colesevelam hydrochloride

(redirected from Welchol)
Also found in: Dictionary.

colesevelam hydrochloride

Cholestagel (UK), Welchol

Pharmacologic class: Bile acid sequestrant

Therapeutic class: Antihyperlipidemic

Pregnancy risk category B


Binds bile acids in GI tract and forms insoluble complex, impeding bile acid reabsorption and promoting its excretion. As a result, cholesterol and low-density lipoprotein (LDL) levels decrease.


Oral suspension: 3.75 g packet

Tablets: 625 mg

Indications and dosages

Adjunct to diet and exercise to reduce LDL cholesterol in patients with primary hypercholesterolemia

Adults and children ages 10 to 17: Three tablets (1,875 mg) P.O. b.i.d., or six tablets (3,750 mg) once daily; or, one 3.75-g packet P.O. once daily.

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Adults: Three tablets (1,875 mg) P.O. b.i.d., or six tablets (3,750 mg) P.O. once daily; or, one 3.75-g packet P.O. once daily


• Hypersensitivity to drug

• Bowel obstruction

• Serum triglyceride level above 500 mg/dl or history of hypertriglyceridemia-induced pancreatitis


Use cautiously in:

• susceptibility to vitamin K deficiency (such as patients on warfarin or those with malabsorption syndrome), concomitant use of fat-soluble vitamins

• patients with dysphagia or swallowing disorders, gastroparesis, other GI motility disorders; those who have had major GI tract surgery and who may be at risk for bowel obstruction

• children (safety and efficacy not established).


• Give with meals and fluids.

• Ensure that patient swallows tablets whole without crushing or chewing.

• Mix prescribed powder packet with 4 to 8 ounces of water, fruit juice, or diet soft drinks.

• Know that drug may be used alone or with HMG-CoA reductase inhibitor.

Adverse reactions

CNS: headache, anxiety, vertigo, dizziness, insomnia, fatigue, syncope

EENT: tinnitus

GI: nausea, vomiting, diarrhea, constipation, abdominal discomfort, flatulence, fecal impaction, loose stools, fatty stools, rectal or hemorrhoidal bleeding, other GI bleeding

GU: increased libido

Hematologic: anemia, bleeding tendency

Metabolic: malabsorption of vitamins A, D, E, and K

Musculoskeletal: back, muscle, or joint pain

Skin: bruising


Drug-drug. Fat-soluble vitamins (A, D, E, and K): decreased vitamin absorption

Patient monitoring

• Monitor lipid levels before starting therapy and periodically thereafter.

Patient teaching

• Instruct patient to take drug with meals as directed.

• Instruct patient to mix powder packet for oral suspension with 4 to 8 ounces of water, fruit juice, or diet soft drinks; stir well, and drink. Tell patient not to take powder in its dry form.

• Instruct patient to take any vitamins at least 4 hours before taking this drug.

• Tell patient to report persistent GI upset, back or muscle pain or weakness, and respiratory problems.

• If drug causes constipation, instruct patient to increase exercise, drink plenty of fluids, consume more fruits and fiber, or take a stool softener.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

Mentioned in ?
References in periodicals archive ?
1c]; WHR, waist-hip ratio; GLOWS, Glucose-Lowering Effect of WelChol Study; SMART, Strategies for Management of Antiretroviral Therapy; Rx, pharmacological treatment; ESTROGEN, study of estrogen in elderly men; H study of hormone replacement therapy on lipoproteins; or hormone replacement therapy; SIMVA, study of simvastatin in mixed hyperlipidemia.
Technology based specialty pharmaceutical company Impax Laboratories Inc (Nasdaq:IPXL) announced on Thursday that it has reached an agreement with Daiichi Sankyo Inc and Genzyme Corporation to settle pending patent litigation relating to its generic versions of WELCHOL (colesevelam HCl) tablets, 625 mg and oral suspensions, 1.
Results of the glucose-lowering effect of WelChol study (GLOWS): A randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes.
Welchol [R] (colesevelam HCI) is a trademark of Daiichi Sankyo, Inc.
sales of WELCHOL[R] Tablets and WELCHOL Oral Suspension were approximately $325 million and $65 million, respectively, for the twelve-month period ending May 2011.
expected to package portfolio products, such as Benicar, Welchol and
Please see the Important Safety Information about Welchol [R] on page 10 and the accompanying Welchol Brief Summary.
Please see adjacent pages for Important Safety Information and Brief Summary of Full Prescribing Information about Welchol.
cholesterol and type 2 diabetes treatment Welchol, and the anemia
Please see the Important Safety Information about Welchol [R] on page l0 and the accompanying Welchol Brief Summary.
Efient prevention of atherothrombotic events in patients with ACS undergoing percutaneous coronary intervention (PCI) (EU) Welchol reduce blood glucose in adults with type 2 diabetes (U.