Grinterol caps 250mg #100

Instruction for Grinterol

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Release form and composition

Dosage form of Grinterol - capsules: No. 0, hard gelatin, white body and cap; inside contains almost white or white powder (10 pieces each in blister packs, in a cardboard bundle 5 or 10 packs).
Composition (per 1 capsule):
    active substance: ursodeoxycholic acid - 250 mg;
    auxiliary ingredients: corn starch, magnesium stearate, silicon dioxide;
    capsule shell (cap and case): gelatin, titanium dioxide (E 171).

Indications for use

    small and medium cholesterol stones with a normally functioning gall bladder - for dissolution;
    PBC (primary biliary cirrhosis) without signs of decompensation - for symptomatic treatment;
    biliary (biliary) reflux gastritis;
    primary sclerosing cholangitis;
    chronic hepatitis caused by various factors;
    cystic fibrosis (cystic fibrosis);
    ABP (alcoholic liver disease);
    NASH (non-alcoholic steatohepatitis);
    biliary dyskinesia.

Contraindications

Absolute contraindications:
    X-ray positive gallbladder stones with a high content of Ca2 +;
    disabled gall bladder;
    diseases of the intestines, gall bladder and bile ducts in acute form;
    decompensated cirrhosis of the liver;
    pancreatitis
    severe impaired liver / kidney function;
    children under 3 years old;
    individual hypersensitivity to any of the components of Grinterol.
Use with caution capsules in children aged 3-4 years due to possible difficulty in swallowing.
Due to the insufficiency of data from clinical studies of the use of Grinterol during pregnancy, the administration of capsules during this period is possible only under strict indications, provided that the expected benefit to the mother exceeds the potential risk to the fetus.
There is no data on the release of ursodeoxycholic acid with breast milk, and therefore, if you need to use Grinterol during lactation, you should refuse to breast-feed.

Dosage and administration

Capsules are taken orally, preferably in the evening, without chewing and drinking with a small amount of water.
Recommended Dosage:
    dissolution of small and medium cholesterol stones with a normally functioning gall bladder: the average daily dose is determined at the rate of 10 mg per kg of patient weight (<60 kg - 2 capsules; 61–80 kg - 3 capsules; 81–100 kg - 4 capsules;> 100 kg - 5 capsules). The duration of treatment is 6-12 months, in order to prevent recurrence of stone formation, it is recommended to continue taking Grinterol for several months after their dissolution;
    PBC without signs of decompensation (symptomatic treatment): a daily dose of 10-15 mg per kg of patient weight (if necessary, up to a maximum of 20 mg / kg) in the first 3 months is divided into 2-3 doses as follows (weight - number of capsules - morning distribution / day / evening): 47–62 kg - 3 pcs. - 1/1/1; 63–78 kg - 4 pcs. - 1/1/2; 79–93 kg - 5 pcs. - 1/2/2; 94–100 kg - 6 pcs. - 2/2/2; over 100 kg - 7 pcs. - 2/2/3; with the improvement of hepatic indices, it is allowed to take the entire daily dose at a time, in the evening; the duration of treatment is not limited. Occasionally, at the initial stage, clinical symptoms may worsen (itching is more frequent), in this case, take 1 capsule daily with a further gradual increase (increasing the daily dose by 1 capsule per week) to the recommended one;
    biliary reflux gastritis (treatment): 1 capsule 1 time per day, in the evening. The duration of treatment is from 1/2 to 6 months, if necessary, the course can be extended to 2 years;
    chronic hepatitis caused by various factors (symptomatic treatment): a daily dose of 10-15 mg per kg of patient weight is divided into 2-3 doses. Duration of treatment - from 6 to 12 months or more;
    primary sclerosing cholangitis: a daily dose of 12-15 mg per kg of patient weight (up to a maximum of 20 mg / kg) is divided into 2-3 doses. Duration of treatment - from 6 months to several years;
    cystic fibrosis (cystic fibrosis): a daily dose of 20-30 mg per kg of patient weight is divided into 2-3 doses. Duration of treatment - from 6 months to several years;
    NASH, ABP: a daily dose of 10-15 mg per kg of patient weight is divided into 2-3 doses. Duration of treatment - from 6 to 12 months or more;
    biliary dyskinesia: the average daily dose of 10 mg per kg of patient weight is divided into 2 doses. The duration of treatment is from 1/2 to 2 months, if necessary, the course should be repeated.
For children over the age of 3 years, the dose is determined individually, at the rate of 10–20 mg per kg of child’s weight per day.
If possible, it is recommended that children and adult patients weighing less than 47 kg ursodeoxycholic acid be used in other formulations in the form of a suspension.

Side effects

    GIT (gastrointestinal tract): unformed stool / diarrhea; during PBC therapy, acute pain in the upper right abdomen may occur;
    hepatobiliary system: calcification of gallstones; during PBC therapy, transient decompensation of cirrhosis of the liver may occur (occurs after discontinuation of Grinterol);
    skin and subcutaneous tissue: hypersensitivity reactions, including urticaria.
Data on cases of overdose of ursodeoxycholic acid were not recorded.

Special instructions

Treatment should be strictly controlled by a doctor.
If Grinterol is used to dissolve gallstones, it is necessary to control the activity of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGTP) and the concentration of bilirubin. Cholecystography in the first 3 months should be carried out 1 time in 4 weeks, in the future - 1 time in 3 months. Monitoring the effectiveness of treatment is carried out using ultrasound (ultrasound) 1 time in 6 months during the first year. If the indicators are elevated and retain values, it is necessary to stop taking Grinterol.
For the effective use of Grinterol, the following conditions are required: the stones must be exclusively cholesterol, stones size ≤ 15–20 mm, the gallbladder is filled with stones no more than ½, the bile ducts must fully retain their function.
After complete dissolution of the stones, it is recommended to continue therapy for at least another 3 months, in order to facilitate the dissolution of residues that are too small to detect.
When the dissolution of gallstones, even partial, is not observed after 6-12 months from the start of treatment, the likelihood of the effectiveness of Grinterol is low.
Detection of non-visualizable gallbladder during therapy is an indication that treatment should be discontinued due to the lack of complete dissolution of calculi.
For patients with diarrhea, the dose of ursodeoxycholic acid is recommended to be reduced, and in the case of persistent diarrhea, stop treatment.
Prolonged use of high doses of ursodeoxycholic acid (up to 28-30 mg per kg of patient weight per day) can contribute to the development of serious side effects in patients with primary sclerosing cholangitis.
The effect of Grinterol on the concentration of attention and the speed of psychomotor reactions has not been identified.

Drug interaction

    antacids containing aluminum oxide, aluminum hydroxide and ion-exchange resins (colestipol, colestyramine): inhibit the absorption of ursodeoxycholic acid in the intestine, reducing the effectiveness of the drug (they should be used 2 hours before taking Grinterol);
    cyclosporine: ursodeoxycholic acid can enhance its absorption in the intestine (dose adjustment of cyclosporin may be necessary);
    ciprofloxacin: ursodeoxycholic acid may decrease its absorption;
    estrogens, lipid-lowering drugs (especially clofibrate), neomycin or progestins, oral contraceptives: increase the saturation of bile with cholesterol, reducing the ability of ursodeoxycholic acid to dissolve cholesterol gallstones.

Terms and conditions of storage

Store at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.

Terms of sell

You don't need a prescription to buy Grinterol.