SOMA-JECT 150 mg/ml

INDICATIONS

Medroxyprogesterone Acetate 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.

PHARMACOLOGY

Pharmacodynamics: Medroxyprogesterone Acetate injection has prolonged progestational effects when administered by intramuscular injection. This injection suppresses the secretion of pituitary gonadotropins which, in turns, prevents follicular maturation producing long-term anovulation in the reproductive aged women. Medroxyprogesterone Acetate injection suppresses the Leydig cell function in the male. i.e. suppresses endogenous testosterone product.Pharmacokinetics: Parenteral Medroxyprogesterone Acetate is a long acting progestational steroid. The 150 mg/ml formulation reaches half its initial concentration in about 27 days. Its long duration of acting results from its slow absorption from the injection site. The principle metabolite of medroxyprogesterone acetate that has been identified is a 6-alpha-methyl-6 beta 17 alpha, 21 trihydroxy-4-pregnene-3, 20-dione-17 acetate which is excreted in the urine.

DOSAGE & ADMINISTRATION

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.

INTERACTION

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

SIDE EFFECTS

Weight gain, feeling heaviness and pain in the abdomen, feeling pain, anxiety
Amenorrhea
Spotting
Excessive bleeding
Infection in the injected site
Headache, Blurring of vision
Pain in the back of the leg
Delay in pregnancy after withdrawing injectable contraceptive.

PREGNANCY & LACTATION

Not recommended for the first 4 months.

PRECAUTIONS & WARNINGS

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 decrease the level of the following endocrine biomarkers: Plasma /urinary steroid (eg: cortisol, oestrogen, pregnanediol , progesterone & testosterone ) Plasma /urinary gonadotrophin (eg: LH & FSH) & sex  hormonebinding- globulin (SHBG)

THERAPEUTIC CLASS

Female Sex hormones

STORAGE CONDITIONS

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