Composition
Composition per tablet:
Active ingredient:
Vicanol, substance-granules-324.47 mg [Active ingredient: Bismuth tripotassium dicitrate-304.60 mg (in terms of bismuth oxide bi2co3-120.00 mg);
excipients: Â povidone K 30-16.01 mg, macrogol 6000-3.86 mg].
Auxiliary substances: Â corn starch-70.60 mg, potassium polyacrylate-23.60 mg, magnesium stearate-2.00 mg, povidone K 30-1.70 mg, macrogol 6000-2.13 mg.
Shell:
Hypromellose 5 MPas – 3.20 mg, macrogol
6000-1.10 mgPharmacological action
Pharmacotherapy group: Anti-ulcer, antiseptic intestinal and astringent agentath:
A. 02. B. X. 05 Bismuth tripotassium dicitrate
Pharmacodynamics :
An anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also has an anti-inflammatory and astringent effect. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are deposited, chelated compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions.
Increasing the synthesis of prostaglandin E, mucus formation and bicarbonate secretion, 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. Leads to the accumulation of epidermal growth factor in the defect area. Reduces the activity of pepsin and pepsinogen.
Pharmacokinetics:
Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. It is mainly excreted in the faeces. A small amount of bismuth that enters the plasma is excreted from the body by the kidneys.
Indications
-Chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori.
– Peptic ulcer of the stomach and duodenum in the acute phase, including those associated with Helicobacter pylori.
– Functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.
– Irritable bowel syndrome, which occurs mainly with symptoms of diarrhea.
Use during pregnancy and lactation
The use of the drug Vikanol Life during pregnancy and lactation is contraindicated.
Contraindications
Severe renal impairment (severe renal insufficiency (creatinine clearance less than 30 ml / min) and chronic renal failure), pregnancy, breast-feeding, individual intolerance to the drug, children under 4 years of age, taking drugs containing bismuth.
Side effects
The frequency of side effects of the drug is estimated as follows:
Very frequent: ≥ 1/10, frequent: ≥ 1/100, < 1/10, infrequent: ≥ 1/1000, <1/100, rare: ≥ 1/10 000, <1/1000, very rare: <1/10 000.
From the gastrointestinal tract: Â very often – fecal staining in black color; infrequently-nausea, vomiting, diarrhea or constipation.
Allergic reactions: Â infrequently-skin rash, pruritus; very rarely-anaphylactic reactions.
Nervous system disorders: Â very rarely – with prolonged use in high doses, encephalopathy associated with the accumulation of bismuth in the central nervous system (CNS) may develop.
Side effects are reversible and quickly disappear after discontinuation of the drug.
Interaction
Within half an hour before and after taking the drug, it is not recommended to use other medications inside, as well as food and liquids, in particular, antacids, milk, fruit and fruit juices. This is due to the fact that they can affect the effectiveness of the drug when taken orally at the same time.
The drug reduces the absorption of tetracyclines.
The drug should not be used simultaneously with other medications containing bismuth, since when taking several bismuth medications at the same time, there is a risk of developing side effects, including the risk of developing encephalopathy.
How to take, course of use and dosage
The drug is taken orally.
Adults and children over 12 years of age are prescribed 1 tablet 4 times a day 30 minutes before meals (breakfast, lunch and dinner) and at night or 2 tablets 2 times a day 30 minutes before meals (breakfast, dinner).
Children from 8 to 12 years of age are prescribed 1 tablet 2 times a day for 30 minutes before meals (breakfast, dinner).
Children from 4 to 8 years of age are prescribed at a dose of 8 mg / kg / day; depending on the child’s body weight,1-2 tablets are prescribed per day (respectively, in 1-2 doses per day). In this case, the daily dose should be as close as possible to the calculated dose (8 mg / kg / day).
The drug is taken 30 minutes before meals, washed down with a small amount of water. The tablet should be swallowed whole, without chewing or grinding, with a sufficient amount of water. It is not recommended to drink tablets with milk.
The duration of treatment is 4-8 weeks. For the next 8 weeks, you should not use drugs containing bismuth (for example, Vikair, Vikalin).
For the eradication of Helicobacter pylori, it is advisable to use the drug in combination with other antibacterial agents that have anti-helicobacter activity (on the recommendation of a doctor).
Overdose
When using the drug in doses that are ten times higher than recommended, or with prolonged use of doses of the drug that exceed the recommended ones, bismuth poisoning may develop.
Symptoms: Â inflammation of the oral mucosa, rash, dyspepsia, darkening in the form of blue lines on the gums; with prolonged use of excessive doses of the drug, renal function may be impaired.
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 (for example, activated charcoal) and symptomatic therapy aimed at maintaining kidney function are indicated.
Also, in case of overdose, the appointment of saline laxatives is 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 – dimercaptoyantaric and dimercaptopropanesulfonic acids-can be administered. In case of severe renal impairment, hemodialysis is indicated.
Special instructions
The drug should not be used for more than 8 weeks. It is also not recommended to exceed the established daily doses for adults and children during treatment. During treatment with the drug, other drugs containing bismuth should not be used. At the end of the course of treatment with the drug in the recommended doses, the concentration of the active Active ingredient in the blood plasma does not exceed 3 – 5-8 mcg/l, and intoxication is observed only at concentrations above 100 mcg/l.
When using the drug, it is possible to stain feces in a dark color due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue. Alcohol intake is not recommended during therapy.
Influence on the ability to drive vehicles and mechanisms:
There are no data on the effect of the drug on the ability to drive vehicles and mechanisms.
Storage conditions
At a temperature not exceeding 25 °C, in the original packaging.
Keep out of reach of children.
Shelf
life is 4 years.
Active ingredient
Bismuth tripotassium dicitrate
Dosage form
Tablets
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