Medication Overview

Prometrium is a brand name for the generic medication progesterone. It is commonly prescribed for hormone replacement therapy, particularly in menopausal or postmenopausal women. This medication helps regulate menstruation and supports pregnancy in certain conditions.

Active Ingredient

The active ingredient in Prometrium is micronized progesterone. Micronization enhances the bioavailability of the hormone, improving its absorption and efficacy when taken orally.

Available Dosages

Prometrium is available in various dosages, typically in 100 mg and 200 mg capsules. These dosages allow for flexible treatment regimens tailored to individual patient needs.

Administration Method

Prometrium is administered orally. It is advised to take the medication at bedtime, preferably with water, to optimize absorption and minimize the risk of side effects like dizziness or drowsiness.

Pharmacokinetics

After oral administration, Prometrium is absorbed in the gastrointestinal tract. Peak serum concentrations are generally achieved within 3 hours. The drug has a half-life of approximately 5 to 20 minutes and is primarily metabolized in the liver.

Clinical Uses

Prometrium is used for hormone replacement therapy in menopausal women. It prevents endometrial hyperplasia in women taking estrogen, supports pregnancy in certain infertility treatments, and helps regulate menstrual cycles in women with irregular periods.

Contraindications

Prometrium is contraindicated in individuals with known hypersensitivity to progesterone or any component of the formulation. It should not be used in patients with unexplained vaginal bleeding, liver dysfunction, or a history of thromboembolic disorders.

Drug Interactions

Prometrium may interact with other medications, including CYP3A4 inhibitors like ketoconazole, which can increase its levels in the blood. Concurrent use with anticoagulants might affect coagulation parameters, necessitating close monitoring.

Side Effects

Common side effects include dizziness, breast tenderness, headache, and abdominal pain. Less common but severe side effects may involve changes in mood, jaundice, and thromboembolic events. Users should be monitored periodically for these adverse reactions.

Storage Instructions

Prometrium should be stored at room temperature, away from moisture and direct light. Keep it in its original container, tightly closed, to maintain its efficacy and prevent degradation.

Special Populations

Dosage adjustments may be necessary for elderly patients due to potential hepatic and renal function decline. Pregnant women should discuss potential risks and benefits with their healthcare provider. It is not recommended for nursing mothers as it can pass into breast milk.

Monitoring Parameters

Patients on Prometrium should undergo regular monitoring of liver function tests, lipid profiles, and blood pressure. Endometrial status should be evaluated periodically to detect hyperplasia or malignancy.

Patient Counseling

Patients should be informed about the potential side effects of Prometrium, the importance of adherence to prescribed dosing schedules, and the need for regular medical follow-ups to monitor for adverse effects and efficacy.

Missed Dose Protocol

If a dose is missed, it should be taken as soon as remembered, unless it is near the time for the next dose. Patients should not double the dose to make up for the missed one to avoid potential overdose.

Overdose Management

Symptoms of overdose may include nausea, vomiting, dizziness, and lethargy. In case of an overdose, supportive and symptomatic care should be provided immediately. Activated charcoal and gastric lavage may be considered if the overdose is recent.

Disposal Guidelines

Expired or unused Prometrium should be disposed of in accordance with local regulations. Do not flush the medication down the toilet. Take advantage of drug take-back programs if available.

Clinical Efficacy

Clinical studies have demonstrated Prometrium’s efficacy in reducing incidence rates of endometrial hyperplasia in postmenopausal women on estrogen therapy, supporting pregnancy in infertility treatments, and regulating menstrual cycles in women with irregular periods.

Mechanism of Action

Prometrium works by binding to progesterone receptors in the uterus, breasts, and brain. This binding activates gene transcription involved in maintaining pregnancy, regulating menstrual cycles, and modulating mood and brain function.