warfarin dosage if requiredb

Antifungals, azoles (itraconazole, ketoconazole)

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

Carbamazepine

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Corticosteroids (hydrocortisone)

Enhanced anti-inflammatory effects in patients with chronic inflammatory skin diseaseb

Observe for signs of excessive corticosteroid effects; adjust corticosteroid dosage when initiating or discontinuing estrogenb

Grapefruit juice

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

Macrolide antibiotics (clarithromycin, erythromycin)

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

Medroxyprogesterone

Interaction unlikely101 106 107

Phenobarbital

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Rifampin

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Ritonavir

Possible increased plasma estrogen concentrations; increased potential for adverse effects101 104 105 106 107 121

St. John’s wort (Hypericum perforatum)

Possible decreased plasma estrogen concentrations; potential for decrease in therapeutic effects and/or changes in uterine bleeding101 104 105 106 107 121

Thyroid agents

Increased thyroid-binding globulin concentrations101 104 105 106 107 121

Increased dosages of thyroid replacement agents may be needed; monitor thyroid function101 104 105 106 107 121

Estrogens, Conjugated Pharmacokinetics Absorption Bioavailability

Conjugated estrogens are well absorbed through mucous membranes and from the GI tract.101 104 105 106 107 121

Food

Conjugated estrogens USP: High-fat meal does not affect extent of oral absorption.107

Synthetic conjugated estrogens A: Effect of food unknown.106

Synthetic conjugated estrogens B: Effects of food unknown.121

Distribution Extent

Widely distributed; highest concentrations found in sex hormone target organs.101 104 105 106 107 121

Plasma Protein Binding

50–80%.b

Elimination Metabolism

Metabolized in the liver; the kidney, gonads, and muscle tissue involved to some extent.b Estrogens metabolized partially by CYP3A4.101 104 105 106 107 121

Extensive metabolic conversion takes place in the liver (e.g., estradiol converted to estrone, both converted to estriol).101 104 105 106 107 121

Estrogens undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the gut followed by reabsorption.101


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Brucellosis Medications


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Drugs associated with Brucellosis

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

Learn more about Brucellosis

Medical Encyclopedia:

Brucellosis
Drug List: Ala-Tet Chloromycetin-Oral-Intravenous-Injection Chloromycetin-Sodium-Succinate Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Garamycin-Solution Monodox Ocudox-Convenience-Kit Oraxyl Sumycin Vibra-Tabs Vibramycin
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Malaria Prevention (Malaria Prophylaxis) Medications


Drugs associated with Malaria Prevention

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


Drug List: Aralen Aralen-Phosphate Daraprim Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Fansidar Lariam Malarone Malarone-Pediatric Monodox Ocudox-Convenience-Kit Oraxyl Plaquenil Vibra-Tabs Vibramycin
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Uveitis Medications


Definition of Uveitis: Uveitis is an inflammation of the the uvea, the layer between the sclera and the retina, which includes the iris, ciliary body, and the choroid.

Drugs associated with Uveitis

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

See sub-topics

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Uveitis

Harvard Health Guide:

Symptoms and treatment for Uveitis
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Lyme Disease, Neurologic Medications


Drugs associated with Lyme Disease, Neurologic

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Drug List: Ala-Tet Amoxil Beepen-Vk Bicillin-L-A-Suspension Claforan Dispermox Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Permapen-Isoject Monodox Ocudox-Convenience-Kit Oraxyl Pc-Pen-Vk Pen-V Penicillin-G-Procaine-Injectable-Suspension Penicillin-Vk Pfizerpen Rocephin Sumycin Trimox Veetids Vibra-Tabs Vibramycin
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Indivina


Indivina 1 mg/2.5 mg tablets

Indivina 1 mg/5 mg tablets

Indivina 2 mg/5 mg tablets

estradiol /medroxyprogesterone

Read all of this leaflet carefully before you start taking 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet:

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

What Indivina Is And What It Is Used For

The name of your medicine is Indivina. It is a hormone replacement therapy (HRT) used to treat some of the symptoms which occur when the oestrogen levels decline and the periods stop (menopause) by replacing the oestrogen that your body is no longer producing. The tablets contain oestrogen and progestogen. Indivina is only recommended for women whose periods stopped more than three years ago and who still have their womb.

Indivina can also be used to help to prevent osteoporosis (thinning of the bones) if you are at an increased risk of fractures due to osteoporosis but are unable to take other treatments or if other therapies prove to be ineffective. Your doctor should discuss all the available options with you.

There is only limited experience of treating women older than 65 years with Indivina.

Before You Take Indivina Medical check-ups

Before you start taking Indivina, your doctor will inform you about the risks and benefits of the treatment (see also section 4, “Other side effects of combined HRT”). Before you start treatment and regularly during treatment, your doctor will evaluate whether Indivina is the right treatment for you. Your doctor will tell you how often you should go for periodic check-ups, taking into account your general state of health. If you have any close relative (mother, sister, maternal or paternal grandmother), who has suffered from serious illness, e.g. blood clot or breast cancer, you might be at increased risk. You should therefore always tell your doctor about any close relative suffering from serious illness, and you should also tell your doctor about any changes, you might find in your breasts.

As well as regular check-ups with your doctor, be sure to:

Regularly check your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel. Go for regular breast screening (mammography) and cervical smear tests. While you are receiving this medication, you should see your doctor regularly, at least every six to twelve months If you have unusual symptoms such as unexplained pains in the chest, abdomen or legs you must consult your doctor immediately. If you have a family history of breast cancer you should use this medication with great caution. Do not take Indivina, if: you are allergic (hypersensitive) to estradiol valerate or medroxyprogesterone acetate or any of the other ingredients of Indivina (see section 6: Further information) you have or have had breast cancer in the past you have or have had an oestrogen-dependent tumour such as endometrial cancer (cancer of the lining of the womb) you have unusual vaginal bleeding that has not been checked by a doctor you have endometrial hyperplasia (abnormal growth of the lining of the womb) that is not being treated you have had a recent blood clot of an artery (leading to chest pain or heart attack) you have had liver disease and have been told by your doctor that your liver function has not yet returned to normal you have or have had a blood clot in a vein in your leg or anywhere else (a “deep vein thrombosis or pulmonary embolism”) you have porphyria (a genetic disorder). Take special care with Indivina

As well as benefits, HRT has some risks which you need to consider when you are deciding whether to take it, or whether to carry on taking it. Tell your doctor if you have any of the following as you may need more frequent check ups’ if:

you think you might be at risk of oestrogen dependent tumors such as breast cancer or endometrial cancer (see the section below on effects on your risk of developing cancer) you have had endometrial hyperplasia (thickening of the lining of the womb) you have uterine fibroids or endometriosis you feel you might be at risk of developing blood clots (see section below on blood clots) you have liver, kidney or heart problems you have gallstones you have asthma, epilepsy or diabetes you have high blood pressure you have otosclerosis (hearing problems due to bone overgrowth in the ear) you have been told that you have an intolerance to some sugars you have systemic lupus erythematosus (SLE) you have migraine or severe headaches you have been told you have high cholesterol or fat levels in your blood you are going to have surgery, make sure your doctor knows about it. You may need to stop taking HRT about 4 to 6 weeks before the operation, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking HRT again.

HRT may change the results of some laboratory tests. If you are going to have any laboratory tests, tell your doctor/nurse that you are taking Indivina.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular tell your doctor if you are taking any of the following:

antibiotics such as rifampicin, rifabutin anti-epileptic medicines such as phenytoin, phenobarbital and carbamazepine HIV medicines such as nelfinavir, ritonavir, nevirapine and efavirenz the herbal preparation St. Johns Wort.

If you are in any doubt about taking other medicines with Indivina, talk to your doctor or your pharmacist.

Taking Indivina with food and drink

Indivina can be swallowed with a glass of water at the same time each day.

Pregnancy and breast-feeding Pregnancy – Do not take Indivina if you are pregnant, think you are pregnant or planning to become pregnant Breast feeding – Do not take Indivina if you are breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Indivina should not affect your ability to drive or operate machinery.

Important information about some ingredients of Indivina

This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

How To Take Indivina

Always take Indivina as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take one Indivina tablet every day, preferably at about the same time each day. Calendar days are printed on the blister sheet to help you follow your daily tablet intake. Swallow the tablet whole with a drink if necessary. You will normally start on the lowest dose of Indivina and this will be increased, if necessary. Your doctor should aim to prescribe the lowest dose for the shortest time that gives you relief from your symptoms. Talk to your doctor if your symptoms are not better after three months. If you feel that the effect of Indivina is too strong or too weak, do not change the dose or stop taking the tablets yourself, but ask your doctor for advice.

If you are not having periods and you have not previously taken HRT or you are changing from another continuous combined HRT product, treatment with Indivina may be started on any day.

If you switch from a cyclic HRT regimen, start Indivina treatment one week after taking the last tablet of the cyclic HRT. Talk to your doctor or pharmacist if you are unsure.

Whilst taking this medicine

When you first start taking Indivina you may get some bleeding at odd times for a few months (Please also refer to the section above on Endometrial cancer). However, if this is still happening after a few months or if you experience heavy bleeding tell your doctor.

If you take more Indivina than you should:

If you or somebody else has taken too many Indivina tablets, talk to your doctor or pharmacist. An overdose of Indivina could make you feel sick or make you get a headache or uterine bleeding.

If you forget to take Indivina:

It is best to take the tablet at the same time each day. If you forget to take a tablet leave the forgotten tablet. You should then continue by taking the next tablet at your usual time. Missing a tablet or irregular use of Indivina tablets may cause breakthrough bleeding or spotting.

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

If you stop taking Indivina

If you want to stop taking Indivina, talk to your doctor first. He/she will explain the effects of stopping treatment and discuss other possibilities with you.

Indivina Side Effects

Like all medicines, Indivina may cause side effects although not everybody gets them, particularly early on (in the first few months of treatment), for example irregular bleeding may occur. These often disappear with continued treatment.

There are a number of situations in which you may have to stop taking Indivina. Tell your doctor immediately if you develop any of the following conditions:

Common (affecting more than 1 person in 100):

feeling sick, stomach pain headache breast tenderness, breast enlargement, breakthrough bleeding weight increase or decrease changes in mood including anxiety and depressive mood, changes in libido increase in size of uterine muscle lumps (fibroids) swelling caused by fluid retention

Uncommon (affecting more than 1 in 1,000 but less than 1 in 100)

dizziness, migraine leg cramps increased blood pressure vaginal thrush (candidiasis) indigestion/heartburn wind, vomiting gall bladder disease and/or gallstones

Rare (affecting more than 1 in 10,000 but less than 1 in 1,000)

skin rash, itching blood clots hair loss, excessive hair growth (hirsutism) Other side effects of combined HRT

The following side effects have been reported after taking other oestrogen/progestagen products:

Oestrogen dependent tumours, heart attack, stroke, disorders of skin and underlying tissues.

Endometrial hyperplasia and endometrial cancer

In women with an intact uterus, the risk of excessive growth of the womb lining (endometrial hyperplasia) is increased. Treatment with unopposed oestrogens for long periods of time increases the risk of cancer of the lining of the womb (endometrial cancer). Adding a progestagen, which Indivina contains, greatly reduces this increased risk.

Compare

Looking at women who still have a uterus and who are not taking HRT, on average, 5 in 1000 will be diagnosed with endometrial cancer between the ages of 50 and 65. For women who take oestrogen-only HRT the number will be 2 to 12 times higher, depending on the dose and how long you take it. The addition of progestogen to oestrogen-only HRT substantially reduces the risk of endometrial cancer.

Breast cancer

Every woman is at risk of getting breast cancer whether or not she takes HRT. There is a small increase in this risk for women who have been using HRT compared with women of the same age who have never used HRT. This risk increases with the duration of intake of HRT, but returns to normal within a few (at most five) years of having stopped HRT. The risk seems to be higher for women who use oestrogen in combination with progestagen as compared to oestrogen alone.

Compare:

Looking at women aged 50 who are not taking HRT – on average, 32 in 1000 will be diagnosed with breast cancer by the time they reach the age of 65.

For women who start taking oestrogen-only HRT at age 50 and take it for 5 years, the figure will be between 33 and 34 in 1000 (i.e. an extra 1-2 cases).

If they take oestrogen-only HRT for 10 years, the figure will be, 37 in 1000 (i.e. an extra 5 cases). For women who start taking oestrogen plus progestogen HRT at age 50 and take it for 5 years, the figure will be 38 in 1000 (i.e. an extra 6 cases).

If they take oestrogen plus progestogen HRT for 10 years, the figure will be 51 in 1000 (i.e. an extra 19 cases).

To be able to detect a breast tumour as early as possible, it’s important to regularly check your breasts for any changes and to discuss any changes with your doctor. Also go for regular health check, including mammography. If you are anxious about the risk of developing breast cancer, you should talk to your doctor about the risks and benefits of hormone replacement therapy.

Blood clots in the deep veins

Every woman is at risk of getting a blood clot whether or not she takes HRT.

HRT may increase the risk of blood clots in the veins up to3 times, especially in the first year of taking it.

If you suspect you are suffering from a blood clot, seek immediate medical attention.

You are also more likely to get a blood clot:

If you are very overweight If you have had a blood clot before, or have had any blood clotting problem that needs treatment with a medicine such as Warfarin If any of your close family has had blood clots If you have had a miscarriage If you are off your feet for a long time through surgery, injury or illness If you have Systemic Lupus Erythematosus ((SLE) – an autoimmune disease)

Compare

Looking at women in their 50’s who are not taking HRT – on average, over a 5 year period, 3 in 1000 would be expected to get a blood clot.

For women in their 50s who are taking HRT, the figure would be 7 in 1000.

Looking at women in their 60s who are not taking HRT – on average, over a 5 year period, 8 in 1000 would be expected to get a blood clot.

For women in their 60’s who are taking HRT, the figure would be 17 in 1000.

Symptoms that may be indicative of blood clots:

Pain and swelling in your leg Sudden chest pain Difficulty breathing.

Seek immediate medical help. Stop taking HRT until your doctor says you can.

Heart disease

If you ever have had angina or heart attack, you should talk to your doctor about the risks and benefits of hormone replacement therapy.

There is no evidence from clinical trials of beneficial effects on the risks of cardiovascular disease with hormone replacement therapy in the menopause. Results from two large clinical studies showed that women, who used another type of oestrogen/progestagen combination, had a slightly increased risk of heart disease in the first year of use.

For other HRT products there are only very limited data from trials examining the effects on the risk of cardiovascular disease.

Stroke

There may be a slightly higher chance of having a stroke if you are taking HRT.

Other things that also increase the risk of stroke are:

Getting older High blood pressure Smoking Drinking too much alcohol An irregular heartbeat.

Compare

Looking at women in their 50’s who are not taking HRT - on average, over a 5 year period, 3 in 1000 would be expected to have a stroke.

For women in their 50s who are taking HRT, the figure would be 4 in 1000.

Looking at women in their 60s who are not taking HRT - on average, over a 5 year period, 11 in 1000 would be expected to have a stroke.

For women in their 60’s who are taking HRT, the figure would be 15 in 1000.

If you get:

Unexplained migraine-type headaches, with or without disturbed vision.

See a doctor as soon as possible. Stop taking HRT until your doctor says you can.

Ovarian cancer

Long-term (at least 5 or 10 years) use of oestrogen-only HRTs and oestrogen plus progestogen HRTs has been associated with an increased risk of ovarian cancer in some epidemiological studies.

Dementia

HRT will not prevent memory loss. In one study of women who started using combined HRT after the age of 65, a small increase in the risk of dementia was observed.

Effects on the skin

Brown patches in the face (chloasma), skin rashes including red inflammation on the hands or the legs (erythema multiforme), formation of tender, red nodules on the front of the legs/knees (erythema nodosum) or a bruise-like rash (vascular purpura).

If you notice any side effects not listed in this leaflet or if any of the side effects mentioned gets serious please tell your doctor or pharmacist.

How To Store Indivina

Keep out of the reach and sight of children. Do not use Indivina after the expiry date which is stated on the pack. Do not store above 30 ?C. Store in the original package in order to protect from moisture. Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information What Indivina contains:

The active ingredients of Indivina tablets are estradiol valerate and medroxyprogesterone acetate. Three different strengths of tablets are available.

Indivina 1 mg/2.5 mg tablets contain 1 mg of estradiol valerate and 2.5 mg medroxyprogesterone acetate.

Indivina 1 mg/5 mg tablets contain 1 mg of estradiol valerate and 5 mg medroxyprogesterone acetate.

Indivina 2 mg/5 mg tablets contain 2 mg of estradiol valerate and 5 mg medroxyprogesterone acetate.

The other ingredients of all Indivina tablets are lactose monohydrate, maize starch, gelatin, and magnesium stearate

What Indivina looks like and contents of the pack:

Indivina 1 mg/2.5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘1 + 2.5’on one side.

Indivina 1 mg/5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘1 + 5’on one side.

Indivina 2 mg/5 mg tablets are white, round, bevelled-edge, diameter 7 mm, flat tablets with a code ‘2 + 5’on one side.

The tablets are packed in a PVC/PVDC-aluminium blister of 28 tablets. The pack sizes available are 1 x 28 tablets and 3 x 28 tablets for all three strengths. All pack sizes may not be available in your country.

Marketing Authorisation Holder: Orion Corporation Orionintie 1 FIN-02200 Espoo FINLAND Manufactured by: Orion Corporation Tengstr?minkatu 8 FIN-20360 Turku FINLAND

This medicinal product is authorised in the Member States of the EEA under the following names:

Indivina, Duova

This leaflet was last revised: June 2010


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Drugs associated with Melioidosis

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


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Medroxyprogesterone


Generic Name: Medroxyprogesterone acetate
Dosage Form: tablet
Medroxyprogesterone Acetate Tablets USP

Iss. 4/2010
11001645

Rx only

(Three Patient Information Leaflet Enclosed-Tear at Perforation)

WARNINGS
CARDIOVASCULAR AND OTHER RISKS

Estrogens with progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Dementia.)

The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined with Medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Malignant Neoplasms, Breast Cancer.)

The Women’s Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Dementia, and PRECAUTIONS, Geriatric Use.)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Medroxyprogesterone Description

Medroxyprogesterone Acetate Tablets USP contain Medroxyprogesterone acetate, USP which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water.

The chemical name for Medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6?)-. The structural formula is:

Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of Medroxyprogesterone acetate, USP. In addition, each tablet contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized starch, and sodium lauryl sulfate.

Medroxyprogesterone - Clinical Pharmacology

Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.

Pharmacokinetics

The pharmacokinetics of MPA were determined in 20 postmenopausal women following a single-dose administration of eight Medroxyprogesterone acetate 2.5 mg tablets or a single administra- tion of two Medroxyprogesterone acetate 10 mg tablets under fasting conditions. In another study, the steady-state pharmacokinetics of MPA were determined under fasting conditions in 30 post- menopausal women following daily administration of one Medroxyprogesterone acetate 10 mg tablet for 7 days. In both studies, MPA was quantified in serum using a validated gas chroma- tography-mass spectrometry (GC-MS) method. Estimates of the pharmacokinetic parameters of MPA after single and multiple doses of Medroxyprogesterone acetate tablets were highly variable and are summarized in Table 1.

Table 1. Mean (SD) Pharmacokinetic Parameters for Medroxyprogesterone Acetate (MPA) * Following Day 7 dose

Tablet

Strength

Cmax

(ng/mL)

Tmax

(h)

Auc0-(?)

(ng·h/mL)

t?

(h)

Vd/f

(L)

CL/f

(mL/min) Single Dose 2 x 10 mg 1.01 (0.599) 2.65 (1.41) 6.95 (3.39) 12.1 (3.49)

78024

(47220)

64110

(42662) 8 x 2.5 mg 0.805 (0.413) 2.22 (1.39) 5.62 (2.79) 11.6 (2.81)

62748

(40146)

74123

(35126) Multiple Dose 10 mg* 0.71 (0.35) 2.83 (1.83) 6.01 (3.16) 16.6
(15)

40564

(38256)

41963

(38402) A. Absorption

No specific investigation on the absolute bioavailability of MPA in humans has been conducted. MPA is rapidly absorbed from the gastrointestinal tract, and maximum MPA concentrations are obtained between 2 to 4 hours after oral administration.

Administration of Medroxyprogesterone acetate with food increases the bioavailability of MPA. A 10 mg dose of Medroxyprogesterone acetate, taken immediately before or after a meal, in- creased MPA Cmax (50 to 70%) and AUC (18 to 33%). The half-life of MPA was not changed with food.

B. Distribution

MPA is approximately 90% protein bound, primarily to albumin; no MPA binding occurs with sex hormone binding globulin.

C. Metabolism

Following oral dosing, MPA is extensively metabolized in the liver via hydroxylation, with subsequent conjugation and elimination in the urine.

D. Excretion

Most MPA metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

E. Special Populations Renal Insufficiency

The pharmacokinetics of MPA in patients with varying degrees of renal insufficiency have not been investigated.

Hepatic Insufficiency

MPA is almost exclusively eliminated via hepatic metabolism. In 14 patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination). In patients with fatty liver, the mean percent dose excreted in the 24-hour urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively.

F. Drug Interactions

No formal pharmacokinetic drug interaction studies have been conducted with Medroxyprogesterone acetate.

Clinical Studies Effects on the Endometrium

In a 3-year, double-blind, placebo-controlled study of 356 nonhysterectomized, postmenopausal women between 45 and 64 years of age randomized to receive placebo (n=119), 0.625 mg conjugated estrogen only (n=119), or 0.625 mg conjugated estrogen plus cyclic Medroxyprogesterone acetate (n=118), results showed a reduced risk of endometrial hyperplasia in the treatment group receiving 10 mg Medroxyprogesterone acetate plus 0.625 mg conjugated estrogens compared to the group receiving 0.625 mg conjugated estrogens only. See Table 2.

Table 2. Number (%) of Endometrial Biopsy Changes Since Baseline After 3 Years of Treatment* * Includes most extreme abnormal result * CEE = conjugated equine estrogens 0.625 mg/day † Medroxyprogesterone acetate = Medroxyprogesterone acetate tablets 10 mg/day for 12 days

Histological

Results

Placebo

(n=119)

CEE* 

(n=119)

Medroxyprogesterone
Acetate† 
+ CEE

(n=118)

Normal/No hyperplasia (%)

116 (97) 45 (38) 112 (95)

Simple (cystic) hyperplasia (%)

1 (1) 33 (28) 4 (3)

Complex (adenomatous) hyperplasia (%)

1 (1) 27 (22) 2 (2) Atypia (%)
0 14 (12) 0 Adenocarcinoma (%)
1 (1) 0 0

In a second 1-year study, 832 postmenopausal women between 45 and 65 years of age were treated with daily 0.625 mg conjugated estrogen (days 1 to 28), plus either 5 mg cyclic Medroxyprogesterone acetate or 10 mg cyclic Medroxyprogesterone acetate (days 1 5to 28), or daily 0.625 mg conjugated estrogen only. The treatment groups receiving 5 or 10 mg cyclic Medroxyprogesterone acetate (days 15 to 28) plus daily conjugated estrogens showed a significantly lower rate of hyperplasia as compared to the conjugated estrogens only group. See Table 3.

Table 3. Number (%) of Women with Endometrial Hyperplasia at 1 Year * CEE = conjugated equine estrogen 0.625 mg every day of a 28-day cycle. † Cyclic Medroxyprogesterone acetate on days 15 to 28. CEE* MPA†  + CEE*
(n=283)

MPA 5 mg

(n=277)

MPA 10 mg

(n=272)

Cystic hyperplasia (%)

55 (19) 3 (1) 0

Adenomatous hyperplasia without

atypia 2 (1) 0 0 Women’s Health Initiative Studies

The Women’s Health Initiative (WHI) enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of either the use of daily oral conjugated estrogens (CE 0.625 mg) alone or in combination with Medroxyprogesterone acetate (MPA 2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (nonfatal myocardial infarction (MI), silent MI and CHD death), with invasive breast cancer as the primary adverse outcome studied. A “global index” included the earliest occurrence of CHD, invasive breast cancer, stroke, pulmonary embolism (PE), endometrial cancer (only in the CE/MPA substudy), colorectal cancer, hip fracture, or death due to other cause. The study did not evaluate the effects of CE or CE/MPA on menopausal symptoms.

The estrogen plus progestin substudy was stopped early. According to the predefined stopping rule, after an average follow-up of 5.2 years of treatment, the increased risk of breast cancer and cardiovascular events exceeded the specified benefits included in the “global index.” The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years (relative risk [RR] 1.15, 95 percent, nominal confidence interval [nCI], 1.03 to 1.28).

For those outcomes included in the WHI “global index,” that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE/MPA were 6 more CHD events, 7 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reduction per 10,000 women-years were 7 fewer colorectal cancers and 5 fewer hip fractures. (See BOXED WARNINGS, WARNINGS and PRECAUTIONS.)

Results of the CE/MPA substudy which included 16,608 women (average age of 63 years, range 50 to 79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 4. These results reflect centrally adjudicated data after an average follow-up of 5.6 years.

Table 4: RELATIVE AND ABSOLUTE RISK SEEN IN THE ESTROGEN PLUS PROGESTIN SUBSTUDY OF WHI AT AN AVERAGE OF 5.6 YEARS* * Results are based on centrally adjudicated data. Mortality data was not part of the adjudicated data; however, data at 5.2 years of follow-up showed no difference between the groups in terms of all-cause mortality (RR 0.98, 95 percent nCI, 0.82 to 1.18). † Includes metastatic and non-metastatic breast cancer with the exception of in situ breast cancer ‡ Nominal confidence intervals unadjusted for multiple looks and multiple comparisons
Event†

Relative Risk CE/MPA vs placebo

(95% nCI‡)


Placebo

n = 8102


CE/MPA

n = 8506 Absolute Risk per 10,000 Women-Years CHD events
Non-fatal MI
CHD death 1.24 (1.00-1.54)
1.28 (1.00-1.63)
1.10 (0.70-1.75) 33
25
8 39
31
8 All strokes 1.31 (1.02-1.68) 24 31 Ischemic stroke 1.44 (1.09-1.90) 18 26 Deep vein thrombosis 1.95 (1.43-2.67) 13 26 Pulmonary embolism 2.13 (1.45-3.11) 8 18 Invasive breast cancer† 1.24 (1.01-1.54) 33 41 Invasive colorectal cancer 0.56 (0.38-0.81) 16 9 Endometrial cancer 0.81 (0.48-1.36) 7 6 Cervical Cancer 1.44 (0.47-4.42) 1 2 Hip fracture 0.67 (0.47-0.96) 16 11 Vertebral fractures 0.65 (0.46-0.92) 17 11 Lower arm/wrist fractures 0.71 (0.59-0.85) 62 44 Total fractures 0.76 (0.69-0.83) 199 152 Women's Health Initiative Memory Study

The estrogen plus progestin Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, enrolled 4,532 predominantly healthy postmenopausal women 65 years of age and older (47 percent were aged 65 to 69 years, 35 percent were 70 to 74 years, and 18 percent were 75 years of age and older) to evaluate the effects of daily conjugated estrogens (CE 0.625 mg) plus Medroxyprogesterone acetate (MPA 2.5 mg) on the incidence of probable dementia (primary outcome) compared with placebo.

After an average follow-up of 4 years, 40 women in the estrogen plus progestin group (45 per 10,000 women-years) and 21 in the placebo group (22 per 10,000 women-years) were diagnosed with probable dementia. The relative risk of probable dementia in the hormone therapy group was 2.05 (95 percent CI, 1.21 to 3.48) compared to placebo.

Indications and Usage for Medroxyprogesterone

Medroxyprogesterone Acetate Tablets USP are a progestin indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Medroxyprogesterone Acetate Tablets USP are also indicated to reduce the incidence of endometrial hyperplasia in nonhysterectomized postmenopausal women receiving daily oral conjugated estrogens 0.625 mg tablets.

Contraindications

Medroxyprogesterone Acetate Tablets USP should not be used in women with any of the following conditions:

Undiagnosed abnormal genital bleeding. Known, suspected, or history of cancer of the breast. Known or suspected estrogen- or progesterone-dependent neoplasia. Active deep vein thrombosis, pulmonary embolism or a history of these conditions. Active or recent (within the past year) arterial thromboembolic disease (for example, stroke and myocardial infarction). Known liver dysfunction or disease. Missed abortion. As a diagnostic test for pregnancy. Known hypersensitivity to the ingredients in Medroxyprogesterone acetate tablets. Known or suspected pregnancy. Warnings

See BOXED WARNINGS.

1. Cardiovascular Disorders.

An increased risk of stroke, deep vein thrombosis (DVT), pulmonary embolism, and myocardial infarction has been reported with estrogen plus progestin therapy. Should any of these events occur or be suspected, estrogen plus progestin therapy should be discontinued immediately.

Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of venous thromboembolism [VTE]), obesity, and systemic lupus erythematosus should be managed appropriately.

a. Stroke

In the estrogen plus progestin substudy of the Women’s Health Initiative (WHI) a statistically significant increased risk of stroke was reported in women receiving daily conjugated estrogens (CE 0.625 mg) plus Medroxyprogesterone acetate (MPA 2.5 mg) compared to women receiving placebo (31 versus 24 per 10,000 women-years). The increase in risk was demonstrated after the first year and persisted. (See CLINICAL STUDIES.)

b. Coronary heart disease

In the estrogen plus progestin substudy of WHI, no statistically significant increase of CHD events (defined as non-fatal myocardial infarction [MI], silent MI or CHD death was reported in women receiving CE/MPA compared to women receiving placebo (39 versus 33 per 10,000 women-years). An increase in relative risk was demonstrated in year one, and a trend toward decreasing relative risk was reported in years 2 through 5. (See CLINICAL STUDIES.)

In postmenopausal women with documented heart disease (n = 2,763, average age 66.7 years), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estro- gen/Progestin Replacement Study [HERS]), treatment with daily CE 0.625 mg/ MPA 2.5 mg per day demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE/MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE/MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty one (2,321) women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE/MPA group and the placebo group in HERS, HERS II, and overall.

c. Venous thromboembolism (VTE)

In the estrogen plus progestin substudy of WHI, a statistically significant two-fold greater rate of VTE, (DVT and pulmonary embolism [PE]), was reported in women receiving daily CE/MPA compared to women receiving placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. The increase in VTE risk was observed during the first year and persisted. (See CLINICAL STUDIES.)

2. Malignant Neoplasms a. Breast cancer

The use of estrogens and progestins by postmenopausal women has been reported to increase the risk of breast cancer in some studies. Observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen alone therapy, after several years of use. The risk increased with duration of use and appeared to return to baseline in about 5 years after stopping treatment (only the observational studies have substantial data on risk after stopping). Observational studies also suggest that the risk of breast cancer was greater, and became apparent earlier, with estrogen plus progestin therapy as compared to estrogen alone therapy. However, these studies have not found significant variation in the risk of breast cancer among different estrogens or among different estrogen plus progestin combinations, doses, or routes of administration.

The most important randomized clinical trial providing information about this issue is the Women’s Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg) plus Medroxyprogesterone acetate (MPA 2.5 mg) (See CLINICAL STUDIES.)

In the estrogen plus progestin substudy of WHI, after a mean follow-up of 5.6 years, the WHI substudy reported an increased risk of breast cancer in women who took daily CE/MPA. In this substudy, prior use of estrogen alone or estrogen plus progestin therapy was reported by 26 percent of the women. The relative risk of invasive breast cancer was 1.24 (95 percent nominal confidence interval [nCI], 1.01 to 1.54), and the absolute risk was 41 versus 33 cases per 10,000 women-years, for estrogen plus progestin compared with placebo, respectively. Among women who reported prior use of hormone therapy, the relative risk of invasive breast cancer was 1.86, and the absolute risk was 46 versus 25 cases per 10,000 women-years, for CE/MPA compared with placebo. Among women who reported no prior use of hormone therapy, the relative risk of invasive breast cancer was 1.09, and the absolute risk was 40 versus 36 cases per 10,000 women-years, for estrogen plus progestin compared with placebo. In the same substudy, invasive breast cancers were larger and diagnosed at a more advanced stage in the CE/MPA group compared with the placebo group. Metastatic disease was rare with no apparent difference between the two groups. Other prognostic factors such as histologic subtype, grade, and hormone receptor status did not differ between the groups.

The use of estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation. All women should receive yearly breast examinations by a health care provider and perform monthly breast self-examinations. In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammogram results.

b. Endometrial cancer

An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in women with a uterus. The reported endometrial cancer risk among unopposed estrogen users is about 2- to 12 times greater than in nonusers, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with the use of estrogens for less than 1 year. The greatest risk appears associated with prolonged use, with increased risks of 15- to 24-fold for 5 to 10 years or more. This risk has been shown to persist for at least 8 to 15 years after estrogen therapy is discontinued.

Clinical surveillance of all women using estrogen plus progestin therapy is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of natural estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

c. Ovarian cancer

The estrogen plus progestin substudy of WHI reported that daily CE/MPA increased the risk of ovarian cancer. After an average follow-up of 5.6 years, the relative risk for ovarian cancer for CE/MPA versus placebo was 1.58 (95 percent nCI, 0.77 to 3.24) but was not statistically significant. The absolute risk for CE/MPA was 4.2 versus 2.7 cases per 10,000 women-years.

3. Dementia

In the estrogen plus progestin Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 4,532 postmenopausal women aged 65 to 79 years was randomized to daily conjugated estrogens (CE 0.625 mg) plus Medroxyprogesterone acetate (MPA 2.5 mg) or placebo.

After an average follow-up of 4 years, 40 women in the CE/MPA group and 21 women in the placebo group were diagnosed with probable dementia. The relative risk of probable dementia for CE/MPA versus placebo was 2.05 (95 percent CI, 1.21 to 3.48). The absolute risk of probable dementia for CE/MPA versus placebo was 45 versus 22 cases per 10,000 women-years. It is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS and PRECAUTIONS, Geriatric Use.)

4. Visual Abnormalities

Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be permanently discontinued.

Precautions A. General Addition of a progestin when a woman has not had a hysterectomy Studies of the addition
of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer. There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (lowering HDL, raising LDL) and impairment of glucose tolerance. Undiagnosed abnormal vaginal bleeding
In cases of undiagnosed abnormal vaginal bleeding, adequate diagnostic measures are indicated. Elevated blood pressure
Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy. Hypertriglyceridemia
In patients with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis and other complications. Impaired liver function and past history of cholestatic jaundice
Estrogens plus progestins may be poorly metabolized in patients with impaired liver function. For patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued. Fluid Retention
Progestins may cause some degree of fluid retention. Patients who have conditions which might be influenced by this factor, such as cardiac or renal dysfunction, warrant careful observation when estrogen plus progestin are prescribed. Hypocalcemia
Estrogen plus progestin therapy should be used with caution in individuals with severe hypocalcemia. Exacerbation of other conditions
Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions. B. Patient Information

Physicians are advised to discuss the Patient Information leaflet with patients for whom they prescribe Medroxyprogesterone acetate.

There may be an increased risk of minor birth defects in children whose mothers are exposed to progestins during the first trimester of pregnancy. The possible risk to the male baby is hypospadias, a condition in which the opening of the penis is on the underside rather than the tip of the penis. This condition occurs naturally in approximately 5 to 8 per 1,000 male births. The risk may be increased with exposure to Medroxyprogesterone acetate. Enlargement of the clitoris and fusion of the labia may occur in female babies. However, a clear association between hypospadias, clitoral enlargement and labial fusion with use of Medroxyprogesterone acetate has not been established.

Inform the patient of the importance of reporting exposure to Medroxyprogesterone acetate in early pregnancy.

 C. Drug/Laboratory Test Interactions

The following laboratory results may be altered by the use of estrogen plus progestin therapy:

Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity. Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay, T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone. Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG) leading to increased circulating corticosteroid and sex steroids, respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin). Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels. Impaired glucose metabolism. D. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term intramuscular administration of Medroxyprogesterone acetate has been shown to produce mammary tumors in beagle dogs. There was no evidence of a carcinogenic effect associated with the oral administration of Medroxyprogesterone acetate to rats and mice. Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays.

Medroxyprogesterone acetate at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.

Long-term continuous administration of estrogen plus progestin therapy, has shown an increased risk of breast cancer and ovarian cancer. (See WARNINGS and PRECAUTIONS.)

E. Pregnancy Teratogenic Effects Pregnancy Category X

Medroxyprogesterone acetate should not be used during pregnancy. (See CONTRAINDICATIONS.)

There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of Medroxyprogesterone acetate has not been established.

F. Nursing Mothers

Medroxyprogesterone acetate should not be used during lactation. Detectable amounts of progestin have been identified in the milk of nursing mothers receiving progestins.

G. Pediatric Use

Medroxyprogesterone acetate is not intended for pediatric use and no clinical data has been collected in children.

H. Geriatric Use

Of the total number of subjects in the estrogen plus progestin substudy of the Women’s Health Initiative (WHI), 44 percent (n = 7,320) were 65 years and older, while 6.6 percent (n = 1,095) were 75 years and older. In women 75 and older compared to women less than 75 years of age, there was a higher relative risk of non-fatal stroke and invasive breast cancer in the estrogen plus progestin group versus placebo. In women greater than 75 years of age, the increased risk of non-fatal stroke and invasive breast cancer observed in the estrogen plus progestin group compared to placebo was 75 versus 24 per 10,000 women-years and 52 versus 12 per 10,000 women-years, respectively.

In the estrogen plus progestin Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, a population of 4,532 postmenopausal women, aged 65 to 70 years, was randomized to receive daily CE 0.625 mg/MPA 2.5 mg or placebo. In the estrogen plus progestin group, after an average follow-up of 4 years, the relative risk (CE/MPA versus placebo) of probable dementia was 2.05 (95 percent CI, 1.21 to 3.48). The absolute risk of developing probable dementia with CE/MPA was 45 versus 22 cases per 10,000 women-years compared with placebo.

Eighty-two percent of the cases of probable dementia occurred in women that were older than 70 in the CE/MPA group. The most common classification of probable dementia in the estrogen plus progestin and placebo groups was Alzheimer’s disease.

When data from the estrogen alone and estrogen plus progestin WHIMS substudies were pooled as planned in the WHIMS protocol, the reported overall relative risk for probable dementia was 1.76 (95 percent CI, 1.19 to 2.60). Since both substudies were conducted in women aged 65 to 79 years, it is unknown whether these findings apply to younger postmenopausal women. (See BOXED WARNINGS and WARNINGS, Dementia.)

ADVERSE REACTIONS

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

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

The following adverse reactions have been reported in women taking progestins, including Medroxyprogesterone acetate tablets, without concomitant estrogens treatment:

1. Genitourinary System

Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.

2. Breasts

Breast tenderness, mastodynia or galactorrhea has been reported.

3. Cardiovascular

Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.

4. Gastrointestinal

Nausea, cholestatic jaundice.

5. Skin

Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.

6. Eyes

Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.

7. Central Nervous System

Mental depression, insomnia, somnolence, dizziness, headache, nervousness.

8. Miscellaneous

Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

1. Genitourinary System

Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.


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Centrine



Dosage Form: FOR ANIMAL USE ONLY
Centrine®
AMINOPENTAMIDE
HYDROGEN SULFATE
Veterinary Injection and Tablets
Centrine Description

Centrine (aminopentamide hydrogen sulfate) is a potent antispasmodic agent. As a cholinergic blocking agent for smooth muscle, its action is similar to atropine.

ACTION

Centrine effectively reduces the tone and amplitude of colonic contractions to a greater degree and for a more extended period than does atropine.

Centrine effects a reduction in gastric secretion, a decrease in gastric acidity and a marked decrease in gastric motility.

The mydriatic and salivary effects of Centrine are less than those produced by atropine at similar dosage, permitting the control of vomiting and diarrhea with less distress to the animal due to dryness of the mouth and blurred vision.

INDICATIONS

Centrine is indicated in the treatment of acute abdominal visceral spasm, pylorospasm or hypertrophic gastritis and associated nausea, vomiting and/or diarrhea.

Contraindications

Centrine should not be used in animals with glaucoma because of the occurrence of mydriasis.

Warning

FOR USE IN DOGS AND CATS ONLY.

Precautions

Dryness of the mouth is the most commonly reported side effect. Blurring of vision may occur and dryness of the eyes may occur if larger (greater than therapeutic) doses are used. Centrine should be used cautiously, if at all, in pyloric obstruction because of its action in delaying gastric emptying. These effects frequently decrease with continued administration of the drug. Disturbances in urination are relatively infrequent. They vary from slightly hesitancy in initiating urination to complete inability to urinate; the latter is an indication for discontinuing the drug. After a day or two, it may be resumed at a lower dosage level.

DOSAGE

Centrine (aminopentamide hydrogen sulfate) may be administered by subcutaneous or intramuscular injection or by oral tablets according to the following schedule. If the desired effect is not obtained, the dosage may be gradually increased up to a maximum of 5 times the doses listed. When the condition has been brought under control by parenteral medication, treatment can be continued, if desired, with 0.2 mg scored tablets according to the dosage schedule.

Weight of Animal Amount to be Administered Every 8 to 12 hours Dosage Injectable Volume Oral Tablets 10 lbs or less 0.1 mg 0.2 mL 1/2 Tab 11 lbs to 20 lbs 0.2 mg 0.4 mL 1 Tab 21 lbs to 50 lbs 0.3 mg 0.6 mL 1 1/2 Tabs 51 lbs to 100 lbs 0.4 mg 0.8 mL 2 Tabs Over 100 lbs 0.5 mg 1.0 mL 2 1/2 Tabs CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

How is Centrine Supplied

0.5 mg/mL Centrine (aminopentamide hydrogen sulfate) VETERINARY INJECTION, 10 mL vials.

0.2 mg Centrine (aminopentamide hydrogen sulfate) VETERINARY TABLETS, bottles of 100.

NDC 0856-2401-10 – 0.5 mg/mL – 10 mL vials.
NDC 0856-2400-60 – 0.2 mg – bottles of 100.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Fort Dodge Animal Health
Fort Dodge, Iowa 50501 USA

92686
Rev. September 1996
4260F

NADA 43-079, Approved by FDA
NADA 43-078, Approved by FDA

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

NDC 0856-2401-10

Centrine®
AMINOPENTAMIDE
HYDROGEN SULFATE
Veterinary Injection

FORT DODGE®

contains 0.5 mg/mL
aminopentamide hydrogen sulfate

10 mL

CAUTION: Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.

NADA 43-079, Approved by FDA


Centrine 
aminopentamide sulfate  injection, solution Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 0856-2401 Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength aminopentamide sulfate (aminopentamide) aminopentamide sulfate 0.5 mg  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 0856-2401-10 10 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA043079 09/05/1970
Labeler - FDAH, Division of Wyeth (149957656) Revised: 07/2010FDAH, Division of Wyeth

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Bartonellosis Medications


Definition of Bartonellosis: Cat scratch disease is an infectious illness caused by the bacteria More...

Drugs associated with Bartonellosis

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

Learn more about Bartonellosis

Medical Encyclopedia:

Cat scratch disease
Drug List: Azithromycin-3-Day-Dose-Pack Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Ilosone Monodox Ocudox-Convenience-Kit Oraxyl Pce Rifadin Rifadin-Iv Rimactane Vibra-Tabs Vibramycin Zithromax Zmax-Extended-Release-Oral-Suspension
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Syphilis, Early Medications


Drugs associated with Syphilis, Early

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


Drug List: Ala-Tet Beepen-Vk Bicillin-L-A-Suspension Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Ilosone Permapen-Isoject Monodox Ocudox-Convenience-Kit Oraxyl Pc-Pen-Vk Pce Pen-V Penicillin-G-Procaine-Injectable-Suspension Penicillin-Vk Pfizerpen Rocephin Sumycin Veetids Vibra-Tabs Vibramycin Wycillin
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Miscellaneous antimalarials


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.

Antimalarials agents are drugs effective in the treatment of malaria. Malaria is an infectious disease caused by the bite of an anopheles mosquito infected with certain protozoans. The best way to prevent malaria is by taking antimalarial drugs prophylactically prior to entering an endemic area.

Antimalarial agents are classified according to their action against different stages of the life cycle of the parasite. Certain antimalarial agents are more effective in the acute attack of malaria, and generally more that one agent will be used simultaneously to avoid resistance. Some antimalarial agents are used as prophylactic agents; they kill the parasite when it enters the host.

See also

Medical conditions associated with miscellaneous antimalarials:

Acne Actinomycosis Amebiasis Anthrax Anthrax Prophylaxis Bacterial Infection Bartonellosis Bronchitis Brucellosis Bullous Pemphigoid Chlamydia Infection Cholera Cutaneous Bacillus anthracis Ehrlichiosis Enterocolitis Epididymitis, Sexually Transmitted Gastroenteritis Granuloma Inguinale Inclusion Conjunctivitis Lyme Disease Lyme Disease, Arthritis Lyme Disease, Carditis Lyme Disease, Erythema Chronicum Migrans Lyme Disease, Neurologic Lymphogranuloma Venereum Malaria Malaria Prevention Melioidosis Mycoplasma Pneumonia Nongonococcal Urethritis Ocular Rosacea Ornithosis Pelvic Inflammatory Disease Pemphigoid Pemphigus Periodontitis Plague Pleural Effusion Pneumocystis Pneumonia Prophylaxis Pneumonia Proctitis Prostatitis Psittacosis Rabbit Fever Rheumatoid Arthritis Rickettsial Infection Rosacea Skin Infection STD Prophylaxis Syphilis, Early Syphilis, Latent Tertiary Syphilis Toxoplasmosis Toxoplasmosis, Prophylaxis Trachoma Upper Respiratory Tract Infection Urinary Tract Infection Drug List: Oraxyl Doxy-100 Adoxa Doxy-200 Oracea Vibramycin Doryx-Delayed-Release-Capsules Monodox Adoxa-Ck-Kit Adoxa-Tt-Kit Alodox Avidoxy Daraprim Halfan Ocudox-Convenience-Kit Periostat Uracil Vibra-Tabs
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Ulcerative Colitis Medications


Definition of Ulcerative Colitis: Ulcerative colitis is a chronic, episodic, inflammatory disease of the large intestine and rectum characterized by bloody diarrhea.

Drugs associated with Ulcerative Colitis

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

See sub-topics

Topics under Ulcerative Colitis Ulcerative Colitis, Active (55 drugs) Ulcerative Colitis, Maintenance (12 drugs) Learn more about Ulcerative Colitis

Micromedex Care Notes:

Ulcerative Colitis

Medical Encyclopedia:

Ulcerative colitis

Harvard Health Guide:

Symptoms and treatment for Ulcerative Colitis
Drug List: A-Hydrocort Acthar Apriso Asacol Asacol-Hd-Delayed-Release-Tablets Azasan Azulfidine Azulfidine-En-Tabs-Delayed-Release-Tablets Baycadron Canasa-Suppositories Canasa-Pac-Rectal Catapres Colazal Colocort-Enema Cortenema-Enema Cortifoam-Foam-Enema De-Sone-La-Injection Decadron Deltasone Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Dipentum Gengraf Hp-Acthar-Gel Imuran Lialda Mesasal-Rectal Meticorten Neoral Pentasa Remicade Rowasa-Enema Salofalk-Rectal Sandimmune Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Sulfazine Zema-Pak-10-Day
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