Colesevelam

Colesevelam lowers "bad" cholesterol in the blood, known as LDL (low-density lipoprotein) cholesterol. Lowering your LDL cholesterol may lower your risk of hardened arteries, which can cause heart attacks, strokes, and circulation problems.

Colesevelam is used to treat high cholesterol in adults and children who are at least 10 years old.

Colesevelam is sometimes used along with "statin" cholesterol medications such as atorvastatin, lovastatin, simvastatin, Crestor, Lipitor, Pravachol, Zocor, and others.

Colesevelam is also used to help improve blood sugar control in adults with type 2 diabetes mellitus. This medication is not for treating type 1 diabetes.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take colesevelam with a meal and a full glass of water or other liquid.

You may need to take several tablets at a time each time you take colesevelam. Tell your doctor if you have trouble swallowing the tablet whole.

Colesevelam powder must be mixed with 8 ounces of water, fruit juice, or a diet soft drink. Stir and drink this mixture right away. Add a little more water to the glass, swirl gently, and drink right away.

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

You will need frequent blood tests.

Colesevelam is only part of a complete treatment program that may also include diet, exercise, and weight control. You may need to follow a special diet to prevent constipation while using colesevelam. Follow all instructions from your doctor or dietitian.

Store at room temperature away from moisture and heat.

You should not take colesevelam if you have diabetic ketoacidosis, very high triglycerides, a history of bowel obstruction, or a history of pancreatitis caused by high triglycerides.

You should not take colesevelam if you are allergic to it, or if you have:

• very high levels of triglycerides (a type of fat) in your blood;
• diabetic ketoacidosis (call your doctor for treatment);
• a history of bowel obstruction; or
• a history of pancreatitis caused by high triglycerides.

Colesevelam may increase your triglycerides, which can increase your risk of pancreatitis (inflammation of the pancreas). Your doctor will perform blood tests to ensure your triglycerides are not too high for you to safely use colesevelam.

Colesevelam is not for use in girls who have not yet started having menstrual periods.

Colesevelam should not be given to a child younger than 10 years old.

Tell your doctor if you have ever had:

• trouble swallowing;
• blockage in your digestive tract (stomach or intestines);
• slow digestion;
• surgery on your stomach or intestines; or
• a vitamin A, D, E, or K deficiency.

Tell your doctor if you are pregnant or if you become pregnant.

The powder form of colesevelam may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

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

Colesevelam may cause serious side effects. Stop using colesevelam and call your doctor right away if you have:

• severe constipation;
• severe stomach pain; or
• pancreatitis—severe pain in your upper stomach that spreads to your back, along with nausea and vomiting.

Common side effects of colesevelam may include:

• constipation;
• nausea; or
• upset stomach.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine (with food and a full glass of water) as soon as you remember, but skip the missed dose if it's nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid eating foods high in fat or cholesterol, or colesevelam will not be as effective.

Colesevelam can make it harder for your body to absorb other medicines, which could make those medicines less effective. If you take any of the following medicines, take them 4 hours before you take colesevelam:

• cyclosporine;
• olmesartan;
• phenytoin;
• levothyroxine or other thyroid medication;
• birth control pills;
• multivitamins;
• warfarin (Coumadin, Jantoven); or
• oral diabetes medication--chlorpropamide, glimepiride, glipizide, or glyburide, tolazamide, tolbutamide.

This list is not complete and many other drugs may affect colesevelam. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.