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GENITO URINARY SYSTEM AND SEX HORMONES › SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM › PROGESTOGENS › Pregnadien derivatives
promegestone
G03DB07
Forms & Strengths
- Oral tablets: 0.5 mg
- Oral tablets: 5 mg
Adult Dosing
- Menstrual disorders: 0.5 mg to 5 mg daily from day 16 to day 25 of the cycle
- Luteal phase support / Hormonal replacement therapy: Dosing varies by protocol, typically 0.5 mg daily
Pediatric Dosing
- Not indicated for pediatric use
Indications
- Menstrual disorders associated with progesterone deficiency
- Secondary amenorrhea
- Dysfunctional uterine bleeding
- Luteal phase insufficiency in assisted reproduction protocols
Mechanism of Action
- Synthetic progestin with high binding affinity for progesterone receptors
- Transforms proliferative endometrium into secretory endometrium
- Suppresses gonadotropin secretion and inhibits ovulation at appropriate doses
Contraindications
- Known hypersensitivity to promegestone or excipients
- Active or history of venous thromboembolism
- Known or suspected sex hormone-dependent malignancies
- Undiagnosed vaginal bleeding
- Severe hepatic impairment or active liver disease
Adverse Reactions
- Menstrual irregularities or breakthrough bleeding
- Breast tenderness and enlargement
- Headache or migraine
- Weight fluctuations
- Mood changes or depressive symptoms
- Nausea and gastrointestinal discomfort
Drug Interactions
- Inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin) may decrease systemic exposure and efficacy
- Inhibitors of CYP3A4 (e.g., ketoconazole, erythromycin) may increase plasma concentrations
- Potential interference with anticoagulant therapy efficacy
Curated Content: Needs Vetting Before Put to Clinical Use