Welchol

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 crosslinking 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 24 mg phenylalanine per 1.875 gram dose and 48 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:

  • constipation;
  • nausea, upset stomach pain, gas, indigestion;
  • feeling weak or tired;
  • muscle weakness; or
  • runny nose, sore throat.

This is not a complete list of...

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of pancreatitis (caused by high triglyceride levels).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high triglyceride levels, trouble swallowing, stomach/intestinal disorders, recent major intestinal surgery, constipation, hemorrhoids.

Because this drug can interfere with the absorption of certain...

Read All Potential Precautions of Welchol


Welchol Consumer (continued)

SIDE EFFECTS: Constipation and upset stomach may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To help prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist in selecting a stool softener or a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: nausea/vomiting, stomach/abdominal pain, trouble swallowing, unusual bleeding/bruising.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of pancreatitis (caused by high triglyceride levels).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high triglyceride levels, trouble swallowing, stomach/intestinal disorders, recent major intestinal surgery, constipation, 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. Take the multivitamin at least 4 hours before taking your colesevelam dose.

The powder form of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this medication safely.

Older adults may be more sensitive to the side effects of this drug, especially constipation.

Tell your doctor if you are pregnant before using this medication.

This medication is unlikely to pass into breast milk or harm a nursing infant. Consult your doctor before breast-feeding.


Welchol Patient Information Including Side Effects

Brand Names: Welchol

Generic Name: colesevelam (Pronunciation: KOH le SEV e lam)

  • What is colesevelam (Welchol)?
  • What are the possible side effects of colesevelam (Welchol)?
  • What is the most important information I should know about colesevelam (Welchol)?
  • What should I discuss with my health care provider before taking colesevelam (Welchol)?
  • How should I take colesevelam (Welchol)?
  • What happens if I miss a dose (Welchol)?
  • What happens if I overdose (Welchol)?
  • What should I avoid while taking colesevelam (Welchol)?
  • What other drugs will affect colesevelam (Welchol)?
  • Where can I get more information?

What is colesevelam (Welchol)?

Colesevelam is a cholesterol-lowering drug.

Colesevelam lowers "bad" cholesterol in the blood, which is also called LDL (low-density lipoprotein) cholesterol. Lowering your LDL cholesterol may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.

Colesevelam is sometimes used together with another cholesterol-lowering medication such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor).

Colesevelam is also used to improve glycemic control in people with type 2 diabetes. This medication is not for treating type 1 (insulin-dependent) diabetes.

Do not take colesevelam if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Colesevelam may also be used for other purposes not listed in this medication guide.

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:

  • constipation;
  • nausea, upset stomach pain, gas, indigestion;
  • feeling weak or tired;
  • muscle weakness; or
  • runny nose, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about colesevelam (Welchol)?

Do not take this medication if you are allergic to colesevelam, or if you have a bowel obstruction or if you have ever had pancreatitis caused by high triglycerides.

Before taking colesevelam, tell your doctor if you have trouble swallowing, or if you have a history of major stomach or bowel surgery, a vitamin deficiency, or a blockage in your stomach or intestines.

Avoid eating foods that are high in fat or cholesterol. Colesevelam will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Do not take any other medications within 4 hours before or after you take colesevelam. Colesevelam can make it harder for your body to absorb certain other medications.

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

Colesevelam is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Do not change the dose or timing of any other cholesterol or diabetes medications without your doctor's advice.

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