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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 As Monotherapy Or In Combination With A Hydroxymethyl-Glutaryl-Coenzyme A (Hmg Coa) Reductase Inhibitor (Statin) ( 1.1 ). Reduce Ldl-C Levels In Boys And Post-Menarchal Girls, 10 To 17 Years Of Age, With Heterozygous Familial Hypercholesterolemia As Monotherapy Or In Combination With A Statin After Failing An Adequate Trial Of Diet Therapy. Important Limitations Of Use ( 1.3 ): Do Not Use For Glycemic Control In Type 1 Diabetes Or For Treating Diabetic Ketoacidosis. 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. 1.1 Primary Hyperlipidemia Colesevelam Hydrochloride Is Indicated As An Adjunct To Diet And Exercise To Reduce Elevated Low-Density Lipoprotein Cholesterol (Ldl-C) In Adults With Primary Hyperlipidemia (Fredrickson Type Iia) As Monotherapy Or In Combination With A Hydroxymethyl-Glutaryl-Coenzyme A (Hmg Coa) Reductase Inhibitor (Statin). Colesevelam Hydrochloride Is Indicated As Monotherapy Or In Combination With A Statin To Reduce Ldl-C Levels In Boys And Post-Menarchal Girls, 10 To 17 Years Of Age, With Heterozygous Familial Hypercholesterolemia If After An Adequate Trial Of Diet Therapy The Following Findings Are Present: A. Ldl-C Remains ≥190 Mg/dl Or B. Ldl-C Remains ≥160 Mg/dl And There Is A Positive Family History Of Premature Cardiovascular Disease Or Two Or More Other Cvd Risk Factors Are Present In The Pediatric Patient. Lipid-Altering Agents Should Be Used In Addition To A Diet Restricted In Saturated Fat And Cholesterol When Response To Diet And Non-Pharmacological Interventions Alone Has Been Inadequate [See Clinical Studies (14.1) ] . In Patients With Coronary Heart Disease (Chd) Or Chd Risk Equivalents Such As Diabetes Mellitus, Ldl-C Treatment Goals Are <100 Mg/dl. An Ldl-C Goal Of <70 Mg/dl Is A Therapeutic Option On The Basis Of Recent Trial Evidence. If Ldl-C Is At Goal But The Serum Triglyceride (Tg) Value Is >200 Mg/dl, Then Non-Hdl Cholesterol (Non-Hdl-C) (Total Cholesterol [Tc] Minus High Density Lipoprotein Cholesterol [Hdl-C]) Becomes A Secondary Target Of Therapy. The Goal For Non-Hdl-C In Persons With High Serum Tg Is Set At 30 Mg/dl Higher Than That For Ldl-C. 1.3 Important Limitations Of Use Colesevelam Hydrochloride Should Not Be Used For The Treatment Of Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis. 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 Pediatric Patients With Type 2 Diabetes. 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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