Classes
DEA Class; Rx
Common Brand Names; WelChol
- Bile Acid Sequestrants
Description
Oral, non-absorbed hydrogel polymer
Used for diabetes mellitus or hypercholesterolemia in adults and familial hypercholesterolemia in boys and postmenarchal girls
Used as monotherapy or with a statin for hypercholesterolemia
Indications
Indicated for the treatment of primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, and hyperlipoproteinemia as an adjunct to diet and exercise to reduce LDL-C.
Contraindications
Serum TG concentrations >500 mg/dL
History of hypertriglyceridemia-induced pancreatitis
History of bowel obstruction
Adverse Effects
Constipation (6.5-11%)
Dyspepsia (2.8-8.3%)
Headache (3.9-7.6%)
Nasopharyngitis (5.4-6.2%)
Upper respiratory tract infection (4.9%)
Nausea (4.2%)
Influenza (3.8%)
Nausea (2.6-3.8%)
Accidental injury (3.7%)
Asthenia (3.6%)
Hypoglycemia (3.4%)
Pharyngitis (3.2%)
Flu syndrome (3.2%)
Rhinitis (3.2%)
Fatigue (3.9%)
Hypertension (2.6%)
Creatine phosphokinase increase (2.3%)
Rhinitis (2.3%)
Vomiting (2.3%)
Back pain (2.3%)
Myalgia (2.1%)
Warnings
Tablets can cause dysphagia or esophageal obstruction due to size; for patients with difficulty swallowing tablets use oral suspension
May increase serum TG concentrations, hypertriglyceridemia can cause acute pancreatitis
Secondary causes of hyperlipidemia must be ruled out before therapy is initiated
Postmarketing cases of bowel obstruction have occurred; not recommended in gastroparesis (constipating effects); instruct patients to promptly discontinue therapy and seek medical attention if severe abdominal pain or severe constipation occurs
May exacerbate preexisting constipation (initiate therapy at lower dosage in patients with history of constipation)
Seek prompt medical attention if symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting)
Phenylalanine can be harmful to patients with phenylketonuria (PKU); before prescribing oral suspension to a patient with PKU, consider combined daily amount of phenylalanine from all sources, including oral suspension
Pregnancy and Lactation
There are no adequate and well-controlled studies of colesevelam hydrochloride use in pregnant women
In the postmarketing setting, there have been reports of pregnancy and a causal association with congenital anomalies has not been established
Not absorbed systemically by mother following oral administration, and breastfeeding is not expected to result in exposure of child to drug
Maximum Dosage
3.75 g/day PO.
3.75 g/day PO.
3.75 g/day PO powder for oral suspension.
10 years or more, including postmenarchal females: 3.75 g/day PO powder for oral suspension.
Less than 10 years and pre-menarchal females: Safety and efficacy have not been established.
How supplied
Colesevelam hydrochloride
tablet
- 625mg
powder for oral suspension
- 3.75g/packet