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.
In patients with complete biliary obstruction, since Quantalan cannot be effective where bile is not secreted into the intestine.
Not applicable.
Frequency categories are defined according to the following convention: 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), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders
Uncommon:
Bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (night blindness has been reported rarely) and D deficiencies.
Metabolism and nutrition disorders
Uncommon:
Anorexia, hyperchloremic acidosis in children
Gastrointestinal disorders
Vey common:
Constipation. Predisposing factors for most of these complaints when Quantalan is used as a cholesterol lowering agent are: high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient and controlled with conventional therapy. Some patients require a temporary decrease in dosage or discontinuation of therapy.
Uncommon:
Abdominal discomfort, flatulence, nausea, vomiting, diarrhea, heartburn, dyspepsia and steatorrhea,
Rare:
Reports of intestinal obstruction have been received postmarketing, including deaths in paediatric patients.
Skin and subcutaneous tissue disorders
Uncommon:
Rash and irritation of skin, tongue and perianal area.
Musculoskeletal and connective tissue disorders
Uncommon:
Osteoporosis.
Reporting of suspected adverse reactions
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.
No further significant information.
Quantalan 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. |
Pharmacotherapeutic group: Bile acid seQuantalants, ATC code: C10AC01.
Cholesterol is a major, if not the sole precursor of bile acids. During normal digestion, bile acids are secreted via the bile from the liver and gall bladder into the small intestine. Bile acids emulsify the fat and lipid materials present in foods, thus facilitating absorption. A major portion of the bile acids secreted are reabsorbed from the ileum and returned via the portal vein to the liver, thus completing the enterohepatic cycle. Only very small amounts of bile acids are found in normal serum.
Colestyramine resin absorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the faeces. This results in a continuous, though partial, removal of bile acids from the enterohepatic circulation by preventing their reabsorption. The increased faecal loss of bile acids leads to an increased oxidation of cholesterol to bile acids and a decrease in serum cholesterol levels and low density lipoprotein serum levels. Colestyramine is hydrophilic but it is not soluble in water, nor is it hydrolysed by digestive enzymes.
In patients with partial biliary obstruction, the reduction of serum bile acid levels reduces excess bile acids deposited in the dermal tissue with resultant decrease in pruritus.
The colestyramine resin in Quantalan Light is not absorbed from the digestive tract.
Reduction of serum folate concentrations has been reported in children with familial hypercholesterolaemia. Supplementation with folic acid should be considered in these cases.
Since Quantalan may interfere with the absorption of fat soluble vitamins, the diet may require supplementation with Vitamins A, D and K during prolonged high dose administration.
Chronic use of Quantalan may be associated with increased bleeding tendency due to hypoprothrombinaemia associated with Vitamin K deficiency. This will usually respond promptly to parenteral Vitamin K administration. Recurrences can be prevented by oral administration of Vitamin K.
There is a possibility that prolonged use of colestyramine resin in high doses may produce hyperchloremic acidosis, since it is the chloride form of an anion exchange resin. This is especially true in younger and smaller patients where the relative dosage may be higher.
Quantalan Light contains aspartame, a source of phenylalanine.
Not relevant.
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 Quantalan 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 Quantalan. These usually pass with continued usage of Quantalan and are minimised by starting therapy gradually.
| Final dose required | Week 1 | Week 2 | Week 3 | Week 4 |
| Sachets per day | ||||
| 3 | 1 | 2 | 3 | 3 |
| 4 | 1 | 2 | 3 | 4 |
| 6 | 1 | 2 | 3 | 6 |
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:
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 Quantalan daily. The dosage is then increased gradually, every five to seven days to the desired level for effective control.
Children under 6 years:
Quantalan 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 Quantalan.
Quantalan should not be taken in its dry form.
Quantalan should be administered mixed with water or a suitable liquid, such as fruit juice, and stirred to a uniform consistency.
Quantalan may also be mixed with skimmed milk, thin soups, pulpy fruits with high moisture content, e.g. apple sauce, etc.
No special instructions.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
