Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL is available as: NDC 0548-5400-00 1 mL single dose vial Stock No. 5400 The 1 mL dose vials are packaged in individual cartons. NDC 0548-5400-25 1 mL single dose vial Stock No. 5401 The 1 mL dose vials are packaged with 25 vials per carton. NDC 0548-5701-00 1 mL single dose syringe Stock No. 5701 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: 1.1 A needle stick with a contaminated needle may cause infectious diseases. 1.2 Intentional disengagement of the Needle-Pro ® EDGE™ safety device may result in a needle stick with a contaminated needle. 1.3 Bent 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. 1.4 Mishandling 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. 1.5 Do 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: 2.1 Follow standard infection control procedures as specified by the Centers for Disease Control and Prevention (USA) or local equivalent. 2.2 Do 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: 3.1 Remove 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. 3.2 Attach 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. 3.3 Pull 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. 3.4 For 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. 3.5 Perform injection according to local standard practice using aseptic technique. 3.6 After 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). 3.7 Visually confirm that the needle is fully engaged into the needle protection sheath.3.8 After 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 orange applied to the needle protection device are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. The products described are covered by one or more of the following: U.S. Patent No. RE37, 110; counterpart foreign patent(s); and other U.S. and/or foreign pending patents. figure 1 & 2 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].; Unit Carton - Stock No. 5400 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5400-00 Stock No. 5400 MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg (150 mg/mL) Rx Only One 1 mL Single-Dose Vial For Intramuscular Use Only Each mL contains: Medroxyprogesterone acetate, 150 mg. Also polyethylene glycol 3350, 28.9 mg; polysorbate 80, 2.41 mg; sodium chloride, 8.68 mg; and added as preservatives, methylparaben, 1.37 mg; propylparaben, 0.150 mg. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Usual Dosage: See package insert for complete product information. Store at 20°-25°C (68°-77°F), [See USP Controlled Room Temperature]. Shake vigorously immediately before use. carton 5400; 25-Pack Carton - Stock No. 5401 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5400-25 Rx Only MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg/mL 25 x 1 mL Single-Dose Vials For Intramuscular Use Only. Stock No. 5401 5254016B/1-18 Carton 5401; Unit Carton - Stock No. 5701 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5701-00 MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg (150 mg/mL) 1 mL Prefilled Syringe Rx Only For Intramuscular Use Only Single Dose Syringe Carton 5701
- 16 HOW SUPPLIED/STORAGE AND HANDLING Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL is available as: NDC 0548-5400-00 1 mL single dose vial Stock No. 5400 The 1 mL dose vials are packaged in individual cartons. NDC 0548-5400-25 1 mL single dose vial Stock No. 5401 The 1 mL dose vials are packaged with 25 vials per carton. NDC 0548-5701-00 1 mL single dose syringe Stock No. 5701 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: 1.1 A needle stick with a contaminated needle may cause infectious diseases. 1.2 Intentional disengagement of the Needle-Pro ® EDGE™ safety device may result in a needle stick with a contaminated needle. 1.3 Bent 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. 1.4 Mishandling 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. 1.5 Do 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: 2.1 Follow standard infection control procedures as specified by the Centers for Disease Control and Prevention (USA) or local equivalent. 2.2 Do 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: 3.1 Remove 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. 3.2 Attach 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. 3.3 Pull 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. 3.4 For 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. 3.5 Perform injection according to local standard practice using aseptic technique. 3.6 After 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). 3.7 Visually confirm that the needle is fully engaged into the needle protection sheath.3.8 After 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 orange applied to the needle protection device are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. The products described are covered by one or more of the following: U.S. Patent No. RE37, 110; counterpart foreign patent(s); and other U.S. and/or foreign pending patents. figure 1 & 2 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].
- Unit Carton - Stock No. 5400 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5400-00 Stock No. 5400 MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg (150 mg/mL) Rx Only One 1 mL Single-Dose Vial For Intramuscular Use Only Each mL contains: Medroxyprogesterone acetate, 150 mg. Also polyethylene glycol 3350, 28.9 mg; polysorbate 80, 2.41 mg; sodium chloride, 8.68 mg; and added as preservatives, methylparaben, 1.37 mg; propylparaben, 0.150 mg. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Usual Dosage: See package insert for complete product information. Store at 20°-25°C (68°-77°F), [See USP Controlled Room Temperature]. Shake vigorously immediately before use. carton 5400
- 25-Pack Carton - Stock No. 5401 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5400-25 Rx Only MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg/mL 25 x 1 mL Single-Dose Vials For Intramuscular Use Only. Stock No. 5401 5254016B/1-18 Carton 5401
- Unit Carton - Stock No. 5701 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5701-00 MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg (150 mg/mL) 1 mL Prefilled Syringe Rx Only For Intramuscular Use Only Single Dose Syringe Carton 5701
Overview
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
Indications & 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 & 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 ) 2.1 Prevention 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. 2.2 Switching 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).
Warnings & 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 ) 5.1 Loss 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. 5.2 Thromboembolic 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. 5.3 Cancer 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 recent US study 1 evaluated the recency and duration of use and found a statistically significantly increased risk of breast cancer in recent users (defined as last use within the past five years) who used DMPA for 12 months or longer; this is consistent with results of a previous study 4 . Odds ratio estimates were adjusted for the following covariates: Lee et al. (1987): age, parity, and socioeconomic status. Paul et al. (1989): age, parity, ethnic group, and year of interview. WHO (1991): age, center, and age at first live birth. Shapiro et al. (2000): age, ethnic group, socioeconomic status, and any combined estrogen/progestogen oral contraceptive use. Li et al. (2012): age, year, BMI, duration of OC use, number of full-term pregnancies, family history of breast cancer, and history of screening mammography. Based on the published SEER-18 2011 incidence rate (age-adjusted to the 2000 US Standard Population) of breast cancer for US women, all races, age 20 to 49 years6, a doubling of risk would increase the incidence of breast cancer in women who use Medroxyprogesterone acetate from about 72 to about 144 cases per 100,000 women. risk estimate Cervical Cancer A statistically nonsignificant increase in RR estimates of invasive squamous-cell cervical cancer has been associated with the use of Medroxyprogesterone acetate in women who were first exposed before the age of 35 years (RR 1.22 to 1.28 and 95% CI 0.93 to 1.70). The overall, nonsignificant relative rate of invasive squamous-cell cervical cancer in women who ever used Medroxyprogesterone acetate was estimated to be 1.11 (95% CI 0.96 to 1.29). No trends in risk with duration of use or times since initial or most recent exposure were observed. Other Cancers Long-term case-controlled surveillance of users of Medroxyprogesterone acetate found no overall increased risk of ovarian or liver cancer. 5.4 Ectopic Pregnancy Be alert to the possibility of an ectopic pregnancy among women using Medroxyprogesterone acetate who become pregnant or complain of severe abdominal pain. 5.5 Anaphylaxis and Anaphylactoid Reaction Anaphylaxis and anaphylactoid reaction have been reported with the use of Medroxyprogesterone acetate. Institute emergency medical treatment if an anaphylactic reaction occurs. 5.6 Injection Site Reactions Injection site reactions have been reported with use of Medroxyprogesterone acetate [see Adverse Reactions (6.2) ]. Persistent injection site reactions may occur after administration of Medroxyprogesterone acetate due to inadvertent subcutaneous administration or release of the drug into the subcutaneous space while removing the needle [see Dosage and Administration (2.1) ]. 5.7 Liver Function Discontinue Medroxyprogesterone acetate use if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and Medroxyprogesterone acetate causation has been excluded. 5.8 Convulsions There have been a few reported cases of convulsions in patients who were treated with Medroxyprogesterone acetate. Association with drug use or pre-existing conditions is not clear. 5.9 Depression Monitor patients who have a history of depression and do not readminister Medroxyprogesterone acetate if depression recurs. 5.10 Bleeding Irregularities Most women using Medroxyprogesterone acetate experience disruption of menstrual bleeding patterns. Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding. Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment. As women continue using Medroxyprogesterone acetate, fewer experience irregular bleeding and more experience amenorrhea. In clinical studies of Medroxyprogesterone acetate, by month 12 amenorrhea was reported by 55% of women, and by month 24, amenorrhea was reported by 68% of women using Medroxyprogesterone acetate. 5.11 Weight Gain Women tend to gain weight while on therapy with Medroxyprogesterone acetate. From an initial average body weight of 136 lb, women who completed 1 year of therapy with Medroxyprogesterone acetate gained an average of 5.4 lb. Women who completed 2 years of therapy gained an average of 8.1 lb. Women who completed 4 years gained an average of 13.8 lb. Women who completed 6 years gained an average of 16.5 lb. Two percent of women withdrew from a large-scale clinical trial because of excessive weight gain. 5.12 Carbohydrate Metabolism A decrease in glucose tolerance has been observed in some patients on Medroxyprogesterone acetate treatment. Monitor diabetic patients carefully while receiving Medroxyprogesterone acetate. 5.13 Lactation Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. In nursing mothers treated with Medroxyprogesterone acetate, milk composition, quality, and amount are not adversely affected. Neonates and infants exposed to medroxyprogesterone from breast milk have been studied for developmental and behavioral effects through puberty. No adverse effects have been noted. 5.14 Fluid Retention Because progestational drugs including Medroxyprogesterone acetate may cause some degree of fluid retention, monitor patients with conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction. 5.15 Return of Fertility Return to ovulation and fertility is likely to be delayed after stopping Medroxyprogesterone acetate. In a large US study of women who discontinued use of Medroxyprogesterone acetate to become pregnant, data are available for 61% of them. Of the 188 women who discontinued the study to become pregnant, 114 became pregnant. Based on Life-Table analysis of these data, it is expected that 68% of women who do become pregnant may conceive within 12 months, 83% may conceive within 15 months, and 93% may conceive within 18 months from the last injection. The median time to conception for those who do conceive is 10 months following the last injection with a range of 4 to 31 months, and is unrelated to the duration of use. No data are available for 39% of the patients who discontinued Medroxyprogesterone acetate to become pregnant and who were lost to follow-up or changed their mind. 5.16 Sexually Transmitted Diseases Patients should be counseled that Medroxyprogesterone acetate does not protect against HIV infection (AIDS) and other sexually transmitted diseases. 5.17 Pregnancy Although Medroxyprogesterone acetate should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy. Neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development. 5.18 Monitoring A woman who is taking hormonal contraceptive should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. 5.19 Interference with Laboratory Tests The use of Medroxyprogesterone acetate may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. [See Drug Interactions (7.2) ].
Boxed 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 )
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 )
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. 6.1 Clinical 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%) 6.2 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 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, 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 Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia
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 ) 7.1 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 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. 7.2 Laboratory 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.
Storage & 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].
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