Medroxy Progesterone Acetate tablets are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.

Female Sex hormones

Medroxyprogesterone is a synthetic progestogen which converts the proliferative phase of the endometrium into secretory phase. It has some androgenic and anabolic activities but no oestrogenic effects. Parenteral use leads to inhibition of pituitary gonadotropins, thus preventing follicular maturation and ovulation.

Oral-

• Palliative treatment of endometrial and renal carcinoma: 200-600 mg daily.
• Mild to moderate endometriosis: 10 mg tid.
• Breast cancer: 0.4-1.5 g daily. Max: 2 g daily.
• Progestogen component in menopausal hormonal replacement therapy: Dosage dependant on oestrogen component of therapy, several regimens are used: 1.5 mg, 2.5 mg or 5 mg daily; 5 or 10 mg daily for 12-14 days of a 28-day cycle; 20 mg daily for 14 days of a 91-day cycle.
• Menorrhagia: 2.5-10 mg daily for 5-10 days starting on the 16th-21st day of the menstrual cycle. Repeat for 2 cycles.
• Palliative treatment of prostatic carcinoma: 100-600 mg daily.
• Secondary amenorrhoea: 2.5-10 mg daily for 5-10 days. Repeated for 3 cycles.

Intramuscular:

• Endometriosis: 50 mg wkly or 100 mg every 2 wk.
• Contraception: 150 mg every 12 wk.
• Palliative treatment of endometrial and renal carcinoma: Initially 0.4-1 g wkly. Reduce as necessary, maintenance may be as low as 0.4 g mthly.
• Palliative treatment of prostatic carcinoma: 0.5 g twice wkly for first 3 mth. Maintenance 0.5 g wkly.
• Breast cancer: 0.5-1 g daily for first 4 wk. Maintenance 0.5 g twice wkly.

Subcutaneous:

• Contraception, Endometriosis: 104 mg every 12-14 wk.

Aminoglutethimide and enzyme-inducing drugs (e.g. carbamazepine, griseofulvin, phenobarbital, rifampicin, phenytoin) may reduce plasma concentrations leading to reduced efficacy. Additional measures required when medroxyprogesterone is used for contraception during coadministration with these drugs.

Thromboembolic disorders; cerebral apoplexy; severe hepatic dysfunction; undiagnosed vaginal bleeding, incomplete abortion, hormone-dependent carcinoma; pregnancy.

Depression, fluid retention. Fatigue, insomnia, dizziness, headache, nausea; breast tenderness; wt gain/loss, anorexia; cholestatic jaundice; pain at Inj site.

Pregnancy Category X. Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Nursing Mothers: Medroxy Progesterone Acetate should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.

Patients with depression, DM, epilepsy, asthma, migraine, hypertension, renal or cardiac dysfunction. Monitor patient closely for loss of vision, proptosis, diplopia and thromboembolic disorders. Lactation.

Pediatric Use: Medroxy Progesterone Acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.

Geriatric Use: There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Medroxy Progesterone Acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to Medroxy Progesterone Acetate alone.