De-Nol: 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

Antiulcer drug with bactericidal activity against Helicobacter pylori.
Drug: DE-NOL®
Active substance drug: bismuthate, tripotassium dicitrato
ATX coding: A02BX05
KFG: A drug that provides protective effect on the gastric mucosa and duodenum. Antiulcer drug
Registration number: P No. 012626/01
Registration date: 12/13/07
Owner reg. credential: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

Cream-coated tablets white, round, biconvex, with the wording "gbr 152" embossed on one side and a graphic design of a square with broken sides and rounded corners embossed on the other side, odorless or with a slight ammonia odor. 1 tab. bismuth tripotassium dicitrate 304.6 mg, which corresponds to the content of bismuth oxide 120 mg
Excipients: corn starch, povidone K30, potassium polyacrylate, macrogol 6000, magnesium stearate.
Shell composition: Opadry OY-S-7366 (hypromellose, macrogol 6000).
8 pcs. - blisters (7) - cardboard packs.
8 pcs. - blisters (14) - cardboard packs.
The description of the drug is based on the officially approved instructions for use.

Pharmacological action De-nol

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 formed, and chelate compounds are formed with the protein substrate in the form of a protective film on the surface of ulcers and erosions. By increasing the synthesis of prostaglandin E, mucus formation and bicarbonate secretion, it stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric (hydrochloric) acid, enzymes and salts bile acids. Leads to the accumulation of epidermal growth factor in the defect area. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics of the drug.

Suction and distribution
Bismuth tripotassium dicitrate is practically not absorbed from the gastrointestinal tract. However, small amounts of bismuth may enter the systemic circulation.
Removal
It is excreted mainly in feces. A small amount of bismuth entering the plasma is excreted 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 predominantly with symptoms of diarrhea;
- functional dyspepsia not associated with organic gastrointestinal diseases.

Dosage and method of administration of the drug.

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/day 30 minutes before meals.
Children aged 8 to 12 years are prescribed 1 tablet. 2 times/day 30 minutes before meals.
Children aged 4 to 8 years are prescribed a dose of 8 mg/kg/day; The daily dose is divided into 2 doses. Take 30 minutes before meals.
The tablets should be taken with a small amount of water.
The duration of treatment is 4-8 weeks. You should not take medications containing bismuth for the next 8 weeks.
For the eradication of Helicobacter pylori, it is advisable to use De-Nol in combination with antibacterial drugs with anti-Helicobacter activity.

Side effects of De-nol:

From the outside digestive system: Possible nausea, vomiting, increased bowel movements, constipation. These effects are transient in nature.
Dermatological reactions: skin rash, itching.
From the side of the central nervous system: with long-term use V high doses- encephalopathy associated with the accumulation of bismuth in the central nervous system.

Contraindications to the drug:

Severe renal dysfunction;
- pregnancy;
- lactation period;
- increased sensitivity to the drug.

Use during pregnancy and lactation.

De-Nol is contraindicated for use during pregnancy and lactation.

Special instructions for use of De-nol.

The drug should not be used for more than 8 weeks.
During treatment, it is not recommended to exceed the established daily doses for adults and children.
During treatment with De-Nol, you should not use other drugs containing bismuth.
At the end of a 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, stool may turn black due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.

Drug overdose:

Symptoms: with long-term use in doses exceeding the recommended ones, renal function may be impaired (completely reversible when the drug is discontinued).
Treatment: gastric lavage, administration of activated charcoal and saline laxatives. Subsequently, symptomatic therapy is carried out. In cases of renal dysfunction accompanied by high level bismuth in the blood plasma, complexing agents can be introduced - dimercaptosuccinic and dimercaptopropanesulfonic acids. When pronounced violation renal function, hemodialysis is indicated.

Interaction of De-nol with other drugs.

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

Terms of sale in pharmacies.

The drug is approved for use as a means of OTC.

Terms of storage conditions for the drug De-nol.

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 4 years.

The Astellas Pharma company from the Netherlands has developed the drug De-Nol for the treatment of digestive ulcers. It has a protective effect on the mucous membranes of the body. In order to use the medicine as intended and not have side effects, you should know more information, studying the instructions for its use.

De-Nol - indications for use

They produce anti-ulcer medicine De-Nol (Latin international name De-Nol) in round tablets with a cream-colored shell. On one side the inscription gbr 152 is embossed, on the other there is a graphic square design with rounded corners. The tablets are packed in 8 pieces in aluminum blisters, which are placed in cardboard packaging of 7 or 14 pieces. The shelf life of the medicine is 4 years. De-Nol belongs to the pharmacological group of gastroprotectors, inexpensive.

The product is used to protect the digestive organs from peptic ulcer. An ulcer is a defect in the mucous membrane formed by the action of enzymes on it. of hydrochloric acid, bile, bacteria Helicobacter pylori. The drug De-Nol should be purchased or ordered for gastritis (inflammation of the internal mucous membrane of the stomach) or gastroduodenitis (inflammation of the mucous membrane of the duodenum and pyloric part of the stomach). A gastroprotector is also prescribed for irritable bowel disease (IBS).

Composition of the drug

One De-Nol tablet contains 120 mg of active substance. The main component (bismuth tripotassium dicitrate) after penetration into the stomach at the site of the lesion forms a protective layer that prevents stomach acid corrode damaged mucous membrane. Excipients of the drug:

• ammonium and potassium citrates;
• povidone K 30;
• polacriline potassium;
• magnesium stearate;
• corn starch;
• macrogol 6000;
• hydroxypropyl methylcellulose.

How De-Nol works

Constant stress poor nutrition, lack of sleep negatively affects health. The first to react are the digestive organs, which make themselves felt with stomach pain and intestinal discomfort. Helps cope with diseases: the instructions for use state that the medicine has wide range actions. Due to its mechanism of action, the drug is often prescribed for complex treatment digestive organs.

Protecting the gastric mucosa

When ulcers appear on the inside of the mucous membrane, it causes great discomfort to a person. Taking De-Nol helps create protection on damaged surfaces in the form of a film, due to which gastric juice cannot penetrate the irritated area. Thanks to this effect, scarring processes are accelerated ulcerative lesions. According to the instructions, the drug improves blood flow through the capillaries, after which acceleration occurs in the cells metabolic processes, which helps damaged tissues recover quickly.

Fighting Helicobacter pylori bacteria

The main cause of peptic ulcers in the human body is the presence of Helicobacter pylori microbes. De-Nol tablets affect bacteria, stopping their activity, due to the following properties:

• penetrate into the deep layers of tissue, neutralizing bacteria;
• reduce the aggressiveness and mobility of Helicobacter pylori;
• impair the ability of the microbe to attach to the mucous membrane;
• violate integrity cell membrane Helicobacter pylori;
• inhibit the activity of bacterial enzymes, disrupting their vital functions.

Bismuth tripotassium dicitrate - instructions for use

The doctor prescribes the medicine De-Nol in dosages based on individual indicators and patient diagnosis. The duration of the course and its price depend on multiple factors, but you should not take the pills for more than two months. After the end of treatment, it is not recommended to carry out therapy with drugs containing bismuth for the next eight weeks, since the substance can accumulate in the body.

How to drink De-Nol for adults

According to the instructions for use, the tablets are taken orally and washed down with water (large quantities). Depending on the diagnosis, doctors treat gastroprotectors with different regimens. As a rule, the drug is prescribed at a dose of 480 mg/day, which is divided into 4 doses. You should take the tablets half an hour before going to bed or eating. Allowed to take 2 times/day 240 mg.

How to take De-Nol tablets for children

Bismuth tripotassium dicitrate is prescribed to children 8-12 years old at 240 mg/day. Take the tablets 2 times a day before meals. If the patient's age is 4-8 years, then the indication daily norm should be calculated based on the child's weight (8 mg/kg). The dose should also be divided into two doses. The duration of use of the drug is prescribed by the pediatrician individually. The medicine combines well with antibiotics.

Contraindications and side effects

The officially confirmed instructions for use of De-Nol say that if the dose is exceeded, a person’s digestive function is impaired and rashes appear on the mucous membranes. A sign of De-Nol poisoning is the appearance on the gums dark spots. Uncontrolled use of a gastroprotector leads to the onset of irreversible renal pathologies. If an overdose occurs, you should immediately rinse your stomach, then take Activated carbon, after this you need to take tests for the condition of your kidneys and the level of bismuth in your blood. At renal failure need hemodialysis.

Since treatment with De-Nol is long-term, patients have a question about how compatible it is with alcohol. With excessive consumption of alcohol-containing drinks, a person’s body becomes intoxicated, and he begins to get sick. Alcohol irritates the gastric mucosa, which leads to weakened immunity. The most common diseases of alcoholics are pancreatitis and ulcers. The instructions for use of De-Nol do not indicate that the medicine is not compatible with alcohol, but since bismuth is a toxic component, the liver will suffer from such an interaction.

De-nol is a medicine from the group of gastroprotectors based on bismuth, which is used to treat diseases of the stomach and duodenum. The drug has an astringent and antimicrobial effect. Contraindicated for children under 14 years of age, during pregnancy, and for women during breastfeeding. The dosage form De-nol is available in the form of tablets for oral use (via digestive tract) white, covered with a film shell. The tablets are packaged in blisters of 8 pieces, in cardboard box 7 or 14 blisters.

Description and composition

Active substance medicinal product– colloidal bismuth subcitrate (120 mg). The active substance has an astringent, antibacterial, anti-inflammatory, gastroprotective (protection of the gastric mucosa) effect. Auxiliary components The drug contains: povidone, magnesium stearate, polacrinil potassium, hypromelose, corn starch. Additional Ingredients necessary to create dosage form, convenient for oral administration, improve absorption of the active substance.

Pharmacological group

De-nol refers to drugs with a predominant effect on the stomach and upper parts small intestine. Pharmacological group– an astringent with an antiseptic effect. Bismuth subcitrate has a protective effect on the gastric mucosa, promotes the regeneration of ulcers and erosions, reduces the synthesis of hydrochloric acid and pepsin, and has a bactericidal effect on Helicobacter pylori.

Pharmacodynamics

De-nol has an astringent and gastroprotective effect due to the formation of chelate compounds with proteins. As a result, a film is formed on the surface of the mucous membrane of the stomach and duodenum in the area where ulcers and erosions are located, which protects the serous layer from the harmful effects of hydrochloric acid. This promotes rapid tissue regeneration, scarring of mucosal defects and deep-lying ulcers in the wall of the stomach or intestines - an anti-ulcer effect.

Bismuth subcitrate in the composition of the drug has a bactericidal effect on Helicobacter pylori - a bacterium causing the appearance gastritis and peptic ulcer. The drug penetrates pathogenic microorganisms, destroys cell membranes and reduces the activity of enzymatic systems. This leads to disruption of vital functions and death of bacteria. Bismuth subcitrate has high degree solubility, which allows it to penetrate into the deep layers of the mucous membrane of the stomach and duodenum and destroy Helicobacter pylori in the submucosal layer - an anti-relapse effect.

The gastroprotective effect is associated with the activation of the synthesis of prostaglandins, which increase the production of mucin and bicarbonates to create a mucosal-bicarbonate protective layer. Bismuth subcitrate inhibits the production of hydrochloric acid and pepsin, reduces the aggressive effect gastric juice to the mucous membrane. The drug normalizes microcirculation in the wall of the stomach and duodenum, which improves metabolism and increases the regenerative properties of tissues.

Pharmacokinetics

At oral administration De-nol has maximum therapeutic effect in the lumen of the stomach and duodenum. The acidic environment of gastric juice activates the components of the drug. The drug enters the general bloodstream in small quantities and has a weak effect. systemic action. Bismuth subcitrate is excreted from the body in feces.

Indications for use

For adults

De-nol is prescribed for infectious and inflammatory diseases of the stomach and upper sections small intestine which occur with damage to the mucous layer. The drug has an antiulcer effect and a bactericidal effect against Helicobacter pylori. The effectiveness of the drug in the treatment of gastritis and gastric ulcers is associated with the lack of resistance of the bacterium to bismuth subcitrate.

1. Spicy and chronic form gastritis.
2. Gastroduodenitis.
3. Esophagitis as a result of gastroesophageal reflux.
4. Peptic ulcer of the stomach and duodenum.
5. Ulceration of the gastric mucosa by drugs and toxic substances (NSAIDs, glucocorticoids, antihypertensive drugs, alcohol).
6. Functional impairment without organic damage digestive tract.
7. Irritable bowel syndrome.

De-nol has an anti-relapse effect against gastritis and peptic ulcers associated with Helicobacter pylori. The drug is prescribed to prevent exacerbation of these diseases through prophylactic courses.

For children

De-nol is not prescribed to children under 14 years of age. The dosage of the drug in older age is selected individually and usually corresponds to the minimum therapeutic dose that is used for adult patients. Based on individual prescription, the drug can be used for children over 8 years of age.

De-nol is not used during pregnancy. The drug affects the development of mutations and disruption of intrauterine development of the fetus, especially early stages pregnancy. If the drug is prescribed during breastfeeding, the child is transferred to artificial feeding. Bismuth subcitrate penetrates into breast milk and causes disruption nervous system child.

Contraindications

Contraindications to the drug are taken into account before starting treatment.

1. Individual intolerance to the components in the drug.
2. Taking medications that contain bismuth.
3. Chronic renal and liver failure in the stage of decompensation.
4. Period of fetal development.
5. Lactation period.
6. Children under 14 years of age.

Prescription during breastfeeding requires cancellation breastfeeding. According to indications, the drug can be prescribed to children over the age of 8 years.

Application and dosage

For adults

For adults and children over 14 years of age, De-nol is prescribed 1 tablet 4 times a day. The drug is taken half an hour before meals and before bedtime with half a glass of water. Alternative way prescription of the drug - 2 tablets 2 times a day half an hour before breakfast and dinner. The duration of the therapeutic course is 4-6 weeks, but not more than 2 months. After completing the therapeutic course, it is not recommended to take bismuth preparations for 6-8 weeks. In the case of treatment of gastritis and peptic ulcers caused by Helicobacter pylori, De-nol is prescribed with antibiotics that have anti-Helicobacter pylori activity.

For children

According to individual indications, De-nol is prescribed in childhood from 8 years old. The drug is taken 1 tablet 2 times a day, half an hour before breakfast and dinner, with half a glass of water.

For pregnant women and during lactation

Pregnant women and women during lactation are not prescribed De-nol.

Side effects

The drug is well tolerated. Side effects rarely occur and go away on their own within a few days after starting to take the drug.

1. Allergies (itching of skin,).
2. Nausea, rarely.
3. Diarrhea, tendency to constipation.
4. Change in color of stool (black).
5. Darkening of the mucous membrane of the tongue.
6. Toxic encephalopathy.

Progression of symptoms of side effects requires discontinuation of the drug and seeking advice from a doctor.

Interaction with other drugs

Simultaneous administration of De-nol and antacids reduces it therapeutic effect. Medicinal substances apply with a time interval of 40-60 minutes. Bismuth subcitrate slows down the absorption of some antibacterial drugs (cephalosporins). Parallel use of medications containing bismuth, such as Vikalin, Bisal, Vikair, increases toxic effect the drug on the brain and causes encephalopathy.

special instructions

During therapy it is not recommended to use alcoholic drinks. De-nol must be taken between meals. Concomitant use taking the drug with dairy products and fruits reduces its effectiveness. The duration of the therapeutic course should not exceed 2 months. During treatment, De-nol can cause darkening of the mucous membrane of the tongue and feces, which is associated with the formation of bismuth sulfide in the body as a result of the reaction of bismuth subcitrate with hydrogen sulfide.

Overdose

Long-term use of the drug in high therapeutic doses can cause bismuth poisoning.

1. Stomach ache.
2. Nausea, repeated.
3. Bloating.
4. Diarrhea.
5. Formation of a black border on the gums.
6. Renal failure (skin itching, hypertension, decreased diuresis).

Withdrawal of the drug leads to normalization general condition And reverse development symptoms. In severe cases of poisoning, hemodialysis is performed.

Storage conditions

The drug should be stored in dark place with low humidity, at a temperature of +10-+30 degrees. Keep away from children.

Analogs

Analogues of the drug are:

• Biskol;
• Ventrisol;
• Biscol Citrate;
• Vis-Nol;
• Tribimol;
• Duosol;
• Ulceron.

Due to the difference in active ingredients, replacement should be carried out after prior medical consultation.

Drug price

The cost of the medicine is on average 686 rubles. Prices range from 254 to 1000 rubles.

Composition and release form of the drug

◊ Tablets, coated film-coated creamy white, round, biconvex, with "gbr 152" embossed on one side and a graphic design of a square with broken sides and rounded corners embossed on the other side.

Excipients: corn starch - 70.6 mg, K30 - 17.7 mg, potassium polyacrylate - 23.6 mg, macrogol 6000 - 6 mg, magnesium stearate - 2 mg.

Compoundshells: opadry OY-S-7366 (hypromellose 5 mPa s - 3.2 mg, macrogol 6000 - 0.5 mg; macrogol 6000 - 0.6 mg).

8 pcs. - blisters (4) - cardboard packs.
8 pcs. - blisters (7) - cardboard packs.
8 pcs. - blisters (14) - cardboard packs.

pharmachologic effect

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 formed, and chelate compounds are formed with the protein substrate in the form of a protective film on the surface of ulcers and erosions. By increasing the synthesis of prostaglandin E, mucus formation and bicarbonate secretion, it stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to the effects of pepsin, hydrochloric (hydrochloric) acid, enzymes and bile salts. Leads to the accumulation of epidermal growth factor in the defect area. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

Bismuth tripotassium dicitrate is practically not absorbed from the gastrointestinal tract. However, small amounts of bismuth may enter the systemic circulation. It is excreted mainly in feces. A small amount of bismuth that enters the body is excreted by the kidneys.

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 predominantly with symptoms; functional dyspepsia not associated with organic gastrointestinal diseases.

Contraindications

Severe renal dysfunction, pregnancy, lactation, hypersensitivity to bismuth tripotassium dicitrate.

Dosage

Adults and children over 4 years old - orally 2-4 times a day 30 minutes before meals. The dose depends on the patient's age.

The course of treatment is 4-8 weeks. You should not take medications containing bismuth for the next 8 weeks.

For eradication Helicobacter pylori, it is advisable to use bismuth tripotassium dicitrate in combination with antibacterial drugs with anti-Helicobacter activity.

Side effects

From the digestive system: Transient effects are possible - nausea, vomiting, increased bowel movements, constipation.

Dermatological reactions:, itching.

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

Drug interactions

When taking other medicines, as well as food and liquids at the same time, in particular

2. indications for use

• Prescribed for gastric and duodenal ulcers in the acute phase, acute and chronic, and gastroduodenitis, including those associated with Helicobacter pylori.
• Irritable bowel syndrome (if symptoms of diarrhea are present).
• Functional dyspepsia(not associated with organic diseases of the gastrointestinal tract).
• Peptic ulcer of the duodenum and stomach;
• Lesions of the gastric mucosa that developed after taking non-steroidal anti-inflammatory drugs;

3. Method of application

Standard daily dose De-Nola is 4 tablets. It is recommended to take the drug in 2-4 doses.

According to the standard treatment regimen of the drug, take 1 tablet 30 minutes before meals (in the case of 3 one meal) and 1 additional tablet before bedtime.

According to an alternative treatment regimen, take 2 tablets of the drug 30 minutes before meals twice a day (only in the morning and evening).

It is recommended to swallow the tablets without chewing, rubbing or crushing them, and wash them down with plenty of water (not milk!). Standard treatment is 1-2 months. For 2 months after treatment with De-Nol, it is not recommended to take medications based on or containing bismuth.

If the results of subsequent microbiological tests indicate the presence of Helicobacter pylori, recommended complex therapy according to one of the following schemes:

• De-Nol – 1 tablet 30 minutes before meals, twice a day;
• Clarithromycin – 500 mg twice daily;
• – 1000 mg twice a day.
• The duration of treatment according to this regimen is 1-2 weeks.
• De-Nol – 1 tablet 30 minutes before meals, twice a day;
• Tetracycline – 500 mg 4 times a day;
• Metronidazole – 500 mg 3 times a day;
• Drugs from the group of proton pump inhibitors (Omeprazole, Lanzoprazole, etc.) are taken in a standard dosage.
• The duration of treatment according to this regimen is 1-2 weeks.

After a course of combined antimicrobial therapy, it is possible to continue treatment additional course the drug De-Nol to accelerate the recovery of the mucous membrane of the stomach and duodenum. In this case, De-Nol is taken according to the standard regimen. However, it must be remembered that the general The duration of treatment with De-Nol should not exceed 2 months.

4. Side effects

From the gastrointestinal tract:

Possible nausea, stool disorders (both constipation and diarrhea are possible), vomiting. Slight darkening and black discoloration of stool was also noted.

Allergic reactions:

Skin itching and rashes. Possible development (extremely rare).

Possible development of encephalopathy with long-term use drug (due to the accumulation of bismuth compounds in the tissues of the central nervous system).

All identified side effects are reversible and go away on their own after stopping the drug.

5. Contraindications

6. During pregnancy and lactation

7. Interaction with other drugs

• Diets with milk and antacids reduce the effectiveness of De-Nol. An interval of at least half an hour is required between taking De-Nol and antacid medications. The drug is taken at least 30 minutes before meals.
• De-Nol is not taken together with other bismuth-containing drugs, since a high total bismuth content significantly increases the risk of side effects, in particular encephalopathy.

8. Overdose

There is no special antidote. In case of overdose, gastric lavage, sorbent drugs and symptomatic therapy to improve kidney function are performed. Also, in case of overdose, saline laxatives are prescribed. IN in case of emergency at severe defeat kidneys undergo hemodialysis.

9. Release form

10. Storage conditions

Shelf life of De-Nol- 4 years.

11. Composition

1 tablet:

• bismuth tripotassium dicitrate - 304.6 mg;
• which corresponds to the content of bismuth oxide - 120 mg;
• Excipients: corn starch, povidone K30, potassium polyacrylate, macrogol 6000, magnesium stearate.

12. Conditions for dispensing from pharmacies

Found a mistake? Select it and press Ctrl + Enter

* Instructions for medical use to the drug De-Nol is published in free translation. THERE ARE CONTRAINDICATIONS. BEFORE USE, YOU MUST CONSULT WITH A SPECIALIST