Progesterone derivative; endogenous progesterone transforms proliferative endometrium into secretory endometrium; inhibits the secretion of pituitary gonadotropins, which prevents follicular maturation and ovulation; inhibits spontaneous uterine contraction.
· Parenteral: Adjunctive therapy and palliation of inoperable, recurrent, and metastatic endometrial carcinoma or renal carcinoma
· Contraindicated with allergy to progestins; thrombophlebitis, thromboembolic disorders, cerebral hemorrhage or history of these conditions; hepatic disease, carcinoma of the breast, ovaries, or endometrium, undiagnosed vaginal bleeding, missed abortion; pregnancy (fetal abnormalities, including masculinization of the female fetus have been reported); lactation.
· Contraception monotherapy: 150 mg IM q 3 mo. For Depo-subQ Provera: 104 mg subcutaneously into thigh or abdomen q 12 to 14 wk.
· Secondary amenorrhea: 5–10 mg/day PO for 5–10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been primed with exogenous or endogenous estrogen is 10 mg/day for 10 days. Start therapy at any time; withdrawal bleeding usually occurs 3–7 days after therapy ends.
· Abnormal uterine bleeding: 5–10 mg/day PO for 5–10 days, beginning on the 16th or 21st day of the menstrual cycle. To produce an optimum secretorytransformation of an endometrium that has been primed with estrogen, give 10 mg/day PO for 10 days, beginning on the 16th day of the cycle. Withdrawal bleeding usually occurs 3–7 days after discontinuing therapy. If bleeding is controlled, administer two subsequent cycles.
· Endometrial or renal carcinoma: 400–1,000 mg/wk IM. If improvement occurs within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg/mo IM.
· Reduction of endometrial hyperplasia: 5–10 mg/day PO for 12–14 days/mo. Start on 1st or 16th day of cycle.
· Management of endometriosis-associated pain: 104 mg subcutaneously (Depo-subQ Provera) into anterior thigh or abdomen every 12–14 wk; do not use for more than 2 yr.
· CNS: Sudden, partial, or complete loss of vision; proptosis, diplopia, migraine, precipitation of acute intermittent porphyria, mental depression, pyrexia, insomnia, somnolence, nervousness, fatigue
· CV: Thrombophlebitis, cerebrovascular disorders, retinal thrombosis, pulmonary embolism, thromboembolic and thrombotic disease, increased BP
· Dermatologic: Rash with or without pruritus, acne, melasma or chloasma, alopecia, hirsutism, photosensitivity, pruritus, urticaria
· GU: Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in cervical erosion and cervical secretions, breast tenderness and secretion
· Other: Fluid retention, edema, increase or decrease in weight, decreased glucose tolerance, bone loss
· History: Allergy to progestins; thrombophlebitis; thromboembolic disorders; cerebral hemorrhage; hepatic disease; carcinoma of the breast, ovaries, orendometrium; undiagnosed vaginal bleeding; missed abortion; epilepsy; migraine; asthma; cardiac or renal dysfunction; pregnancy; lactation
· Physical: Skin color, lesions, turgor; hair; breasts; pelvic examination; orientation, affect; ophthalmologic examination; P, auscultation, peripheral perfusion, edema; R, adventitious sounds; liver evaluation; LFTs, renal function tests, glucose tolerance, Pap smear
· Arrange for pretreatment and periodic (at least annual) history and physical, which should include BP, breasts, abdomen, pelvic organs, and a Pap smear.
· Before therapy begins, caution patient to prevent pregnancy and to have frequent medical follow-up visits.
· WARNING: Discontinue medication and consult physician if sudden, partial, or complete loss of vision occurs; if papilledema or retinal vascular lesions are present, discontinue drug.
· WARNING: Discontinue medication and consult physician at the first sign of thromboembolic disease (leg pain, swelling, peripheral perfusion changes,shortness of breath).
Teaching points
· If you are taking the oral form of this drug, mark days you should take the medication on a calendar.
· This drug should not be taken during pregnancy due to risk of serious fetal abnormalities; using barrier contraceptives is suggested.
· You may experience these side effects: Sensitivity to light (avoid exposure to the sun; use sunscreen and protective clothing); dizziness, sleeplessness, depression (use caution driving or performing tasks that require alertness); skin rash, color changes, loss of hair; fever; nausea.
· Report pain or swelling and warmth in the calves, acute chest pain or shortness of breath, sudden severe headache or vomiting, dizziness or fainting, visual disturbances, numbness or tingling in the arm or leg.
Adverse effects in Italic are most common; those in Bold are life-threatening.
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