Cholestyramine

Generic name
Cholestyramine
Brand name
ATC Code
C10AC01

Cholestyramine

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Cholestyramine is not absorbed.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Diarrhoea caused by bile salts
  • Oral
    • < 6 years
      • Initial dose: 1 - 4 g/day in 4 doses. Max: 16 g/day. Maintenance dose:  Adjust the dose if necessary every 5-7 days depending on the effect.
      • Duration of treatment:

        If no improvement occurs in 3 days, a different therapy must be used.

    • 6 years up to 18 years
      • Initial dose 16 g/day in 4 doses. Max: 24 g/day. Maintenance dose: minimum effective dose, to be determined depending on the effect..
      • Duration of treatment:

        If no improvement occurs in 3 days, a different therapy must be used.

    • < 6 years
      • Initial dose: 1 - 4 g/day in 4 doses. Max: 16 g/day. Maintenance dose:  Adjust the dose if necessary every 5-7 days depending on the effect.
      • Duration of treatment:

        If no improvement occurs in 3 days, a different therapy must be used.

    • 6 years up to 18 years
      • Initial dose 16 g/day in 4 doses. Max: 24 g/day. Maintenance dose: minimum effective dose, to be determined depending on the effect..
      • Duration of treatment:

        If no improvement occurs in 3 days, a different therapy must be used.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The most common side effect is obstipation. Also noted: deficiencies of fat-soluble vitamins (A, D, E and K) and folic acid, hypoprothrombinaemia (as a result of vitamin K deficiency), drop in the serum calcium concentration, hyperchloraemic acidosis (particularly in children), skin reactions (rashes, urticaria, dermatitis) and irritation of the tongue or perianal area. There have been rare reports of intestinal obstruction, including two fatal cases in children, and urticaria and dermatitis.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Questran/Questran A should never be used in the dry form. The contents of a sachet are sprinkled onto about 150 ml of liquid, allowed to stand for 1-2 minutes and then stirred to obtain an even mixture. The prescribing doctor should be aware that the quantity of liquid can be a lot for younger children.

To keep the potential gastrointestinal side effects to a minimum, starting the therapy in children with a single dose of Questran/Questran A is desirable. The dosage can be increased gradually (every 5-7 days) to obtain the desired effect. There is a possibility that long-term use of cholestyramine in high doses can cause hyperchloraemic acidosis, given that cholestyramine is the chloride of an anion exchanger. This could in particular happen in younger and more lightweight patients, in whom the relative dose can be higher. When high doses are used in the longer term, the normal absorption of fats can be disrupted and the resorption of lipid-soluble vitamins is lowered. In that event, vitamins A and D should be included. Chronic use of cholestyramine can cause an increased tendency to bleed, which is the consequence of hypoprothrombinaemia caused by vitamin K deficiency. Parenteral vitamin K administration may be indicated in such cases. Reductions in the serum folic acid level or in red blood cells have been described, in which case treatment with folic acid can be considered.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

LIPID MODIFYING AGENTS, PLAIN

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

HMG CoA reductase inhibitors
C10AA05
C10AA03
C10AA07
C10AA01
Other lipid modifying agents
C10AX09

References

  1. Farah JR, et al, Dose-effect relation of cholestryamine in children and young adults with familial hypercholesterolaemia, Lancet, 1977, 1, 59-63.
  2. Glueck CJ, et al, Therapy of familial hypercholesterolemia in childhood: diet and cholestyramine resin for 24 to 36 months, Pediatrics, 1977, 59, 433-41
  3. Liacouras CA, et al, Use of cholestyramine in the treatment of children with familial combined hyperlipidemia, J Pediatr., 1993, 122, 477-82
  4. Bristol Myers Squibb BV, SPC Questran 04-01-2013, www.cbg-meb.nl
  5. Tonstad S, et al, Efficacy and safety of cholestyramine therapy in peripubertal and prepubertal children with familial hypercholesterolemia, J Pediatr, 1996, 129, 42-9
  6. Vesikari T, et al, A comparative trial of cholestyramine and loperamide for acute diarrhoea in infants treated as outpatients, Acta Paediatr Scand, 1985, 74, 650-4
  7. Vesikari T, et al, Efficacy of cholestyramine in acute infantile diarrhoea: placebo-controlled double-blind trial in hospitalized children and in outpatients, J Diarrhoeal Dis Res, 1984, 2, 151-8
  8. MMI, Gelbe Liste | Online, Accessed May 30, 2018
  9. Dr. Felgenträger, SmPC Vasosan® S (3000151.00.00), 02/2015
  10. Dr. Felgenträger, SmPC Vasosan® P (3000152.00.00), 02/2015
  11. Merz, SmPC Lipocol-Merz® Kautablette, 2 g (6143685.00.00), 10/2016
  12. Hexal, SmPC Colestyramin HEXAL 4 g Beutel, Pulver zur Herstellung einer Suspension zum Einnehmen (21776.00.00), 01/2017
  13. Bristol-Myers Squibb, SmPC Quantalan® zuckerfrei Pulver zur Herstellung einer Suspension zum Einnehmen (24903.00.00), 04/2014
  14. CHEPLAPHARM Arzneimittel GmbH, SmPC Questran (RVG 06761) 17-02-2023, www.geneesmiddelinformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose