Application Nr Approved Date Route Status External Links
NDA021176 2000-05-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Welchol 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 Postmenarchal 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. Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus (1.2). Important Limitations Of Use (1.3): Do Not Use For Glycemic Control In Type 1 Diabetes Or For Treating Diabetic Ketoacidosis. Welchol Has Not Been Studied In Type 2 Diabetes In Combination With A Dipeptidyl Peptidase 4 Inhibitor. Welchol Has Not Been Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias. Welchol Has Not Been Studied In Children Younger Than 10 Years Of Age Or In Pre-Menarchal Girls. 1.1 Primary Hyperlipidemia Welchol 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). Welchol Is Indicated As Monotherapy Or In Combination With A Statin To Reduce Ldl-C Levels In Boys And Postmenarchal 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. 1.2 Type 2 Diabetes Mellitus Welchol Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [see Clinical Studies (14.2)]. Diabetes Mellitus Is Considered A Chd Risk Equivalent. In Addition To Glycemic Control, Intensive Lipid Control Is Warranted [see Indications And Usage (1.1) And Warnings And Precautions (5.2)]. 1.3 Important Limitations Of Use Welchol Should Not Be Used For The Treatment Of Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis. Welchol Has Not Been Studied In Type 2 Diabetes In Combination With A Dipeptidyl Peptidase 4 Inhibitor. Welchol Has Not Been Studied In Pediatric Patients With Type 2 Diabetes. Welchol Has Not Been Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias. Welchol Has Not Been Studied In Children Younger Than 10 Years Of Age Or In Pre-Menarchal Girls.

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Colesevelam Hydrochloride

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