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

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.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is colesevelam?

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.


Precautions

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 are allergic to any drugs, or if you have:

  • trouble swallowing;
  • a stomach, intestinal, or digestive disorder;
  • a history of major stomach or bowel surgery; or
  • if you have a vitamin A, D, E, or K deficiency.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take colesevelam.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking colesevelam can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not take colesevelam without telling your doctor if you are breast-feeding a baby.

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.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Because colesevelam is not absorbed into the bloodstream, an overdose of this medication is not expected to produce life-threatening symptoms. It is possible that an overdose may cause severe constipation.

Take the missed dose as soon as you remember (be sure to take the medicine with food and a full glass of water). If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side-effects

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.

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Interactions

Do not take your other medications at the same time you take colesevelam, unless your doctor has told you to. Colesevelam can make it harder for your body to absorb certain other medications.

Before taking colesevelam, tell your doctor if you are using any of the following drugs:

  • phenytoin (Dilantin);
  • a blood thinner such as warfarin (Coumadin);
  • glyburide (DiaBeta, Glynase Presab, Micronase, Glucovance);
  • thyroid hormone replacement; or
  • birth control pills.

This list is not complete and there may be other drugs that can interact with colesevelam. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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