Prometrium is a bioidentical progesterone capsule indicated for use in hormone replacement therapy and the management of specific gynecological conditions. As a micronized formulation, it offers improved bioavailability and a favorable safety profile compared to synthetic progestins. This product is specifically designed to complement estrogen therapy in postmenopausal women and address progesterone deficiency states under medical supervision.

Features

• Contains 100mg or 200mg micronized progesterone per soft gelatin capsule
• Bioidentical molecular structure identical to endogenous progesterone
• Formulated in peanut oil for enhanced absorption
• Available in oral and vaginal administration routes
• Manufactured under strict pharmaceutical quality standards
• Packaged with light-resistant blister packs to maintain stability

Benefits

• Provides physiological progesterone replacement to restore hormonal balance
• Reduces risk of endometrial hyperplasia in women receiving estrogen therapy
• Supports maintenance of pregnancy in cases of corpus luteum deficiency
• Minimizes androgenic side effects associated with synthetic progestins
• Offers flexible administration routes based on clinical indication
• Demonstrates predictable pharmacokinetics for consistent therapeutic effects

Common use

Prometrium is primarily prescribed for two main indications: protection of the endometrium in postmenopausal women with an intact uterus who are receiving conjugated estrogens, and the support of early pregnancy in cases of progesterone deficiency. It is also used off-label for luteal phase support in assisted reproductive technology, management of secondary amenorrhea, and treatment of premenstrual syndrome when progesterone deficiency is suspected. The medication requires proper diagnostic evaluation before initiation and ongoing medical supervision throughout treatment.

Dosage and direction

For endometrial protection in postmenopausal women: 200 mg orally daily at bedtime for 12 sequential days per 28-day cycle. For assisted reproductive technology: 200-600 mg daily vaginally or orally, typically starting after oocyte retrieval and continuing through early pregnancy. For progesterone deficiency: 400 mg orally at bedtime for 10 days. Administration at bedtime is recommended due to potential sedative effects. Vaginal administration may be preferred in certain clinical scenarios to achieve higher local concentrations with reduced systemic effects. Capsules should be swallowed whole with water; not to be crushed or chewed.

Precautions

Patients should be monitored for signs of depression, especially those with a history of mood disorders. Regular breast examinations and mammograms are recommended as progesterone may affect breast tissue. Use with caution in patients with conditions that may be aggravated by fluid retention (epilepsy, migraine, asthma, cardiac or renal dysfunction). Diabetic patients should be closely monitored as progesterone may alter glucose tolerance. Patients should avoid activities requiring mental alertness, such as driving or operating machinery, until they know how the medication affects them. Regular liver function tests are advised during prolonged therapy.

Contraindications

Known hypersensitivity to progesterone, peanut oil, or any component of the formulation. Active or history of thromboembolic disorders, including deep vein thrombosis, pulmonary embolism, and cerebral vascular accident. Undiagnosed abnormal genital bleeding. Known or suspected breast cancer or other progesterone-sensitive malignancies. Severe hepatic dysfunction or disease. Missed abortion or ectopic pregnancy. Porphyria. Concurrent use with other progesterone-containing products.

Possible side effects

Common side effects (≥5% incidence) include drowsiness, dizziness, breast tenderness, headache, mood swings, bloating, and hot flashes. Less frequent effects (1-5%) may include nausea, vomiting, diarrhea, constipation, fatigue, irritability, and rash. Rare but serious adverse reactions include thromboembolic events, allergic reactions, depression, visual disturbances, and jaundice. Vaginal administration may cause local irritation, discharge, or spotting. Most side effects are dose-dependent and often diminish with continued use or dosage adjustment.

Drug interaction

Strong CYP3A4 inducers (rifampin, carbamazepine, St. John’s wort) may decrease progesterone levels. CYP3A4 inhibitors (ketoconazole, ritonavir, grapefruit juice) may increase progesterone concentrations. May enhance effects of CNS depressants including alcohol, barbiturates, and benzodiazepines. Concurrent use with other hormonal therapies may lead to additive effects. May interfere with laboratory tests including thyroid function tests and various hormone assays. Always inform healthcare providers of all medications, including over-the-counter products and herbal supplements.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one. For cyclic regimens, contact your healthcare provider for guidance if multiple doses are missed, as this may affect treatment efficacy and require schedule adjustment. Maintain a medication diary or use reminder tools to ensure consistent dosing.

Overdose

Acute overdose may manifest as enhanced pharmacological effects including profound drowsiness, dizziness, nausea, and lethargy. There is no specific antidote for progesterone overdose. Treatment should be symptomatic and supportive, including monitoring of vital signs and management of any respiratory depression. Gastric lavage may be considered if ingestion was recent. Hemodialysis is not effective due to high protein binding. Contact poison control center (1-800-222-1222) or seek immediate medical attention for guidance.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) in the original container. Protect from light and moisture. Keep the blister strips sealed until immediately before use. Do not freeze. Keep out of reach of children and pets. Do not use capsules that appear discolored, damaged, or beyond the expiration date printed on the packaging. Properly dispose of unused medication through take-back programs or according to FDA guidelines.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Individual treatment decisions should be made in consultation with a qualified healthcare professional based on specific clinical circumstances. The prescribing physician should be familiar with the complete prescribing information and latest clinical guidelines. Patients should not alter their dosage or discontinue treatment without medical supervision.

Reviews

Clinical studies demonstrate Prometrium’s efficacy in endometrial protection with 1.7% incidence of hyperplasia versus 20% with unopposed estrogen. Patient satisfaction surveys indicate preference for natural progesterone over synthetic alternatives due to reduced side effects. Medical professionals appreciate its predictable pharmacokinetics and flexible administration options. Long-term safety data supports its use in hormone replacement regimens when appropriately prescribed and monitored.