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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. Zypitamag Is An 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 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. The Effect Of Zypitamag On Cardiovascular Morbidity And Mortality Has Not Been Determined. Zypitamag Has Not Been Studied In Fredrickson Type I, Iii, And V Dyslipidemias. 1.1 Primary Hyperlipidemia And Mixed Dyslipidemia Zypitamag™ 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 Zypitamag 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 Zypitamag. The Effect Of Zypitamag On Cardiovascular Morbidity And Mortality Has Not Been Determined. Zypitamag Has Not Been Studied In Fredrickson Type I, Iii, And V Dyslipidemias.
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