Primary hypercholesterolaemia

Active Ingredient: Colesevelam

Indication for Colesevelam

Population group: only adults (18 years old or older)

Colesevelam co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.

For this indication, competent medicine agencies globally authorize below treatments:

2500-4375 mg in 1-2 divided doses daily

Route of admnistration

Oral

Defined daily dose

2,500 - 4,375 mg

Dosage regimen

From 1,250 To 2,187.5 mg 2 time(s) per day every day

Detailed description

Combination therapy

The recommended dose of colesevelam for combination with a statin with or without ezetimibe is 2500-3750 mg per day. The maximum recommended dose is 3750 mg per day taken as 1875 mg twice per day with meals or 3750 mg taken once per day with a meal. Clinical trials have shown that colesevelam and statins can be co-administered or dosed apart, and that colesevelam and ezetimibe can be co- administered or dosed apart.

Monotherapy

The recommended starting dose of colesevelam is 3750 mg per day taken as 1875 mg twice per day with meals or 3750 mg once per day with a meal. The maximum recommended dose is 4375 mg per day.

During therapy, the cholesterol-lowering diet should be continued, and serum total-C, LDL-C and triglyceride levels should be determined periodically during treatment to confirm favourable initial and adequate long-term responses.

When a drug interaction cannot be excluded with a concomitant medicinal product for which minor variations in the therapeutic level would be clinically important, or where no clinical data are available on co-administration, colesevelam should be administered at least four hours before or at least four hours after the concomitant medication in order to minimize the risk of reduced absorption of the concomitant medication.

Dosage considerations

Colesevelam tablets should be taken orally with a meal and liquid.

Active ingredient

Colesevelam

Colesevelam is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.

Read more about Colesevelam

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