Medroxyprogesterone Acetate 150 mg/mL
Medroxyprogesterone acetate · INJECTION, SUSPENSION, EXTENDED RELEASE · Amphastar Pharmaceuticals, Inc.
Medroxyprogesterone Acetate is a injection, suspension, extended release containing medroxyprogesterone acetate at 150 mg/mL, taken intramuscular. Manufactured by Amphastar Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Medroxyprogesterone Acetate
- Generic Name
- Medroxyprogesterone acetate
- NDC Code (Product)
0548-5701- Manufacturer
- Amphastar Pharmaceuticals, Inc.
- Strength
- 150 mg/mL
- Dosage Form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA077334
- Marketing Start
- 11/28/2017
Recall History
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Bayer HealthCare Pharmaceuticals Inc.
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Aidapak Services, LLC
Labeling:Label Mixup; medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD46312_13, EXP: 5/16/2014.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
SUN PHARMACEUTICAL INDUSTRIES INC
Lack of assurance of sterility
JD & SN Inc., dba Moses Lake Professional Pharmacy
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 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)
Dosage & Administration
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 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…
Contraindications
4 CONTRAINDICATIONS The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: 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 [ 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 or any of its other ingredients [ see Warnings and Precautions ( 5.5 ) ]. Significant liver disease [ see Warnings and Precautions ( 5. 7) ]. Undiagnosed vaginal bleeding [ see Warnings and Precautions ( 5. 10) ]. Known or suspected pregnancy or as a diagnostic test for pregnancy. ( 4 ) 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 or any of its other ingredients. ( 4 ) Significant liver disease. ( 4 ) Undiagnosed vaginal bleeding. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with medroxyprogesterone acetate injectable suspension. ( 7.1 ) 7.1 Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes (increase or decrease) in the plasma levels o…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions observed with the use of medroxyprogesterone acetate injectable suspension 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 ( 5.5 ) ] Bleeding Irregularities [ see Warnings and Precautions ( 5. 10) ] Weight Gain [ see Warnings and Precautions ( 5. 11) ] 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%. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a …
Frequently Asked Questions
What is Medroxyprogesterone Acetate used for?
Medroxyprogesterone Acetate contains Medroxyprogesterone acetate. It is a injection, suspension, extended release taken intramuscular. Consult your doctor for specific uses.
Is Medroxyprogesterone Acetate a controlled substance?
Medroxyprogesterone Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Medroxyprogesterone Acetate?
The generic name for Medroxyprogesterone Acetate is Medroxyprogesterone acetate. There are 3 other brand versions of Medroxyprogesterone acetate.
What is the NDC code for Medroxyprogesterone Acetate 150 mg/mL?
The NDC (National Drug Code) for Medroxyprogesterone Acetate 150 mg/mL is 0548-5701, listed by Amphastar Pharmaceuticals, Inc..
Other Medroxyprogesterone Acetate Dosages
- Medroxyprogesterone Acetate2.5 mg/10555-0872
- Medroxyprogesterone Acetate10 mg/151655-520
- Medroxyprogesterone Acetate10 mg/155289-160
- Medroxyprogesterone Acetate10 mg/150090-0166
- Medroxyprogesterone Acetate2.5 mg/150090-0490
- Medroxyprogesterone Acetate5 mg/163629-8826
- Medroxyprogesterone Acetate5 mg/168788-8112
- Medroxyprogesterone Acetate10 mg/168071-4132
Other Medroxyprogesterone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)