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Fact Table
| Fact Table | |
|---|---|
| Formula | Variable polymer; representative PubChem formula C31H67Cl3N4O for colesevelam |
| License | FDA approved (NDA 021176; initial U.S. approval 2000); EMA authorized as Cholestagel in 2004 |
| Bioavailability | Not systemically absorbed; conventional bioavailability not applicable |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | Allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride |
| Elimination half-life | Not applicable; non-absorbed polymer, not systemically metabolized |
| Dosage (Strength) | 625 mg oral tablets and 3.75 g oral suspension packets; recommended dose 3.75 g daily as 6 tablets once daily, 3 tablets twice daily, or one 3.75 g packet once daily with a meal |
| Pregnancy | Not absorbed systemically, so fetal exposure is not expected; limited human data; may decrease absorption of fat-soluble vitamins |
| Brands | Welchol; Cholestagel; Lodalis; generic colesevelam hydrochloride products available |
| Protein binding | Not applicable; not systemically absorbed and distribution is limited to the gastrointestinal tract |
| PubChem CID | 160051 |
| MedlinePlus | a699050 |
| ChEBI | 59599 (colesevelam hydrochloride); 59594 (colesevelam) |
| ATC code | C10AC04 |
| DrugBank | DB00930; DBSALT000790 (colesevelam hydrochloride) |
| KEGG | D03582 (colesevelam hydrochloride); D07743 (colesevelam) |
| Routes of administration | By mouth (oral tablets; powder for oral suspension) |
Welchol (colesevelam) is a medication used to lower LDL cholesterol and help improve blood sugar control in adults with type 2 diabetes. It works by binding to bile acids in the intestine, allowing the liver to use more cholesterol to produce new bile acids. This action lowers cholesterol levels in the blood. It is typically available as tablets or powder packets.
Directions
Take Welchol with meals and a liquid. For high cholesterol and type 2 diabetes, the usual dose is 6 tablets taken once daily or 3 tablets taken twice daily with meals. Swallow tablets whole; do not crush, chew, or break them.
If using the oral suspension, the usual dose is one 3.75 gram packet once daily mixed with 4 to 8 ounces of water. Do not take the powder in its dry form. Other medications should be taken at least 4 hours before Welchol, as it may reduce the absorption of certain drugs.
Ingredients
The active ingredient in Welchol is colesevelam hydrochloride. Inactive ingredients in the tablets include magnesium stearate, microcrystalline cellulose, silicon dioxide, hydroxypropyl methylcellulose (HPMC), and acetylated monoglyceride. The oral suspension may also contain lemon flavor, orange flavor, propylene glycol alginate, simethicone, aspartame, citric acid, medium chain triglycerides, and magnesium trisilicate.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Welchol can increase triglyceride levels, particularly in patients also taking insulin or sulfonylureas. Your doctor should monitor your triglyceride levels while you are taking this medication.
This medication may decrease the absorption of fat-soluble vitamins, including vitamins A, D, E, and K. Your doctor may recommend vitamin supplementation.
Welchol may cause constipation and should be used with caution in patients who are at risk for bowel obstruction.
Welchol can reduce the absorption of other medications. Take other drugs at least 4 hours before taking Welchol.
The oral suspension contains phenylalanine. Patients with phenylketonuria, also known as PKU, should be aware of this before using the suspension form.
Contraindications
Avoid taking or using this medication if any of the following apply:
- You have a history of bowel obstruction
- Your triglyceride levels are greater than 500 mg/dL
- You have a history of pancreatitis, or inflammation of the pancreas, caused by high triglycerides
Side Effects
Common side effects of Welchol include:
- Constipation
- Indigestion
- Nausea
Serious side effects are rare but can include bowel obstruction, difficulty swallowing, severe constipation or fecal impaction, and pancreatitis related to high triglyceride levels.
Seek medical attention immediately if you experience severe abdominal pain, vomiting, or difficulty swallowing.
Frequently Asked Questions about Welchol
What is Welchol?
Welchol is a prescription medicine that contains colesevelam hydrochloride. It is a bile acid sequestrant used along with diet and exercise to lower LDL, or “bad,” cholesterol, and it can also help improve blood sugar control in adults with type 2 diabetes.
What is Welchol used for?
Welchol is used to reduce elevated LDL cholesterol in adults with primary hyperlipidemia. It is also used in boys and postmenarchal girls ages 10 to 17 with heterozygous familial hypercholesterolemia who have not reached LDL goals with diet and lifestyle changes, and it is used to improve glycemic control in adults with type 2 diabetes.
How does Welchol work?
Welchol is not absorbed into the bloodstream in a meaningful way. It works mainly in the intestine by binding bile acids, which reduces bile acid reabsorption and causes the liver to use more cholesterol to make bile acids, helping lower LDL cholesterol. Its exact mechanism for improving blood sugar in type 2 diabetes is not fully known.
How is Welchol usually taken?
Welchol is usually taken with a meal and liquid. The adult daily dose is commonly 3.75 grams per day, taken as 6 tablets once daily, 3 tablets twice daily, or one oral suspension packet once daily, depending on the prescribed form.
How should Welchol oral suspension be prepared?
Welchol oral suspension should be mixed with liquid before use and should not be taken as dry powder. The packet contents are mixed with water, fruit juice, or diet soft drink, stirred well, and taken with a meal.
How long does Welchol take to work?
For cholesterol lowering, the maximum therapeutic response may occur within about 2 weeks. For type 2 diabetes, A1C improvement may begin after about 4 to 6 weeks and may reach maximal or near-maximal effect after 12 to 18 weeks.
What are common side effects of Welchol?
Common side effects include constipation, indigestion, nausea, headache, weakness, muscle pain, and cold-like symptoms. In people with type 2 diabetes, constipation, indigestion, nausea, low blood sugar, and increased blood pressure have also been reported.
What serious risks are associated with Welchol?
Welchol can increase triglyceride levels, which may raise the risk of pancreatitis in some patients. It can also cause or worsen constipation and has been associated with bowel obstruction, swallowing difficulty, esophageal obstruction, fecal impaction, and reduced absorption of fat-soluble vitamins.
Who should not take Welchol?
Welchol should not be used by people with triglycerides over 500 mg/dL, a history of pancreatitis caused by high triglycerides, or a history of bowel obstruction. It is not used to treat type 1 diabetes or diabetic ketoacidosis.
What medications or supplements can interact with Welchol?
Welchol can reduce the absorption of some medicines and vitamins. Drugs with known interactions, certain narrow-therapeutic-index medicines, and fat-soluble vitamins such as A, D, E, and K may need to be taken at least 4 hours before Welchol; examples of concern include levothyroxine, phenytoin, warfarin, cyclosporine, glyburide, and some oral contraceptives.
