De-Nol 120mg (Bismuthi tripotassium)

Cream-white film-coated tablets, round, biconvex, labeled "gbr 152", extruded on one side, and a graphic design in the form of a square with intermittent sides and rounded corners extruded on the other side, odorless or with a slight smell ammonia.

Excipients:

corn starch - 70.6 mg,

povidone K30 - 17.7 mg,

potassium polyacrylate - 23.6 mg,

macrogol 6000 - 6 mg,

magnesium stearate - 2 mg.

Shell composition:

 Opadry OY-S-7366 (hypromellose 5 MPa · s - 3.2 mg, macrogol 6000 - 1.1 mg).

De-Nol - gastroprotective, antiulcer, antibacterial.

Pharmacodynamics

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.

Increasing the synthesis of PGE, 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

Bismuth subcitrate is practically not absorbed from the digestive tract. It is excreted mainly with feces. A small amount of bismuth received in the plasma is excreted from the body by the kidneys.

• Peptic ulcer of the stomach and duodenum in the phase of exacerbation, including associated with Helicobacter pylori;
• chronic gastritis and gastroduodenitis in the acute phase, including associated with Helicobacter pylori;
• irritable bowel syndrome, occurring mainly with symptoms of diarrhea;
• functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.

• Individual intolerance to the drug;
• severe renal impairment;
• pregnancy;
• lactation

From the digestive system: the appearance of nausea, vomiting, more frequent stools, constipation. These phenomena are not hazardous to health and are temporary in nature.

Allergic reactions: skin rash, itching of the skin.

With prolonged use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.

Inside, washed down with a small amount of water.

Adults and children over 12 years old - 1 tablet 4 times a day 30 minutes before meals and at night or 2 tablets 2 times a day 30 minutes before meals.

Children from 8 to 12 years old - 1 tablet 2 times a day 30 minutes before meals.

Children from 4 to 8 years old - at a dose of 8 mg / kg / day; the daily dosage is divided into 2 doses. Take 30 minutes before meals.

The duration of treatment is 4-8 weeks. Over the next 8 weeks, preparations containing bismuth should not be used.

For the eradication of Helicobacter pylori, it is advisable to use De-Nola ^®  in combination with other antibacterial agents with anti-Helicobacter pylori activity.

Symptoms (with prolonged use of doses exceeding the recommended): impaired renal function. These symptoms are completely reversible when De-Nola ^{® is} canceled .

Treatment: gastric lavage, the appointment of activated charcoal and saline laxatives. Further treatment should be symptomatic. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, the use of complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. In case of severe renal impairment, hemodialysis is indicated.

The drug should not be used for more than 8 weeks. It is also not recommended during treatment to exceed the established daily doses for adults and children. During the treatment with De-Nol ^®  , other preparations containing bismuth should not be used. 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 De-Nola ^®  , stool may be dark in color due to the formation of bismuth sulfide. Sometimes a slight darkening of the tongue is noted.