QUESTRAN LITE 4G powder sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

colestyramine, Quantity: 850 mg/g

Available from:

Viatris Pty Ltd

INN (International Name):

colestyramine

Pharmaceutical form:

Powder, oral

Composition:

Excipient Ingredients: xanthan gum; colloidal anhydrous silica; citric acid; aspartame; propylene glycol alginate; Flavour

Administration route:

Oral

Units in package:

8g sachet x 50, 4g sachet x 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 1 JANUARY 1991 : 1. Reduction of serum cholesterol levels and prevention of coronary heart disease. QUESTRAN LITE is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins). QUESTRAN LITE may be useful to lower elevated cholesterol that occurs in patients with combined hypercholesterolemia and hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. 2. Relief of pruritus associated with partial biliary obstruction. Patients with primary biliary cirrhosis may exhibit elevated serum cholesterol as part of their disease. When cholestyramine is used to treat the pruritus of partial biliary obstruction, it may lower serum cholesterol levels, produce no change, or cause rapid escape from a temporary lowering to pre-treatment levels or rebound. 3. Relief of diarrhoea following ileal resection or ileal disease (cholerrhoeic enteropathy).

Product summary:

Visual Identification: A cream coloured, fine, dispersible powder.; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

QUESTRAN LITE
_colestyramine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about QUESTRAN LITE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking QUESTRAN
LITE against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT QUESTRAN LITE
IS USED FOR
QUESTRAN LITE is used:
•
to reduce high levels of
cholesterol in the blood assist in
the prevention of coronary heart
disease. It also used as an
accompanying therapy to you diet
in order to reduce cholesterol
•
for the relief of pruritis (itching)
associated with the flow of bile
being partially blocked
•
for the relief of diarrhoea caused
by surgery or disease of the small
bowel
This medicine belongs to a group of
medicines called resins. It reduces
the level of cholesterol in the blood
by combining with bile in the small
intestine to form an insoluble
complex, which is then excreted in
faeces.
The reduction of blood cholesterol
levels helps to prevent blockages in
the blood vessels to the heart which
reduces the likelihood of angina
(chest pain with heart disease) and
heart attacks.
QUESTRAN LITE may be used
alone or in combination with other
medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is not addictive.
This medicine is only available with
a doctor’s prescription.
The safety and effectiveness of using
QUESTRAN LITE in infants and
children has not been established.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT_
DO NOT USE QUESTRAN LITE IF
YOU HAVE AN ALLERGY TO
•
any medicine containing
colestyramine
•
any of the ingredients listed at the
end of this leaflet
Symptoms of an allergic rea

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
QUESTRAN LITE
_colestyramine powder for oral solution _
1
NAME OF THE MEDICINE
Colestyramine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUESTRAN LITE is a powder for oral solution containing 850 mg per gram
of colestyramine as the active
ingredient. The 4.7 g sachet contains 4 g of colestyramine and the 9.4
g sachet contains 8 g of colestyramine.
Excipients of known effect: aspartame
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
QUESTRAN LITE is a cream coloured, fine, dispersible powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Reduction of serum cholesterol levels and prevention of coronary heart
disease. QUESTRAN LITE
is indicated as adjunctive therapy to diet for the reduction of
elevated serum cholesterol in patients
with primary hypercholesterolemia (elevated low-density lipoproteins).
QUESTRAN LITE may be
useful to lower elevated cholesterol that occurs in patients with
combined hypercholesterolemia and
hypertriglyceridemia, but it is not indicated where
hypertriglyceridemia is the abnormality of most
concern
2.
Relief of pruritus associated with partial biliary obstruction.
Patients with primary biliary cirrhosis
may exhibit elevated serum cholesterol as part of their disease. When
colestyramine is used to treat
the pruritus of partial biliary obstruction, it may lower serum
cholesterol levels, produce no change,
or cause rapid escape from a temporary lowering to pre-treatment
levels or rebound
3.
Relief of diarrhoea following ileal resection or ileal disease
(cholerrhoeic enteropathy)
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
Usual maintenance therapy: 12 to 16 g of colestyramine equivalent to
14.1 to 18.8 g QUESTRAN LITE per
day (without regard to meals), is usually effective.
CHILDREN
Dosage in infants and children has not been established. Begin therapy
with small doses. Subsequent
adjustment should be made according to clinical response or laboratory
results and the benefit/risk ratio.
USE FOR CHOLESTEROL LOWE