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COLESEVELAM HYDROCHLORIDE tablet, coated


  1. Patient Information
  2. Drug Interactions:
  3. Gastrointestinal:
  4. Hypertriglyceridemia And Pancreatitis:
  5. Hypertriglyceridemia And Cardiovascular Disease:

Patient Information 

Dosing:

Patients should be advised to take colesevelam hydrochloride tablets with a meal and liquid. Colesevelam hydrochloride can be taken as 6 tablets once daily or 3 tablets twice daily[seeDosage and Administration (2)].

Drug Interactions: 

Drugs with a known interaction with colesevelam (e.g., cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives) should be administered at least 4 hours prior to colesevelam hydrochloride. In anin vivodrug interaction study, there was no significant effect on the bioavailability of phenytoin; however, due to its narrow therapeutic index and post-marketing reports consistent with potential drug-drug interactions, phenytoin should be administered at least 4 hours prior to colesevelam hydrochloride. 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 colesevelam hydrochloride. Alternatively the physician should monitor blood levels of the coadministered drug. Patients receiving concomitant metformin ER and colesevelam should be monitored for clinical response as is usual for the use of anti-diabetes drugs[seeDrug Interactions (7)].

Gastrointestinal: 

Colesevelam hydrochloride can cause constipation. Colesevelam hydrochloride is contraindicated in patients with a history of bowel obstruction. Colesevelam hydrochloride 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 colesevelam hydrochloride and seek medical attention if severe abdominal pain or severe constipation occurs. Because of the tablet size, colesevelam hydrochloride tablets can cause dysphagia or esophageal obstruction and should be used with caution in patients with dysphagia or swallowing disorders[seeWarnings and Precautions (5.4)].

Hypertriglyceridemia And Pancreatitis: 

Patients should be instructed to discontinue colesevelam hydrochloride and seek prompt medical attention if the hallmark symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting)[seeWarnings and Precautions (5.2)].

17.1 Primary Hyperlipidemia

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

Hypertriglyceridemia And Cardiovascular Disease: 

Patients should be informed that colesevelam hydrochloride may increase serum triglyceride concentrations and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain[seeWarnings and Precautions (5.2)].



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