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| __NOTOC__
| | #REDIRECT [[Colesevelam]] |
| {{Colesevelam}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use In Specific Populations==
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| === Pregnancy===
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| '''Pregnancy Category B'''. There are no adequate and well-controlled studies of colesevelam use in pregnant women. Animal reproduction studies in rats and rabbits revealed no evidence of fetal harm. Requirements for vitamins and other nutrients are increased in pregnancy. However, the effect of colesevelam on the absorption of fat-soluble vitamins has not been studied in pregnant women. This drug should be used during pregnancy only if clearly needed.
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| In animal reproduction studies, colesevelam revealed no evidence of fetal harm when administered to rats and rabbits at doses 50 and 17 times the maximum human dose, respectively. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.
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| ===Nursing Mothers===
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| Colesevelam hydrochloride is not expected to be excreted in human milk because colesevelam hydrochloride is not absorbed systemically from the gastrointestinal tract.
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| ===Pediatric Use===
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| The safety and effectiveness of WELCHOL as monotherapy or in combination with a statin were evaluated in children, 10 to 17 years of age with heFH [See Clinical Studies (14.1)]. The adverse reaction profile was similar to that of patients treated with placebo. In this limited controlled study, there were no significant effects on growth, sexual maturation, fat-soluble vitamin levels or clotting factors in the adolescent boys or girls relative to placebo [See Adverse Reactions (6.1)].
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| Due to tablet size, WELCHOL for Oral Suspension is recommended for use in the pediatric population. Dose adjustments are not required when WELCHOL is administered to children 10 to 17 years of age.
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| WELCHOL has not been studied in children younger than 10 years of age or in pre-menarchal girls.
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| ===Geriatric Use===
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| Primary [[Hyperlipidemia]]: Of the 1350 patients enrolled in the [[Hyperlipidemia]] clinical studies, 349 (26%) were ≥65 years old, and 58 (4%) were ≥75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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| Type 2 [[Diabetes Mellitus]]: Of the 1128 patients enrolled in the four add-on combination diabetes studies, 249 (22%) were ≥65 years old, and 12 (1%) were ≥75 years old. In these trials, WELCHOL 3.8 g/day or placebo was added onto background anti-diabetic therapy. No overall differences in safety or effectiveness were observed between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Of the 357 patients enrolled in the monotherapy diabetes trial, 28 (8%; 11 WELCHOL and 17 placebo) were ≥65 years old, too few to determine whether they respond differently from younger patients.
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| ===Hepatic Impairment===
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| No special considerations or dosage adjustments are recommended when WELCHOL is administered to patients with hepatic impairment.
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| ===Renal Impairment===
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| Type 2 Diabetes Mellitus: Of the 1128 patients enrolled in the four add-on combination diabetes studies, 696 (62%) had mild [[renal insufficiency ]](creatinine clearance [CrCl] 50-<80 mL/min), 53 (5%) had moderate [[renal insufficiency ]](CrCl 30-<50 mL/min), and none had severe [[renal insufficiency ]](CrCl <30 mL/min), as estimated from baseline serum creatinine using the Modification of Diet in Renal Disease (MDRD) equation. No overall differences in safety or effectiveness were observed between patients with CrCl <50 mL/min (n=53) and those with a CrCl≥50 mL/min (n=1075). Of the 357 patients enrolled in the monotherapy diabetes trial, only 3 patients had CrCl <50 mL/min.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4a06d3b2-7229-4398-baba-5d0a72f63821 | publisher = | date = | accessdate = 10 February 2014 }}</ref>
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| ==References==
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| {{Reflist|2}}
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| {{Lipid modifying agents}}
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| [[Category:Hepatology]]
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| [[Category:Bile acid sequestrants]]
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| [[Category:Cardiovasuclar Drugs]]
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| [[Category:Drugs]]
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