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Colesevelam

    Brands

    DEA Class; Rx

    Common Brand Names; WelChol

    • Bile Acid Sequestrants

    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

    Indicated for the treatment of primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, and hyperlipoproteinemia as an adjunct to diet and exercise to reduce LDL-C.

    For the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.

    Serum TG concentrations >500 mg/dL

    History of hypertriglyceridemia-induced pancreatitis

    History of bowel obstruction

    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%)

    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

    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

    Adults

    3.75 g/day PO.

    Geriatric

    3.75 g/day PO.

    Adolescents

    3.75 g/day PO powder for oral suspension.

    Children

    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.

    Colesevelam hydrochloride

    tablet

    • 625mg

    powder for oral suspension

    • 3.75g/packet