Progesterone Micronized softgel capsule is indicated for

• maintenance of pregnancy in cases of threatened or recurrent abortion.
• Luteal support during IUI and ART procedures including IVF-ET.
• Luteal support in cases of proven luteal phase insufficiency.
• Along with estrogen in post-menopausal hormone replacement therapy (HRT), either in sequential or continuous regimen.
• To prevent endometrial hyperplasia where endogenous estrogen is present.
• As a progesterone challenge test in secondary amenorrhoea.
• For cycle control along with estrogen therapy.
• Dysfunctional uterine bleeding (DUB).
• Premenstrual tension.
• Endometriosis.
• Oocyte donation programme.
• Benign mastopathy.

Progesterone Micronized softgel capsule contains micronised progesterone, which is structurally and biologically identical to natural endogenous progesterone. Micronisation increases the bioavailability of progesterone. When micronised progesterone is administered after meals, maximal serum progesterone levels are significantly increased. Progesterone concentrations in the endometrial and breast tissue attain high levels. Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%). Progesterone is metabolized to pregnanediols and pregnanolones in the liver. The glucuronide and sulfate conjugates of pregnanediol and pregnanolone are excreted in the bile and urine. Progesterone metabolites, which are excreted in bile, may undergo enterohepatic circulation.

The usual recommended dose: Progesterone 100 mg/200 mg 2 to 3 soft gel capsules daily by the oral or vaginal routes in divided doses. Flexible dosage regimen can be followed depending on the indication and requirements of patients.

Maintenance of Pregnancy in cases of Threatened / Recurrent abortion: Progesterone 200 to 400 mg per day in divided doses.

In-vitro fertilization and embryo transfer: Progesterone 200 mg thrice a day from the day of embryo transfer till pregnancy is confirmed. If pregnant, it is continued till 12th week of pregnancy.

HRT: In sequential regimen: Progesterone 200 mg daily for 12 days in last 2 weeks of each therapeutic cycle. In continuous regimen: Progesterone 100 mg daily throughout the month along with estrogen.

Oocyte donation program: Progesterone 100 mg twice daily from the day of transfer till pregnancy is confirmed. This may be increased to a maximum of 600 mg per day and continued till 12th week of pregnancy.

Luteal support: Progesterone 100 mg thrice a day from the 17th day of the cycle for 10 days in induced cycle. If pregnant, it is continued till 12th week of pregnancy.

Luteal phase insufficiency: Progesterone 100 mg thrice daily to be continued up to 12 weeks of pregnancy, increasing the dose by 100 mg/day/week to a maximum of 600 mg/day in divided doses if required.

In secondary amenorrhoea: Progesterone 300 mg for 10 days results in withdrawal bleeding in 80% of cases.

Premenstrual syndrome: Progesterone 100-200 mg daily for 10 days from 17th to 26th day of each menstrual cycle.

Benign mastopathy: Progesterone 200-300 mg for 10 days per month, usually from 17th to 26th day of the monthly cycle.

Ketoconazole may reduce the metabolism of progesterone and increase its effect in the body.

Progesterone should not be used in patients with hypersensitivity to progesterone or any of its ingredients. It is contraindicated in patients with liver dysfunction, unexplained vaginal bleeding, porphyria, cancer of the uterus or genital organs, and breast cancer. Patients with a history of stroke or blood clots should also avoid using this medicine. It should not be used in cases of miscarriage where fetal tissue remains inside the uterus.

Progesterone does not show estrogenic, androgenic, or mineralocorticoid effects. Mild drowsiness and other central nervous system side effects such as depression may occur. Breast tenderness and abdominal bloating have also been reported. Side effects are usually less common when the vaginal route is used.

Use with caution in patients with severe renal impairment, diabetes mellitus, seizure disorders, migraine, persistent headache, heart disease, or depression.

Drugs for menopausal symptoms: Hormone replacement therapy, Female sex hormones. Oral contraceptive preparations

Store below 30°C temperature, protected from light and moisture. Keep out of the reach of children.