Medroxy 10-MG Tablet

Medroxy is indicated for:

• Ovulation suppression.
• The treatment of endometriosis.
• Adjunctive and/or pallivative treatment of recurrent and/or metastatic endometrial or renal carcinoma.
• The treatment of hormonally-dependant recurrent breast cancer in post-menopausal women.

Medroxyprogesterone Acetate has prolonged progestational effects when administered by intramuscular injection. Medroxy suppresses the secretion of pituitary gonadotropins which, in turns, prevents follicular maturation producing long-term anovulation in the reproductive aged women. Medroxy suppresses the Leydig cell function in the male. i.e. suppresses endogenous testosterone product.

Ovulation suppression: Medroxyprogesterone injectables suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg of Medroxyprogesterone 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; of 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 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.

Endometriosis: 50 mg weekly intramuscularly or 100 mg every 2 weeks intramuscularly for at least 6 months.

Endometrial and Renal Carcinoma: Doses of 500 mg to 1000 mg of intramuscularly per week are recommended initially. It may be possible to maintain improvement with 500 mg per week or less. Medroxyprogesterone is not recommended as primarily therapy, but as adjunctive & palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.

Breast Cancer: 500 mg to 1000 mg per day intramuscularly for 28 days. Maintenance dose is 500 mg twice weekly as long as she is responding to treatment. Response to hormonal therapy (Medroxyprogesterone) for breast cancer may not be evident until 8-10 weeks of therapy. Treatment with Medroxyprogesterone should be terminated if rapid progression of disease occurs at any time during therapy.

Aminoglutethimide administered concomitantly with high doses of medroxyprogestrone acetate may significant depress the serum concentration of medroxyprogestrone acetate. User should be warned of the possiblety of decreases efficacy with the use of amoniglutethimide.

Known or suspected pregnancy, Undiagnosed vaginal bleeding, Known or suspected malignancy of breast ( when used for ovulation suppression or gynaecology indications), Severe liver dysfunction, Known hypersensitivity to Medroxyprogesterone Acetate or any component of the drug.

Genitourinary: Abnormal uterine bleeding (irregular, increase, decrease), amenorrhea.

Breast: Galactorrhea, mastodynia, tenderness.

Central Nervous System: Convulsion, confusion, depression, dizziness.

Gastrointestinal/Hepabilary: Abdominal pain or discomfort, cholestatic icterus/ jaundice, constipation, diarrhea, dry mouth, nausea, vomiting.

Metabolic & nutritional: Adrenergic-like effect (e.g., fine-hand tremors, sweating, crams in calves at night), exacerbation of diabetes mellitus, glycosuria.

Cardiovascular: Cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitation. Skin & Mucous

Membrane: Acne, alopecia, hirsutism, pruritis, rash, urticaria.

Medroxyprogesterone Acetate should not be used during pregnancy. There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to Medroxyprogesterone Acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of this tablet has not been established. This tablet should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.

Unexpected vaginal bleeding during therapy, patient with a pre-existing medical condition that might be adversely affected by fluid retention, patients with a history of treatment for clinical depression diabetic patient. It may decrees the level of the following endocrine biomarkers: Plasma /urinary steroid (eg: cortisol, oestrogen, pregnanediol , progesterone & testosterone) Plasma /urinary gonadotrophin (eg: LH & FSH) & sex -hormone- binding- globulin (SHBG).

Female Sex hormones

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.