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1 Indications And Usage Colesevelam Hydrochloride Is 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 Should Not Be Used For The Treatment Of Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis. The Effect Of Colesevelam Hydrochloride On Cardiovascular Morbidity And Mortality Has Not Been Determined. Colesevelam Hydrochloride Has Not Been Studied In Type 2 Diabetes In Combination With A Dipeptidyl Peptidase 4 Inhibitor. Colesevelam Hydrochloride Has Not Been Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias. Colesevelam Hydrochloride Has Not Been Studied In Children Younger Than 10 Years Of Age Or In Pre Menarchal Girls.
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