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  • Depo-Provera
    / Pfizer


    Active Ingredient
    Medroxyprogesterone Acetate 150 mg/ml, 500 mg / 3.3 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    1 ml X 150 mg/ml

    not in the basket chart 9278 4163

    Vial

    500 mg / 3.3 ml

    full basket chart 626 4058

    Dosage

    Depo Provera 150 mg/ml – DMPA intramuscular (IM) 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 DMPA injectable suspension every 3 months (12-13 weeks) administered by intramuscular injection in the gluteal or deltoid muscle. The IM suspension is not formulated for subcutaneous injection. First injection
    The initial IM injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days postpartum if not breast-feeding; or, if exclusively breastfeeding, at or after 6 weeks postpartum. Second and subsequent injections If the time interval between IM injections is greater than 13 weeks, pregnancy should be ruled out before administering the next IM injection. Switching from other Methods of Contraception When switching from other contraceptive methods, DMPA IM should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of DMPA within 7 days after taking their last active pill)..For full details see prscribing information.


    Indications

    Adjunctive therapy and palliative treatment of inoperable, recurrent and metastatic carcinoma of endometrium, breast, ovary and kidney.


    Contra-Indications

    Known or suspected pregnancy or as a diagnostic test for pregnancy. Undiagnosed vaginal bleeding. Known or suspected malignancy of breast. Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. Liver dysfunction or disease. Known hypersensitivity to any of the components.


    Special Precautions

    If abnormal bleeding persists or is severe, appropriate investigation should be instituted to rule out the possibility of organic pathology. Use may be considered among the risk factors for development of osteoporosis. Long-term case-controlled surveillance of users found slight or no increased overall risk of breast cancer and no overall increased risk of ovarian, liver, or cervical cancer. Thromboembolic disorders. Ocular disorders: medicdbation should not be readministered pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia or migraine. Accidental pregnancies: Infants from accidental pregnancies that occur 1-2 months after injection may be at increased risk of low birth weight. Such pregnancies are uncommon. Ectopic pregnancy. The pretreatment and annual physical examination should include special reference to breast and pelvic organs, as well as a Papanicolaou smear. Fluid retention. Weight changes. Return of fertility: In a large U.S. study, 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection. Lactation: Adverse effects have not been determined. Patients who have a history of psychic depression should be carefully observed. A decrease in glucose tolerance has been observed, diabetic patients should therefore be carefully observed while receiving such therapy. If jaundice develops, consideration should be given to not readministering the drug. The effect of prolonged use is not known.
    For full details see prscribing information.


    Side Effects

    More than 5% of subjects: weight changes, headache, nervousness, abdominal pain or discomfort, dizziness, asthenia. 1%-5%: Insomnia, leukorrhea, acne, vaginitis, pelvic pain, decreased libido or anorgasmia, backache, leg cramps, depression, nausea, edema, hot flashes, arthralgia, breast pain, no hair growth or alopecia, bloating rash. Rise in blood pressure in suceptible individuals, premenstrual syndrome, changes in libido, changes in appetite, cystitis-like syndrome. Fatigue, hirsutism, erythema multiforma, erythema nodosum, hemorrhagic eruption, itching.
    For full details see prscribing information.


    Drug interactions

    Rifampicin, griseofulvin, barbiturates, phenytoin, primidone, carbamazepine.


    Pregnancy and Lactation

    Pregnancy: MPA is contraindicated in women who are pregnant. Some reports suggest under certain circumstances, an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in fetuses. Infants from unintentional pregnancies that occur 1 to 2 months after injection of DMPA injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because pregnancies while on DMPA are uncommon. There is no definitive information for the other formulations of MPA, If the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.
    Lactation: MPA and its metabolites are excreted in breast milk. There is no evidence to suggest that this presents any hazard to the nursing child.
    For full details see prescribing information.


    Overdose

    Oral doses up to 3 g per day have been well tolerated.  Overdose treatment is symptomatic and supportive.


    Manufacturer
    PFIZER Manufacturing Belgium NV, Belgium
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