It may be recommended as an adjuvant therapy (as an adjunct to diet and exercise) to reduce elevated serum cholesterol in patients with primary hypercholesterolemia to reduce the risk of atherosclerotic coronary artery disease and myocardial infarction. The drug can be used as a means to reduce high cholesterol in patients with combined hypercholesterolemia and hypertriglyceridemia, but the drug is not indicated in cases where hypertriglyceridemia is the dominant pathology. This drug can be used for the symptomatic treatment of diarrhea caused by bile acids in patients with short bowel syndrome, as well as to relieve itching in cholestasis due to partial obstruction of the biliary tract.
active substance: cholestyramine resin, a copolymer of styrene and divinylbenzene with Quaternary ammonium functional groups;
1 sachet of powder contains cholestyramine rubber 4 g;
Excipients: sucrose, citric acid anhydrous, colloidal anhydrous silica, dye yellow FCF (E 110), dye D&C yellow № 10 (quinoline yellow E 104), dye D&C yellow № 10 aluminum lacquer 15% (quinoline yellow E 104) , propylene glycol alginate, orange flavor, containing: orange flavor, maltodextrin, acacia (gum arabic E 414), butylhydroxytoluene (E 321).
Powder for oral suspension.
PMS-Cholestiramin is an anion exchange resin with Quaternary ammonium groups based on a polystyrene polymer framework. As a chloride, it binds bile acids in vivo and in vitro, exchanging the chloride ion for bile acid ions.
Indication PMS-Cholestiramin it may be recommended as an adjuvant therapy (as an adjunct to diet and exercise) to reduce elevated serum cholesterol in patients with primary hypercholesterolemia to reduce the risk of atherosclerotic coronary artery disease and myocardial infarction. The drug can be used as a means to reduce high cholesterol in patients with combined hypercholesterolemia and hypertriglyceridemia, but the drug is not indicated in cases where hypertriglyceridemia is the dominant pathology. This drug can be used for the symptomatic treatment of diarrhea caused by bile acids in patients with short bowel syndrome, as well as to relieve itching in cholestasis due to partial obstruction of the biliary tract.
The drug is contraindicated in complete obstruction of the biliary tract, when bile does not enter the intestine.
The drug is contraindicated in case of hypersensitivity to the active substance or to other components of the drug.
Use during pregnancy or breastfeeding
Because cholestyramine is not absorbed in the intestine, in theory it cannot adversely affect the fetus when taken in the recommended doses. However, controlled clinical trials in pregnant women have not been performed. In addition, cholestyramine may interfere with the absorption of fat-soluble vitamins in the intestine, which may adversely affect fetal development.
The drug should be used with caution in breastfeeding women, as it can interfere with the absorption of vitamins in the intestines, which can lead to malnutrition.
Thus, the use of the drug in pregnant and breastfeeding women is possible only in cases where the potential benefit of the drug outweighs the potential risk to the fetus or child.
Method of application and dosage
PMS-Cholestiramin should be administered orally.
In order to minimize possible side effects from the gastrointestinal tract, it is desirable to start therapy with a single dose of the drug once a day. Then after 1-2 days the dosage can be increased.
It is important to motivate the patient to follow the established treatment regimen, despite the side effects arising from the gastrointestinal tract. For successful treatment, control over compliance with the drug regimen plays an important role.
The recommended dose of PMS-Cholestiramin for adults is 4 g of cholestyramine 1 to 6 times a day. The dosage can be changed to best suit the individual needs of the patient.
The drug should not be taken in dry form, it is intended only for use as an aqueous suspension.
Preparation of the drug for administration: the color of the drug may vary from batch to batch, which does not affect the quality of the drug itself.
To prepare the suspension, place the contents of 1 sachet in a glass of 120-180 ml of water or a beverage that does not contain carbon dioxide (milk or fruit juice). After 1 minute, mix the powder vigorously in the liquid. The powder can also be mixed in soup or juice with pulp squeezed from fruit (apples or pineapples).
The safety and efficacy of cholestyramine in children have not been established.
One case of overdose was described in a patient who took the drug for several weeks at a dose of 150% of the maximum recommended daily dose. No significant phenomena were noted. The main consequence of an overdose may be impaired patency of the gastrointestinal tract. The presence of such obstruction, the degree of its severity and determines the necessary symptomatic therapy.
Constipation is most common with cholestyramine, especially at high doses and in elderly patients (60 years). In most cases, these side effects are removed by conventional therapy in such cases. In some cases, it may be necessary to temporarily reduce the dose or discontinue the drug.
- Changes in laboratory parameters: liver dysfunction.
- Hematological changes: changes in the value of prothrombin time (decrease or increase), ecchymosis, anemia, bleeding gums.
- From the musculoskeletal system: back pain, muscles, joints, arthritis.
- Neurological changes: headache, dizziness, anxiety, fatigue, tinnitus, loss of consciousness, drowsiness, sciatica, paresthesia.
- From the kidneys: hematuria, dysuria, burnt urine, diuresis (increased urine output).
- From the eyes: uveitis.
- Hypersensitivity reactions: urticaria, bronchial asthma, difficulty breathing, wheezing.
- Other changes: weight loss or gain, increased libido, swollen glands, edema, caries.
Store in a dry place, out of reach of children at a temperature not exceeding 30 ºC.