De Nol 120 instructions for use. De Nol - instructions for use. Reviews about the drug, analogues, price. Possible side effects, mechanism of action, information on how to take the drug. Absorption and excretion

INN or grouping name: bismuth tripotassium dicitrate

Dosage form: film-coated tablets

Compound:

One film-coated tablet contains:
Active ingredient: bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 120 mg).

Excipients:
corn starch - 70.6 mg, povidone K30 - 17.7 mg, potassium polyacrylate - 23.6 mg, macrogol 6000 - 6.0 mg, magnesium stearate - 2.0 mg.

Shell:
Opadry OY-S-7366: hypromellose 5 mPa s - 3.2 mg, macrogol 6000 - 0.5 mg; macrogol 6000 - 0.6 mg.

Description:

Creamy white, round, biconvex film-coated tablets, debossed on one side with "gbr 152" and embossed on the other side with a graphic pattern in the form of a square with broken sides and rounded corners.

Pharmacotherapeutic group: antiseptic intestinal and astringent.

Pharmacological properties

Pharmacodynamics

Antiulcer 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 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.

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

Decompensated renal failure, pregnancy, lactation, individual intolerance to the drug, children under 4 years of age.

Dosage and administration

For 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.

For 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: prescribed at a dose of 8 mg / kg / day; depending on the body weight of the child, 1-2 tablets are prescribed per day (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 little 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

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 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, chelating agents (D-penicillamine, unithiol) can be administered. 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, when taken orally, they can affect the effectiveness of De-Nol.

The combined use of De-Nol with tetracycline reduces the absorption of the latter.

Pregnancy and lactation

The use of the drug De-Nol® during pregnancy and lactation is contraindicated.

Influence on the ability to drive vehicles and mechanisms

There are no data on the effect of De-Nol® on the ability to drive vehicles and mechanisms.

special instructions

The drug should not be used for more than 8 weeks.

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 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-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

Manufactured by Astellas Pharma Europ B.V., The Netherlands
8 tablets in a blister of laminated aluminum foil.

By production at R-Pharm JSC, Russia

Produced at CJSC ZiO-Zdorovye, Russia
8 tablets in a blister of aluminum foil and laminated aluminum foil.

When packaging and / or packaging at ORTAT JSC, Russia
8 tablets in a blister of aluminum foil and PVC laminated with aluminum foil.

For all manufacturers

On 4, 7 or 14 blisters together with the application instruction in a cardboard pack.

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

3D images

Composition and form of release

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 side, odorless or with a slight smell of ammonia.

Characteristic

Bismuth drug.

pharmachologic effect

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.

Indications for De-Nol ®

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, which occurs mainly with symptoms of diarrhea;

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

Contraindications

individual intolerance to the drug;

severe impairment of kidney function;

pregnancy;

breastfeeding period.

Use during pregnancy and lactation

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

Side effects

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.

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 ® .

Dosage and administration

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

Overdose

Symptoms(with long-term use of doses exceeding those recommended): impaired renal function. These symptoms are completely reversible upon discontinuation of De-Nol ® .

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.

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 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-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.

Storage conditions for De-Nol ®

Keep out of the reach of children.

Shelf life of De-Nol ®

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

Synonyms of nosological groups

(equivalent to 120 mg Bi2O3), as well as potassium polyacrylate, povidone K30, corn starch, magnesium (Mg) stearate, macrogol 6000.

Tablet shell composition: hypromellose 5 mPa×s and macrogol 6000 (Opadry OY-S-7366).

Release form

Biconvex, round shaped film-coated tablets with imprint gbr 152 on one side and a square graphic with rounded corners and broken sides on the other. The color of the tablets is white with a creamy tint, the smell is light ammonia (may be absent).

Tablets are packaged in blisters of 8 pieces. One carton box contains 56 or 112 tablets.

pharmachologic effect

Bismuth drug. Renders antibacterial , antiulcer and gastroprotective action.

In accordance with the information provided in Wikipedia, bismuth subcitrate in the "Pharmacological index" is included in the group " Antacids and adsorbents «.

Pharmacodynamics and pharmacokinetics

Bismuthate tripotassium dicitrate is characterized by a multifaceted effect, due to which the drug De-Nol has an impact on all links of the origin and development peptic ulcer .

The astringent effect is due to the ability bismuth subcitrate precipitate proteins by forming chelate complexes with them. As a result, on the surface of the affected peptic ulcer plots mucous membrane of the stomach and duodenum a protective film is formed, which eliminates the possibility of the harmful effects of the acidic environment of the stomach on the affected mucosa. This, in turn, contributes to faster scarring of ulcers.

De-Nol manifests bactericidal properties in a relationship Gram (-) bacteria Helicobacter pylori . This effect is based on the ability of the active substance of the drug to suppress the enzymatic activity in the microbial cell, disrupt the microstructure and permeability of its membranes, as well as the course of vital intracellular processes, reduce the mobility and virulence of microorganisms, as well as their ability to adhere. All of the above leads to the death of microorganisms.

An important feature of the drug and its difference from other drugs used for treatment helicobacter pylori , it is believed that to date not a single strain has been identified that would be resistant to the action of bismuth subcitrate.

The substance dissolves very well, due to which the drug penetrates deep into the mucus layer and inactivates the microorganisms under the mucosa.

Thus, the use of De-Nol tablets can reduce the likelihood of relapse. peptic ulcer .

Gastrocytoprotective effect The drug is based on stimulation of the body's production prostaglandin E2 ; improvement of microcirculation in the mucous membrane of the antrum of the stomach and duodenum 12; a decrease in the amount of hydrochloric acid; inactivation of pepsin due to the fact that this digestive enzyme forms complex compounds with bismuth subcitrate.

Bismuth subcitrate after oral administration is practically not absorbed in the digestive tract. A small amount of the substance can enter the systemic circulation, and its plasma concentration increases with prolonged use. Bismuth subcitrate is eliminated with intestinal contents.

Indications for use De-Nol

Indications for the use of De-Nol are erosive and ulcerative lesions of the gastric and duodenal mucosa .

In particular, the drug is prescribed for gastropathy that are the result of taking NSAIDs or alcohol; at gastroduodenitis and with (including if the diseases occur in or are associated with Helicobacter pylori); with exacerbated (including if the disease is associated with Helicobacter pylori); with IBS ( irritable bowel syndrome ), as well as with functional, which is not associated with organic lesions of the gastrointestinal tract.

In some cases, it is considered appropriate to use De-Nol and when pancreatitis (especially with biliary-dependent). The drug is prescribed in complex therapy to eliminate gastroduodenostasis (hypomotor dyskinesia of the intestine), which is often observed in the chronic form of the disease.

Contraindications

The drug has contraindications. It is forbidden to prescribe De-Nol:

• sick with decompensated renal failure ;
• pregnant women;
• women who are breastfeeding;
• children under 4 years of age;
• with hypersensitivity to bismuth subcitrate or auxiliary components included in the tablets.

Side effects

Side effects of De-Nol on the part of the digestive system are manifested by nausea, vomiting, constipation or frequent stools. These phenomena do not pose a danger to the health of the patient and are transient.

In some patients, side effects of treatment may occur in the form of hypersensitivity reactions (for example, itching or skin rashes).

Long-term use of the drug in high doses can cause development due to the accumulation of bismuth in the central nervous system.

Tablets De-Nol, instructions for use (Method and dosage)

The manufacturer in the instructions for the use of De-Nol indicates that patients older than 12 years of age should take 4 tablets per day.

There are two alternative ways to use De-Nol:

• one tablet four times a day;
• two tablets twice a day.

Tablets are taken half an hour before meals. With what to take De-Nol? It is necessary to drink it with a small amount of water.

How to take De-Nol for children?

In accordance with the instructions for the use of De-Nol, for children older than 4 years of age, the optimal dose of the drug is calculated using the formula 8 mg / day. per 1 kg of body weight. Thus, depending on the weight of the child, the daily dose can be from 1 to 2 tablets. At the same time, it should be as close as possible to the calculated one (8 mg / kg / day). You can take the medicine once, or you can divide it into two doses.

The duration of the course is four to eight weeks. After completion of treatment, the use of bismuth-containing preparations should be avoided for the next eight weeks.

Recipe in Latin for tablets:
Rep.: Tab. "De-Nol" N.112
D.S. 2 tablets 2 r / day

Why drink and how to drink D-Nol in diseases associated with H. pylori?

De-Nol is characterized by the ability to accumulate in the cells of Helicobacter pylori bacteria, which leads to the destruction of their cytoplasmic membranes and the death of microorganisms.

This, as well as the ability of bismuth subcitrate to dissolve well in gastric or duodenal mucus and prevent H. pylori adhesion to the epithelial tissue of the gastrointestinal tract, makes it possible to use De-Nol in various schemes for the destruction of these microorganisms.

Frequent use antibacterial drugs and widespread use of anti-Helicobacter pylori therapy has caused doctors to note a significant increase in the number of patients with antibiotic-resistant strains of H. pylori. Therefore, to solve the problem of eradication, treatment regimens are involved, which include reserve funds.

The patient can often be prescribed De-Nol and, or.

• 240 mg of bismuth subcitrate (De-Nol) twice a day for 30 days + 400 mg metronidazole and 500 mg three times a day for a weekly course (eradication - 81%);
• 120 mg bismuth subcitrate, 500 mg and 400 mg metronidazole four times a day for a weekly course (eradication - 89%);
• 240 mg of bismuth subcitrate, 400 mg metronidazole and 250 mg clarithromycin twice a day for a 10-day course (eradication - 95%);
• 240 mg bismuth subcitrate twice daily, 500 mg Flemoxin Solutab , 100 mg furazolidone four times a day with a two-week course (eradication - 86%);
• 240 mg of bismuth subcitrate, 200 mg furazolidone and 750 mg tetracycline twice a day for a weekly course (eradication - 85%);
• 240 mg of bismuth subcitrate, 100 mg furazolidone and 250 mg clarithromycin twice a day for a weekly course (eradication - 92%);
• 240 mg of bismuth subcitrate, 1000 mg Flemoxin Solutab and 250 mg clarithromycin twice a day for a weekly course (eradication - 93%);
• 120 mg of bismuth subcitrate, 250 mg clarithromycin and 250 mg tetracycline four times a day for a 10-day course (eradication - 72%);
• 120 mg of bismuth subcitrate and 500 mg Flemoxin Solutab four times a day and twice a day 20 mg omeprazole two-week course (eradication - 77%);
• 120 mg bismuth subcitrate four times a day, 500 clarithromycin and 40 mg omeprazole twice a day for a weekly course (eradication - 83%).

The challenge of eradicating strains of H. pylori resistant to metronidazole , at the lowest cost allows you to decide the use of the drug De-Nol in combination with furazolidone .

The most effective from a clinical and economic point of view is considered to be the scheme " bismuth subcitrate +amoxicillin + furazolidone «.

Overdose

A symptom of an overdose of De-Nol is a violation of the functional activity of the kidneys. The phenomenon is reversible, kidney function is fully restored after discontinuation of the drug.

Treatment of an overdose involves a gastric lavage procedure, the appointment of saline laxatives and enterosorbents. Further therapy is symptomatic.

If renal dysfunction is accompanied by a sharp increase in the plasma concentration of bismuth, the patient is administered chelating agents (for example, or D-penicillamine ). With severe violations of renal function may be required.

Interaction

The effectiveness of De-Nol may change when taken simultaneously with other drugs, as well as food and liquids (in particular, with antacids , fruits, milk, fruit juices), from which it is considered optimal to take the tablets half an hour before and half an hour after eating or taking any other medicines.

The use of the drug in combination with tetracyclines reduces the absorption of the latter.

Terms of sale

Non-prescription drug.

Storage conditions

Keep away from children, exposure to sunlight and moisture. The optimum temperature for storage is 15-25 °C.

Best before date

48 months.

special instructions

The annotation indicates that the maximum duration of the course of De-Nol is 8 weeks.

During treatment, you should not exceed the dose of the drug prescribed by the doctor and take other bismuth-containing drugs.

After completion of treatment with De-Nol, the plasma concentration of bismuth subcitrate ranges from 3 to 58 μg / l. Symptoms of intoxication appear only in cases where the concentration of the substance exceeds 100 μg / l.

During the period of use of the drug, black stools are possible. The reason for this phenomenon is the formation of Bi2S3 (bismuth sulfide). Sometimes the tongue may darken slightly.

There are no data on the effect of De-Nol on the ability to drive machinery and a car.

Sometimes you can find the names De-Nol and Di-Nol, however, it is still correct to write De-Nol.

De-Nol - an antibiotic or not?

Despite their antimicrobial properties De-Nol does not belong to the group of antibiotics and, therefore, is devoid of their inherent side effects.

For specialists, the tool is interesting primarily because H. pylori does not have even the slightest possibility of forming resistance to it. The inclusion of De-Nol in the combined scheme antihelicobacter therapy allows you to significantly increase its effectiveness and in most cases, completely get rid of the infection.

In addition, the drug enhances the protection of the gastric mucosa from the damaging effects of the digestive juice contained in it and contributes to its restoration. These effects develop due to the fact that De-Nol turns into a colloidal solution in the stomach.

Particles of the solution form a protective film on the damaged and inflamed areas of the mucous membrane, which accelerates the healing of tissues and prevents the formation of a rough scar. The latter is very important to prevent exacerbations of the disease.

Analogues of De-Nol

What can replace De-Nol? Synonyms for the drug are Vitridinol and .

Import analogues of the drug are cheaper than its cost: (Biofet, Bulgaria), (Reckitt Benckiser France S.A.), (Dr. Reddy's lab, India).

Domestic analogues: (JSC KhFK Akrikhin), (JSC Pharmstandard-Tomskhimfarm), (Irbitsky KhPZ), Flax seeds medicinal raw materials (JSC Evalar, LLC Faros-21).

The price of De-Nol analogues is from 20 Russian rubles.

Alcohol compatibility

During treatment with the drug, alcohol should be avoided.

Taking De-Nol during pregnancy

De-Nol is contraindicated during pregnancy. It should also be avoided in breastfeeding women.

Reviews about De-Nol

Reviews about De-Nol on the forums are mostly positive. Many patients call the drug a salvation from diseases caused by H. pylori. At the same time, the medicine effectively eliminates not only the symptoms (a feeling of fullness in the stomach after eating, gastralgia, loss of appetite, belching and diarrhea), but also the cause of the disease.

De-Nol suppresses the activity of pathogenic flora, restores the protective properties of the stomach and reduces the likelihood of relapse.

Doctors in reviews of De-Nol note that the best result can be achieved if the remedy is used as part of complex therapy. Quadruple schemes showed the greatest efficiency, in which, along with bismuth subcitrate tablets, Omeprazole ,

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

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.

Pharmacodynamics

Antiulcer 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 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.

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

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®.

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.

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 decreases. When taking de-nol in the "solo" mode, eradication of Helicobacter 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 effects. 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.