How does this medication work? What will it do for me?

Colesevelam belongs to the class of medications known as bile acid sequestrants. When used along with changes to diet and exercise, this medication helps to reduce cholesterol levels in the blood. Colesevelam is used for people who are unable to tolerate or who have not had enough of a response to a HMG-CoA reductase inhibitor (a "statin").

Colesevelam works by binding to cholesterol-like substances called bile acids in the intestines and preventing them from being reabsorbed into the body. This prevents your body from recycling bile acids from your intestine. Normally, the bile acids are recycled from your intestines. Instead, the bile acids that are now bound to colesevelam are carried out of your body as part of your bowel movements. In order to make additional bile acids, your liver uses cholesterol from your blood, which lowers the level of cholesterol in your blood. Colesevelam may begin to work within 2 weeks of starting treatment.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each off-white, capsule-shaped, film-coated tablet, imprinted with "LODALIS" on one side, contains 625 mg of colesevelam hydrochloride. Non-medicinal ingredients: tablet core: colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, and purified water; film-coating: diacetylated monoglycerides and hypromellose; printing ink: hypromellose, iron oxide black, and propylene glycol.

Powder for Oral Suspension
Each package of white-to-pale-yellow powder containing yellow granules for oral suspension contains 3.75 g of colesevelam hydrochloride. Nonmedicinal ingredients: lemon flavor, orange flavor, propylene glycol alginate, simethicone, aspartame, citric acid, medium chain triglycerides, and magnesium trisilicate. Each 3.75 g dose contains 27 mg of phenylalanine.

How should I use this medication?

If you are taking colesevelam on its own (without other cholesterol-lowering medications), the usual adult starting dose is 3 tablets (1875 mg) twice a day with meals or 6 tablets (3750 mg) once a day with a meal. Your doctor may increase the dose to a maximum of 7 tablets (4375 mg) a day.

If you are taking colesevelam along with other cholesterol-lowering medications (i.e., a "statin"), the usual recommended dose of colesevelam is 4 to 6 tablets a day, with a maximum of 6 tablets a day. Your doctor may instruct you to take the colesevelam dose once or twice a day. This medication should be taken with a meal. You can take colesevelam at the same time or at separate times from your statin medication.

If you are using colesevelam powder for oral suspension, either alone or with other cholesterol-lowering medications, the dose is one 3.75 g packet once daily with a meal. To prepare the oral suspension, empty the contents of one packet into a drinking glass. Add ½ to 1 cup (4 to 8 ounces) of water, fruit juice, or diet soft drinks. Stir well and drink.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture and keep it out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take colesevelam if you:

  • are allergic to colesevelam or any of the ingredients of the medication
  • have a bowel or biliary obstruction (blockage in your intestines or bile ducts)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • abnormal stools
  • constipation
  • diarrhea
  • flatulence (gas)
  • headache
  • indigestion
  • muscle pain
  • nausea
  • runny nose
  • sore throat
  • weakness
  • worsening hemorrhoids

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • black, tarry stools
  • flu-like symptoms (sudden fever, lack of energy, cough, sore throat)
  • increased levels of triglycerides (fats) in your blood
  • increased levels of liver enzymes in your blood
  • rash
  • severe constipation and/or diarrhea
  • stomach pain (severe) with nausea and vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • difficulty swallowing
  • symptoms of bowel obstruction (abdominal pain, cramps or distension, vomiting, fecal vomiting, constipation)
  • symptoms of fecal impaction (chronic constipation, abdominal pain and bloating, loss of appetite)
  • symptoms of pancreatitis (severe upper abdominal pain that radiates to back, nausea, vomiting)
  • symptoms of a serious allergic reaction (swelling of face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Constipation: Colesevelam may cause or worsen constipation. Fecal impaction (a large mass of stool that may be lodged in the colon) and worsening of hemorrhoids may occur. Talk to your doctor as soon as possible if any of these side effects become bothersome.

Drug interactions: Colesevelam can interact with other medications, such as birth control pills, cyclosporine, and warfarin (see "What medications can interact with colesevelam?" for more medications). If you take any of these medications, you should wait at least 4 hours before taking colesevelam. Your doctor will monitor you and the other medications you are taking while you are taking colesevelam. In general, if a drug interaction cannot be ruled out, you should take colesevelam at least 4 hours after your other medications in order to lessen the risk of the other medications not being fully absorbed into the body.

Gastrointestinal: The safety and efficacy of colesevelam have not been established for people with swallowing problems, severe gastrointestinal motility disorder, inflammatory bowel disease, liver failure, or major gastrointestinal tract surgery. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Phenylketonuria: The powder for oral suspension form of this medication contains aspartame, an artificial sweetener which contains phenylalanine. People with phenylketonuria are unable to break phenylalanine down to get rid of it. If you have phenylketonuria, talk to your doctor about other alternatives.

Triglyceride levels: Colesevelam can increase triglyceride (blood fat) levels. If your triglyceride (blood fat) levels are greater than 3.4 mmol/L, your doctor should monitor them while you are on this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if colesevelam passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years old.

What other drugs could interact with this medication?

There may be an interaction between colesevelam and any of the following:

  • amiodarone
  • anticoagulant medications (e.g., warfarin)
  • anti-seizure medications (e.g., carbamazepine, phenytoin, valproic acid)
  • birth control pills
  • corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • deferasirox
  • diabetes medication (e.g., gliclazide, glyburide)
  • diuretics (also known as "water pills"; e.g., furosemide, hydrochlorothiazide, indapamide)
  • doxycycline
  • ethinyl estradiol
  • ezetimibe
  • leflunomide
  • lomitapide
  • methotrexate
  • minocycline
  • multivitamins
  • mycophenolate
  • niacin
  • norethindrone
  • NSAIDs (non-steroidal anti-inflammatory drugs; e.g., diclofenac, ibuprofen, naproxen)
  • obeticholic acid
  • olmesartan
  • pravastatin
  • propranolol
  • raloxifene
  • teriflunomide
  • tetracycline
  • thyroid replacement therapy (e.g., thyroxine, levothyroxine)
  • ursodiol
  • vancomycin (oral)
  • vitamin D analogs (e.g., calcitriol, cholecalciferol)

In general, if a drug interaction cannot be ruled out, you should take colesevelam at least 4 hours after your other medications in order to lessen the risk of the other medications not being fully absorbed into the body.

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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