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| __NOTOC__
| | #REDIRECT [[Colesevelam]] |
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===General===
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| The effect of WELCHOL on cardiovascular morbidity and mortality has not been determined.
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| ===Serum Triglycerides (TG)===
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| WELCHOL, like other [[bile acid sequestrant]]s, can increase serum TG concentrations.
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| WELCHOL had small effects on serum TG (median increase 5% compared to placebo) in trials of patients with primary hyperlipidemia [See Adverse Reactions (6.1) and Clinical Studies (14.1)].
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| In clinical trials in patients with type 2 [[diabetes]], greater increases in TG levels occurred when WELCHOL was used in combination with sulfonylureas (median increase 18% compared to placebo in combination with sulfonylureas) and when WELCHOL was used as monotherapy (median increase 9.7% compared to placebo) and in combination with insulin (median increase 22% compared to placebo in combination with insulin) [See Adverse Reactions (6.1) and Clinical Studies (14.2)][See Contraindications(4)][See Adverse Reactions (6.1)]. Lipid parameters, including TG levels and non-HDL-C, should be obtained before starting WELCHOL and periodically thereafter. WELCHOL should be discontinued if TG levels exceed 500 mg/dL or if the patient develops [[hypertriglyceridemia]]-induced [[pancreatitis]]. [[Hypertriglyceridemia]] of sufficient severity can cause [[acute pancreatitis]]. The long-term effect of [[hypertriglyceridemia]] on the risk of [[coronary artery disease]] is uncertain. In patients with type 2 [[diabetes]], the effect of WELCHOL on LDL-C levels may be attenuated by WELCHOL’s effects on TG levels and a smaller reduction in non-HDL-C compared to the reduction in LDL-C. Caution should be exercised when treating patients with TG levels greater than 300 mg/dL. Because most patients in the WELCHOL clinical trials had baseline TG <300 mg/dL, it is unknown whether patients with more uncontrolled baseline [[hypertriglyceridemia]] would have greater increases in serum TG levels with WELCHOL. In addition, the use of WELCHOL is contraindicated in patients with TG levels >500 mg/dL
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| ===Vitamin K or Fat-Soluble Vitamin Deficiencies Precautions===
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| Bile acid sequestrants may decrease the absorption of fat-soluble vitamins A, D, E, and K. No specific clinical studies have been conducted to evaluate the effects of WELCHOL on the absorption of co-administered dietary or supplemental vitamin therapy. In non-clinical safety studies, rats administered colesevelam [[hydrochloride ]]at doses greater than 30-fold the projected human clinical dose experienced [[hemorrhage ]]from vitamin K deficiency. Patients on oral vitamin supplementation should take their vitamins at least 4 hours prior to WELCHOL. Caution should be exercised when treating patients with a susceptibility to deficiencies of vitamin K (e.g., patients on [[warfarin]], patients with malabsorption syndromes) or other fat-soluble vitamins.
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| ===Gastrointestinal Disorders===
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| Because of its constipating effects, WELCHOL is not recommended in patients with [[gastroparesis]], other gastrointestinal motility disorders, and in those who have had major gastrointestinal tract surgery and who may be at risk for [[bowel obstruction]]. Because of the tablet size, WELCHOL Tablets can cause [[dysphagia ]]or [[esophageal obstruction ]]and should be used with caution in patients with [[dysphagia ]]or [[swallowing disorders]]. To avoid [[esophageal distress]], WELCHOL for Oral Suspension should not be taken in its dry form. Always mix WELCHOL for Oral Suspension with water, fruit juice, or diet soft drinks before ingesting.
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| ===Drug Interactions===
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| WELCHOL reduces gastrointestinal absorption of some drugs. Drugs with a known interaction with colesevelam should be administered at least 4 hours prior to WELCHOL. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, should also be administered at least 4 hours prior to WELCHOL. Alternatively, the physician should monitor drug levels of the co-administered drug [See Drug Interactions (7) and Clinical Pharmacology (12.3)].
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| ===Phenylketonurics===
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| WELCHOL for Oral Suspension contains 13.5 mg [[phenylalanine]] per 1.875 gram packet and 27 mg [[phenylalanine]] per 3.75 gram packet [See Description (11)].
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| ===Macrovascular Outcomes===
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| There have been no clinical studies establishing conclusive evidence of macrovascular disease risk reduction with WELCHOL or any other antidiabetic drugs.<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:Bile acid sequestrants]]
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| [[Category:Cardiovasuclar Drugs]]
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| [[Category:Drugs]]
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