PROMETRIUM Capsule (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Virtus Pharmaceuticals

Λέξεις κλειδιά

69543-372 69543-373

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BOXED WARNING SECTION

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens plus progestin therapy ...

1. Description

PROMETRIUM (progesterone, USP) Capsules contain micronized progesterone for oral administration. Progesterone has a molecular weight of 314.47 and a molecular formula of C21H30O ...

2. Clinical Pharmacology

PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. ...

3. Indications and Usage

PROMETRIUM (progesterone, USP) Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They ...

4. Contraindications

PROMETRIUM Capsules should not be used in women with any of the following conditions: PROMETRIUM Capsules should not be used in patients with known hypersensitivity to its ingredients. PROMETRIUM Capsules ...

5. Warnings

See BOXED WARNING. 1. Cardiovascular disorders An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy. ...

6.1. General

1. 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 ...

6.2. Information for Patients

General: This product contains peanut oil and should not be used if you are allergic to peanuts. Physicians are advised to discuss the contents of the Patient Information leaflet with patients for ...

6.5. Drug/Laboratory Test Interactions

The following laboratory results may be altered by the use of estrogen plus progestin therapy: Increased sulfobromophthalein retention and other hepatic function tests. Coagulation tests: increase in prothrombin ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Progesterone has not been tested for carcinogenicity in animals by the oral route of administration. When implanted into female mice, progesterone produced mammary carcinomas, ovarian granulosa cell tumors ...

6.7. Pregnancy

PROMETRIUM Capsules should not be used during pregnancy. (See CONTRAINDICATIONS). Pregnancy Category B: Reproductive studies have been performed in mice at doses up to 9 times the human oral dose, in rats ...

6.9. Nursing Mothers

Detectable amounts of progestin have been identified in the milk of nursing women receiving progestins. Caution should be exercised when PROMETRIUM Capsules are administered to a nursing woman.

6.10. Pediatric Use

PROMETRIUM Capsules are not indicated in children. Clinical studies have not been conducted in the pediatric population.

6.11. Geriatric Use

There have not been sufficient numbers of geriatric women involved in clinical studies utilizing PROMETRIUM Capsules to determine whether those over 65 years of age differ from younger subjects in their ...

7. Adverse Reactions

See BOXED WARNING, 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 ...

9. Overdosage

No studies on overdosage have been conducted in humans. In the case of overdosage, PROMETRIUM (progesterone, USP) Capsules should be discontinued and the patient should be treated symptomatically.

10. Dosage and Administration

Prevention of Endometrial Hyperplasia PROMETRIUM Capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to a postmenopausal woman with a uterus ...

11. How Supplied

PROMETRIUM (progesterone, USP) Capsules 100 mg are round, peach-colored capsules branded with black imprint SV. NDC 69543-372-10 (Bottle of 100) PROMETRIUM (progesterone, USP) Capsules 200 mg are oval, ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in tight, light-resistant container as defined in ...

13. Clinical Studies

Effects on the endometrium In a randomized, double-blind clinical trial, 358 postmenopausal women, each with an intact uterus, received treatment for up to 36 months. The treatment groups were: PROMETRIUM ...