Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/189
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Depo-Provera (Injection, Suspension)
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The suspension is intended for intramuscular administration only. Endometrial or renal carcinoma���doses of 400 mg to 1000 mg of DEPO-PROVERA Sterile Aqueous Suspension per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Medroxyprogesterone acetate is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease. When multi-dose vials are used, special care to prevent contamination of the contents is essential .
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DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200��and 210��C. It is freely soluble in chloroform, soluble in acetone and in 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: DEPO-PROVERA for intramuscular injection is available as 400 mg/mL medroxyprogesterone acetate. Each mL of the 400 mg/mL suspension contains: Medroxyprogesterone acetate .............400 mgPolyethylene glycol 3350.....................20.3 mgSodium sulfate anhydrous ......................11 mgwithMyristyl-gamma-picoliniumchloride ............................................1.69 mgadded as preservative When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
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DEPO-PROVERA Sterile Aqueous Suspension is available as 400 mg/mL in 2.5 mL vials.
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1. Physical Examination: It is good medical practice for all women to have annual history and physical examinations, including women using DEPO-PROVERA Sterile Aqueous Suspension. The physical examination, however, may be deferred until after initiation of DEPO-PROVERA 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 which might be influenced by this condition, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation.<br/>3. Vaginal Bleeding: In cases of breakthrough bleeding, as in all cases of irregular bleeding per vaginum, nonfunctional causes should be borne in mind and adequate diagnostic measures undertaken.<br/>4. Depression: Patients who have a history of psychic depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.<br/>5. Masking of Climacteric: The age of the patient constitutes no absolute limiting factor although treatment with progestin may mask the onset of the climacteric.<br/>6. Use with Estrogen: Studies of the addition of a progestin product to an estrogen replacement regimen for seven or more days of a cycle of estrogen administration have reported a lowered incidence of endometrial hyperplasia. Morphological and biochemical studies of endometrial suggest that 10���13 days of a progestin are needed to provide maximal maturation of the endometrium and to eliminate any hyperplastic changes. Whether this will provide protection from endometrial carcinoma has not been clearly established. There are possible risks which may be associated with the inclusion of progestin in estrogen replacement regimen, including adverse effects on carbohydrate and lipid metabolism. The dosage used may be important in minimizing these adverse effects. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination treatment. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving such therapy.<br/>7. Prolonged Use: The effect of prolonged use of DEPO-PROVERA Sterile Aqueous Suspension at the recommended doses on pituitary, ovarian, adrenal, hepatic, and uterine function is not known.<br/>8. Multi-dose Use: When multi-dose vials are used, special care to prevent contamination of the contents is essential. There is some evidence that benzalkonium chloride is not an adequate antiseptic for sterilizing DEPO-PROVERA Sterile Aqueous Suspension multi-dose vials. A povidone-iodine solution or similar product is recommended to cleanse the vial top prior to aspiration of contents.<br/>DRUG INTERACTIONS: Aminoglutethimide administered concomitantly with DEPO-PROVERA Sterile Aqueous Suspension may significantly depress the serum concentrations of medroxyprogesterone acetate. DEPO-PROVERA users 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 DEPO-PROVERA Sterile Aqueous Suspension:<br/>CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term intramuscular administration of Medroxyprogesterone acetate (MPA) has been shown to produce mammary tumors in beagle dogs. There is no evidence of a carcinogenic effect associated with the oral administration of MPA to rats and mice. Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays. Medroxyprogesterone acetate at high doses is an anti-fertility drug and high doses would be expected to impair fertility until the cessation of treatment.<br/>INFORMATION FOR THE PATIENT: See Patient Information at end of insert.
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medroxyprogesterone acetate
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Depo-Provera (Injection, Suspension)
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| dailymed-instance:adverseRe... |
���(See WARNINGS for possible adverse effects on the fetus)���breakthrough bleeding���spotting���change in menstrual flow���amenorrhea���headache���nervousness���dizziness���edema���change in weight (increase or decrease)���changes in cervical erosion and cervical secretions���cholestatic jaundice, including neonatal jaundice���breast tenderness and galactorrhea���skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash���acne, alopecia and hirsutism���rash (allergic) with and without pruritis���anaphylactoid reactions and anaphylaxis���mental depression���pyrexia���fatigue���insomnia���nausea���somnolence In a few instances there have been undesirable sequelae at the site of injection, such as residual lump, change in color of skin, or sterile abscess. A statistically significant association has been demonstrated between use of estrogen-progestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis. The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: ���rise in blood pressure in susceptible individuals���premenstrual syndrome���changes in libido���changes in appetite���cystitis-like syndrome���headache���nervousness���fatigue���backache���hirsutism���loss of scalp hair���erythema multiforma���erythema nodosum���hemorrhagic eruption���itching���dizziness The following laboratory results may be altered by the use of estrogen-progestin combination drugs: ���increased sulfobromophthalein retention and other hepatic function tests���coagulation tests: increase in prothrombin factors VII, VIII, IX, and X���metyrapone test���pregnanediol determinations���thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in Tuptake values
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Depo-Provera
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