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Welchol

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Welchol

WELCHOL
(colesevelam hydrochloride) Tablets and Oral Suspension

DRUG DESCRIPTION

WELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule.

Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula:

WELCHOL (colesevelam hydrochloride) Structural Formula Illustration

wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated, and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water.

WELCHOL Tablets are an off-white, oval, film-coated, solid tablet containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, silicon dioxide, HPMC (hydroxypropyl methylcellulose), and acetylated monoglyceride. The tablets are imprinted using a water-soluble black ink.

WELCHOL for Oral Suspension is a citrus-flavored, white to pale yellow powder containing yellow granules packaged in single-dose packets containing either 1.875 gram or 3.75 gram colesevelam hydrochloride. In addition, each packet contains the following inactive ingredients: lemon flavor, orange flavor, propylene glycol alginate, simethicone, aspartame, citric acid, medium chain triglycerides, and magnesium trisilicate.

Phenylketonurics

WELCHOL for Oral Suspension contains 13.5 mg phenylalanine per 1.875 gram dose and 27 mg phenylalanine per 3.75 gram dose.

What are the possible side effects of colesevelam (Welchol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using colesevelam and call your doctor at once if you have severe constipation or stomach pain.

Less serious side effects may include:

  • mild constipation;
  • nausea, vomiting, upset stomach, gas, indigestion;
  • feeling weak or tired;
  • headache;
  • muscle pain; or
  • runny nose, sore throat, flu symptoms.

This is not a complete list of side effects and others may...

Read All Potential Side Effects and See Pictures of Welchol »

What are the precautions when taking colesevelam hcl (Welchol)?

Before taking colesevelam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis (caused by high triglyceride levels), high triglyceride levels, trouble swallowing, stomach/intestinal disorders (such as constipation, blockage, gastroparesis), recent major intestinal surgery, hemorrhoids.

Because this drug can interfere with the absorption of certain vitamins (such as vitamins A, D, E, K) when used for a long period of time, your doctor may direct you to take a multivitamin supplement....

Read All Potential Precautions of Welchol »

Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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Welchol - User Reviews

Welchol User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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