Welchol (Colesevelam Hydrochloride)

(koh le sev' e lam)

Colesevelam is used in adults along with diet, weight loss, and exercise to reduce the amount of cholesterol and certain fatty substances in the blood alone or in combination with other cholesterol-lowering medications known as HMG-CoA reductase inhibitors (statins). Colesevelam is also used alone or in combination with HMG-CoA reductase inhibitors in certain boys and in girls, ages 10 to 17, with familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally) to decrease the amount of cholesterol and other fatty substances in the blood. Colesevelam is also used along with diet and exercise to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Colesevelam is in a class of medications called bile acid sequestrants. It works by binding bile acids in your intestines to form a product that is removed from the body. Bile acids are made when cholesterol is broken down in your body. Removing these bile acids helps to lower your blood cholesterol. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help prevent heart disease, angina (chest pain), strokes, and heart attacks.

Colesevelam comes as a tablet, in a chewable bar, and as a powder to be mixed with a liquid to take by mouth. The tablets are usually taken once or twice a day with meals and a beverage. The chewable bars and the powder are usually taken once a day with a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take colesevelam exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you are taking the powder for oral suspension, empty the entire contents of 1 packet into a glass. Add 8 ounces of water, fruit juice, or a diet soft drink. Stir well and drink the entire contents of the glass. It is normal for the contents to appear cloudy and not fully dissolve. Do not take the powder in its dry form. If you are taking the chewable bars, you should know that the chewable bars contain 80 calories per bar. Colesevelam controls your condition but does not cure it. Continue to take colesevelam even if you feel well. Do not stop taking colesevelam without talking to your doctor.

Before taking colesevelam,
• tell your doctor and pharmacist if you are allergic to colesevelam or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: anticoagulants such as warfarin and metformin extended-release (Glucophage XR, Glumetaza).
• if you are taking cyclosporine (Gengraf, Neoral, Sandimmune),, glipizide (Glucotrol), glimepride (Amaryl), glyburide (Diabeta), levothyroxine (Synthroid), olmesartan (Benicar), oral contraceptives (birth control pills), phenytoin (Dilantin), or vitamins, take them at least 4 hours before colesevelam.
• tell your doctor if you have or have ever had a blockage in your stomach or intestines, high levels of triglycerides (fatty substance) in the blood, or swelling of the pancreas caused by high levels of triglycerides in the blood. Your doctor will probably tell you not to take colesevelam.
• tell your doctor if you have had gastrointestinal surgery, and if you have or have ever had any problem with the ability to digest or absorb nutrients from food, any type of stomach problem such as slow stomach emptying, or difficulty swallowing.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking colesevelam, call your doctor.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the powder for oral suspension contains aspartame that forms phenylalanine.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Side effects from colesevelam can occur. Tell your doctor if any of these symptoms are severe or do not go away:

• gas
• constipation
• nausea
• vomiting
• diarrhea
• heartburn
• stomach or back pain
• headache
• weakness
• muscle pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• severe abdominal pain with or without nausea and vomiting

Colesevelam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your response to colesevelam. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.