Prometrium is a prescription medication containing micronized progesterone, identical to the hormone naturally produced by the female body. It is specifically formulated to address progesterone deficiency in various clinical scenarios, from supporting reproductive health to managing menopausal symptoms. This bioidentical formulation offers superior bioavailability compared to synthetic progestins, with a safety profile that aligns with physiological hormone replacement. Healthcare providers frequently prescribe Prometrium as part of comprehensive hormone therapy regimens.

Features

• Contains 100mg or 200mg micronized progesterone per soft gelatin capsule
• Bioidentical structure identical to endogenous progesterone
• Peanut oil base (contains peanut allergens)
• Oral administration with specific food requirements for optimal absorption
• FDA-approved for multiple indications including amenorrhea and menopausal hormone therapy
• Available in sealed blister packs with tamper-evident packaging

Benefits

• Restores natural progesterone levels to support endometrial health
• Reduces risk of endometrial hyperplasia in women receiving estrogen therapy
• Supports successful embryo implantation in assisted reproductive technology
• Provides natural hormone replacement with fewer synthetic side effects
• Helps regulate menstrual cycles in women with progesterone deficiency
• May improve sleep quality due to progesterone’s neurosteroid effects

Common use

Prometrium is primarily prescribed for three main indications: secondary amenorrhea, where it induces withdrawal bleeding when estrogen levels are adequate; menopausal hormone therapy, where it protects the uterine lining in women receiving estrogen; and assisted reproductive technology, where it supports the luteal phase during fertility treatments. Off-label uses include treating premenstrual syndrome, preventing preterm birth in certain high-risk pregnancies, and managing perimenopausal symptoms. The medication is typically used cyclically for menstrual disorders and continuously when combined with estrogen for menopausal hormone therapy.

Dosage and direction

For secondary amenorrhea: 400 mg orally once daily at bedtime for 10 days. For menopausal hormone therapy: 200 mg orally once daily at bedtime for 12 sequential days per 28-day cycle in combination with estrogen. For assisted reproductive technology: 300 mg orally once daily at bedtime, starting at egg retrieval and continuing through the 10th week of pregnancy. All doses should be taken at bedtime to minimize dizziness and drowsiness. Capsules must be swallowed whole with a full glass of water and should be taken with food to enhance absorption. Dosage adjustments may be necessary based on individual response and tolerability.

Precautions

Patients should be monitored for signs of depression, particularly those with a history of mood disorders. Regular breast examinations and mammograms are recommended for women on long-term therapy. Caution is advised in patients with conditions that may be aggravated by fluid retention, such as epilepsy, migraine, asthma, or cardiac or renal dysfunction. Blood glucose levels should be monitored in diabetic patients. Patients should avoid activities requiring mental alertness, such as driving or operating machinery, after taking Prometrium due to potential drowsiness. Regular gynecological examinations are essential to monitor endometrial status.

Contraindications

Prometrium is contraindicated in patients with known hypersensitivity to progesterone, peanut oil, or any component of the formulation. It should not be used in individuals with known or suspected breast cancer, active deep vein thrombosis, pulmonary embolism, or active arterial thromboembolic disease. Additional contraindications include undiagnosed abnormal genital bleeding, history of hormone-sensitive cancers, liver dysfunction or disease, and missed abortion. It is contraindicated in pregnancy for use without an established progestational need.

Possible side effects

Common side effects (≥5% incidence) include dizziness, drowsiness, breast tenderness, headache, and abdominal bloating. Less frequent side effects (1-5% incidence) may include mood swings, nausea, hot flashes, fatigue, and joint pain. Rare but serious adverse effects include allergic reactions, vision changes, severe depression, thromboembolic events, and jaundice. Most side effects are dose-dependent and often diminish with continued use. Patients should report persistent or severe symptoms to their healthcare provider.

Drug interaction

Prometrium may interact with medications that induce hepatic enzymes, including rifampin, carbamazepine, and St. John’s Wort, potentially reducing progesterone efficacy. Concurrent use with other CNS depressants (alcohol, benzodiazepines, opioids) may enhance sedative effects. It may alter the effectiveness of anticoagulants and antidiabetic medications. Ketoconazole and other potent CYP3A4 inhibitors may increase progesterone levels. Hormonal contraceptives may have altered efficacy when used concomitantly. Always inform healthcare providers of all medications, including over-the-counter drugs and supplements.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume the regular schedule. Do not double the dose to make up for a missed one. For patients using Prometrium cyclically, contact your healthcare provider if multiple doses are missed, as this may affect treatment efficacy and cycle timing. Consistent timing is particularly important for fertility treatment protocols.

Overdose

No serious adverse effects have been reported with progesterone overdose. In cases of significant overdose, symptoms may include severe drowsiness, dizziness, and nausea. There is no specific antidote for progesterone overdose. Treatment should be symptomatic and supportive. Gastric lavage may be considered if ingestion was recent. Medical attention should be sought for evaluation, particularly if large quantities have been ingested or if concerning symptoms develop.

Storage

Store at controlled room temperature (20-25°C or 68-77°F). Keep in original container with lid tightly closed. Protect from light, moisture, and excessive heat. Do not freeze. Keep out of reach of children and pets. Do not use if capsules appear damaged, discolored, or if the expiration date has passed. Proper disposal of unused medication should follow local regulations, typically through medication take-back programs.

Disclaimer

This information is for educational purposes only and does not constitute medical advice. Individual treatment decisions should be made in consultation with a qualified healthcare professional. The prescribing physician should be consulted for specific recommendations based on individual health status and needs. Actual clinical use may vary based on practitioner judgment and patient-specific factors.

Reviews

Clinical studies demonstrate Prometrium’s efficacy in maintaining endometrial protection with improved patient tolerance compared to synthetic progestins. Physicians report favorable patient responses regarding symptom management and overall tolerability. Patients often note improved sleep quality and reduced menopausal symptoms, though some report initial drowsiness that typically diminishes with continued use. The natural progesterone formulation is frequently cited as a preferred option among both providers and patients seeking bioidentical hormone therapy.