Not to be used in prevention of CV disease or dementia. Increased risks of MI, stroke, invasive breast cancer, pulmonary emboli & DVT in postmenopausal women (50-79 yr). Increased risk of developing probable dementia & mild cognitive impairment in postmenopausal women ≥65 yr. Not recommended in patients w/ history of VTE. Discontinue treatment in cases of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, & retinal thrombosis); patients who develops VTE. May cause wt gain, fluid retention. Discontinue medication in sudden partial or complete loss of vision or sudden onset of proptosis, diplopia or migraine, exam reveals papilledema or retinal vascular lesions. Carefully observe patients w/ diabetes, history of treatment for mental depresion, epilepsy, migraine, asthma, cardiac or renal dysfunction. Adequate diagnostic measures in case of undiagnosed vag bleeding. If endometrial or endocervical tissue is submitted for exam inform the pathologist. Gonadotropin levels, plasma progesterone levels, urinary pregnanediol levels, plasma testosterone levels (in male), plasma estrogen levels (in female), plasma cortisol levels, glucose tolerance test, metyrapone test & sex-hormone-binding-globulin test may be affected w/ use of Provera. Concomitant use w/ aminoglutethimide may significantly depress bioavailability. May produce cushingoid symptoms; exhibit suppressed adrenal function & decrease ACTH & hydrocortisone blood levels. May cause partial adrenal insufficiency during metyrapone testing. May mask the onset of the climacteric. Before initiating treatment carefully evaluate the status of the patient; medical & family history & check for -ve pregnancy test. Pretreatment physical exam should include breast & pelvic organs as well as papanicolaou smear. Not recommended during the 1st 4 mth of pregnancy. Lactation. 10 mg: Exclude presence of genital or breast neoplasia before initiating the treatment. 100 mg: Treatment of breast carcinoma may cause hypercalcaemia. Occasional uterine bleeding in patients w/ high dose therapy. Observe closely patients receiving large doses continuously & for long period.
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