Colesevelam suspension

Generic Name: colesevelam (KOE-le-SEV-e-lam)
Brand Name: Welchol

Colesevelam suspension is used for:

Reducing high cholesterol levels. It is used along with diet and exercise. It may be used alone or with other medicines. It is also used along with diet and exercise to control blood sugar in patients with type 2 diabetes. It should not be used to treat type 1 diabetes or diabetic ketoacidosis.

Colesevelam suspension is a bile acid sequestrant. It works in the bowel to help remove bile acids from the body. The body then uses cholesterol to make more bile acids, which causes blood cholesterol levels to decrease. Exactly how colesevelam suspension works to treat type 2 diabetes is not known.

Do NOT use colesevelam suspension if:

  • you are allergic to any ingredient in colesevelam suspension
  • you have a history of certain bowel problems (eg, blockage, paralysis, slow movement of the bowel muscles) or major stomach or bowel surgery, or you are at risk of bowel blockage
  • you have very high triglyceride levels or a history of inflammation of the pancreas (pancreatitis) caused by high triglyceride levels

Contact your doctor or health care provider right away if any of these apply to you.

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Before using colesevelam suspension:

Some medical conditions may interact with colesevelam suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have hemorrhoids, phenylketonuria (PKU), low levels of certain vitamins (A, D, E, or K), or nutrient absorption problems
  • if you have a history of high triglyceride levels, pancreatitis, or stomach or bowel problems

Some MEDICINES MAY INTERACT with colesevelam suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Insulin or sulfonylureas (eg, glipizide) because the risk of high triglyceride levels may be increased
  • Metformin because the risk of its side effects may be increased by colesevelam suspension
  • Cyclosporine, hydantoins (eg, phenytoin), thyroid hormones (eg, levothyroxine), or warfarin because their effectiveness may be decreased by colesevelam suspension

Ask your health care provider if colesevelam suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use colesevelam suspension:

Use colesevelam suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take colesevelam suspension by mouth with meals.
  • Empty the entire contents of 1 packet into a glass or cup. Add ½ to 1 cup (4 to 8 oz [120 to 240 mL]) of water, fruit juice, or a diet soft drink. Stir well and drink.
  • Do not take colesevelam suspension in its dry form. This may cause throat irritation.
  • If you also take birth control pills, cyclosporine, glimepiride, glipizide, glyburide, hydantoins (eg, phenytoin), olmesartan, thyroid hormones (eg, levothyroxine), or vitamins, take them at least 4 hours before you take colesevelam suspension.
  • Continue to take colesevelam suspension even if you feel well. Do not miss any doses.
  • If you miss a dose of colesevelam suspension, take it at your next meal. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use colesevelam suspension.

Important safety information:

  • Follow the diet and exercise program given to you by your health care provider.
  • It may take several weeks for colesevelam suspension to begin working. Do not take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Colesevelam suspension may cause constipation. To prevent constipation, it is important to maintain a diet adequate in fiber, drink plenty of water, and exercise. If colesevelam suspension causes constipation, check with your doctor or pharmacist for ways to lessen this effect.
  • Colesevelam suspension may decrease the absorption of certain other medicines into your body. Check with your doctor or pharmacist to see how you should take your other medicines with colesevelam suspension.
  • This product contains phenylalanine. Check with your doctor or pharmacist if you must have a diet that is low in phenylalanine.
  • Tell your doctor or dentist that you take colesevelam suspension before you receive any medical or dental care, emergency care, or surgery.
  • Diabetes patients - Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take colesevelam suspension exactly as prescribed, tell your doctor.
  • Diabetes patients - Colesevelam suspension may lower your blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Lab tests, including cholesterol, triglyceride, and blood glucose levels, may be performed while you use colesevelam suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Colesevelam suspension should be used with extreme caution in CHILDREN younger than 10 years old or in girls who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using colesevelam suspension while you are pregnant. It is not known if colesevelam suspension is found in breast milk. If you are or will be breast-feeding while you use colesevelam suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of colesevelam suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; headache; indigestion; mild stomach pain; muscle aches or pain; nausea; sore throat; stomach upset; stuffy or runny nose; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty swallowing; severe or persistent constipation, diarrhea, or stomach pain; severe or persistent dizziness or headache; symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting, stomach tenderness or swelling); throat pain or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe constipation.

Proper storage of colesevelam suspension:

Store colesevelam suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep colesevelam suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about colesevelam suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Colesevelam suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take colesevelam suspension or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about colesevelam suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to colesevelam suspension. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using colesevelam suspension.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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