Injection site abscess and injection site infections have been reported; therefore strict aseptic injection technique should be followed when administering medroxyprogesterone acetate injectable suspension in order to avoid injection site infections [see Dosage and Administration (2.1)]. However, it is not clear that cumulative exposure, which may include periods of intermittent use separated by periods of non-use, is a useful measure of risk, as compared to exposure measures based on continuous use.There were very few osteoporotic fractures (fracture sites known to be related to low BMD) in the study overall, and the incidence of osteoporotic fractures was not found to be higher in DMPA users compared to non-users. Association with drug use or pre-existing conditions is not clear. However, medroxyprogesterone acetate injectable suspension has not been causally associated with the induction of thrombotic or thromboembolic disorders.
Use of medroxyprogesterone acetate injectable suspension is associated with significant loss of BMD. Do not re-administer if examination reveals papilledema or retinal vascular lesions. If you would like more information, talk with your healthcare provider. The decline in BMD was more pronounced during the first two years of use, with smaller declines in subsequent years. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.The effect of hepatic and/or renal impairment on the pharmacokinetics of medroxyprogesterone acetate injectable suspension is unknown.In five clinical studies using medroxyprogesterone acetate injectable suspension, the 12-month failure rate for the group of women treated with medroxyprogesterone acetate injectable suspension was zero (no pregnancies reported) to 0.7 by Life-Table method. Discontinue medroxyprogesterone acetate injectable suspension use if jaundice or acute or chronic disturbances of liver function develop. Dosage does not need to be adjusted for body weight [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. Altered menstrual bleeding patterns include amenorrhea, irregular or unpredictable bleeding or spotting, prolonged spotting or bleeding, and heavy bleeding. (c) Sex-hormone-binding-globulin concentrations are decreased. Medroxyprogesterone intramuscular (into a muscle) injection and medroxyprogesterone subcutaneous (under the skin) injection are used to prevent pregnancy. There have been a few reported cases of convulsions in patients who were treated with medroxyprogesterone acetate injectable suspension. You should use a different method of birth control, such as condoms until you receive the injection that you missed.If you are younger than 35 years old and began to receive medroxyprogesterone injection in the last 4 to 5 years, you may have a slightly increased risk that you will develop breast cancer. Select one or more newsletters to continue. A decrease in glucose tolerance has been observed in some patients on medroxyprogesterone acetate injectable suspension treatment. Women who completed 6 years gained an average of 16.5 lb. 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. Your doctor may test your bones to be sure they are not becoming too thin before you continue to use medroxyprogesterone injection.Keep all appointments with your doctor and the laboratory. The more carefully you follow the directions (such as returning every 3 months for your next injection), the less chance you have of getting pregnant.In clinical studies, about 1 out of 100 women got pregnant during the first year that they used medroxyprogesterone acetate injectable suspension.The following chart shows the chance of getting pregnant for women who use different methods of birth control. Medroxyprogesterone acetate injectable suspension and certain other medicines may affect each other, causing serious side effects.
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