De-Nol, 120 mg 32 pcs.

De-Nol is gastroprotective, antiulcer, antibacterial.

Pharmacodynamics

An anti-ulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent activity. 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.

Augmenting the synthesis of PGE, mucus formation and bicarbonate secretion, stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to 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

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

Indications

Active ingredient

Composition

The film-coated tablets are creamy white, round, biconvex, with the inscription “gbr 152” stamped on one side and a graphic drawing in the form of a square with broken sides and rounded corners, stamped on the other side, odorless or with a slight smell of ammonia.

Excipients:

Corn starch – 70.6 mg,

Povidone K30 – 17.7 mg,

polyacrylate of potassium – 23.6 mg,

macrogol 6000 – 6 mg,

magnesium stearate – 2 mg.

Shell composition:

Operaday OY-S-7366 (hypromellose 5 mPa-s – 3.2 mg, macrogol 6000 – 1.1 mg).

How to take, the dosage

Overly with a small amount of water.

Adults and children over 12 years of age – 1 tablet 4 times daily 30 minutes before a meal and at night or 2 tablets 2 times daily 30 minutes before a meal.

Children from 8 to 12 years of age – 1 tablet 2 times a day 30 minutes before a meal.

In children from 4 to 8 years of age – in a dose of 8 mg/kg/day; the daily dose is divided into 2 doses. It is taken 30 minutes before a meal.

The course of treatment is 4-8 weeks. For the next 8 weeks, no medications containing bismuth should be used.

For eradication of Helicobacter pylori it is reasonable to use De-Nol® in combination with other antibacterial agents having anti-Helicobacterial activity.

Interaction

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. No other drugs containing bismuth should be used during treatment with De-Nol®. At the end of the course of treatment with the drug in the recommended doses, the concentration of the active substance in blood plasma does not exceed 3-58 µg/L, and intoxication is observed only at concentrations above 100 µg/L.

When using De-Nol®, stool staining due to bismuth sulfide formation is possible. Sometimes a slight darkening of the tongue is noted.

Contraindications

Side effects

The digestive system: nausea, vomiting, more frequent stools, constipation are possible. These phenomena are not dangerous to health and are temporary.

Allergic reactions: skin rash, skin itching.

In long-term use in high doses – encephalopathy associated with the accumulation of bismuth in the CNS.

Overdose

Symptoms (with prolonged use beyond recommended doses): impaired renal function. These symptoms are completely reversible when De-Nol® is discontinued.

Treatment: gastric lavage, administration of activated charcoal and saline laxatives. Further treatment should be symptomatic. In cases of impaired renal function accompanied by high levels of bismuth in the blood plasma, the use of complexing agents – dimercaptoyanthate and dimercaptopropanesulfonic acids. Hemodialysis is indicated in cases of marked impairment of renal function.

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