Colesevelam HCL

COLESEVELAM HCL

Manufacturer: Ascend Laboratories, LLC

Score: 145.0

Quick Summary

Colesevelam HCL is a bile acid sequestrant used to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and to improve glycemic control in adults with type 2 diabetes mellitus. The recommended dosage is 3.75 grams daily, taken as 6 tablets once daily or 3 tablets twice daily with a meal and liquid. Colesevelam HCL is contraindicated in patients with serum triglyceride concentrations greater than 500 mg/dL, history of hypertriglyceridemia-induced pancreatitis, and history of bowel obstruction. Common adverse reactions include constipation, dyspepsia, and nausea.

Key Clinical Findings and Indications

Reduces elevated LDL-C in adults with primary hyperlipidemia
Improves glycemic control in adults with type 2 diabetes mellitus
Reduces LDL-C levels in boys and postmenarchal girls with heterozygous familial hypercholesterolemia

Important Safety Information

Warning

May decrease the absorption of fat-soluble vitamins

Contraindications

Serum triglyceride concentrations greater than 500 mg/dL
History of hypertriglyceridemia-induced pancreatitis
History of bowel obstruction

Adverse Reactions

Constipation
Dyspepsia
Nausea
Hypertriglyceridemia
Gastrointestinal obstruction
Vitamin K or fat-soluble vitamin deficiencies

Dosing Recommendations

General Guidance

None specified

Primary hyperlipidemia

Adult Dose

3.75 grams daily

Pediatric Dose

3.75 grams daily for boys and postmenarchal girls aged 10 to 17 years

Type 2 diabetes mellitus

Adult Dose

3.75 grams daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Colesevelam HCL is not absorbed systemically and is not expected to result in fetal exposure
May decrease the absorption of fat-soluble vitamins

Nursing Mothers

Use of colesevelam HCL may reduce the efficacy of oral contraceptives
Advise patients to take oral contraceptives at least 4 hours prior to taking colesevelam HCL

Pediatric Use

Safety and effectiveness established in boys and postmenarchal girls aged 10 to 17 years with primary hyperlipidemia
Not established in pediatric patients with type 2 diabetes mellitus

Geriatric Use

No overall differences in safety or effectiveness observed between elderly and younger patients
Greater sensitivity of some older individuals cannot be ruled out

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