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Colesevelam (Oral route)

Pronunciation:

koe-le-SEV-e-lam hye-droe-KLOR-ide

Brand Names:

  • Welchol

Dosage Forms:

  • Tablet
  • Powder for Suspension

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

Colesevelam

Uses of This Medicine:

Colesevelam is used together with proper diet 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.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of colesevelam to lower high cholesterol in children 10 years of age and older. However, safety and efficacy of colesevelam in children younger than 10 years of age have not been established.

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal 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—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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
  • Pravastatin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cholic Acid
  • Cyclosporine
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Glimepiride
  • Glipizide
  • Glyburide
  • Levonorgestrel
  • Levothyroxine
  • Medroxyprogesterone Acetate
  • Mestranol
  • Metformin
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Olmesartan Medoxomil
  • Phenytoin
  • Warfarin

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 blockage, history of or
  • Hypertriglyceridemia (high triglycerides or fatty acids in the blood), severe or
  • Pancreatitis caused by hypertriglyceridemia, history of—Should not be used in patients with these conditions.
  • Diabetic ketoacidosis (high ketones and acid in the blood) or
  • Type 1 diabetes—Should not be used in patients with these conditions. Your doctor must give you insulin to treat these conditions.
  • Dysphagia (trouble swallowing) or
  • Esophageal blockage (problem with swallowing) or
  • Vitamin deficiency (e.g., vitamin A, D, E, or K)—Use with caution. 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.
  • Phenylketonuria (PKU)—The powder for oral suspension contains phenylalanine, which can make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. .

Take this medicine (tablet or liquid form) with a meal. Drink some kind of liquid (e.g., water, milk, or juice) when you swallow the tablet. Follow the instructions for mixing the powder for oral suspension.

If you use this medicine for diabetes, carefully follow the special diet your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. 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 change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet and exercise regularly.

To use the powder for oral suspension:

  • Empty one packet into a glass or cup.
  • Add a half to 1 cup (4 to 8 ounces) of water, fruit juice, or a diet soft drink.
  • Stir well and drink it right away.

This medicine can be taken at the same time with a lipid-lowering medicine called "statins" or the two medicines can be dosed apart. If you need help deciding the best times to take your other medicines, ask your doctor or pharmacist.

If you are taking vitamins, take them at least 4 hours before taking colesevelam.

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 (powder for suspension):
    • For high cholesterol:
      • Adults—One 3.75 gram-packet once a day or one 1.875 gram-packet two times a day.
      • Children and teenagers 10 to 17 years of age—One 3.75 gram-packet once a day or one 1.875 gram-packet two times a day.
      • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    • For type 2 diabetes:
      • Adults—One 3.75 gram-packet once a day or one 1.875 gram-packet two times a day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For high cholesterol:
      • Adults—6 tablets each day. This may be taken as a single dose or 3 tablets two times a day.
      • Children—The oral suspension is recommended in this age group.
    • For type 2 diabetes:
      • Adults—6 tablets each day. This may be taken as one dose or 3 tablets two times a day.
      • 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.

Your doctor may want to measure the cholesterol levels in your blood on a regular basis to make sure this medicine is working properly. Be sure to keep all of your appointments. You will also need to check your blood sugar regularly at home.

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.

Stop using this medicine and check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness. These may be symptoms of acute pancreatitis.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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
sweating
tender, swollen glands in the neck
trouble with sleeping
trouble with swallowing
unusual tiredness or weakness
voice changes
vomiting
Incidence not known
Bleeding after defecation
darkened urine
difficulty with 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 or stomach
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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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