Questran 4g/sachet, Powder for oral suspension

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Colestyramine resin

Disponibil de la:

Bristol-Myers Squibb Pharmaceuticals uc

Codul ATC:

C10AC; C10AC01

INN (nume internaţional):

Colestyramine resin

Dozare:

4 gram(s)

Forma farmaceutică:

Powder for oral suspension

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Bile acid sequestrants; colestyramine

Statutul autorizaţiei:

Marketed

Data de autorizare:

1979-04-01

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Questran 4g/sachet, Powder for oral suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 4g of colestyramine resin.
Excipient with known effect: each sachet contains 3.79g sucrose (421mg
of sucrose per gram of powder).
For the full list of excipients, see section 6.1.
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.
4 CLINICAL PARTICULARS
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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).
Doses of more than 24 g a day of colestyramine resin may interfere
with normal fat absorption.
_Children 6 - 12 years_:
The usual