Де-Нол®

General characteristics. Structure:

Active agent: Bismuth a trikaliya dicitrate of-304,6 mg, in terms of Bi2O3 bismuth oxide - 120 mg.
Excipients: starch corn, KZ0 povidone, potassium polyacrylate, macrogoal 6000, magnesium stearate.
Оболочка:Опадрай OY-S-7366, consists from: gipromelloza and macrogoal 6000.

Description: Round biconvex tablets, coated cream-white color, with
text of "gbr 152" which is squeezed out on one party and the graphic drawing in a look
square with the discontinuous parties and the rounded-off corners, squeezed out on another,
inodorous or with a light smell of ammonia.

Pharmacological properties:

Pharmacodynamics. Antiulcerous means with bactericidal activity concerning Helicobacter pylori. Possesses also antiinflammatory and knitting action. In acid medium of a stomach  insoluble oxychloride of bismuth and citrate are besieged, chelate connections with proteinaceous substrate in the form of a protective film on a surface of ulcers and erosion are formed. Increasing prostaglandin E synthesis, a myxopoiesis and secretion of a hydrocarbonate, stimulates activity of cytoprotective mechanisms, increases   resistance of a mucous membrane  of digestive tract to influence of pepsin, hydrochloric acid, enzymes and salts of bile acids. Leads to accumulation of an epidermal growth factor in a defect zone. Reduces activity of pepsin and a pepsinogen.

Pharmacokinetics. Bismuth subcitrate is practically not soaked up from digestive tract. It is removed preferential with a stake. The insignificant amount of bismuth which came to plasma is brought out of an organism by kidneys.

Indications to use:

The peptic ulcer of a stomach and duodenum in an aggravation phase including associated with  Helicobacter pylori.       
Chronic gastritis also gastroduodenit in an aggravation phase, including associated with Helicobacter pylori.
The syndrome  of the angry  intestines proceeding  preferential  with  diarrhea symptoms.
The functional dyspepsia which is not connected with organic diseases of digestive tract.

Route of administration and doses:

To adults and children drug is more senior than 12 years appoint on 1 tablet 4 times a day in 30 minutes prior to meal and to night or 2 tablets 2 times a day in 30 minutes prior to meal.
Dutyam from 8 to 12 years appoint drug on 1 tablet 2 times a day in 30 minutes prior to food.
To children from 4 to 8 years: appoint 8 mg/kg/days in a dose; the daily dose is divided into 2 receptions. Accept in 3 minutes prior to food.
Tablets need to be washed down with a small amount of water.
Duration of a course of treatment is 4-8 weeks. Within the next 8 weeks it is not necessary to use the drugs containing bismuth.
For an eradikation of Helicobacter pylori De-Nol's use in a combination with other antibacterial agents having antikhelikobakterny activity is reasonable.

Features of use:

It is not necessary to use drug more than 8 weeks. Also it is not recommended to exceed during treatment  the established daily doses for adults and children.  During treatment
De-Nol should not use other drugs containing bismuth. Upon termination of course treatment by drug in the recommended doses concentration of active active ingredient in a blood plasma does not exceed 3-58 mkg/l, and intoxication is observed only at concentration higher than 100 mkg/l.
At De-Nol's use coloring a calla in dark color owing to formation of bismuth sulfide is possible. Insignificant darkening of language is sometimes noted.

Side effects:

From the alimentary system: emergence of nausea, vomiting, more frequent chair, locks is possible. These phenomena are not hazardous to health and are temporary. Allergic reactions: skin rash, skin itch.
At prolonged use in high doses - the encephalopathy connected with accumulation of bismuth in TsNS.
Drug overdose
The drug overdose caused by long reception of the doses exceeding recommended can lead to a renal failure. These symptoms are completely reversible at De-Nol's cancellation.
At emergence of symptoms of poisoning with drug it is necessary to make a gastric lavage, to apply absorbent carbon and salt laxatives. Further treatment has to be symptomatic. In case of the renal failure which is followed by the high level of bismuth in a blood plasma it is possible to enter kompleksoobrazovatel - dimercaptoamber and dimercaptopro-pan-sulfonic acids. In case of the expressed renal failure the hemodialysis is shown.

Interaction with other medicines:

Within half an hour before De-Nol's reception use in other medicines, and also meal and liquids, in particular, of antacids, milk, fruit and fruit juice is not recommended. It is connected with the fact that they at a concomitant use inside can exert impact on De-Nol's efficiency.

Contraindications:

The expressed renal failure, pregnancy, lactation, individual intolerance of drug.

Overdose:

The drug overdose caused by long reception of the doses exceeding recommended can lead to a renal failure. These symptoms are completely reversible at De-Nol's cancellation.
At emergence of symptoms of poisoning with drug it is necessary to make a gastric lavage, to apply absorbent carbon and salt laxatives. Further treatment has to be symptomatic. In case of the renal failure which is followed by the high level of bismuth in a blood plasma it is possible to enter kompleksoobrazovatel - dimercaptoamber and dimercaptopro-pan-sulfonic acids. In case of the expressed renal failure the hemodialysis is shown.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 4 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 8 tablets in the blister from aluminum foil, on 7 or 14 blisters together with the application instruction in a cardboard pack.