Full Prescribing Info
Medroxyprogesterone acetate.
Each mL contains: Medroxyprogesterone Acetate 50 mg.
Each vial contains 3 mL.
Medroxyprogesterone Acetate (DEPOTRUST) is a progestin-only injectable, a derivative of progesterone that gives three months of contraceptive protection. It contains a progestin similar to the natural hormone that a woman's body produces. The hormone is slowly released into the bloodstream.
Pharmacotherapeutic group: Progestogens. ATC Code: G03AC06.
Pharmacology: Pharmacodynamics: Medroxyprogesterone Acetate exerts anti-estrogenic, anti-androgenic and anti-gonadotrophic effects.
Mechanism of Action: Medroxyprogesterone Acetate (DEPOTRUST) primarily prevents pregnancy by inhibiting ovulation (preventing the release of eggs from the ovaries). It also prevents pregnancy by thickening and decreasing the quality of cervical mucus, an anti-estrogen effect that prevents sperm penetration.
Pharmacokinetics: Parenteral Medroxyprogesterone Acetate (MPA) is a long acting progestational steroid. The long duration of action results from its slow absorption from the injection site. Immediately after injection of 150 mg MPA, plasma levels were 1.7 ± 0.3 nmol/L. Two weeks later, levels were 6.8 ± 0.8 nmol/L. Concentrations fell to the initial levels by the end of 12 weeks. At lower doses, plasma levels of MPA appear directly related to the dose administered. Serum accumulation over time was not demonstrated. MPA is eliminated via fecal and urinary excretion. Plasma half-life is about six weeks after a single intramuscular injection. At least 11 metabolites have been identified and almost all are excreted as conjugated forms in the urine.
Medroxyprogesterone Acetate (DEPOTRUST) is indicated for contraception and treatment of menorrhagia, secondary amenorrhea and mild to moderate endometriosis.
Dosage/Direction for Use
Consult a healthcare provider for a medical and gynecological examination before the administration of Medroxyprogesterone Acetate (DEPOTRUST).
For contraception and menorrhagia: A single vial (150 mg Medroxyprogesterone Acetate in 3 mL Suspension) within the first seven days of cycle or within first 4 weeks after giving birth (delay until six weeks after giving birth if breastfeeding). The patient can also have it injected any day as long as the patient is not pregnant and be sure to use a back-up method such as condoms for the next seven days as a precaution to avoid pregnancy.
For secondary amenorrhea: 5 to 10 mg daily by intramuscular injection for about five to ten days until two days before the anticipated onset of menstruation.
For mild to moderate endometriosis: 50 mg weekly or 100 mg every two weeks by intramuscular injection for at least six months.
As follows are the steps in using Medroxyprogesterone Acetate (DEPOTRUST): Wash hands with soap and water. If injection site is dirty, wash it with soap and water.
Gently shake the vial. If vial is cold, warm to skin temperature before injecting.
Pierce top of vial with sterile needle and fill syringe with proper dose.
Insert sterile needle deep into the hip (ventrogluteal muscle), the upper arm (deltoid muscle), or the buttocks (gluteal muscle, upper outer portion), whichever the woman prefers. Inject the contents of the syringe. Do not massage the injection site. This could cause Medroxyprogesterone Acetate (DEPOTRUST) to be absorbed too fast.
Used disposable syringes and needle must be properly disposed by placing in a puncture-proof sharps container.
The next injection can be administered two weeks before or four weeks after the scheduled day.
No serious ill effects have been reported, although nausea and irregular bleeding may occur when patient used large doses over a long period of time.
Make sure the patient is not pregnant before the administration of Medroxyprogesterone Acetate (DEPOTRUST). The patient should inform the healthcare provider if the patient has the following conditions before the administration of Medroxyprogesterone Acetate (DEPOTRUST): undiagnosed vaginal bleeding; possible pregnancy; history or current high risk of arterial disease; hormone-dependent neoplasms; hepatic impairment especially if severe; porphyria; after recent evacuation of hydatidiform mole.
Special Precautions
Regular consultation with a healthcare provider is recommended while using Medroxyprogesterone Acetate (DEPOTRUST). Inform the healthcare provider if the patient is suffering from the following conditions: cardiac or renal impairment; epilepsy; asthma; past ectopic pregnancy; history of depression; diabetes mellitus; hypertension; migraine; thromboembolism; other conditions which may be aggravated by fluid retention.
Breastfeeding women should wait six weeks after giving birth before the administration of Medroxyprogesterone Acetate (DEPOTRUST).
Adverse Reactions
Some women may experience adverse reactions such as gastrointestinal disturbances, changes in appetite or weight, fluid retention, edema, acne, chloasma (melasma), allergic skin rashes, urticaria, mental depression, breast changes including discomfort or occasionally gynecomastia, changes in libido, hair loss, hirsutism, fatigue, drowsiness, insomnia, fever, headache, premenstrual syndrome-like symptoms, altered menstrual cycles or irregular menstrual bleeding, anaphylaxis or anaphylactoid reaction (rarely) and injection-site reactions. Alterations in serum lipid profile may occur and rarely, alterations in liver function test and jaundice.
Drug Interactions
Taking antibacterial drugs that induce liver enzyme production affect the effectiveness of parenteral progesterone-only contraceptive.
Taking aminoglutethimide markedly reduces the plasma concentrations of Medroxyprogesterone Acetate, possibly through hepatic enzyme-inducing effect. An increase in the dose of Medroxyprogesterone Acetate (DEPOTRUST) is likely to be required.
Medroxyprogesterone Acetate (DEPOTRUST) can influence diabetic control. Adjustment in antidiabetic dosage could be required.
Medroxyprogesterone Acetate (DEPOTRUST) may inhibit ciclosporin metabolism leading to increase plasma-ciclosporin concentration and a risk of toxicity.
Store at temperatures not exceeding 30°C. Protect from light. Do not freeze.
MIMS Class
Depot Contraceptives / Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03AC06 - medroxyprogesterone ; Belongs to the class of progestogens. Used as systemic contraceptives.
Depot inj 50 mg/mL x 3 mL x 1's.
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