Description
Latin name
De-Nol
release form
film-coated tablets
packaging 112 pcs
Pharmacological action
De-Nol – gastroprotective, antiulcer, antibacterial.
Pharmacodynamics
An antiulcer 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 of
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.
Indications
peptic ulcer of the stomach and duodenum in the exacerbation phase, incl. chronic gastritis and gastroduodenitis associated with Helicobacter pylori
in the exacerbation phase, including associated with Helicobacter pylori
irritable bowel syndrome, occurring mainly with symptoms of
diarrhea, functional dyspepsia, not associated with organic gastrointestinal diseases.
Contraindications
individual intolerance to the pregnancy
Use during pregnancy and lactation
Contraindicated in pregnancy.
Breastfeeding should be discontinued during treatment.
Ingredients
1 tablet contains:
Active ingredient:
bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 – 120 mg)
Excipients:
starch corn srd Shell:
Opadry OY-S-7366 (hypromellose, macrogol 6000).
Dosage and administration
Inside, with a little water.
Adults and children over 12 years of age – 1 tablet 4 times a day 30 minutes before meals and at night or 2 tablets 2 times a day 30 minutes before meals.
For children from 8 to 12 years old – 1 tablet 2 times a day 30 minutes before meals.
For 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.
Duration of treatment – 4-8 weeks. Over the next 8 weeks, preparations containing bismuth should not be used.
To eradicate Helicobacter pylori, it is advisable to use De-Nol ® in combination with other antibacterial agents with anti-Helicobacter pylori activity.
Side effects
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.
Drug Interaction
Within half an hour before and after taking De-Nol ®, it is not recommended to use other medicines inside, as well as food and liquids, in particular antacids, milk, fruits and fruit juices.
This is due to the fact that they can, when taken internally, affect the effectiveness of De-Nol ®.
Overdose
Symptoms (with prolonged doses in excess of recommended doses): impaired renal function. These symptoms are completely reversible upon de-Nol ® withdrawal.
Treatment: gastric lavage, administration of activated charcoal and salt laxatives. In the future, treatment should be symptomatic. In the case of impaired renal function, accompanied by high levels of bismuth in the blood plasma, the use of complexing agents – dimercaptoantaric and dimercaptopropanesulfonic acids. Hemodialysis is indicated in case of severe renal dysfunction.
Storage conditions
The drug should be stored at a temperature of 15 ° to 25 ° C.
Expiration
4 years.
Deystvuyuschee substances
Vysmuta trykalyya dytsytrat
dosage form
dosage form
tablets
Astellas Pharma Europe B.V., Ro Russia