Escape, 120 mg 40 pcs.

Gastroprotective and antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent action.

In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated; chelated compounds with protein substrate are formed in the form of a protective film on the surface of ulcers and erosions.

Thereby 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. By increasing the synthesis of prostaglandin E, mucus formation and hydrocarbonate secretion, it stimulates the activity of cytoprotective mechanisms and increases resistance of the gastrointestinal mucous membrane to the influence of pepsin, hydrochloric acid, enzymes and salts of bile acids.

Leads to the accumulation of epidermal growth factor in the defect area. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

It is practically not absorbed from the gastrointestinal tract. It is excreted mainly with the feces. A small amount of bismuth entered the plasma is excreted by the kidneys.

Indications

Gastric and 12 duodenal ulcer, Gastroduodenitis, Irritable bowel syndrome, Bloating, Gastritis, GI infections caused by Helicobacter pylori, Heartburn, Pelvic pain, Diarrhea

– 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;

– Gastric and duodenal ulcer in the acute phase, including those associated with Helicobacter pylori;

– Irritable bowel syndrome, mainly with diarrhea symptoms.

Active ingredient

Bismuth tricalium dicitrate

Composition

Active ingredient:

Bismuth tricalium dicitrate – 300.00 mg, in terms of bismuth oxide – 120.00 mg.

Auxiliary substances:

corn starch – 54.22 mg,

povidone (polyvinylpyrrolidone medium molecular weight, povidone K 25) – 42.00 mg,

Polacryline (potassium polacryline) – 20.00 mg,

Magnesium stearate – 3.78 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.

How to take, the dosage

Ingestion. The duration of the course of treatment and the dosage of the drug are determined by the attending physician individually for each patient, depending on the nature of the disease.

Adults and children over 12 years of age take 1 tablet 4 times a day, 30 min before a meal (breakfast, lunch, dinner) and at night, or 2 tablets 2 times a day 30 min before a meal (breakfast, dinner).

Children between 8 and 12 years of age are prescribed 1 tablet 2 times a day 30 minutes before a meal (breakfast, dinner).

Children aged 4 to 8 years are prescribed in a dose of 8 mg/kg/day; depending on the body weight of the child, 1 to 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).

The tablets are taken 30 minutes before a meal with plenty of water.

The tablet should be swallowed in whole without chewing or crushing with plenty of water. It is not recommended to wash down the tablets with milk. The duration of the treatment course is usually from 4 to 8 weeks. After the end of taking the drug, it is not recommended to take medicines containing bismuth (e.g., Vicalin, Vicair) for 2 months.

For eradication of Helicobacter pylori it is reasonable to use Bismuth tricalium dicitrate in combination with antibacterial drugs that have anti-Helicobacterial activity.

Interaction

A half an hour before and half an hour after taking the drug, it is not recommended to use other medicines or take food and liquids, particularly antacids, milk, fruit and fruit juices. This is due to the fact that they may affect the effectiveness of bismuth tricalium dicitrate when taken simultaneously.

The drug reduces absorption of tetracyclines.

The drug is not used simultaneously with other medicinal products containing bismuth, since simultaneous use of several bismuth drugs increases the risk of side effects, including the risk of encephalopathy.

Special Instructions

The drug should not be used for more than 8 weeks. It is not recommended to exceed the established daily doses for adults and children during treatment. During treatment with the drug, do not use other drugs containing bismuth (see section “Interaction with other medicinal products”). At the end of a course of treatment with the drug in the recommended doses the concentration of the active substance in blood plasma does not exceed 3 – 58 mcg/L, and intoxication is observed only at concentrations above 100 mcg/L.

When using bismuth tricalium dicitrate staining of feces in a dark color is possible

due to formation of bismuth sulfide.

Sometimes there is a slight darkening of the tongue.

Alcohol consumption is not recommended during therapy.

Influence on driving and operating ability

There are no data on the effect of the drug Escape^® film-coated tablets on driving and operating ability.

Contraindications

• Excessive individual sensitivity to the components of the drug
• pregnancy
• breastfeeding period;
• taking medications containing bismuth;
• chronic renal failure;
• children under 4 years of age.

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Side effects

The following adverse events noted during the use of bismuth tricalium dicitrate are distributed according to the following frequency of occurrence: very frequently (≥ 1/10); frequently (≥ 1/100, < 1/10); infrequently (≥ 1/1000, < 1/100); rarely (≥ 1/10 000, < 1/1 000); very rarely (< 1/10 000).

Gastrointestinal tract: very common – staining of feces black; infrequent – nausea, vomiting, diarrhea or constipation.

Allergic reactions: infrequent – skin rash, itching; very rare – anaphylactic reactions.

Nervous system disorders: very rarely – with prolonged use in high doses

Encephalopathy associated with bismuth accumulation in the CNS.

The side effects are reversible and disappear quickly after discontinuation of the drug.

Overdose

Bismuth poisoning is possible when using the drug in doses ten times higher than recommended or when using excessive doses of the drug for a long time.

Symptoms: dyspepsia, rash, inflammation of the oral mucosa, characteristic darkening in the form of blue lines on the gums; with long-term use in doses higher than recommended, renal failure may occur.

These symptoms are completely reversible when the drug is discontinued.

Treatment: there is no specific antidote. In case of overdose of the drug gastric lavage, use of enterosorbents and symptomatic therapy aimed at maintaining renal function is indicated.

In case of overdose prescription of saline laxatives is also indicated. Further treatment should be symptomatic. In case of renal dysfunction accompanied by high levels of bismuth in plasma, complexing agents – dimercaptoyanthate and dimercaptopropanesulfonic acid can be administered. Hemodialysis is indicated if severe renal dysfunction develops.

Pregnancy use

Bismuth tricalium dicitrate is contraindicated for use in pregnant women. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Similarities

De-Nol, Novobismol, Ulcavis, Escape, Vitridinol, Bismuth tricalium dicitrate