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1 Indications And Usage Colesevelam Hydrochloride Tablets Are A Bile Acid Sequestrant Indicated As An Adjunct To Diet And Exercise To: • Reduce Elevated Low-Density Lipoprotein Cholesterol (Ldl-C) In Adults With Primary Hyperlipidemia ( 1.1 ). • Reduce Ldl-C Levels In Boys And Postmenarchal Girls, 10 To 17 Years Of Age, With Heterozygous Familial Hypercholesterolemia (Hefh) ( 1.1 ). Limitations Of Use ( 1.3 ): • Do Not Use For Treatment Of Type 1 Diabetes Or For Diabetic Ketoacidosis. • The Effect On Cardiovascular Morbidity And Mortality Has Not Been Determined. • Not Studied In Type 2 Diabetes With A Dipeptidyl Peptidase 4 Inhibitor. • Not Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias. • Not Studied In Children Less Than 10 Years Of Age Or In Pre-Menarchal Girls. 1.1 Primary Hyperlipidemia Colesevelam Hydrochloride Tablets Are Indicated As An Adjunct To Diet And Exercise To Reduce Elevated Low-Density Lipoprotein Cholesterol (Ldl-C) In Adults With Primary Hyperlipidemia. Colesevelam Hydrochloride Tablets Are Indicated To Reduce Ldl-C Levels In Boys And Postmenarchal Girls, 10 To 17 Years Of Age, With Heterozygous Familial Hypercholesterolemia (Hefh) Who Are Unable To Reach Ldl-C Target Levels Despite An Adequate Trial Of Dietary Therapy And Lifestyle Modification. 1.3 Limitations Of Use • Colesevelam Hydrochloride Tablets Should Not Be Used For The Treatment Of Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis. • The Effect Of Colesevelam Hydrochloride Tablets On Cardiovascular Morbidity And Mortality Has Not Been Determined. • Colesevelam Hydrochloride Tablets Have Not Been Studied In Type 2 Diabetes In Combination With A Dipeptidyl Peptidase 4 Inhibitor. • Colesevelam Hydrochloride Tablets Have Not Been Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias. • Colesevelam Hydrochloride Tablets Have Not Been Studied In Children Younger Than 10 Years Of Age Or In Pre-Menarchal Girls.
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