API

Progesterone (Natural Micronized) (200mg)

Drug classification

Progestin; natural micronized progesterone (hormonal agent, luteal phase support subclass).

Dosage form

Oral tablet containing 200 mg natural micronized progesterone.

API strength per dosage

Dose

Ultigest-SR 200 Tablet contains micronized progesterone 200 mg, typically used in adults for luteal phase support or hormone replacement therapy. Dosing varies by indication; always follow prescriber instructions. Safety and efficacy in paediatric patients are not established. Use with caution in hepatic impairment; contraindicated in severe liver dysfunction. No specific renal dosing adjustments are established.

Mechanism of action

Ultigest-SR 200 Tablet contains micronized progesterone, which binds to intracellular progesterone receptors, modulating gene transcription. This stabilizes the endometrium, inhibits gonadotropin-releasing hormone (GnRH) secretion, suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and supports pregnancy by preparing the uterus for implantation and maintaining gestation.

Indications

Hormone replacement therapyTreatment of Female infertility

Side effects

Abdominal pain Nausea Abnormal vaginal bleeding Edema swelling Hair loss Abdominal bloating Headache Breast pain Vomiting Vaginal yeast infection

Pregnancy category

Use in pregnancy only if clearly needed; safety not fully established. Prescribed for specific indications under medical supervision. Consult healthcare provider before use.

Precautions

History of thromboembolic disorders, liver dysfunction, undiagnosed vaginal bleeding, hormone-dependent tumors, depression, fluid retention, epilepsy, migraine, asthma, cardiac or renal impairment, monitor for breakthrough bleeding, mood changes, blood pressure, liver function, and signs of thromboembolism.

Contraindications

Hypersensitivity to progesterone, undiagnosed vaginal bleeding, known or suspected breast or genital malignancy, active or history of thromboembolic disorders, severe hepatic impairment, missed abortion, porphyria.