Pronunciation:

koh-le-SEV-e-lam

Brand Names:

• Welchol

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

Bile Acid Sequestrant

Uses of This Medicine:

Colesevelam is used to lower high cholesterol levels in the blood. This may help prevent medical problems caused by cholesterol clogging the blood vessels. This medicine is also used to treat high blood sugar levels for patients with type 2 diabetes .

Colesevelam works by attaching to food substances in the intestine. This medicine is not absorbed from the intestine, so these substances pass out of the body without being absorbed .

Colesevelam does not help patients with diabetic ketoacidosis or those who have insulin-dependent type 1 diabetes. Their blood glucose is best controlled with insulin injections .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of colesevelam in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of colesevelam in the elderly .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Mycophenolate Mofetil
• Mycophenolic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel obstruction, history of or
• Hypertriglyceridemia, severe or
• Pancreatitis caused by hypertriglyceridemia, history of—Should not use in patients with these conditions .

• Dysphagia (problem with speaking) or
• Esophageal obstruction (problem with swallowing) or
• Vitamin deficiency (e.g., vitamin A, D, E, or K)—May make these conditions worse .

• Gastrointestinal motility disorder (e.g., chronic constipation) or
• Gastrointestinal surgery, major and recent (e.g., colostomy) or
• Gastroparesis (intestines move slowly) or
• Malabsorption syndrome (food not absorbed in stomach or intestine)—May cause side effects to become worse .

Proper Use of This Medicine:

The tablets should be taken with a meal and liquid .

If you use this medicine for diabetes, follow the special diet plan your doctor gave you while you take this medicine. Also, exercise regularly and test for sugar in your blood or urine as directed .

If you use this medicine to lower blood cholesterol, your doctor may give you instructions for a special diet. Follow the diet plan, exercise regularly, and take the medicine as directed .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults—6 tablets each day. This may be taken as one dose or divided into two doses.
    • Children—Use and dose must be determined by your doctor .
  • For type 2 diabetes:
    • Adults—6 tablets each day. This may be taken as one dose or divided into two doses.
    • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it .

Do not stop taking this medicine without first checking with your doctor. When you stop taking this medicine, your blood cholesterol and sugar levels may increase again .

This medicine can cause low blood sugar (hypoglycemia). The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). People may feel different symptoms with a low blood sugar. It is important that you learn which symptoms you get when your blood sugar is low. The symptoms of low blood sugar include anxiety; a behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; a fast heartbeat; a headache that continues; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; and unusual tiredness or weakness .

If you have any symptoms of low blood sugar, check your blood sugar level right away. If needed, you can eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or you can drink fruit juice, a non-diet soft drink, or sugar dissolved in water .

This medicine can cause constipation, and for some people this can be very uncomfortable. If you have problems with severe constipation while taking this medicine, talk to your doctor .

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Anxiety

blurred vision

chills

cold sweats

coma

confusion

congestion

cool, pale skin

cough

depression

diarrhea

dizziness

dry or sore throat

fast heartbeat

fever

general feeling of discomfort or illness

headache

hoarseness

increased hunger

joint pain

loss of appetite

muscle aches or pain

nausea

nervousness

nightmares

pounding in the ears

runny nose

seizures

shakiness

shivering

slow or fast heartbeat

slurred speech

sore throat

sweating

tender, swollen glands in the neck

trouble sleeping

trouble with swallowing

unusual tiredness or weakness

voice changes

vomiting

Incidence not known

Bleeding after defecation

darkened urine

difficulty swallowing

indigestion

pain or discomfort in the chest

pains in the stomach, side, or abdomen, possibly radiating to the back

pressure in the stomach

severe stomach pain

swelling of the abdominal or stomach area

unable to swallow saliva

uncomfortable swelling around the anus

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

bloating

constipation

full or bloated feeling

heartburn

pain or cramping in the abdomen

stomach discomfort, upset, or pain

Less common

Lack or loss of strength

sneezing

stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.