Micronized Progesterone is indicated for:

• Luteal phase support as part of Assisted Reproductive Technology (ART) treatment in women.
• The treatment of premenstrual syndrome (PMS), including premenstrual tension and depression.
• The treatment of puerperal (postpartum) depression.

Micronized Progesterone Vaginal Pessary is structurally and biologically identical to natural progesterone.

Absorption: Vaginal administration of 400 mg progesterone every 12 hours in healthy women rapidly achieves and maintains serum progesterone levels appropriate for the mid-luteal phase and early pregnancy.

Distribution: Approximately 96–99% of progesterone binds to serum proteins, mainly albumin and corticosteroid-binding globulin.

Metabolism (Biotransformation): Progesterone is primarily metabolized by the liver into pregnanediols and pregnanolones, which are conjugated to glucuronide and sulfate metabolites. These metabolites excreted in bile may be deconjugated and further metabolized in the gut.

Elimination: Progesterone is excreted via the kidneys and bile.

For luteal phase support as part of an ART treatment: 400 mg administered vaginally twice a day starting at oocyte retrieval. The administration of Progesterone should be continued for 38 days, if pregnancy has been confirmed.

For maintenance of Pregnancy in cases of Threatened or recurrent abortion: 200 to 400 mg per day in divided doses.

For the treatment of premenstrual syndrome and puerperal depression: 200 mg daily to 400mg twice a day, by vaginal or rectal insertion. For premenstrual syndrome commence treatment on day 14 of menstrual cycle and continue treatment until onset of menstruation. If symptoms are present at ovulation commence treatment on day 12.

Drugs inducing hepatic CYP3A4 (e.g., rifampicin, carbamazepine, phenytoin) may increase progesterone elimination and reduce bioavailability. Vaginal products’ effects on progesterone absorption are unknown; co-use is not recommended.

• Hypersensitivity to progesterone or excipients
• Undiagnosed vaginal bleeding
• Progesterone-sensitive malignancies
• Porphyria
• Severe liver disease
• Known missed abortion or ectopic pregnancy
• Active or history of arterial/venous thromboembolism or severe thrombophlebitis

Micronized progesterone lacks estrogenic, androgenic, and mineralocorticoid effects. Mild drowsiness, depression, breast tenderness, and bloating may occur. Vaginal administration has fewer side effects.

• Not indicated in threatened miscarriage.
• Discontinue if miscarriage occurs.
• Stop use if suspected: myocardial infarction, cerebrovascular disorders, thromboembolism, thrombophlebitis, or retinal thrombosis.

• Renal/hepatic impairment: No experience reported.
• Pediatric: Not established.
• Elderly (65+ years): No clinical data available.

Corticosteroid, Other Topical corticosteroids.

Store in a cool, dry, and dark place at a temperature below 30°C. Keep out of reach of children.