Dosing: Patients should be advised to take WELCHOL with a meal and liquid. WELCHOL can be taken as 6 tablets once daily or 3 tablets twice daily. [See DOSAGE AND ADMINISTRATION]

Drug interactions: Drugs with a known interaction with colesevelam (e.g., glyburide, levothyroxine, oral contraceptives) 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 (e.g., phenytoin), should also be administered at least 4 hours prior to WELCHOL. Alternatively the physician should monitor blood levels of the coadministered drug. [See DRUG INTERACTIONS]

Gastrointestinal: WELCHOL can cause constipation. WELCHOL is contraindicated in patients with a history of bowel obstruction. WELCHOL is not recommended in patients who may be at risk of bowel obstruction, including patients with gastroparesis, other gastrointestinal motility disorders, or a history of major gastrointestinal surgery. Patients should be instructed to consume a diet that promotes bowel regularity. Patients should be instructed to promptly discontinue WELCHOL and seek medical attention if severe abdominal pain or severe constipation occurs. Because of the tablet size, WELCHOL can cause dysphagia or esophageal obstruction and should be used with caution in patients with dysphagia or swallowing disorders. [See WARNINGS and PRECAUTIONS]

Hypertriglyceridemia and pancreatitis: Patients should be instructed to discontinue WELCHOL and seek prompt medical attention if the hallmark symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting). [See WARNINGS and PRECAUTIONS]

Primary Hyperlipidemia

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)- recommended diet.

Type 2 Diabetes Mellitus

General: Patients should be advised that it is important to adhere to dietary instructions, a regular exercise program, and regular testing of blood glucose.

Hypertriglyceridemia and cardiovascular disease: Patients receiving a sulfonylurea or insulin should be informed that WELCHOL may increase serum triglyceride concentrations and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain. [See WARNINGS and PRECAUTIONS]

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