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Laboratory Tests: In the Rosuvastatin clinical trial program, dipstick-positive proteinuria and microscopic hematuria were observed among Rosuvastatin treated patients, predominantly in patients dosed above the recommended dose range (i.e., 80 mg). A dose reduction should be considered for patients on Rosuvastatin 40 mg therapy with unexplained persistent proteinuria during routine urinalysis testing.
Use in Lactation: It is not known whether Rosuvastatin is excreted in human milk. Since many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Rosuvastatin, a decision should be made whether to discontinue nursing or administration of Rosuvastatin taking into account the importance of the drug to the lactating woman.
Use in Children: The safety and effectiveness in pediatric patients have not been established.
Use in the Elderly: In clinical studies with Rosuvastatin, the overall frequency of adverse events and types of adverse events were similar in patients above and below 65 years of age. The efficacy of Rosuvastatin in the geriatric population (=65 years of age) was comparable to the efficacy observed in the non-elderly.
