Presentation and Status in Health Basket
50 X 5 gr
29G: 50 X 5 gr
Treatment for elevated serum cholesterol levels should begin with dietary therapy. A minimum of six months of dietary therapy and counseling should usually be undertaken before initiating drug therapy; shorter periods can be considered in patients with severe elevations of LDLcholesterol (>225 mg/dl or 5.8 mmol/L) or definite Coronary Heart Disease. Drug therapy should be added to dietary therapy, and not substituted for it. Colestipol hydrochloride granules should never be taken in dry form. Esophageal spasm or respiratory distress can result from attempting to swallow the granules dry. The recommended daily adult dose is one to six sachets or level scoopfuls (5-30 grams) taken once or in divided doses (each sachet or level scoopful contains approximately 5 grams of colestipol hydrochloride). Treatment should be started with 5 grams colestipol hydrochloride taken once or twice daily; increments of 5 grams colestipol hydrochloride/day are recommended no more frequently than at one month intervals, as needed. Appropriate use of lipid profiles including LDL-cholesterol and triglycerides is advised so that optimal, but not excessive doses are used to obtain the desired therapeutic effect. If the desired therapeutic effect is not obtained at 5-30 grams colestipol hydrochloride/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered. Colestipol hydrochloride should always be taken with fluids. Each sachet (or scoopful) of colestipol hydrochloride should be added to 100-150 ml of any appropriate fluid (e.g. fruit juices, milk, carbonated beverage or water), based on patient preference. Stir the mixture until the medication is completely suspended (cholestipol hydrochloride will not dissolve in the liquid). Colestipol hydrochloride may also be mixed with cereals, soups, or other foods provided that sufficient fluid is also ingested. (Each subsidiary may recommend local recipes or foodstuffs as vehicles.)
Adjunct therapy to diet in management of elevated cholesterol levels.
Colestipol hydrochloride is contraindicated in those individuals who have shown hypersensitivity to colestipol hydrochloride or any of its components.
Before instituting therapy with colestipol hydrochloride, diseases contributing to increased blood cholesterol such as hypothyroidism, poorly controlled diabetes mellitus, nephrotic syndrome, dysproteinemias, other drug therapy, alcoholism and obstructive liver disease should be looked for and specifically treated. The patient’s current medications should be reviewed for their potential to increase serum LDL-cholesterol or total cholesterol. When used as sole therapy, colestipol hydrochloride will not improve hypertriglyceridemia and may elevate serum triglycerides. 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.
Effect on Vitamin Absorption Because it sequesters bile acids, colestipol hydrochloride may interfere with normal fat absorption and thus may reduce absorption of folic acid and fat soluble vitamins such as A, D, and K.
Use in Children Information on the use of colestipol hydrochloride granules in children is limited; therefore, dosage and long-term safety have not been established. However, clinical trials conducted with colestipol hydrochloride granules in children have usually employed doses of 5 to 20 grams per day. The NCEP Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents recommends a titration approach in children ages 10 and older, based on cholesterol levels and therapeutic response as an adjunct to dietary measures. Because bile acid sequestrants may interfere with the absorption of fat-soluble vitamins, appropriate monitoring of growth and development is essential.
Metabolism and Nutrition Disorders: Decreased appetite
Psychiatric Disorders: Insomnia
Nervous System Disorders: Headache, Migraine, Sinus headache, and Dizziness.
Cardiac Disorders: Angina pectoris, Chest pain, and Tachycardia
Respiratory, Thoracic and Mediastinal Disorders: Dyspnoea
Gastrointestinal Disorders: Peptic ulcer, Haematochezia, Constipation, Haemorrhoidal haemorrhage, Diarrhoea, Vomiting, Haemorrhoids aggravated, Abdominal pain, Abdominal discomfort, Nausea, Abdominal distention, Flatulence, and Dyspepsia.
Hepatobiliary Disorders: Cholecystitis and Cholelithiasis
Skin and Subcutaneous Tissue Disorders: Urticaria, Rash, and Dermatitis.
Musculoskeletal,Connective Tissue and Bone Disorders:Arthritis,Musculoskeletal pain,Pain in extremity,Arthralgia and Back pain
General Disorders and Administration Site Conditions: Fatigue, Asthenia, and Oedema peripheral
Investigations: Alanine aminotransferase increased, Aspartate aminotransferase increased, and Alkaline phosphatase increased.
Since colestipol hydrochloride is an anion exchange resin, it may have a strong affinity for anions other than the bile acids. In vitro studies have indicated that colestipol hydrochloride binds a number of drugs. Therefore, colestipol hydrochloride may delay or reduce the absorption of concomitant oral medication. The interval between the administration of colestipol hydrochloride and other medication should be as long as possible. Patients should take other drugs at least one hour before or four hours after colestipol hydrochloride to avoid impeding their absorption. Repeated doses of colestipol hydrochloride 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 colestipol hydrochloride 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 colestipol hydrochloride is either added or deleted from a therapeutic regimen. Studies in humans show that absorption of chlorothiazide is markedly decreased even when administered one hour before or after administration of colestipol hydrochloride. The absorption of tetracycline, furosemide, penicillin G, hydrochlorothiazide and gemfibrozil was significantly decreased when given simultaneously with colestipol hydrochloride; however, colestipol hydrochloride and gemfibrozil can be used in the same patient when administered two hours apart. Concurrent administration of colestipol hydrochloride with phenytoin, aspirin, tolbutamide, clofibrate, methyldopa, nicotinic acid (niacin), clindamycin, phenprocoumon or warfarin does not affect the respective drugs bioavailability. Particular caution should be observed with digitalis preparations since there are conflicting results for the effect of colestipol hydrochloride on the availability of digoxin and digitoxin. The potential for binding of these drugs if given concomitantly is present. The serum digoxin and digitoxin levels should be monitored during periods of administration or discontinuation of colestipol hydrochloride. Bile acid binding resins may also interfere with the absorption of oral phosphate supplements.
Pregnancy and Lactation
Due to its known interference with absorption of fat-soluble vitamins, the use of colestipol hydrochloride in pregnancy or lactation or by women of childbearing age requires that the potential benefits of drug therapy be weighed against the possible hazards to the mother and child. The safe use of colestipol hydrochloride resin by pregnant women has not been established.
Overdose with colestipol hydrochloride has not been reported. Should overdose occur, however, the chief harm would be obstruction of the gastrointestinal tract. Treatment would be determined by the location and degree of obstruction.