Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension, Extended Release, 1 vial
Other active recalls for Medroxyprogesterone Acetate (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Progestin class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Medroxyprogesterone injection is used to prevent pregnancy and to treat endometriosis (a condition in which the type of tissue that lines the uterus (womb) grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Medroxyprogesterone is in a class of medications called progestins. It works to prevent pregnancy by preventing ovulation (the release of eggs from the ovaries). Medroxyprogesterone also thins the lining of the uterus which helps to prevent pregnancy in all women and slows the spread of tissue from the uterus to other parts of t...
Read the full MedlinePlus article ↗- It depends on the form. The injectable versions — like Depo-Provera — are mainly used for birth control, and one of them (Depo-subQ Provera 104, the under-the-skin shot) is also ap...
- What exactly is medroxyprogesterone used for — is it just birth control?
- Irregular bleeding and spotting are very common, especially in the first few months. As you continue using the shot, many women find their periods become lighter and less frequent...
- What should I expect to happen to my periods on the birth control shot?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Medroxyprogesterone Acetate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $26.215 | $26.22 / 1 ml |
| Medicaid paysCMS SDUD · 12 mo | $73.40 | $73.40 / 1 ml |
| Medicare drug plans payPart D · Q2 2026 | $27.44 | $27.44 / 1 ml |
| Medicare Part B allowsASP · J1050 | No ASP payment limit on file for J1050 this quarter. | |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Medroxyprogesterone Acetate 150 mg/mL 00548-5400-00 | Amphastar | 1 vial | $18.313 | AB | Availability likely | save 30% |
| Medroxyprogesterone Acetate 150 mg/mL 55150-0329-01 | Eugia | 1 vial | $18.313 | AB | Availability likely | save 30% |
| Medroxyprogesterone Acetate 150 mg/mL 60219-1467-01 | Amneal | 1 vial | $18.313 | AB | Availability likely | save 30% |
| medroxyprogesterone acetate 150 mg/mL 70121-1467-02 | Amneal | 1 vial | $18.313 | AB | Availability likely | save 30% |
| Medroxyprogesterone Acetate 150 mg/mL 70700-0315-22 | Xiromed | 1 ml | $18.313 | AB | Availability likely | save 30% |
| medroxyprogesterone acetate 150 mg/mL 66993-0370-25 | Prasco | 25 vials | $22.850 | AB | Availability likely | save 13% |
| Medroxyprogesterone Acetate 150 mg/mL 67457-0887-01 | Mylan | 25 vials | $22.850 | AB | Availability likely | save 13% |
| Medroxyprogesterone Acetate 150 mg/mLthis 00548-5410-00 | Amphastar | 1 vial | $26.215 | AB | Discontinued | — |
| Medroxyprogesterone Acetate 150 mg/mL 62756-0090-40 | Sun | 1 vial | $26.215 | — | FDA listed | — |
| Medroxyprogesterone Acetate 150 mg/mL 00548-5701-00 | Amphastar | 1 syringe | $28.491 | AB | Availability likely | +9% |
| medroxyprogesterone acetate 150 mg/mL 66993-0371-79 | Prasco | 1 syringe | $28.491 | AB | Availability likely | +9% |
| medroxyprogesterone acetate 150 mg/mL 70121-1480-01 | Amneal | 1 syringe | $28.491 | AB | Availability likely | +9% |
| Medroxyprogesterone Acetate 150 mg/mL 55150-0330-01 | Eugia | 1 syringe | $28.491 | AB | Availability likely | +9% |
| Medroxyprogesterone Acetate 150 mg/mL 00548-5711-00 | Amphastar | 1 syringe | $38.621 | AB | Discontinued | +47% |
| Medroxyprogesterone Acetate 150 mg/mL 62756-0091-40 | Sun | 1 syringe | $38.621 | — | FDA listed | +47% |
| Depo-Provera 150 mg/mL 00009-0746-30 | Pharmacia | 1 vial | $50.994 | AB | Availability likely | +95% |
| Depo-Provera 150 mg/mL 00009-7376-11 | Pharmacia | 1 syringe | $52.328 | AB | Availability likely | +100% |
| Medroxyprogesterone Acetate Injectable Suspension 150 mg/mL 24201-0150-01 | Hikma | 1 vial | — | — | FDA listed | — |
| medroxyprogesterone acetate 150 mg/mL 50090-5619-00 | A-S | 1 vial | — | AB | FDA listed | — |
| medroxyprogesterone acetate 150 mg/mL 50090-5925-00 | A-S | 1 syringe | — | AB | FDA listed | — |
| medroxyprogesterone acetate 150 mg/mL 70518-4324-00 | REMEDYREPACK | 1 syringe | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00548-5410-00 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-00) / 1 mL in 1 VIAL, SINGLE-DOSE | $26.22 / mL | $26.22 | 2019-05-01 | Discontinued by firm |
| 00548-5410-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-25) / 1 mL in 1 VIAL, SINGLE-DOSE | $30.77 / mL | $769.31 | 2019-05-01 | Discontinued by firm |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($26.22 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 76% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00548-5410-00?
What is the difference between NDC 00548-5410-00 and NDC 00548-5410-25?
What NDC number is used to bill for this package of Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: LOSS OF BONE MINERAL DENSITY Women who use Medroxyprogesterone acetate Contraceptive Injection 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 Contraceptive Injection 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 Contraceptive Injection 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. [See Warnings and Precautions (5.1) ]. WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning. Women who use Medroxyprogesterone acetate Contraceptive Injection may lose significant bone mineral density.
Bone loss is greater with increasing duration of use and may not be completely reversible. ( 5.1 ) It is unknown if use of Medroxyprogesterone acetate Contraceptive Injection 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. ( 5.1 ) Medroxyprogesterone acetate Contraceptive Injection 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.
( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Medroxyprogesterone acetate is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone acetate long-term [see Warnings and Precautions (5.1) ] . Medroxyprogesterone acetate is a progestin indicated only for the prevention of pregnancy.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dose is 150 mg of Medroxyprogesterone acetate every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. ( 2.1 )
2.1Prevention of Pregnancy Both the 1 mL vial and the 1 mL prefilled syringe of Medroxyprogesterone acetate 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 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.
Medroxyprogesterone acetate 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. 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; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum 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 depends on adherence to the dosage schedule of administration.
2.2Switching from other Methods of Contraception When switching from other contraceptive methods, Medroxyprogesterone acetate 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 on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sterile Aqueous suspension: 150 mg/ml Prefilled syringes are available packaged with a 22-gauge × 1 1/2 inch Needle Pro ® EDGE™ Safety Device. Vials containing sterile aqueous suspension: 150 mg per mL ( 3 ) Prefilled syringes: prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Needle-Pro ® EDGE™ Safety Device ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of Medroxyprogesterone acetate 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 or any of its other ingredients [see Warnings and Precautions (5.5) ] . Significant liver disease [see Warnings and Precautions (5.6) ]. Undiagnosed vaginal bleeding [see Warnings and Precautions (5.9) ] .
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 (medroxyprogesterone acetate or any of its other ingredients). ( 4 ) Significant liver disease. ( 4 ) Undiagnosed vaginal bleeding.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders: Discontinue Medroxyprogesterone acetate in patients who develop thrombosis ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Medroxyprogesterone acetate becomes pregnant or complains of severe abdominal pain. ( 5.4 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment.
( 5.5 ) Liver Function: Discontinue Medroxyprogesterone acetate if jaundice or disturbances of liver function develop. ( 5.6 ) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.11 )
5.1Loss of Bone Mineral Density Use of Medroxyprogesterone acetate reduces serum estrogen levels and is associated with significant 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. It is unknown if use of Medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.
After discontinuing Medroxyprogesterone acetate in adolescents, mean BMD loss at total hip and femoral neck did not fully recover by 60 months (240 weeks) post-treatment [see Clinical Studies (14.3) ] . Similarly, in adults, there was only partial recovery of mean BMD at total hip, femoral neck and lumbar spine towards baseline by 24 months post-treatment. [See Clinical Studies (14.2) .] Medroxyprogesterone acetate 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.
BMD should be evaluated when a woman needs to continue to use Medroxyprogesterone acetate long-term. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. Other birth control methods should be considered in the risk/benefit analysis for the use of Medroxyprogesterone acetate in women with osteoporosis risk factors.
Medroxyprogesterone acetate can pose an additional risk in patients with risk factors for osteoporosis (e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids). Although there are no studies addressing whether calcium and Vitamin D may lessen BMD loss in women using Medroxyprogesterone acetate, all patients should have adequate calcium and Vitamin D intake.
5.2Thromboembolic Disorders There have been reports of serious thrombotic events in women using Medroxyprogesterone acetate (150 mg). However, Medroxyprogesterone acetate has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with Medroxyprogesterone acetate should discontinue treatment unless she has no other acceptable options for birth control.
Do not readminister Medroxyprogesterone acetate 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. Do not readminister if examination reveals papilledema or retinal vascular lesions.
5.3Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including Medroxyprogesterone acetate, because breast cancer may be hormonally sensitive [see Contraindications (4) ]. Women with a strong family history of breast cancer should be monitored with particular care. The results of five large case-control studies 1, 2, 3, 4, 5 assessing the association between depomedroxyprogesterone acetate (DMPA) use and the risk of breast cancer are summarized in Figure 1.
Three of the studies suggest a slightly increased risk of breast cancer in the overall population of users; these increased risks were statistically significant in one study. One…
🤒 Adverse Reactions ▾
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 (5.5) ] 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 Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, 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 1–84 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 Body System represented from COSTART medical dictionary. Adverse Reactions [Incidence (%)] Body as a Whole Headache (16.5%) Abdominal pain/discomfort (11.2%) Metabolic/Nutritional Increased weight > 10 lbs at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Urogenital Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months) Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System Body System represented from COSTART medical dictionary.
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%) Urogenital Leukorrhea (2.9%) Breast pain (2.8%) Vaginitis (1.2%) Adverse reactions leading to study discontinuation in ≥ 2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%)
6.2Post-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 Body System represented from COSTART medical dictionary. 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, Inj…
🔄 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. ( 7.1 )
7.1Changes 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 of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors. Antibiotics: There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
7.2Laboratory Test Interactions The pathologist should be advised of progestin therapy when relevant specimens are submitted. The following laboratory tests may be affected by progestins including Medroxyprogesterone acetate: (a)Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol).(b)Gonadotropin levels are decreased.(c)Sex-hormone-binding-globulin concentrations are decreased.(d)Protein-bound iodine and butanol extractable protein-bound iodine may increase.
T 3 -uptake values may decrease.(e)Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.(f)Sulfobromophthalein and other liver function test values may be increased.(g)The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. ( 8.3 ) Pediatric Patients: Medroxyprogesterone acetate is not indicated before menarche. ( 8.4 )
8.1Pregnancy Medroxyprogesterone acetate should not be administered during pregnancy. [See Contraindications and Warnings and Precautions (5.17) .]
8.3Nursing Mothers Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. [See Warnings and Precautions (5.13) .]
8.4Pediatric Use Medroxyprogesterone acetate is not indicated before menarche. Use of Medroxyprogesterone acetate is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.
In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of Medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.
8.5Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.
8.6Renal Impairment The effect of renal impairment on Medroxyprogesterone acetate pharmacokinetics has not been studied.
8.7Hepatic Impairment The effect of hepatic impairment on Medroxyprogesterone acetate pharmacokinetics has not been studied. Medroxyprogesterone acetate should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [See Contraindications (4) and Warnings and Precautions (5.7) .]
🤰 Pregnancy ▾
8.1Pregnancy Medroxyprogesterone acetate should not be administered during pregnancy. [See Contraindications and Warnings and Precautions (5.17) .]
🧒 Pediatric Use ▾
8.4Pediatric Use Medroxyprogesterone acetate is not indicated before menarche. Use of Medroxyprogesterone acetate is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.
In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of Medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.
🧓 Geriatric Use ▾
8.5Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Medroxyprogesterone acetate (MPA), when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.
12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Medroxyprogesterone acetate.
12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of Medroxyprogesterone acetate in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL. Distribution Plasma protein binding of MPA averages 86%. MPA binding occurs primarily to serum albumin.
No binding of MPA occurs with sex-hormone-binding globulin (SHBG). Metabolism MPA is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.
Excretion The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of Medroxyprogesterone acetate is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.
Specific Populations The effect of hepatic and/or renal impairment on the pharmacokinetics of Medroxyprogesterone acetate is unknown.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Medroxyprogesterone acetate (MPA), when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL is available as: NDC 0548-5410-00 1 mL single dose vial Stock No. 5410 The 1 mL dose vials are packaged in individual cartons. NDC 0548-5410-25 1 mL single dose vial Stock No.
5411 The 1 mL dose vials are packaged with 25 vials per carton. NDC 0548-5711-00 1 mL single dose syringe Stock No. 5711 The 1 mL dose syringes are packaged in individual cartons.
Each syringe is packaged with a 22 gauge × 1 1/2 inch needle with the Needle-Pro ® EDGE TM Safety Device. Instructions for using the Needle: 1. WARNINGS for use with the Needle-Pro ® EDGE™ Safety Device:
1.1A needle stick with a contaminated needle may cause infectious diseases.
1.2Intentional disengagement of the Needle-Pro ® EDGE™ safety device may result in a needle stick with a contaminated needle.
1.3Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture. If the needle is bent or damaged, no attempt should be made to straighten the needle or engage the Needle-Pro ® EDGE™ safety device. Immediately discard into a sharps container.
The Needle-Pro ® EDGE™ safety device may not properly contain a bent needle and/or the needle could puncture the needle protection device which may result in a needle stick with a contaminated needle.
1.4Mishandling of this device, including excessive engagement force, may cause the needle to protrude from the needle protection device which may result in a contaminated needle stick.
1.5Do not use free hand to press sheath over the needle. This may result in a needle stick with a contaminated needle. 2. CAUTIONS for use with the Needle-Pro ® EDGE™ Safety Device:
2.1Follow standard infection control procedures as specified by the Centers for Disease Control and Prevention (USA) or local equivalent.
2.2Do Not Reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent reuse may adversely affect the integrity of the device or lead to deterioration in performance. 3. INSTRUCTIONS for use of the Prefilled Syringe with the Needle-Pro ® EDGE™ Safety Device:
3.1Remove syringe end cap exposing the luer fitting. Peel blister pouch for the Needle-Pro ® EDGE™ safety device open half way. Grasp sheath using the plastic peel pouch. To prevent contamination, be careful not to touch the needle’s Luer connector.
3.2Attach prefilled syringe to the Luer connection of the Needle-Pro ® EDGE™ safety device. Insert plunger rod into open end of syringe until it contacts the stopper. Secure with 3 clockwise half turns. Shake vigorously with needle cap in place.
3.3Pull needle cap (plastic component covering needle) straight away from the needle. Do not twist cap as Needle-Pro ® EDGE™ safety device may be loosened from the prefilled syringe.
3.4For user convenience, the needle is in the “bevel up” position when the safety sheath is located to the right as indicated by the “arrow” on the device.
3.5Perform injection according to local standard practice using aseptic technique.
3.6After procedure is completed, actuate needle protection by pressing the sheath against a flat surface using a one-handed technique. An audible click may be heard as an indication that the needle is engaged into the needle protection device. AS THE SHEATH IS PRESSED (FIGURE 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (FIGURE 2).
3.7Visually confirm that the needle is fully engaged into the needle protection sheath.
3.8After use, place syringe and needle into a sharps container. Dispose of sharps container containing used syringe and needle in a safe manner according to Centers for Disease Control and Prevention, USA and Federal/State/Local regulations (EPA, OSHA) and health care facility guidelines or local equivalent. The Smiths Medical and Jelco design marks; Needle-Pro ® EDGE; and the color…
📦 Storage and Handling ▾
Syringe must be stored in carton at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] until ready for use. Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
📋 Description ▾
11 DESCRIPTION Medroxyprogesterone acetate contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C.
It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α-). The structural formula is as follows: Medroxyprogesterone acetate for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.
Each mL contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.9 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.150 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION "See FDA approved patient labeling (Patient Information)." Advise patients at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with Medroxyprogesterone acetate continues, without other therapy being required. Counsel patients about the possible increased risk of breast cancer in women who use Medroxyprogesterone acetate [see Warnings and Precautions (5.3) ].
Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Counsel patients on Warnings and Precautions associated with use of Medroxyprogesterone acetate. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Medroxyprogesterone acetate.