medroxyprogesterone acetate

medroxyprogesterone acetate is an FDA-registered drug product whose active ingredient is MEDROXYPROGESTERONE ACETATE. It is labelled by REMEDYREPACK INC. taken by intramuscular and marketed as a human prescription drug product. Identifiers on file: NDC 70518-4324, application ANDA215397, label effective 20260904. It is one of 13 FDA drug label records sharing the active ingredient MEDROXYPROGESTERONE ACETATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing MEDROXYPROGESTERONE ACETATE are most often described in connection with: medroxyprogesterone acetate, injectable suspension, females reproductive, potential prevent, pregnancy limitations, recommended long-term, years birth, control method. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e. longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . Medroxyprogesterone acetate injectable suspension is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1) Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1 , 5.1)

2 DOSAGE AND ADMINISTRATION The recommended dose is 150 mg of medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. (2.1) 2.1 Prevention of Pregnancy Both the 1 mL vial and the 1 mL prefilled syringe of medroxyprogesterone acetate injectable 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 medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection. Use for longer than 2 years is not recommended (unless other birth control methods are considered inadequate) due to the impact of long-term medroxyprogesterone acetate injectable suspension treatment on bone mineral density (BMD) [see Warnings and Precautions (5.1) ] . Dosage does not need to be adjusted for body weight [see Clinical Studies (14.1) ] . To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period or within the first 5-days post-partum. In post-partum mothers who exclusively breastfeed, administer medroxyprogesterone acetate injectable suspension during or after the sixth post-partum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of medroxyprogesterone acetate injectable suspension depends on adherence to the dosage schedule of administration. 2.2 Switching from Other Methods of Contraception When switching from other contraceptive methods, medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension on the day after the last active tablet or at the latest, on the day following the final inactive tablet).

4 CONTRAINDICATIONS The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2) ] . Known or suspected malignancy of breast [see Warnings and Precautions (5.3) ] . Known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate) or any of its other ingredients [see Warnings and Precautions ( 5.6 ) ] . Significant liver disease [see Warnings and Precautions ( 5.8 ) ] . Undiagnosed vaginal bleeding [see Warnings and Precautions ( 5.11 ) ] . Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. (4) Known or suspected malignancy of breast. (4) Known hypersensitivity to medroxyprogesterone acetate injectable suspension (medroxyprogesterone acetate or any of its other ingredients). (4) Significant liver disease. (4) Undiagnosed vaginal bleeding. (4)

6 ADVERSE REACTIONS The following important adverse reactions observed with the use of medroxyprogesterone acetate are discussed in greater detail in the Warnings and Precautions section ( 5 ) : Loss of Bone Mineral Density [see Warnings and Precautions (5.1) ] Thromboembolic disease [see Warnings and Precautions (5.2) ] Breast Cancer [see Warnings and Precautions (5.3) ] Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions ( 5.6 ) ] Bleeding Irregularities [see Warnings and Precautions ( 5.11 ) ] Weight Gain [see Warnings and Precautions ( 5.12 ) ] Most common adverse reactions (incidence > 5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lb at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Clinical trials are conducted under widely varying conditions, therefore, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the two clinical trials with medroxyprogesterone acetate, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of medroxyprogesterone acetate. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg medroxyprogesterone acetate every 3-months (90 days). The median study duration was 13 months with a range of 1 to 84 months. Fifty-eight percent of patients remained in the study after 13 months and 34% after 24 months. Table 1: Adverse Reactions that Were Reported by More than 5% of Subjects Body System * Adverse Reactions [Incidence (%)] Body as a Whole Headache (16.5%) Abdominal pain/discomfort (11.2%) Metabolic/Nutritional Increased weight > 10 lb at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Reproductive (Urogenital*) Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months) * Body System represented from COSTART medical dictionary. Table 2: Adverse Reactions that Were Reported by between 1% and 5% of Subjects Body System * Adverse Reactions [Incidence (%)] Body as a Whole Asthenia/fatigue (4.2%) Backache (2.2%) Dysmenorrhea (1.7%) Hot flashes (1.0%) Digestive Nausea (3.3%) Bloating (2.3%) Metabolic/Nutritional Edema (2.2%) Musculoskeletal Leg cramps (3.7%) Arthralgia (1.0%) Nervous Depression (1.5%) Insomnia (1.0%) Skin and Appendages Acne (1.2%) No hair growth/alopecia (1.1%) Rash (1.1%) Reproductive (Urogenital*) Leukorrhea (2.9%) Breast pain (2.8%) Vaginitis (1.2%) * Body System represented from COSTART medical dictionary. Adverse reactions leading to study discontinuation in ≥ 2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2%). 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of medroxyprogesterone acetate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking medroxyprogesterone acetate. Table 3: Adverse Reactions Reported during Post-Marketing Experience Body System * Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess † , Injection site infection † , Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding Hematologic and Lymphatic Anemia, Blood dyscrasia Musculoskeletal Osteoporosis Neoplasms Cervical cancer, Breast cancer Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness Respiratory Dyspnea and asthma, Hoarseness Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma, Melasma, Chloasma Reproductive (Urogenital*) Lack of return to fertility, Unexpected pregnancy, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Increased libido, Uterine hyperplasia, Vaginal cysts, Genitourinary infections, Dyspareunia * Body System represented from COSTART medical dictionary. † Injection site abscess and injection site infections have been reported; therefore, strict aseptic injection technique should be followed when administering medroxyprogesterone acetate in order to avoid injection site infections [see Dosage and Administration (2.1) ].

FDA lists 13 drug label records with MEDROXYPROGESTERONE ACETATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is medroxyprogesterone acetate used for?
1 INDICATIONS AND USAGE Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e. longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration …

Who makes medroxyprogesterone acetate?
REMEDYREPACK INC. is the labeler of record for medroxyprogesterone acetate. 13 FDA label records share the active ingredient MEDROXYPROGESTERONE ACETATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does medroxyprogesterone acetate come in?
administered by intramuscular. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is medroxyprogesterone acetate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing MEDROXYPROGESTERONE ACETATE?
Yes. 13 FDA drug label records list MEDROXYPROGESTERONE ACETATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has medroxyprogesterone acetate been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.