As safety in pregnant women has not been established and there is no apparent benefit to therapy with PRAVACHOL (pravastatin sodium) during pregnancy (see CONTRAINDICA-TIONS), treatment should be immediately discontinued as soon as pregnancy is recognized. PRAVACHOL should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. Nursing Mothers A small amount of pravastatin is excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, women taking PRAVACHOL should not nurse (see CONTRAINDICATIONS). Pediatric Use The safety and effectiveness of PRAVACHOL in children and adolescents from 8-18 years of age have been evaluated in a placebo-controlled study of two years duration. Patients treated with pravastatin had an adverse experience profile generally similar to that of patients treated with placebo with influenza and headache commonly reported in both treatment groups. (See ADVERSE REACTIONS: Pediatric Patients.) Doses greater than 40 mg have not been studied in this population. Children and adolescent females of childbearing potential should be counseled on appropriate contraceptive methods while on pravastatin therapy (see CONTRAINDICATIONS and PRECAUTIONS: Pregnancy). For dosing information see DOSAGE AND ADMINISTRATION: Adult Patients and Pediatric Patients. Double-blind, placebo-controlled pravastatin studies in children less than 8 years of age have not been conducted. Geriatric Use Two secondary prevention trials with pravastatin (CARE and LIPID) included a total of 6,593 sub-jects treated with pravastatin 40 mg for periods ranging up to 6 years. Across these two studies, 36.1% of pravastatin subjects were aged 65 and older and 0.8% were aged 75 and older. | ||||
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