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medroxyprogesterone (Rx)Brand and Other Names:DepoProvera, Depo-SubQ Provera 104, more...MPA, Provera

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg

injectable suspension

  • 150mg/mL
  • 400mg/mL

prefilled syringe suspension

  • 104mg/0.65mL
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Amenorrhea, Uterine Bleeding

Uterine bleeding: 5-10 mg/day PO for 5-10 days; beginning day 16 or 21 of the menstrual cycle; withdrawal bleeding may be expected within 3 to 7 days after discontinuing medroxyprogesterone

Amenorrhea, secondary: 5-10 mg/day PO for 5-10 days; may be started at any time; withdrawal bleeding may be expected within 3-7 days after discontinuing medroxyprogesterone

Contraception

150 mg deep IM or 104 mg SC every 3 months

Endometriosis

Prefilled syringe suspension: 104 mg SC every 3 months for no longer than 2 years

Dosing considerations

  • Give initial injection during first 5 days of menstrual cycle to avoid inadvertent administration to pregnant woman
  • If patient is nursing, give initial injection no earlier than 6 weeks post partum

Paraphilia (Off-label)

100-600 mg IM weekly; alternatively, 100-500 mg PO qDay; maintenance: 100 mg IM every 1-4 weeks

Immune Thrombocytopenic Purpura (Orphan)

Orphan indication sponsor

  • ZaBeCor Pharmaceutical Company, LLC; 821 Westview Street; Philadelphia, PA 19119

Safety and efficacy not established

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Interactions

Interaction Checker

medroxyprogesterone and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Amenorrhea

            Breakthrough bleeding

            Change in menstrual flow

            Spotting

            Edema

            Anorexia

            Weakness

            Pain at injection site

            Frequency Not Defined

            Angioedema

            Change in weight

            Depression

            Dizziness

            Headache

            Nervousness

            Somnolence

            Breast tenderness

            Galactorrhea

            Abdominal pain

            Nausea and vomiting

            Cholestatic jaundice

            Deep vein thrombosis (DVT)

            Thrombophlebitis

            Postmarketing reports

            Rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance

            Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides

            Injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, lipodystrophy acquired, injection site nodule/lump

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            Warnings

            Black Box Warnings

            Bone mineral density loss (injection)

            • Medroxyprogesterone contraceptive injection may cause significant loss of bone mineral density
            • Bone loss is greater with increasing duration of use and may not be completely reversible
            • Unknown whether use during critical period of bone accretion (adolescence or early adulthood) will reduce peak bone mass and increase osteoporotic fracture risk in later life
            • Use for long-term (>2 years) birth control only if other contraceptive methods are inadequate or poorly tolerated

            Cardiovascular risks (oral)

            • Estrogens with progestins should not be used to prevent cardiovascular disease
            • Women’s Health Initiative (WHI) Estrogen Plus Progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women aged 50-79 years undergoing 5.6 years of treatment with oral conjugated estrogens (CE) 0.625 mg/day plus medroxyprogesterone acetate (MPA) 2.5 mg/day versus placebo

            Dementia risks (oral)

            • Estrogens with progestins should not be used to prevent dementia
            • Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of probable dementia in postmenopausal women aged 65 years or older undergoing 4 years of treatment with CE 0.625 mg/day plus MPA 2.5 mg/day versus placebo
            • Unknown whether this finding applies to younger postmenopausal women

            Dose & duration (oral)

            • In the absence of comparable data, cardiovascular and dementia risks should be assumed to be similar for other doses of CE and MPA and for other combinations and dosage forms of estrogens and progestins
            • Accordingly, estrogens, with or without progestins, should be prescribed at lowest effective dosage and for shortest duration consistent with treatment goals and individual risks

            Contraindications

            Known or suspected pregnancy or as a diagnostic test for pregnancy

            Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease

            Known or suspected malignancy of breast

            Malignancy of breast or genital organs

            Missed abortion

            Undiagnosed vaginal bleeding

            Known or suspected estrogen-or progesterone-dependent neoplasia.

            Known anaphylactic reaction or angioedema

            Known liver impairment or disease

            Documented hypersensitivity

            Cautions

            Use caution in patients with asthma, diabetes mellitus, history of depression, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas

            Not recommended as primary therapy for renal or endometrial cancer

            If used with conjugated estrogens, may increase risk of MI, stroke, pulmonary emboli, DVT, breast cancer; discontinue therapy in patients who develop thrombosis

            Depo-Provera: Prolonged use may result in significant loss of bone density

            Monitor women with a strong family history of breast cancer

            Consider ectopic pregnancy if a woman receiving therapy becomes pregnant or complains of severe abdominal pain

            Provide emergency medical treatment if anaphylaxis occurs

            Discontinue if jaundice or disturbances of liver function develop

            Use may mask onset of menopause in women treated for endometrial cancer

            Not for use in children prior to menarche

            Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer

            In some epidemiologic studies, use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with increased risk of ovarian cancer; however, duration of exposure associated with increased risk is not consistent across all epidemiologic studies and some report no association

            Discontinue if the following develop: hepatic impairment/ cholestatic jaundice, visual problems, 4-6 wk before major surgery, any symptoms of VTE, massive BP increase, unusually severe migraines or first-time migraines, depression

            Studies of addition of progestin for 10 or more days of cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone; possible risks associated with the use of progestins with estrogens compared to estrogen-alone regimens include an increased risk of breast cancer

            In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated

            Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy

            In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis; consider discontinuation of treatment if pancreatitis occurs

            Progestins may cause some degree of fluid retention; women with condition influenced by fluid retention including epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation

            Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur

            Therapy should be discontinued 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; if examination reveals papilledema or retinal vascular lesions, medication should be withdrawn

            Patients may exhibit suppressed adrenal function; medroxyprogesterone acetate may have cortisol-like glucocorticoid activity and provide negative feedback to hypothalamus or pituitary; this may result in decreased plasma cortisol levels, decreased cortisol secretion, and low plasma ACTH levels; use of sterile aqueous suspension may, due to its cortisol-like glucocorticoid activity, also produce Cushingoid symptoms such as weight gain, edema/fluid retention, and facial swelling

            Medroxyprogesterone acetate reduces serum estrogen levels when given as 150 mg IM every 3 months and is associated with loss of bone mineral density (BMD); this loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion; unknown if use by younger women will reduce peak bone mass and increase risk for osteoporotic fracture in later life; an evaluation of BMD may be appropriate in some patients who use higher doses of medroxyprogesterone acetate for long-term treatment of endometrial or renal carcinoma

            Monitor patients for hepatic dysfunction periodically and temporarily interrupt therapy if patient develops hepatic dysfunction; do not resume use until markers of liver function return to normal

            Any multi-dose use of vials may lead to contamination unless strict aseptic technique is observed

            Treatment with progestin may mask the onset of the climacteric

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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Safe

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Progestin; inhibits secretion of gonadotropins from pituitary gland, prevents follicular maturation and ovulation, and stimulates growth of mammary tissues

            Absorption

            Bioavailability: PO, 0.6-10%

            Duration: IM, 3 months

            Peak plasma time: IM, 3 wk; PO, 2-4 hr

            Distribution

            Protein bound: 90%

            Metabolism

            Metabolized by liver

            Metabolites: At least 16 have been identified

            Elimination

            Half-life: IM, 50 days

            Excretion: Urine

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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