Prometrium

Prometrium is a prescription medication containing micronized progesterone, identical to the hormone naturally produced by the ovaries. It is specifically formulated to support a woman’s endocrine system, addressing deficiencies and restoring physiological balance. This bioidentical hormone therapy is a cornerstone in managing conditions linked to progesterone insufficiency, offering a targeted approach with a favorable safety profile. Its unique formulation ensures reliable absorption and predictable pharmacokinetics, making it a trusted choice for clinicians specializing in reproductive endocrinology and menopause management.

Features

• Contains 100mg or 200mg of micronized progesterone per soft gelatin capsule.
• Bioidentical structure, molecularly identical to endogenous human progesterone.
• Formulated in a peanut oil base within a soft gelatin capsule for oral administration.
• Designed for predictable absorption and consistent bioavailability.
• Prescription-only medication requiring medical supervision.

Benefits

• Effectively restores progesterone levels to mitigate symptoms of hormonal deficiency.
• Provides endometrial protection against estrogen-induced hyperplasia in postmenopausal women on estrogen therapy.
• Supports the luteal phase of the menstrual cycle, crucial for fertility and early pregnancy maintenance.
• Helps manage vasomotor symptoms, such as hot flashes and night sweats, associated with menopause.
• May contribute to improved sleep quality and a reduction in anxiety for some individuals due to the neuroactive properties of progesterone and its metabolites.
• Offers a natural hormone replacement option, aligning with the body’s inherent biochemical pathways.

Common use

Prometrium is primarily indicated for use in two key patient populations. First, it is used in conjunction with estrogen in postmenopausal women with a uterus to prevent abnormal thickening of the uterine lining (endometrial hyperplasia). Second, it is indicated for the treatment of secondary amenorrhea (the absence of menstrual periods in women who previously had periods). It is also widely used off-label to support the luteal phase in assisted reproductive technology (ART) cycles and to prevent preterm birth in certain high-risk obstetric patients, though specific formulations may be preferred for obstetric use.

Dosage and direction

Dosage is highly individualized and must be precisely determined by a healthcare provider based on the specific condition being treated, patient response, and concomitant medications.

• For Postmenopausal Women (with estrogen): The typical dosage is 200 mg taken orally once daily at bedtime for 12 sequential days per 28-day cycle.
• For Secondary Amenorrhea: The typical dosage is 400 mg taken orally once daily at bedtime for 10 days.
• Administration: Capsules should be taken at bedtime to mitigate potential dizziness or drowsiness. They must be swallowed whole with a full glass of water. The medication can be taken with or without food, but consistency is advised.

Precautions

• Use with caution in patients with a history of depression, as mood changes can occur.
• Monitor patients with conditions that may be influenced by fluid retention (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction).
• May cause drowsiness and dizziness. Patients should exercise caution when driving, operating machinery, or engaging in activities requiring alertness until they know how the medication affects them.
• Regular physical examinations, including breast and pelvic exams, and Pap smears, are recommended for patients on long-term therapy.
• Inform your healthcare provider of any visual disturbances, as discontinuation may be necessary.

Contraindications

Prometrium is contraindicated in patients with:

• Known hypersensitivity to progesterone, peanut oil, or any other component of the capsule.
• Known or suspected breast cancer.
• Undiagnosed abnormal genital bleeding.
• Active or history of arterial thromboembolic disease (e.g., stroke, myocardial infarction).
• Active liver disease or dysfunction.
• Known or suspected pregnancy (for certain indications, outside of obstetric use under specialist care).

Possible side effect

Progesterone therapy is associated with a range of potential side effects, though not everyone will experience them. Common side effects include:

• Drowsiness, dizziness
• Headache
• Breast tenderness or pain
• Abdominal bloating or cramping
• Mood swings, depression
• Nausea
• Fluid retention
• Hot flashes Less common but serious side effects require immediate medical attention and can include: sudden severe headache, vision changes, speech problems, chest pain, shortness of breath, pain or swelling in the legs, lumps in the breast, severe abdominal pain, and symptoms of depression.

Drug interaction

Prometrium can interact with several other medications, potentially altering its effectiveness or increasing the risk of side effects.

• Enzyme Inducers: Drugs such as carbamazepine, rifampin, and St. John’s Wort may increase the metabolism (breakdown) of progesterone, reducing its plasma concentrations and clinical efficacy.
• CNS Depressants: The drowsiness caused by Prometrium can be potentiated by other agents that cause central nervous system depression, including alcohol, barbiturates, benzodiazepines, and certain antidepressants.
• Ketoconazole: This strong CYP3A4 inhibitor may increase progesterone levels, potentially increasing the risk of side effects.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If it is not remembered until the next day, the missed dose should be skipped, and the regular dosing schedule resumed. Do not double the dose to make up for a missed one. Maintaining a consistent schedule is important for efficacy.

Overdose

There have been no reports of acute overdose with Prometrium. Given its pharmacological profile, acute overdose would be expected to amplify its known side effects, particularly severe drowsiness, dizziness, and nausea. There is no known specific antidote. In cases of suspected overdose, symptomatic and supportive care is indicated. Medical attention should be sought.

Storage

Store Prometrium capsules at controlled room temperature, between 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F). Keep the container tightly closed and protect from light, moisture, and excessive heat. Always keep all medications out of the reach of children and pets.

Disclaimer

This information is for educational purposes only and is not a substitute for the professional judgment of a qualified healthcare provider in diagnosing and treating patients. The content does not cover all possible uses, directions, precautions, interactions, or adverse effects. The reader should not use this information to self-diagnose or self-treat a health problem. Always consult with a physician or other qualified health provider regarding any medical condition or treatment plan before starting any new therapy. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “As a reproductive endocrinologist, I have prescribed Prometrium for years in my IVF protocols for luteal phase support. Its bioavailability and consistency are reliable, and my patients tolerate it well, especially with bedtime dosing to manage the sedative effects.” – Dr. E.L., MD
• “Prescribing Prometrium alongside estrogen for my postmenopausal patients provides essential endometrial protection. The bioidentical nature of the hormone is a significant advantage, and I find the side effect profile to be manageable for most women.” – Dr. A.S., OB/GYN
• “After struggling with severe secondary amenorrhea, my doctor prescribed a 10-day course of Prometrium. It successfully induced a withdrawal bleed and helped regulate my cycle. The drowsiness was noticeable, but taking it at night solved that issue completely.” – Patient, 34
• “The peanut oil base is a critical consideration. I always double-check patient allergies before prescribing. For those without an allergy, it’s an effective delivery system, but it absolutely limits use in a specific patient population.” – Pharmacist, R.Ph.