Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1016
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medroxyprogesterone acetate (Injection, Suspension)
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Both the 1 mL vial and the 1 mL prefilled syringe of Medroxyprogesterone Acetate Injectable Suspension, USP 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, USP every 3 months (13 weeks) administered by deep, IM injection in the gluteal or deltoid muscle. To ensure the patient is not pregnant at the time of the first injection, the first injection MUST 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 depends on adherence to the dosage schedule of a Medroxyprogesterone Acetate Injectable Suspension, USP administration.
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Medroxyprogesterone Acetate Injectable Suspension, USP 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-, (6��-). The structural formula is as follows: Medroxyprogesterone Acetate Injectable Suspension, USP 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: When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
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Medroxyprogesterone Acetate Injectable Suspension, USP, 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. Following a single 150 mg IM dose of Medroxyprogesterone Acetate Injectable Suspension, USP, 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. The levels then 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 Injectable Suspension, USP is approximately 50 days. Women with lower body weights conceive sooner than women with higher body weights after discontinuing Medroxyprogesterone Acetate Injectable Suspension, USP. The effect of hepatic and/or renal disease on the pharmacokinetics of Medroxyprogesterone Acetate Injectable Suspension, USP is unknown.
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Medroxyprogesterone Acetate Injectable Suspension, USP (Medroxyprogesterone Acetate sterile aqueous suspension 150 mg/mL) is available as: NDC 59762-4537-1 1 mL vialNDC 59762-4537-2 25��1 mL vials Medroxyprogesterone Acetate Injectable Suspension, USP prefilled syringes are available packaged with 22-gauge��1 1/2 inch BD SafetyGlide���Needles in the following presentation: NDC 59762-4538-1 1 mL prefilled syringe Store at controlled room temperature 20��to 25��C (68��to 77��F) [see USP].
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Women who use Medroxyprogesterone Acetate Injectable Suspension, USP 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 Injectable Suspension, USP 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 Injectable Suspension, USP should be used as a long-term birth control method (e.g. longer than 2 years) only if other birth control methods are inadequate.
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GENERAL:<br/>1. Physical Examination: It is good medical practice for all women to have annual history and physical examinations, including women using Medroxyprogesterone Acetate Injectable Suspension, USP. The physical examination, however, may be deferred until after initiation of Medroxyprogesterone Acetate Injectable Suspension, USP if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.<br/>2. Fluid Retention: Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.<br/>3. Weight Changes: There is a tendency for women to gain weight while on therapy with Medroxyprogesterone Acetate Injectable Suspension, USP. From an initial average body weight of 136 lb, women who completed 1 year of therapy with Medroxyprogesterone Acetate Injectable Suspension, USP 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.<br/>4. Return of Fertility: Medroxyprogesterone Acetate Injectable Suspension, USP has a prolonged contraceptive effect. In a large US study of women who discontinued use of Medroxyprogesterone Acetate Injectable Suspension, USP to become pregnant, data are available for 61% of them. 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 Injectable Suspension, USP to become pregnant and who were lost to follow-up or changed their mind.<br/>5. CNS Disorders and Convulsions: Patients who have a history of psychic depression should be carefully observed and the drug not be readministered if the depression recurs. There have been a few reported cases of convulsions in patients who were treated with Medroxyprogesterone Acetate Injectable Suspension, USP. Association with drug use or pre-existing conditions is not clear.<br/>6. Carbohydrate Metabolism: A decrease in glucose tolerance has been observed in some patients on Medroxyprogesterone Acetate Injectable Suspension, USP treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.<br/>7. Liver Function: If jaundice develops, consideration should be given to not readministering the drug.<br/>8. Protection Against Sexually Transmitted Diseases: Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.<br/>DRUG INTERACTIONS: Aminoglutethimide administered concomitantly with the Medroxyprogesterone Acetate Injectable Suspension, USP may significantly depress the serum concentrations of medroxyprogesterone acetate.Users of Medroxyprogesterone Acetate Injectable Suspension, USP should be warned of the possibility of decreased efficacy with the use of this or any related drugs.<br/>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 Injectable Suspension, USP:<br/>CARCINOGENESIS: See "WARNINGS" section 3.<br/>PREGNANCY:<br/>Pregnancy Category X: See "WARNINGS" section 6.<br/>NURSING MOTHERS: See "WARNINGS" section 8.<br/>PEDIATRIC USE: Medroxyprogesterone Acetate Injectable Suspension, USP is not indicated before menarche. Use of Medroxyprogesterone Acetate Injectable Suspension, USP 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 BMDresults should take into account patient age and skeletal maturity. It is unknown if use of Medroxyprogesterone Acetate Injectable Suspension, USP 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.<br/>INFORMATION FOR THE PATIENT: See Patient Labeling. Patient labeling is included with each single-dose vial and prefilled syringe of Medroxyprogesterone Acetate Injectable Suspension, USP to help describe its characteristics to the patient. It is recommended that prospective users be given this labeling and be informed about the risks and benefits associated with the use of Medroxyprogesterone Acetate Injectable Suspension, USP, as compared with other forms of contraception or with no contraception at all. It is recommended that physicians or other health-care providers responsible for those patients advise them 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 Injectable Suspension, USP continues, without other therapy being required.
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medroxyprogesterone acetate
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medroxyprogesterone acetate (Injection, Suspension)
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In the largest clinical trial with Medroxyprogesterone Acetate Injectable Suspension, USP, 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 Injectable Suspension, USP. The following adverse reactions were reported by more than 5% of subjects: Adverse reactions reported by 1% to 5% of subjects using Medroxyprogesterone Acetate Injectable Suspension, USP were: Events reported by fewer than 1% of subjects included: galactorrhea, melasma, chloasma, convulsions, changes in appetite, gastrointestinal disturbances, jaundice, genitourinary infections, vaginal cysts, dyspareunia, paresthesia, chest pain, pulmonary embolus, allergic reactions, anemia, drowsiness, syncope, dyspnea and asthma, tachycardia, fever, excessive sweating and body odor, dry skin, chills, increased libido, excessive thirst, hoarseness, pain at injection site, blood dyscrasia, rectal bleeding, changes in breast size, breast lumps or nipple bleeding, axillary swelling, breast cancer, prevention of lactation, sensation of pregnancy, lack of return to fertility, paralysis, facial palsy, scleroderma, osteoporosis, uterine hyperplasia, cervical cancer, varicose veins, dysmenorrhea, hirsutism, unexpected pregnancy, thrombophlebitis, deep vein thrombosis.<br/>Postmarketing Experience: There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking Medroxyprogesterone Acetate Injectable Suspension, USP. In addition, there have been voluntary reports of anaphylaxis and anaphylactoid reaction associated with the use of Medroxyprogesterone Acetate Injectable Suspension, USP.
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Medroxyprogesterone Acetate Injectable Suspension, USP 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 Injectable Suspension, USP long-term It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight. In five clinical studies using Medroxyprogesterone Acetate Injectable Suspension, USP, the 12-month failure rate for the group of women treated with Medroxyprogesterone Acetate Injectable Suspension, USP was zero (no pregnancies reported) to 0.7 by Life-Table method. Pregnancy rates with contraceptive measures are typically reported for only the first year of use as shown in Table 1. Except for intrauterine devices (IUD), implants, sterilization, and Medroxyprogesterone Acetate Injectable Suspension, USP, the efficacy of these contraceptive measures depends in part on the reliability of use. The effectiveness of MedroxyprogesteroneAcetate Injectable Suspension, USP is dependent on the patient returning every 3 months (13 weeks) for reinjection.
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medroxyprogesterone acetate
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