FDA Safety Recalls, Healthline Media does not provide medical advice, diagnosis, or treatment. Learn ways to manage the birth control shot side effect of irregular bleeding and when you should see a doctor. Medroxyprogesterone injection may make you sleepy. Medroxyprogesterone injectable suspension may cause drowsiness. The efficacy of medroxyprogesterone acetate injectable suspension depends on adherence to the dosage schedule of administration. 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)]. The impact of Depo-Provera CI (150 mg) use for up to 240 weeks (4.6 years) was evaluated in an open-label non-randomized clinical study in 389 adolescent females (12 to 18 years of age). For women who are breastfeeding: Medroxyprogesterone may pass into breast milk and cause side effects in a child who is breastfed. 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. Injection site reactions have been reported with use of medroxyprogesterone acetate injectable suspension [see Adverse Reactions (6.2)]. The following laboratory tests may be affected by progestins including Depo-Provera CI: Depo-Provera CI should not be administered during pregnancy. Most women using Depo-Provera CI experience disruption of menstrual bleeding patterns. Rule out the possibility of organic pathology if abnormal bleeding persists or is severe, and institute appropriate treatment. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6-). 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. Lopez LM, et al. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. You should not use Depo-Provera CI for more than two years unless you cannot use other birth control methods. What is the most important information I should know about Depo-Provera CI? Detectable amounts of drug have been identified in the milk of mothers receiving medroxyprogesterone acetate injectable suspension. Prepare for your injection. 0009-7376-11, See full prescribing information for complete boxed warning, Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) may lose significant bone mineral density. Updated Vasomotor symptoms are a common occurrence during menopause. Black box warnings alert doctors and patients about drug effects that may be dangerous. Both the 1 mL vial and the 1 mL prefilled syringe of Depo-Provera CI should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. MPA is extensively metabolized in the liver by P450 enzymes. Dosage does not need to be adjusted for body weight [see Clinical Studies (14.1)]. A class of drugs is a group of medications that work in a similar way. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. From an initial average body weight of 136 lb, women who completed 1 year of therapy with medroxyprogesterone acetate injectable suspension gained an average of 5.4 lb. There have been a few reported cases of convulsions in patients who were treated with Depo-Provera CI. (, Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis. The recommended dose is 150 mg of Depo-Provera CI 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. Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. being able to get an erection sometimes, but not every time you want to have sex. Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. Unusually heavy or continuous bleeding is not a usual effect of Depo-Provera CI and if this happens you should see your healthcare provider right away. Oncology Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma. The pathologist should be advised of progestin therapy when relevant specimens are submitted. Of the 188 women who discontinued the study to become pregnant, 114 became pregnant. In fact, some studies suggest that hormonal contraceptives such as Depo-Provera might increase your risk of chlamydia and HIV. Depo-Provera CI is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy. ED is often a symptom of another health problem or health-related factor. Files, All Mapping If you need a birth control method for more than 2 years, your healthcare provider may switch you to another birth control method instead of using Depo-Provera CI. If these . Medroxyprogesterone Acetate Injectable Suspension, USP, medroxyPROGESTERone acetate Progestin-only contraceptives: Effects on weight. More common side effects. Long VE, et al., eds. The overall, nonsignificant relative rate of invasive squamous-cell cervical cancer in women who ever used Depo-Provera CI was estimated to be 1.11 (95% CI 0.96 to 1.29). The effect of hepatic impairment on Depo-Provera CI pharmacokinetics has not been studied. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. Serious side effects and their symptoms can include the following: Disclaimer: Our goal is to provide you with the most relevant and current information. We avoid using tertiary references. The incidence rates of fracture were compared between medroxyprogesterone acetate injectable suspension users and contraceptive users who had no recorded use of medroxyprogesterone acetate injectable suspension. Medroxyprogesterone acetate, administered parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative endometrium into secretory . Physician Information Depo-ProveraContraceptive Injection medroxyprogesterone acetate injectable suspension, USP 5R4606 15 Patients should be counseled that this product does not protect. What does it mean? Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available. Depo-Provera is given as an injection every three months. 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 median study duration was 13 months with a range of 184 months. Vaginitis (1.2%), Adverse reactions leading to study discontinuation in 2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%). How to tell if the drug is working: If youre taking this drug to treat cancer, you may not be able to tell if the drug is working. No trends in risk with duration of use or times since initial or most recent exposure were observed. You should also learn about other birth control methods to choose the one that is best for you. Sometimes the doses of other medicines may need to be changed while you are taking medroxyprogesterone acetate injectable suspension. For Depo-Provera CI prefilled syringes, each mL of sterile aqueous suspension contains: 1 mL in 1 VIAL; Type 0: Not a Combination Product, 1 mL in 1 SYRINGE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product), ANALYSIS(0009-0746, 0009-7376) , MANUFACTURE(0009-0746, 0009-7376) , API MANUFACTURE(0009-0746, 0009-7376) , PACK(0009-0746, 0009-7376) , LABEL(0009-0746, 0009-7376), MANUFACTURE(0009-0746, 0009-7376) , PACK(0009-0746, 0009-7376) , LABEL(0009-0746, 0009-7376), 25 Medroxyprogesterone acetate injectable suspension is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy. You can learn more about how we ensure our content is accurate and current by reading our. As we age, our estrogen decreases, which can cause side. Table 5 summarizes the study findings. A decrease in glucose tolerance has been observed in some patients on Depo-Provera CI treatment. Discontinue medroxyprogesterone acetate injectable suspension use if jaundice or acute or chronic disturbances of liver function develop. Tell your doctor about all health conditions you have before your healthcare provider administers this drug to you. Medroxyprogesterone intramuscular injection comes as a suspension (liquid) to be injected into the buttocks or upper arm. Kaunitz AM. For more information, ask your healthcare provider or pharmacist. 21st ed. Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Each box on the chart contains a list of birth control methods that are similar in effectiveness. Table 5 summarizes the study findings. sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible clot in the lung), sudden severe headache or vomiting, dizziness or fainting, problems with your eyesight or speech, weakness, or numbness in an arm or leg (indicating a possible stroke), severe pain or swelling in the calf (indicating a possible clot in the leg), sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye), severe pain or tenderness in the lower abdominal area, persistent pain, pus, or bleeding at the injection site, swelling of the face, mouth, tongue or neck, irregular vaginal bleeding, such as lighter or heavier menstrual bleeding, or continued spotting. The mean number of injections per medroxyprogesterone acetate injectable suspension user was 9.3. Institute emergency medical treatment if an anaphylactic reaction occurs. For the most recent prescribing information, please visit www.pfizer.com. 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