We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Bristol-Myers Squibb Holdings Limited

Swords, Co.Dublin, Ireland
Fax: +44 (0)208 754 3677
Medical Information Direct Line: +1 800 749 749
Medical Information e-mail: medical.information@bms.com


Summary of Product Characteristics last updated on medicines.ie: 09/08/2012
SPC Questran 4g/sachet Powder for Oral Suspension



Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Questran 4g/sachet Powder for Oral Suspension


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 4g of colestyramine resin.

Each sachet also contains 3.39g of sucrose.

For full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Powder for oral suspension.

A fine, homogeneous, cream to buff-coloured powder for oral suspension. On reconstitution with 150 ml of water or fruit juice, a uniform suspension is formed.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

1. A basic anion exchange resin to complex bile acids and reduce plasma levels of cholesterol.

2. Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Fredrickson's Type II (high plasma cholesterol with normal or slightly elevated triglycerides).

3. Relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis.

4. Relief of diarrhoea associated with ileal reaction, Crohn's disease, vagotomy and diabetic vagal neuropathy.

5. Management of radiation-induced diarrhoea.


Go to top of the page
4.2 Posology and method of administration

Adults (including the elderly):

1. Hypercholesterolaemia

The usual total daily dose is 12 to 24g (the contents of 3 to 6 sachets) in single or up to 4 divided doses. The maximum daily intake should not exceed 36g (contents of 9 sachets).

2. Management of Diarrhoea

The usual daily dose is 12 to 24g (the contents of 3 to 6 sachets) in single or up to 4 divided doses. The maximum daily intake should not exceed 36g (contents of 9 sachets). In all patients presenting with diarrhoea induced by bile acid malabsorption, if a response is not seen within 3 days, then alternative therapy should be initiated.

3. Pruritus

The usual daily dose is 4 to 8g (contents of 1 to 2 sachets).

Children Aged 6 to 12 years only

The usual total daily dose is:

The dose has not been established in infants and children under 6 years of age.

Questran should not be taken in its dry form.

Questran should be administered mixed with water or a suitable liquid, such as fruit juice, and stirred to a uniform consistency.

Questran may also be mixed with skimmed milk, thin soups, pulpy fruits with high moisture content, e.g. apple sauce, etc.


Go to top of the page
4.3 Contraindications

Questran is contra-indicated in patients who have shown hypersensitivity to any of the product ingredients.

Use in patients with complete biliary obstruction, since Questran cannot be effective where bile is not secreted into the intestine.


Go to top of the page
4.4 Special warnings and precautions for use

Reduction of serum folate concentrations has been reported in children with familial hypercholesterolaemia. Supplementation with folic acid should be considered in these cases. Rare reports of intestinal obstruction have been received.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Diabetic patients should be warned that each sachet of Questran contains 3.39g sucrose.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

Questran may delay or reduce the absorption of certain drugs (such as digitalis and its alkaloids, tetracycline, chlorothiazide, warfarin and thyroxin). The response to concomitant medication should be closely monitored and appropriate adjustments made if necessary.

Colestyramine also interferes with the absorption of fat soluble vitamins, A, D and K. If it is to be administered over prolonged periods, supplementation of vitamin intake with water-miscible forms or by the parenteral route should be undertaken.

Patients should take other drugs at least one hour before or 4-6 hours after Questran to minimise possible interference with their absorption.

Questran may interfere with the pharmacokinetics of drugs that undergo enterohepatic recirculation.


Go to top of the page
4.6 Pregnancy and lactation

The safety of colestyramine in pregnancy and lactation has not been established and the possibility of interference with absorption of fat soluble vitamins should be considered.


Go to top of the page
4.7 Effects on ability to drive and use machines

None known.


Go to top of the page
4.8 Undesirable effects

Gastrointestinal side-effects are those most frequently reported. The principal complaint is constipation which may be controlled with the usual remedies and frequently disappears on continued usage of Questran.

Large doses of Questran can cause diarrhoea. Taste disturbance and skin rashes have been reported rarely but causal relationship to colestyramine remains undetermined.

Hyperchloraemic acidosis and steatorrhoea have occasionally been reported following the prolonged use of anion exchange resins.

Chronic use of Questran may be associated with increased bleeding tendency due to hypoprothrombinaemia associated with Vitamin K deficiency. This will usually respond promptly to parenteral Vitamin K administration. Recurrences can be prevented by oral administration of Vitamin K.


Go to top of the page
4.9 Overdose

One case of medication error experienced heartburn and nausea after taking colestyramine 27g t.i.d. for a week. The potential problem in overdosage would be obstruction of the gastrointestinal tract.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Colestyramine resin absorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the faeces. This results in a continuous, though partial, removal of bile acids from the enterohepatic circulation by preventing their reabsorption. The increased faecal loss of bile acids leads to an increased oxidation of cholesterol to bile acids and a decrease in serum cholesterol levels and low density lipoprotein serum levels. Colestyramine is hydrophilic but it is not soluble in water, nor is it hydrolysed by digestive enzymes.

In patients with partial biliary obstruction, the reduction of serum bile acid levels reduces excess bile acids deposited in the dermal tissue with resultant decrease in pruritus.


Go to top of the page
5.2 Pharmacokinetic properties

Colestyramine is not absorbed from the digestive tract.


Go to top of the page
5.3 Preclinical safety data

No further significant information.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

Acacia

Citric acid anhydrous

Orange juice flavour

Polysorbate 80

Propylene glycol alginate

Sucrose


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

3 years.


Go to top of the page
6.4 Special precautions for storage

Do not store above 30°C.

Store in the original package.


Go to top of the page
6.5 Nature and contents of container

Original packs containing 50 low density polyethylene laminated sachets per carton.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Holdings Limited,

t/a Bristol-Myers Pharmaceuticals,

Swords,

County Dublin.


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 0048/020/001


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 April 1979 / 1 April 2009


Go to top of the page
10. DATE OF REVISION OF THE TEXT

May 2010


Go to top of the page
11. LEGAL CATEGORY

POM – Medicinal product subject to medical prescription.



Link to this document from your website:
http://www.medicines.ie/medicine/2821/SPC/Questran+4g+sachet+Powder+for+Oral+Suspension/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients

 
   Cholestyramine