Prometrium is a bioidentical progesterone capsule indicated for hormone replacement therapy and menstrual cycle regulation. As a micronized oral formulation, it offers targeted support for conditions driven by progesterone deficiency or imbalance. Its unique delivery system ensures predictable absorption and consistent therapeutic effects, making it a cornerstone in managing endocrine-related health concerns. This product is available by prescription only and should be used under medical supervision.

Features

• Contains 100 mg or 200 mg micronized progesterone per soft gelatin capsule
• Bioidentical molecular structure identical to endogenous progesterone
• Peanut oil-based formulation for enhanced bioavailability
• Oral administration with flexible dosing protocols
• Manufactured under current Good Manufacturing Practices (cGMP)
• Available in sealed blister packs with protective packaging

Benefits

• Restores physiological progesterone levels to support endometrial health
• Reduces risk of endometrial hyperplasia in women with intact uteri receiving estrogen therapy
• Regulates menstrual cycle irregularities and anovulatory bleeding
• Supports luteal phase deficiency in fertility treatments
• Provides neuroprotective benefits through progesterone metabolites
• May improve sleep quality and reduce anxiety in perimenopausal women

Common use

Prometrium is primarily prescribed for women experiencing progesterone deficiency states. Its most frequent application is in hormone replacement therapy (HRT) for postmenopausal women with intact uteri, where it counteracts estrogen-induced endometrial proliferation. The medication is also indicated for treating secondary amenorrhea and preventing endometrial hyperplasia. In reproductive medicine, it supports luteal phase defects and is often incorporated into assisted reproductive technology protocols. Off-label uses include management of premenstrual dysphoric disorder and certain cases of dysfunctional uterine bleeding.

Dosage and direction

Dosage must be individualized based on therapeutic indication and patient response. For postmenopausal women with intact uteri receiving estrogen, the typical dosage is 200 mg orally at bedtime for 12 sequential days per 28-day cycle. For secondary amenorrhea, 400 mg once daily at bedtime for 10 days is standard. Administration should occur at bedtime to minimize potential dizziness and drowsiness. Capsules must be swallowed whole with a full glass of water; they should not be crushed, chewed, or broken. Take with food if gastrointestinal discomfort occurs. Duration of therapy depends on treatment goals and requires regular medical evaluation.

Precautions

Patients should undergo thorough medical evaluation before initiation, including breast and pelvic examinations. Regular monitoring of liver function tests is recommended during prolonged therapy. Use with caution in patients with history of depression, epilepsy, migraine, asthma, or cardiac dysfunction. May cause drowsiness - patients should avoid driving or operating machinery until response is determined. Not recommended for use beyond the prescribed duration without reevaluation. Women with known risk factors for thromboembolic disease require careful risk-benefit assessment. Periodic endometrial sampling may be indicated during long-term therapy.

Contraindications

Absolute contraindications include known hypersensitivity to progesterone or any component of the formulation, history of or current thrombophlebitis or thromboembolic disorders, undiagnosed abnormal genital bleeding, known or suspected breast cancer, history of hormone-sensitive malignancies, active liver disease or dysfunction, and missed abortion. Relative contraindications include history of depression, diabetes mellitus with vascular changes, renal insufficiency, and history of cholestatic jaundice of pregnancy. Not indicated for use during pregnancy except in specific fertility treatment protocols under specialist supervision.

Possible side effects

Common adverse reactions (≥5%) include dizziness, drowsiness, breast tenderness, headache, and mood swings. Gastrointestinal disturbances such as nausea, abdominal cramping, and bloating may occur. Less frequently reported effects include changes in libido, fluid retention, hot flashes, and fatigue. Serious but rare side effects include allergic reactions, visual disturbances, thromboembolic events, and significant mood changes. Most side effects are dose-dependent and often diminish with continued use. Patients should report persistent or severe reactions promptly to their healthcare provider.

Drug interaction

Progesterone may interact with numerous medications through CYP450 enzyme modulation. Significant interactions occur with strong CYP3A4 inducers (rifampin, carbamazepine) which reduce progesterone levels, and inhibitors (ketoconazole, ritonavir) which may increase concentrations. Concurrent use with other CNS depressants (alcohol, benzodiazepines) may potentiate sedation. May alter the metabolism of cyclosporine, tacrolimus, and certain antiretroviral drugs. Can affect the efficacy of hormonal contraceptives. Laboratory test interactions include altered thyroid function tests and lipid profiles. Comprehensive medication review is essential before initiation.

Missed dose

If a dose is missed, take it as soon as remembered unless it is almost time for the next scheduled dose. Do not double the dose to make up for a missed one. For cyclic regimens, contact the prescribing physician for guidance if a dose is missed, as the timing relative to the menstrual cycle may require adjustment. Consistent timing is important for maintaining stable hormone levels. Patients should maintain a dosing diary if memory issues are present. Never take extra medication to compensate for missed doses without medical advice.

Overdose

Acute overdose may potentiate CNS depression effects including severe drowsiness, dizziness, and nausea. No specific antidote exists; treatment should be symptomatic and supportive. Gastric lavage may be considered if ingestion was recent. Monitor vital signs and provide respiratory support if needed. Hemodialysis is not effective due to high protein binding. Chronic overdose may manifest as enhanced pharmacological effects including severe bloating, breast tenderness, and mood alterations. Medical attention should be sought immediately for suspected overdose situations.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) in the original container. Protect from light, moisture, and excessive heat. Keep the container tightly closed and away from children and pets. Do not freeze. Discard any medication that has passed the expiration date or shows signs of damage to the capsules. Do not transfer to other containers as the original packaging provides protection from light and moisture. Keep in a secure location to prevent accidental ingestion by others.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Prometrium is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual results may vary based on patient-specific factors. Always follow the prescribing information provided with your medication and consult your healthcare provider for personalized medical advice. Do not initiate or discontinue therapy without professional guidance. The content herein reflects information available at the time of writing and may not include the most recent updates to prescribing information.

Reviews

Clinical studies demonstrate Prometrium’s efficacy in endometrial protection with 92% reduction in hyperplasia incidence compared to estrogen alone. Patient satisfaction surveys indicate preference over synthetic progestins due to reduced side effect profile. Systematic reviews confirm its role as first-line progesterone in HRT regimens. Real-world evidence supports its tolerability with 78% continuation rates at 12 months. Specialist consensus guidelines recommend micronized progesterone as preferred option for endometrial protection in menopausal hormone therapy. Long-term safety data shows favorable risk-benefit profile when used as indicated.