Medroxyprogesterone Acetate is indicated for:

• Ovulation suppression
• Treatment of endometriosis
• Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma
• Treatment of hormonally-dependent recurrent breast cancer in post-menopausal women

Pharmacodynamics: Medroxyprogesterone Acetate injection produces prolonged progestational effects after intramuscular administration. It suppresses pituitary gonadotropin secretion, thereby inhibiting follicular maturation and causing long-term anovulation in reproductive-aged women. In males, it reduces Leydig cell activity and decreases endogenous testosterone production.

Pharmacokinetics: Medroxyprogesterone Acetate is a long-acting progestational steroid. The 150 mg/ml formulation reaches half of its initial concentration in approximately 27 days. Its prolonged action is due to slow absorption from the injection site. The main metabolite identified is 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate, which is excreted in urine.

Ovulation suppression: Medroxyprogesterone Acetate injectables suspension should be gently shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg/ml of this injectable suspension every three months administered by intramuscular injection in the gluteal or deltoid muscle. The initial injection should be given during the first 5 days after the onset of a menstrual period; within the 5 days post partum if not breast feeding; if exclusively breast-feeding at or after six weeks post partum.

Based on limited experience, some investigators favour the use of a second injection of Medroxyprogesterone Acetate before 90 days to control troublesome bleeding. The third and subsequent injections should be administered at separate 90 days intervals.

If abnormal bleeding persists, appropriate investigations should be instituted to rule out the possibility of organic pathology. Uterine curettage may be required on rare occations.

Concomitant use of aminoglutethimide with high doses of medroxyprogesterone acetate may significantly reduce serum concentrations of medroxyprogesterone acetate. Patients should be warned about possible reduced efficacy when aminoglutethimide is used.

Known or suspected pregnancy, undiagnosed vaginal bleeding, known or suspected malignancy of breast (when used for ovulation suppression or gynecological indications), severe liver dysfunction, and hypersensitivity to medroxyprogesterone acetate or any component of the drug.

• Weight gain, abdominal heaviness and pain, pain, anxiety,
• amenorrhea,
• spotting,
• excessive bleeding,
• injection site infection,
• headache, blurred vision,
• pain in the back of the leg,
• delayed return to fertility after discontinuation of injectable contraceptive have been reported.

Not recommended during the first 4 months of pregnancy.

Caution is required in cases of unexpected vaginal bleeding during therapy, patients with conditions that may be worsened by fluid retention, patients with a history of depression, and diabetic patients. It may reduce levels of endocrine biomarkers such as plasma/urinary steroids (cortisol, oestrogen, pregnanediol, progesterone, testosterone), plasma/urinary gonadotrophins (LH, FSH), and sex hormone-binding globulin (SHBG).

Female Sex hormones

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