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Request free samples and patient resourcesRegister to receive free samples of Welchol® (colesevelam HCl). Offer your adult patients with type 2 diabetes and/or primary hyperlipidemia a choice of options: Welchol for Oral Suspension or Welchol Tablets.
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Important Safery Information
Welchol is indicated as an adjunct to diet and exercise to :
- reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin)
- 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
- 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 Fredrickson Type I, III, IV, and V dyslipidemias
- Welchol has not been studied in children younger than 10 years of age or in premenarchal girls
IMPORTANT SAFETY INFORMATION ABOUT WELCHOL (colesevelam HCI)
Welchol is contraindicated in:
- individuals with a history of bowel obstruction
- those with serum triglyceride (TG) concentrations of >500 mg/dL, or
- those with a history of hypertriglyceridemia-induced pancreatitis.
The effect of Welchol on cardiovascular morbidity and mortality has not been determined.
Welchol can increase serum TG concentrations particularly when used in combination with pioglitazone, sulfonylureas, or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.
Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies.
Caution should also be exercised when treating patients with gastroparesis, gastrointestinal motility disorders, a history of major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.
Welchol interacts with some drugs. Drugs with a known interaction with colesevelam (cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives [ethinyl estradiol, norethindrone], and metformin extended release [ER]) 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.
To avoid esophageal distress, Welchol for Oral Suspension should not be taken in its dry form.
Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.
Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 gram dose.
In clinical trials, the adverse reactions observed in ≥2% of patients, and more commonly with Welchol than placebo, regardless of investigator assessment of causality seen in:
- Adult patients with Primary Hyperlipidemia were: constipation, dyspepsia, nausea, accidental injury, asthenia, pharyngitis, flu syndrome, rhinitis, and myalgia
- Pediatric patients with heFH primary hyperlipidemia were: nasopharyngitis, headache, fatigue, creatine phosphokinase increase, rhinitis, and vomiting
- Adult patients with Type 2 Diabetes were: constipation, hypoglycemia, dyspepsia, nausea, hypertension, and back pain
Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship:
- Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol
- Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol
- Elevated thyroid-stimulating hormone (TSH) has been reported in patients receiving thyroid hormone replacement therapy
- Dysphagia has been reported with both tablet and oral suspension formulations
Welchol is Pregnancy Category B.
Please click here for Full Prescribing Information about Welchol.