Prometrium 200 mg/1

Progesterone · CAPSULE · Acertis Pharmaceuticals, LLC

No Recall HistoryCurrently in Shortage

Plain English

Prometrium is a capsule containing progesterone at 200 mg/1, taken oral. Manufactured by Acertis Pharmaceuticals, LLC.

Key Facts

Brand Name: Prometrium
Generic Name: Progesterone
NDC Code (Product): 72989-373
Manufacturer: Acertis Pharmaceuticals, LLC
Strength: 200 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA019781
Drug Class: Progesterone [EPC]
Marketing Start: 11/01/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 are also indicated for use in secondary amenorrhea.

Dosage & Administration

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 who is receiving daily conjugated estrogens tablets. Treatment of Secondary Amenorrhea PROMETRIUM Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days. Some women may experience difficulty swallowing PROMETRIUM Capsules. For these women, PROMETRIUM Capsules should be taken with a glass of water while in the standing position.

Warnings

WARNINGS 1. Cardiovascular disorders PROMETRIUM is contraindicated in females with active DVT, PE, arterial thromboembolic disease (e.g., stroke, MI) disease, or a history of these conditions (See CONTRAINDICATIONS ). Immediately discontinue PROMETRIUM if a PE, DVT, stroke, or MI occurs or is suspected. If feasible, discontinue PROMETRIUM at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. The safety and efficacy of estrogen plus progestogen for the prevention of cardiovascular disorders has not been established. (See CLINICAL STUDIES ) The Women’s Health Initiative (WHI) estrogen plus progestin trial reported increased risks of PE, DVT, stroke, and MI in postmenopausal women (50 to 79 years of age, average age 63.4 years) 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. Analyses were also conducted in women aged 50-59 years, a group of women more likely to present with new onset of moderate to severe VMS compared to women in other age groups in the trial. (See CLINICAL STUD…

Contraindications

CONTRAINDICATIONS PROMETRIUM is contraindicated in women with any of the following conditions: 1. Hypersensitivity to its ingredients. PROMETRIUM Capsules contain peanut oil and is contraindicated in patients allergic to peanuts. 2. Abnormal genital bleeding of unknown etiology. 3. Known, suspected, or history of breast cancer. 4. Active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6. Known liver dysfunction or disease.

Adverse Reactions

ADVERSE REACTIONS See 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. In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of PROMETRIUM Capsules on the endometrium was studied in a total of 875 postmenopausal women. Table 7 lists adverse reactions greater than or equal to 2 percent of women who received cyclic PROMETRIUM Capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo. TABLE 7. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting] PROMETRIUM Capsules 200 mg with Conjugated Estrogens 0.625 mg Placebo (n=178) (n=174) Headache 31 27 Breast Tenderness 27 6 Joint Pain 20 29 Depression 19 12 Dizziness 15 9 Abdominal Bloating 12 5 Hot Flashes 11 35 Urinary Problems 11 9 Abdominal Pain 10 10 Vaginal Discharge 10 3 Nausea / Vomiting 8 7 Worry 8 4 Chest Pa…

Frequently Asked Questions

What is Prometrium used for?

Prometrium contains Progesterone. It is a capsule taken oral. Consult your doctor for specific uses.

Is Prometrium a controlled substance?

Prometrium is not classified as a controlled substance by the DEA.

What is the generic name for Prometrium?

The generic name for Prometrium is Progesterone. There are 12 other brand versions of Progesterone.

What is the NDC code for Prometrium 200 mg/1?

The NDC (National Drug Code) for Prometrium 200 mg/1 is 72989-373, listed by Acertis Pharmaceuticals, LLC.

Product NDC

72989-373

Package NDC

72989-373-30

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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