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De Nol 120 mg instructions for use. De Nol - instructions for use

De-Nol®

Active substance

Bismuth tripotassium dicitrate (Bismuthi trikalii dicitras (Bismuthi subcitras))

ATX

A02BX05 Bismuth tripotassium dicitrate

Pharmacological group

Gastroprotectors

Nosological classification (ICD-10)

K25 Gastric ulcer K26 Duodenal ulcer K29 Gastritis and duodenitis K30 Dyspepsia K58.0 Irritable bowel syndrome with diarrhea

pharmachologic effect

Pharmacological action - antibacterial, antiulcer, gastroprotective.

Dosage and administration

Inside, drinking a small amount of water. Adults and children over 12 years old - 1 table. 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 table. 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. It is taken 30 minutes before meals. The duration of the course 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-Nol® in combination with other antibacterial agents with anti-Helicobacter pylori activity.

Storage conditions

At a temperature not higher than 25°C. Keep out of the reach of children.

Best before date

4 years. Do not use after the expiry date stated on the packaging.2000-2017. Register of medicines of Russia

Composition and form of release

Tablets 1 tab. bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg) excipients: corn starch; povidone K30; potassium polyacrylate; macrogol 6000; magnesium stearate shell: Opadry OY-S-7366 (hypromellose, macrogol 6000) in a blister 8 pcs.; in a box of 7 or 14 blisters.

Indications

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

Contraindications

individual intolerance to the drug; severe renal dysfunction; pregnancy; breastfeeding period.

Use during pregnancy and lactation

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Description of the dosage form

Round, biconvex, film-coated tablets, creamy white, debossed with "gbr 152" on one side and a square graphic with broken sides and rounded corners on the other side, odorless or with a slight smell of ammonia.

Pharmacodynamics

Antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent properties. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated, chelate compounds with a protein substrate are formed in the form of a protective film on the surface of ulcers and erosions. By increasing the synthesis of PGE, the formation of mucus and the secretion of bicarbonate, 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 area of the defect. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

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

Interaction

Within half an hour before and after taking De-Nol®, it is not recommended to use other drugs orally, as well as the intake of food and liquids, in particular antacids, milk, fruits and fruit juices. This is due to the fact that, when taken orally, they can affect the effectiveness of De-Nol®.

Overdose

Symptoms (with prolonged use of doses exceeding those recommended): impaired renal function. These symptoms are completely reversible upon withdrawal of De-Nol®. Treatment: gastric lavage, administration 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.

special instructions

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 period of treatment with De-Nol®, other preparations containing bismuth should not be used. At the end of a course of treatment with the drug at recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3-58 mcg / l, and intoxication is observed only at a concentration above 100 mcg / l. bismuth sulfide. Sometimes there is a slight darkening of the tongue.

Characteristic

Bismuth drug.

Side effects

On the part of the digestive system: nausea, vomiting, more frequent stools, constipation may occur. These phenomena are not dangerous to health and are temporary. 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.

De-nol is used as a gastroprotective and antiulcer agent.

This is a rather interesting drug: unlike other antiulcer drugs (proton pump inhibitors or H2-histamine receptors), de-nol also has bactericidal activity against Helicobacter, as well as an astringent and anti-inflammatory effect. The active substance of de-nol is bismuth tripotassium dicitrate. Once in the acidic environment of the stomach, this substance precipitates with the formation of two insoluble compounds: bismuth oxychloride and bismuth citrate, which, interacting with the protein substrate, form a protective film on the surface of erosive and ulcerative lesions. This polymer glycoprotein film, to a greater extent than normally secreted mucus, protects the gastric mucosa from the effects of hydrochloric acid, bile salts and pepsin. Visually, it looks like a white foamy coating that covers the entire ulcerative surface and persists for several hours.

In addition to the above, de-nol has a whole scattering of useful properties. It promotes the accumulation of epidermal growth factor (a protein involved in cell growth and differentiation) in the affected area, reduces the activity of digestive enzymes, stimulates the synthesis of prostaglandin E2, which increases mucus formation and alkaline secretion, improves the physicochemical characteristics of gastric mucus, coagulates proteins and destroys Helicobacter.

Together, all this biochemical "mosaic" leads to the desired therapeutic result: under the action of de-nol, ulcers heal, the protective functions of the gastric mucosa are restored, and the likelihood of recurrence of gastric and duodenal ulcers is reduced. When taking de-nol in the "solo" mode, eradication of Helicobacter pylori is successful in 30% of cases, in combination with antibacterial drugs (metronidazole, amoxicillin) - in 90%.

De-nol is available only in tablets, a single recommended dose for adults and children under 12 years of age is 120 mg taken 4 times a day (as an option - 240 mg 2 times a day). Children 8-12 years old take de-nol 120 mg twice a day. For children aged 4-8 years, the drug is prescribed depending on body weight: 8 mcg per 1 kg per day with the same two-time intake. Within half an hour after taking de-nol, it is recommended not to drink drinks (including milk, fruit juices), fruits, solid foods, drugs that reduce the acidity of the stomach. You should not panic if the feces after taking de-nol are black: this is normal for bismuth preparations. The duration of the course of treatment is 4-8 weeks, then a break is made for 8 weeks, after which the course can be repeated.

Pharmacology

Antiulcer drug with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent properties. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated, and chelate compounds with a protein substrate are formed in the form of a protective film on the surface of ulcers and erosions. By increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, 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 area of the defect. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

Suction and distribution

Bismuth tripotassium dicitrate is practically not absorbed from the gastrointestinal tract.

breeding

It is excreted mainly with feces. A small amount of bismuth that enters the plasma is excreted by the kidneys.

Release form

Creamy white, round, biconvex, film-coated tablets, debossed on one side with "gbr 152" and embossed on the other side, odorless or slightly odorous 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).

8 pcs. - blisters (7) - packs of cardboard.
8 pcs. - blisters (14) - packs of cardboard.

Dosage

For adults and children over 12 years of age, the drug is prescribed 1 tab. 4 times / day 30 minutes before meals and at night or 2 tab. 2 times / day 30 minutes before meals.

Children aged 8 to 12 years are prescribed 1 tab. 2 times / day 30 minutes before meals.

Children aged 4 to 8 years are prescribed at a dose of 8 mg / kg / day; depending on the body weight of the child, 1-2 tablets / day are prescribed (respectively, 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).

Tablets are taken 30 minutes before meals with a small amount of water.

The duration of the course of treatment is 4-8 weeks. For the next 8 weeks, you should not take drugs containing bismuth.

For the eradication of Helicobacter pylori, it is advisable to use De-Nol in combination with antibacterial drugs with anti-Helicobacter pylori activity.

Overdose

Symptoms: with prolonged use in doses exceeding those recommended, renal dysfunction is possible (completely reversible when the drug is discontinued).

Treatment: gastric lavage, administration of activated charcoal and saline laxatives. In the future, symptomatic therapy is carried out. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, chelating agents (D-penicillamine, unithiol) can be administered. In case of severe renal impairment, hemodialysis is indicated.

Interaction

While taking other medicines, as well as food and liquids, in particular, antacids, milk, fruits and fruit juices, the effectiveness of De-Nol may change (it is not recommended to take it orally within 30 minutes before and after taking De-Nol).

The combined use of De-nol with tetracyclines reduces the absorption of the latter.

Side effects

On the part of the digestive system: nausea, vomiting, frequent stools, constipation are possible. These effects are not dangerous to health and are temporary.

Allergic reactions: skin rash, skin itching.

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

Indications

peptic ulcer of the stomach and duodenum in the acute phase (including those associated with Helicobacter pylori);
chronic gastritis and gastroduodenitis in the acute phase (including those associated with Helicobacter pylori);
irritable bowel syndrome, which occurs mainly with symptoms of diarrhea;
functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.

During the period of 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 substance in the blood plasma does not exceed 3-58 mcg / l, and intoxication is observed only at a concentration of more than 100 mcg / l.

When using De-Nol, it is possible to stain the feces black due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.

Influence on the ability to drive vehicles and control mechanisms

There is no data on the effect of the drug De-nol ® on the ability to drive vehicles and mechanisms.

P N012626/01.INN Bismuth tripotassium dicitrate&
Trade name De-Nol
Registration number P N012626/01
Date of registration 13.12.2007

Cancellation date
Manufacturer Astellas Pharma Europe B.V. - Netherlands

Packaging:
No. Packing ID EAN
1 film-coated tablets 120 mg 35000 pcs., plastic bags (1) - metal drums ND 42-4717-06 ~
2 film-coated tablets 120 mg 8 pcs.
3 film-coated tablets 120 mg 8 pcs.

Composition and form of release: 1 tablet contains bismuth tripotassium decitrate (in the form of colloidal bismuth subcitrate) 120 mg; in a blister 8 pcs., in a box of 7 or 14 blisters.

Pharmacological action: Antiulcer, gastroprotective, antibacterial. Active against Helicobacter pylori. In an acidic environment, the gastrointestinal tract forms a protective film on the surface of ulcers and erosions, which contributes to their scarring and protects them from exposure to gastric juice; increases the synthesis of PGE2, which stimulates the formation of mucus, and bicarbonates, leads to the accumulation of epidermal growth factor in the defect zone, weakens the activity of pepsin and pepsinogen.

Indications: Peptic ulcer of the stomach and duodenum associated with Helicobacter pylori; gastritis caused by Helicobacter pylori; exacerbation of peptic ulcer of the stomach and duodenum; Helicobacter pylori reinfection; dyspepsia, unrelated to organic changes in the gastrointestinal tract, associated with Helicobacter pylori; the presence of ulcerative diseases of the gastrointestinal tract in a family history.

Contraindications: Severe renal dysfunction, pregnancy, lactation.

Use during pregnancy and lactation: Contraindicated. At the time of treatment should stop breastfeeding.

Side effects: Rarely - nausea, vomiting, frequent stools, allergic reactions (skin rash, itching).

Interaction: Reduces the absorption of tetracyclines. The simultaneous administration of drugs containing bismuth (Vicalin, Vikair, Roter) increases the risk of an excessive increase in the concentration of bismuth in the blood.

Overdose: Manifested with frequent use of large doses of symptoms characteristic of reversible renal dysfunction.

Treatment: gastric lavage, activated charcoal, saline laxatives (monitoring of kidney function, bismuth concentration in the blood and urine is shown), then symptomatic treatment. In case of impaired renal function, accompanied by a high level of bismuth in the blood plasma, it is possible to administer complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. In severe renal failure - hemodialysis.

Dosage and administration: Inside, the tablet is washed down with 1-2 sips of water (but not milk). Adults: 120 mg 3 times a day 30 minutes before breakfast, lunch, dinner and the fourth time - at bedtime, for 4-6 weeks (maximum - up to 8 weeks), then a break is needed for 8 weeks, during which it should not be take drugs containing bismuth. Children: up to 12 years, 120 mg 2 times a day, 12 years and older - 240 mg 2 times a day. If the patient has Helicobacter pylori bacteria, the treatment is supplemented with metronidazole - 250 mg 4 times a day and amoxicillin - 250 mg 4 times a day for 7-10 days. In case of intolerance or hypersensitivity to amoxicillin, it is recommended to take tetracycline at a dose of 500 mg 3 times a day. Combinations with other antibiotics are possible.

Composition and form of release

Tablets - 1 tab. bismuth tripotassium dicitrate - 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg) excipients: corn starch; povidone K30; potassium polyacrylate; macrogol 6000; magnesium stearate shell: Opadry OY-S-7366 (hypromellose, macrogol 6000) in a blister 8 pcs.; in a box of 7 or 14 blisters.

Description of the dosage form

Round, biconvex, film-coated tablets, creamy white, debossed with "gbr 152" on one side and a square graphic with broken sides and rounded corners on the other, odorless or with a slight smell of ammonia.

Characteristic

Bismuth drug.

Pharmacokinetics

Pharmacodynamics

Indications for use

Peptic ulcer of the stomach and duodenum in the acute phase (including those associated with Helicobacter pylori);

Chronic gastritis and gastroduodenitis in the acute phase (including those associated with Helicobacter pylori);

Irritable bowel syndrome, occurring mainly with symptoms of diarrhea;

Functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.

Contraindications for use

Pronounced impaired renal function;

Pregnancy;

lactation period;

Hypersensitivity to the drug.

Use in pregnancy and children

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects

On the part of the digestive system: nausea, vomiting, more frequent stools, constipation may occur. These phenomena are not dangerous to health and are temporary.

Allergic reactions: skin rash, skin itching.

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

drug interaction

Dosage

Inside, washing down with a small amount of water.

Adults and children over 12 years old - 1 tab. 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 tab. 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. Taken 30 minutes before meals.

The duration of the course of treatment is 4–8 weeks. For the next 8 weeks, preparations containing bismuth should not be used.

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

Overdose

Symptoms (with prolonged use of doses exceeding those recommended): impaired renal function. These symptoms are completely reversible upon discontinuation of De-Nol®. Treatment: gastric lavage, administration 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.

Registration number:

Tradename: De-Nol®

Dosage form: coated tablets

Compound:

Each tablet contains:
Active substance: Bismuth tripotassium dicitrate - 304.6 mg, in terms of bismuth oxide B120z - 120 mg.
Excipients: corn starch, povidone KZO, potassium polyacrylate, macrogol 6000, magnesium stearate.
Shell: Opadray OY-S-7366, consists of: hypromellose and macrogol 6000,

Description:

Creamy white, round, biconvex film-coated tablets, debossed on one side with "gbr 152" and embossed on the other side, odorless or with a slight smell of ammonia.

Pharmacotherapeutic group: antiseptic intestinal and astringent.

ATX code: A02BX05

Pharmacological properties

Pharmacodynamics
Antiulcer agent with bactericidal activity against Helicobacter pylori. It also has anti-inflammatory and astringent properties. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate are precipitated, chelate compounds with a protein substrate are formed in the form of a protective film on the surface of ulcers and erosions. By increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, it stimulates the activity of cytoprotective mechanisms, increases the resistance of the mucous membrane of the gastrointestinal tract to the effects of pepsin, hydrochloric acid, enzymes and bile salts. Leads to the accumulation of epidermal growth factor in the area of the defect. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics
Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. It is excreted mainly with feces. A small amount of bismuth that enters the plasma is excreted from the body by the kidneys.

Indications for use

Peptic ulcer of the stomach and duodenum in the acute phase, including those associated with Helicobacter pylori.
Chronic gastritis and gastroduodenitis in the acute phase, including those associated with Helicobacter pylori.
Irritable bowel syndrome, which occurs mainly with symptoms of diarrhea.
Functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.

Contraindications

Severe renal dysfunction, pregnancy, lactation, individual intolerance to the drug.

Dosage and administration

Adults and children over 12 years of age the drug is prescribed 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 the drug is prescribed 1 tablet 2 times a day 30 minutes before meals.
Children from 4 to 8 years old: administered at a dose of 8 mg / kg / day; The daily dosage is divided into 2 doses. Taken 30 minutes before meals.
Tablets should be taken with a small amount of water.
The duration of the course of treatment is 4-8 weeks. For the next 8 weeks, preparations containing bismuth should not be used.
For the eradication of Helicobacter pylori, it is advisable to use De-Nol in combination with other antibacterial agents with anti-Helicobacter pylori activity.

Side effect

From the digestive system: Nausea, vomiting, more frequent stools, and constipation may occur. These phenomena are not dangerous to health and are temporary.
Allergic reactions: skin rash, skin itching.
With prolonged use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.

drug overdose

An overdose of the drug, caused by long-term use of doses exceeding the recommended ones, can lead to impaired renal function. These symptoms are completely reversible with the abolition of De-Nol.
If signs of drug poisoning appear, it is necessary to do a gastric lavage, apply 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, it is possible to introduce complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. In case of severe renal impairment, hemodialysis is indicated.

Interaction with other drugs

Within half an hour before and after taking De-Nol, it is not recommended to use other medicines inside, as well as the intake of food and liquids, in particular, antacids, milk, fruits and fruit juices. This is due to the fact that they, when taken orally, can affect the effectiveness of De-Nol.

special instructions

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 period of treatment with De-Nol, other preparations containing bismuth should not be used. At the end of the course treatment with the drug in recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3-5.8 μg / l, and intoxication is observed only at a concentration above 100 μg / l.
When using De-Nol, it is possible to stain the feces in a dark color due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue,

Release form

8 tablets in an aluminum foil blister, 7 or 14 blisters with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25°C. Keep out of the reach of children.

Best before date

4 years. Do not use after the expiry date stated on the packaging

Terms of dispensing from pharmacies

Over the counter

Manufacturer:
Astellas Pharma Europ B.V., Netherlands Elizabethof 19, Leiderdorp.

Packed and packaged:
Astellas Pharma Europ B.V., the Netherlands, or CJSC ORTAT, Russia.

Claims for quality are accepted by the representative office in Moscow:
Moscow representative office:
109147 Moscow, Marksistskaya st. 16 "Mosalarko Plaza-1" business center, floor 3.