QUESTRAN Powder for oral suspension Ref.[7190] Active ingredients: Colestyramine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Therapeutic indications

Questran Light is used for:

  1. Primary prevention of coronary heart disease in men between 35 and 59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate measures.
  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 resection, Crohn’s disease, vagotomy and diabetic vagal neuropathy.
  5. Management of radiation-induced diarrhoea.

Posology and method of administration

Posology

Adults

1. For primary prevention of coronary heart disease and to reduce cholesterol: After initial introduction over a three to four week period, 3 to 6 Questran Light sachets per day, administered either as a single daily dose or in divided doses up to four times daily, according to dosage requirements and patient acceptability. Dosage may be modified according to response and can be increased to 9 sachets per day if necessary.

Occasional slight gastrointestinal upsets, e.g. constipation, may occur when starting Questran Light. These usually pass with continued usage of Questran Light and are minimised by starting therapy gradually.

Final dose requiredWeek 1Week 2Week 3Week 4
 Sachets per day
31233
41234
61236

2. To relieve pruritus: One or two sachets daily are usually sufficient.

3. To relieve diarrhoea: As for reduction of cholesterol but it may be possible to reduce this dosage. 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.

Doses of more than 24 g a day of colestyramine resin may interfere with normal fat absorption.

Children 6-12 years

The initial dose is determined by the following formula: Child’s Weight in Kg x Adult Dose / 70

Subsequent dosage adjustment may be necessary where clinically indicated.

To minimize potential gastrointestinal side effects, it is desirable to begin all therapy in children with one dose of Questran Light daily. The dosage is then increased gradually, every five to seven days to the desired level for effective control.

Children under 6 years

Questran Light should not be used in children under 6 years. There are no data to support its use.

Elderly

No dosage adjustment is necessary.

Method of administration

As a precautionary measure, where concurrent drug therapy exists then such drugs should be administered at least one hour before or 4-6 hours after Questran Light.

Questran Light should not be taken in its dry form.

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

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

Overdose

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

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Original packs containing 50 or 60 laminate sachets composed of paper, polyethylene and aluminium.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special instructions.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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