Description
Pharmacological action
Gastroprotective and anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent effects.
In the acidic environment of the stomach insoluble bismuth oxychloride and citrate precipitate, chelating compounds with a protein substrate form in the form of a protective film on the surface of ulcers and erosion. Thus, the drug forms a protective layer, which for a long period of time protects the affected areas of the mucous membrane from the influence of aggressive factors. Increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric acid, enzymes and bile salts. It leads to the accumulation of epidermal growth factor in the defect zone. Reduces the activity of pepsin and pepsinogen.
Pharmacokinetics
Virtually not absorbed from the gastrointestinal tract. It is excreted mainly with feces. A small amount of bismuth received in the plasma is excreted from the body by the kidneys.
Indications
functional dyspepsia not associated with organic diseases of the gastrointestinal tract
chronic gastritis and gastroduodenitis in the acute phase, including Helicobacter pylori
associated gastric ulcer and duodenal ulcer pyloric arrhythmia
irritable bowel syndrome, which occurs predominantly with symptoms of diarrhea.
Contraindications
increased individual sensitivity to the components of the drug
pregnancy
period of breastfeeding
taking drugs, containing bismuth
chronic renal failure
children under 4 years of age.
Special instructions
The drug should not be used for more than 8 weeks. It is not recommended during treatment to exceed the established daily doses for adults and children. During treatment with the drug, other drugs containing bismuth should not be used (see section “Interaction with other drugs”). At the end of the course of treatment with the drug in recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3-58 μg / l, and intoxication is observed only at a concentration above 100 μg / l.
When using bismuth tripotassium dicitrate, stool may be stained dark due to the formation of bismuth sulfide.
Sometimes a slight darkening of the tongue is noted.
Alcohol is not recommended during therapy.
Influence on the ability to drive vehicles and mechanisms
There are no data on the effect of the drug Bismuth tripotassium dicitrate on the ability to drive vehicles and mechanisms.
Composition
For 1 tablet: active substance: bismuth tripotassium dicitrate – 304.6 mg, calculated as bismuth oxide – 120.0 mg.
excipients: corn starch – 71.1 mg potassium polyacrylate – 23.6 mg povidone-K25 – 17.7 mg macrogol-6000 – 6.0 mg magnesium stearate – 2.0 mg.
Shell composition: hypromellose – 5.5 mg titanium dioxide – 3.0 mg macrogol-4000 – 1.5 mg.
Dosage and Administration
Inside. The duration of the course of treatment and the dose of the drug is determined by the attending physician individually for each patient, depending on the nature of the disease.
For adults and children over 12 years of age, the drug is prescribed 1 tablet 4 times a day, 30 minutes before meals (breakfast, lunch, dinner) and at night, or 2 tablets 2 times a day 30 minutes before meals (breakfast , dinner).
Children aged 8 to 12 are prescribed 1 tablet 2 times a day, 30 minutes before eating (breakfast, dinner).
Children aged 4 to 8 years are prescribed at a dose of 8 mg / kg / day, depending on the body weight of the child, 1-2 tablets per day are prescribed (respectively, in 1-2 doses per day).
In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day).
Tablets are taken 30 minutes before meals with a little water. It is recommended to swallow the tablet whole, without chewing and not crushing, drinking plenty of water. It is not recommended to drink tablets with milk.
The duration of treatment is usually 4 to 8 weeks. After taking the drug, it is not recommended to take medicines containing bismuth (for example, Vicalin, Vicair) for 2 months.
To eradicate Helicobacter pylori, it is advisable to use bismuth tripotassium dicitrate in combination with antibacterial drugs with anti-Helicobacter pylori activity.
If there is no improvement during treatment, then consult a doctor. Use the drug only according to the method of application and at the doses indicated in the instructions. If necessary Please consult your doctor before using the medicine.
Side effects
The following adverse events observed with bismuth tripotassium dicitrate are distributed according to the frequency of occurrence according to the following gradation: very often (> 1/10) often (> 1/100, <1/10) infrequently (> 1/1 000, <1/100) rarely (> 1/10 000, <1/1 000) very rarely (<1/10 000). From the gastrointestinal tract: very often – staining black feces infrequently – nausea, vomiting, diarrhea or constipation. Allergic reactions: infrequently – skin rash, itching very rarely – anaphylactic reactions. From the nervous system: very rarely – with prolonged use in high doses – encephalopathy associated with the accumulation of bismuth in the central nervous system. Side effects are reversible and quickly disappear after discontinuation of the drug. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor. Overdose When using the drug in doses ten times higher than recommended, or with prolonged use of high doses of the drug, bismuth poisoning may develop. Symptoms: dyspepsia, rash, inflammation of the oral mucosa, characteristic darkening in the form of blue lines on the gums with prolonged use in doses exceeding the recommended, impaired renal function. These symptoms are completely reversible when the drug is discontinued. Treatment: there is no specific antidote. With an overdose of the drug, gastric lavage, intake of enterosorbents and symptomatic therapy aimed at maintaining the function of the nights are indicated. In case of overdose, saline laxatives are also indicated. Further treatment should be symptomatic. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, complexing agents – dimercaptosuccinic and dimercaptopropanesulfonic acid can be introduced. With the development of severe renal impairment, hemodialysis is indicated. Storage conditions At a temperature not exceeding 25 ° C. Keep out of the reach of children. Expiration 3 years. Do not use after expiration date. Deystvuyuschee substances Vysmuta trykalyya dytsytrat dosage form tablets
