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Bile acid sequestrant Pregnancy: No clinical data in pregnant women; animal studies show no direct/indirect harmful effects. Safety not established in breastfeeding. Caution should be exercised when prescribing to pregnant or breastfeeding women.

Colesevelam hydrochloride

Brand names: Cholestagel

Colesevelam is a bile-acid sequestrant used as an adjunct in the management of primary hypercholesterolaemia, often alongside a statin.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 4 to 6 tablets (625 mg each) per day (combination therapy with a statin, with or without ezetimibe)
Route: Oral
Frequency: 3 tablets twice daily with meals, or 6 tablets once daily with a meal
Max: 6 tablets per day (combination therapy); 7 tablets per day (monotherapy)
Combination therapy with a statin (with or without ezetimibe): 4-6 tablets/day, maximum 6 tablets/day. Monotherapy: recommended starting dose 6 tablets/day (3 twice daily with meals, or 6 once daily with a meal); maximum 7 tablets/day. Take with a meal and liquid, swallow whole (do not break, crush or chew). Where a drug interaction cannot be excluded, give colesevelam at least 4 hours before or after the concomitant medicine. No dose adjustment needed in the elderly. Paediatric safety and efficacy (0-17 years) not established - no posology recommendation.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Bowel or biliary obstruction

Side effects

  • Flatulence, constipation (very common)
  • Vomiting, diarrhoea, dyspepsia, abdominal pain, nausea, abdominal distension (common)
  • Headache (common)
  • Serum triglycerides increased (common)
  • Dysphagia (uncommon); pancreatitis and intestinal obstruction (rare/not known)

Interactions

  • Ciclosporin: colesevelam reduces its bioavailability - monitor blood concentrations and adjust dose when starting/stopping colesevelam
  • Warfarin or similar anticoagulants: bile acid sequestrants reduce vitamin K absorption and may interfere with anticoagulant effect - monitor closely
  • Oral contraceptives: administer colesevelam at least 4 hours after the pill to minimise reduced bioavailability

Clinical monograph

How it works

It binds bile acids in the intestine to prevent their reabsorption, increasing hepatic conversion of cholesterol to bile acids and upregulating LDL-receptor activity to lower LDL-cholesterol.

Prescribing in practice

  • Because it can bind other drugs in the gut and reduce their absorption, separate the administration of interacting medicines, such as some thyroid hormones and certain anticoagulants, as advised in the SPC.
  • It may raise serum triglycerides, so use with caution in patients with hypertriglyceridaemia.
  • Gastrointestinal effects such as constipation are common and it can reduce absorption of fat-soluble vitamins with prolonged use.

Monitoring

Monitor the lipid profile including triglycerides to confirm response and detect any rise in triglycerides.

Counselling the patient

  • Take other medicines at a separate time from this one, as advised.
  • Take it with a meal and plenty of fluid.
  • Report troublesome constipation so it can be managed.

Evidence & guidelines

Bile-acid sequestrants lower LDL-cholesterol and are positioned by NICE as add-on therapy when statins are insufficient or not tolerated.

Reference: Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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