medroxyPROGESTERone Acetate Injectable Suspension, USP

150 mg/mL for intramuscular use

Please see Product Information here.

A ready-to-use, prefilled syringe
medroxyPROGESTERone Acetate
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medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg/ml for intramuscular use is a ready-to-use injectable contraceptive in a prefilled syringe

Compares to: Depo-Provera®
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50102-591-40 Box Containing 1 Prefilled Syringe
ndc # 50102-591-40
package size Box Containing
1 Prefilled Syringe
order numbers

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Important Safety Information

Indication

Medroxyprogesterone acetate is a progestin indicated only for the prevention of pregnancy.

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; known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients; significant liver disease and undiagnosed vaginal bleeding

WARNING: LOSS OF BONE MINERAL DENSITY

Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

Medroxyprogesterone acetate injectable suspension should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.

Other Warnings and Precautions include thromboembolic disorders: discontinue medroxyprogesterone acetate injectable suspension in patients who develop thrombosis; cancer risks: monitor women with a strong family history of breast cancer carefully; ectopic pregnancy: consider ectopic pregnancy if a woman using medroxyprogesterone acetate injectable suspension becomes pregnant or complains of severe abdominal pain; anaphylaxis and anaphylactoid reactions: provide emergency medical treatment; liver function: discontinue medroxyprogesterone acetate injectable suspension if jaundice or disturbances of liver function develop; carbohydrate metabolism: monitor diabetic patients carefully.

Adverse Reactions

Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs. at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reference: MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION prescribing information. Charleston, SC: Afaxys Pharma, LLC; September 2020.

Please see full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, call 1-855-888-2467 or report via the FDA MedWatch Program at www.fda.gov/medwatch or 1-800-FDA-1088.