Description
Release form
Film-coated tablets
Packing
10 pcs. – blister packs (4) – packs of cardboard.
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 are formed with a protein substrate 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, It 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 those associated with Helicobacter pylori.
peptic ulcer of the stomach and duodenum in the exacerbation phase, including those associated with Helicobacter pylori.
irritated 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.
Pregnancy and lactation
Bismuth tripotassium dicitrate is contraindicated in pregnant women.
If you need to use the drug during lactation, you should stop breastfeeding.
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 Ñg / l, and intoxication is observed only at a concentration above 100 Ñg / 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.
Effects on the ability to drive vehicles and mechanisms
There is no evidence of the effect of Escape ® film-coated tablets on the ability to drive vehicles and mechanisms.
Composition
Active substance: bismuth tripotassium
dicalitrate – 300.00 mg, in terms of bismuth oxide.
Excipients:
corn starch – 54.22 mg,
povidone (polyvinylpyrrolidone medium molecular weight, povidone K 25) – 42.00 mg,
polacrilin (potassium polacrilin) ??- 20.00 mg,
magnesium 3 mg –
Shell:
AquaPolish® P white 019.49 MS [Hydroxypropyl methylcellulose (E 464) – 7, 80 mg hydroxypropyl cellulose (E 463) – 1.30 mg, stearic acid (E 570) – 0.91 mg talc (E 553b) – 1.30 mg polyethylene glycol – 0.39 mg titanium dioxide (E171) – 1.30 mg ] – 13.00 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 meals (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).
Takes tablets 30 minutes before meals with a little water.
It is recommended to swallow the tablet whole, without chewing or crushing, with 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.
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 (? 1/1000, <1/100) rarely (? 1/10000, <1/1000) very rarely (<1/10000). 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. Drug interaction For half an hour before and half an hour after taking the drug, it is not recommended to use other drugs inside, as well as food and liquid, in particular antacids, milk, fruits and fruit juices. This is due to the fact that, with simultaneous ingestion, they can affect the effectiveness of bismuth tripotassium dicitrate. The drug reduces the absorption of tetracyclines. The drug is not used simultaneously with other bismuth-containing drugs, since the simultaneous use of several bismuth preparations increases the risk of side effects, including the risk of developing encephalopathy. overdose When using the drug in doses ten times the recommended dose, or with prolonged use of high doses of the drug may develop bismuth poisoning. Symptoms: dyspepsia, rash, inflammation of the mucous membrane of the oral cavity, characteristic darkening in the form of blue lines on the gums with prolonged use in doses in excess of the recommended, impaired renal function. These symptoms are completely reversible upon discontinuation of the drug. Treatment: There is no specific antidote. At drug overdose, gastric lavage, enterosorbent intake, and symptomatic therapy aimed at maintaining renal function have been shown. In case of overdose, the prescription of salt laxatives is also indicated. In the future, treatment should be symptomatic. In the case of impaired renal function, accompanied by high levels of bismuth in the blood plasma, it is possible to enter complexing agents – dimercaptoantaric and dimercaptopropanesulfonic acid. Hemodialysis is indicated in the development of severe renal dysfunction. Storage conditions Do not store above 25 ° C. Keep out of reach of children. Shelf life 2 years. Do not use after the expiration date indicated on the package. Terms and conditions without prescription dosage form tablets Possible Product Names Escape Tablets coated film 120 mg 40 pcs.
