colesevelam hydrochloride

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colesevelam hydrochloride

Cholestagel (UK), Welchol

Pharmacologic class: Bile acid sequestrant

Therapeutic class: Antihyperlipidemic

Pregnancy risk category B

Action

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.

Availability

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

Contraindications

• Hypersensitivity to drug

• Bowel obstruction

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

Precautions

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).

Administration

• 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

Interactions

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.

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References in periodicals archive ?
Pharmaceutical company Amneal Pharmaceuticals Inc (NYSE:AMRX) disclosed on Thursday the receipt of final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for the generic version of Welchol (colesevelam HCI) tablets in 625 mg.
Welchol: Daiichi Sankyo Inc, Tokyo, Japan; Colestid: Pfizer Inc, New York, New York; LoCholest: Warner Chilcott Inc, Rockaway, New Jersey; Prevalite: Upsher-Smith Laboratories, Maple Grove, Minnesota; Questran: Par Pharmaceutical, Woodcliff Lake, New Jersey; Kayexalate: Concordia International Corp, Oakville, Ontario, Canada; and Renvela and Renagel: Sanofi SA, Paris, France.
One of the preliminary studies demonstrating the glucose-lowering potential of colesevelam HCI in patients with T2DM was entitled the Glucose-Lowering Effect of WelChol Study (GLOWS).
Bays, medical director of the Louisville (Ky.) Metabolic and Atherosclerosis Research Center and author of one of the studies, in which colesevelam (WelChol) was added to the treatment of patients on metformin.
Two polymer products have been brought to market, Renagel (sevelamer hydrochloride), a calcium-free, metal-free phosphate binder for patients with end-stage renal disease, and WelChol (colesevelum hydrocholoride), a cholesterol-lowering agent.
Other resins include the bile sequestrants cholestyramine (Questran, Par Pharmaceutical Inc, Spring Valley, New York), colesevelam (Welchol, Daiichi Sankyo, Parsippany, New Jersey), and colestipol (Colestid, Cholestabyl, Pfizer, New York, New York), used to lower high levels of cholesterol in the blood, especially low-density lipoprotein.
Diurnal glucose profiles using continuous glucose monitoring to identify the glucose-lowering characteristics of colesevelam HC1 (Welchol).
Welchol is another option that can be used as an alternative to cholestyramine for those who cannot tolerate it, though it is not as effective.
The three main bile acid resins prescribed in the United States are cholestyramine (Questran), colestipol (Colestid) and colesevelam (WelChol).
M2 EQUITYBITES-July 1, 2011-Impax Laboratories settles litigation relating to WELCHOL tablets and WELCHOL oral suspension products(C)2011 M2 COMMUNICATIONS http://www.m2.com
Watson's Colesevelam HCI powder for oral suspension is a generic version of Daiichi Sankyo Inc's Welchol oral suspension, which is indicated to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutarylcoenzyme A (HMG CoA) reductase inhibitor (statin); to 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; and to improve glycemic control in adults with Type 2 diabetes mellitus.
Other medications that can improve cholesterol levels include ezetimibe (Zetia) and colesevelam (Welchol).