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Before Using
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.
Pediatric
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 .
Geriatric
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. |
Breastfeeding
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.
Drug Interactions
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
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.
- Ethinyl Estradiol
- Glyburide
- Levothyroxine
- Norethindrone
- 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 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 .
