pitavastatin 4 mg

1 INDICATIONS AND USAGE Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate. Pitavastatin tablets is a HMG-CoA reductase inhibitor indicated for: Patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) ( 1.1 ) Limitations of Use ( 1.2 ): Doses of pitavastatin tablets greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of pitavastatin tablets. The effect of pitavastatin tablets on cardiovascular morbidity and mortality has not been determined. Pitavastatin tablets has not been studied in Fredrickson Type I, III, and V dyslipidemias. 1.1 Primary Hyperlipidemia and Mixed Dyslipidemia Pitavastatin tablets is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. 1.2 Limitations of Use Doses of pitavastatin tablets greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of pitavastatin tablets. The effect of pitavastatin tablets on cardiovascular morbidity and mortality has not been determined. Pitavastatin tablets has not been studied in Fredrickson Type I, III, and V dyslipidemias.

quinn pharmaceuticals, llc

FDA Reported Adverse Reactions
[1] nausea    [2] fatigue    [3] diarrhoea    [4] dyspnoea    [5] drug ineffective    [6] headache    [7] off label use    [8] vomiting    [9] pain    [10] dizziness