Medroxyprogesterone depot

FDA label

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Renal Undefined (effect of renal impairment unknown)

Hepatic Undefined (effect of hepatic impairment unknown; significant liver disease is a contraindication)

150 mg every 3 months (13 weeks); not recommended for use longer than 2 years unless other options inadequate

Instructions

• Shake vigorously just before use
• Give by deep IM injection using strict aseptic technique in gluteal or deltoid muscle, rotating sites
• First injection only during first 5 days of a normal menstrual period or within first 5 days postpartum
• In mothers who exclusively breastfeed, administer during or after the sixth postpartum week
• Dosage does not need adjustment for body weight; if interval >13 weeks, confirm not pregnant before dosing

Available strengths

• inj 150 mg/mL (IM)
• inj 104 mg/0.65 mL (SC (Depo-SubQ Provera 104))

Contraindications

• Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease
• Known or suspected malignancy of breast
• Significant liver disease
• Undiagnosed vaginal bleeding

Cautions

• Loss of bone mineral density
• Thromboembolic disorders
• Cancer risks (breast, cervical)
• Meningioma - discontinue if diagnosed
• Ectopic pregnancy
• Anaphylaxis and anaphylactoid reactions
• Liver function disturbances - discontinue if jaundice/abnormal LFTs
• Bleeding irregularities
• Weight gain
• Decreased glucose tolerance - monitor diabetics
• Fluid retention
• Delayed return of fertility

Adverse reactions

• Menstrual irregularities (bleeding/spotting, amenorrhea)
• Weight gain
• Headache
• Abdominal pain/discomfort
• Nervousness
• Dizziness
• Decreased libido

Pregnancy No use for contraception in pregnancy; discontinue during pregnancy. Epidemiologic studies have not found an increased risk of birth defects with progestins.

Lactation Medroxyprogesterone acetate is detectable in milk; milk composition/quality/amount not adversely affected; in exclusive breastfeeders initiate during or after sixth postpartum week; no adverse effects noted in exposed infants.