Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Colestid is indicated as adjunctive therapy to diet in the management of patients with elevated cholesterol levels who have not responded adequately to diet. It may be used alone or in combination with additional lipid lowering agents.
Dietary therapy specific for the type of hypercholesterolemia should be the initial treatment of choice. Excess body weight may be an important factor and weight reduction should be attempted prior to drug therapy in the overweight. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug method. When drug therapy is begun, the patient should be instructed of the importance of adhering to the correct diet.
Although Colestid is effective in all types of hypercholesterolemia, it is medically most appropriate in patients with Fredrickson’s type II hyperlipoproteinaemia.
Oral, mixed with water or other fluids.
The recommended initial daily adult dosage of colestipol hydrochloride is 5 g either once or twice daily.
For adults colestipol hydrochloride is recommended in doses of 5-30 g taken as one dose or two divided doses. Initiation of therapy is recommended at 5 g either once or twice daily with 5 g increments at one month intervals. Appropriate use of lipid profiles including LDL-C and triglycerides is advised so that optimal, but not excessive doses are used to obtain the desired therapeutic effect on LDL-cholesterol level. If the desired therapeutic effect is not obtained at a dose of 5-30 g per day with good compliance and acceptable side-effects, combined therapy or alternate treatment should be considered.
Patients should take other drugs at least 1 hour before or 4 hours after the administration of Colestid to minimise possible interference with their absorption. However, Colestid and Gemfibrozil may be used in the same patient when administered 2 hours apart (see section 4.5).
Colestid Granules should always be taken mixed in a liquid such as orange or tomato juice, water, skimmed milk or non-carbonated beverage. The contents of the sachet or level scoopful should be added to 100 ml to 150 ml of the preferred aqueous vehicle and mixed thoroughly until dispersed. Colestid may also be taken in soups or with cereals, pulpy fruits with a higher water content or yoghurt.
At present there are no extensive clinical studies with colestipol in patients over the age of 65. Review of available data does not suggest that the elderly are more predisposed to side effects attributable to colestipol than the general population; however, therapy should be individualised and based on each patient’s clinical characteristics and tolerance to the medication.
Dosage in children has not been established.
No toxic effects due to overdosage have been reported. Should overdosage occur, obstruction of the gastro-intestinal tract would be expected to occur. Treatment would be determined by the location and degree of obstruction.
4 years.
Do not store above 25°C.
Paper/Aluminium foil/vinyl sachets of 5 g (in packs of 10 or 30 sachets).
Pack size: 5 g.
Amber glass bottle with screw cap or HDPE bottle with screw cap or tamper-evident cap.
Pack size: 250 g.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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