Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Before instituting therapy with Colestid, diseases contributing to increased blood cholesterol such as hypothyroidism, diabetes mellitus, nephrotic syndrome, dysproteinaemias and obstructive liver disease should be looked for and specifically treated.
To avoid accidental inhalation or oesophageal distress, Colestid should not be taken in its dry form.
Colestid may elevate serum triglyceride levels when used as sole therapy. This elevation is generally transient but may persist in some individuals. A significant rise in triglyceride level should be considered as an indication for dose reduction, drug discontinuation, or combined or alternate therapy.
The use of Colestid in children has been limited; however, it does appear to be effective in lowering serum cholesterol in older children and young adults. Because bile acid sequestrants may interfere with the absorption of fat soluble vitamins, appropriate monitoring of growth and development is essential. Dosage and long term safety in children has not been established.
Because it sequesters bile acids, Colestid may interfere with normal fat absorption and may thus alter the absorption of fat soluble vitamins such as A, D, E and K. A study in humans found only one patient in whom a prolonged prothombin time was noted. Most studies did not show a decrease in vitamin A, D or E levels during the administration of Colestid; however, if Colestid is to be given for a long period these vitamin levels should be monitored and supplements given if necessary.
Both clinical usage and animal studies with Colestid have provided no evidence of drug related intestinal neoplasms. Colestid is not mutagenic in the Ames test.
In man, Colestid may delay or reduce the absorption of certain concomitant oral drugs (digitalis and its glycosides, propranolol and hydrochlorothiazide, tetracycline hydrochloride, penicillin G, gemfibrozil and furosemide). Studies in humans have shown that the absorption of chlorothiazide is markedly decreased even when administered 1 hour before the administration of colestipol hydrochloride. Particular caution should be taken with digitalis preparations since conflicting results have been obtained for the effect of Colestid on the availability of digoxin and digitoxin. Colestid has been shown not to interfere with the bioavailability of the respective drugs clindamycin, clofibrate, aspirin, tolbutamide, warfarin, methyldopa and phenytoin. The clinical response to concomitant medication should be closely monitored and appropriate adjustments made.
Repeated doses of Colestid given prior to a single-dose of propranolol in human trials have been reported to decrease propranolol absorption. However, in a follow-up study in normal subjects, single dose administration of Colestid and propranolol or multiple-dose administration of both agents did not affect the extent of propranolol absorption. Effects on the absorption of other beta-blockers have not been determined. Patients on propranolol should be observed when Colestid is either added or deleted from a therapeutic regimen.
A study has shown that cholestyramine binds bile acids and reduces mycophenolic acid exposure. As colestipol also binds bile acids, colestipol may reduce mycophenolic acid exposure and potentially reduce efficacy of mycophenolate mofetil.
No clinical data are available on the use of colestipol hydrochloride in pregnant women. Though animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3), caution should be exercised when prescribing to pregnant women.
The use of Colestid in pregnancy or lactation or by women of childbearing age requires that the potential benefits of treatment be weighed against the possible hazards to the mother and child.
The safety of colestipol hydrochloride has not been established in breast-feeding women. Caution should be exercised when prescribing to breast-feeding women.
There are no data on the effect of colestipol hydrochloride on fertility in humans. A study conducted in rats did not result in any differences in reproductive parameters that might imply reproductive effects attributable to colestipol hydrochloride.
No adverse effect has been reported.
Adverse events are described by system organ class and frequency (very common ≥1/10; common ≥1/100 to <1/10; uncommon ≥1/1,000 to <1/100; rare ≥1/10,000 to <1/1,000; very rare <1/10,000) in the table below:
Uncommon: Decreased appetite
Uncommon: Insomnia
Very common: Migraine, Sinus headache, Headache
Uncommon: Dizziness
Uncommon: Angina pectoris, Tachycardia
Uncommon: Dyspnoea
Very common: Constipation, Abdominal pain, Abdominal discomfort
Common: Haematochezia, Haemorrhoidal haemorrhage, Abdominal distention, Dyspepsia, Nausea, Vomiting, Diarrhoea, Flatulence, Eructation
Uncommon: Peptic ulcer and bleeding, Haemorrhoids, Impaction
Uncommon: Cholecystitis, Cholelithiasis
Common: Rash
Uncommon: Urticaria, Dermatitis
Common: Arthritis, Arthralgia, Back pain, Musculoskeletal pain, Pain in extremity
Common: Fatigue
Uncommon: Chest pain, Oedema peripheral, Asthenia
Uncommon: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Not applicable.
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