RURAL-zero

Active material: Bismuth tripotassium dicitratobismuthate
When ATH: A02BX05
CCF: Preparation, has a protective effect on the mucous membrane of the stomach and duodenum. Anti-ulcer drug
ICD-10 codes (testimony): K25, K26, K29, K30, K58
When CSF: 11.02
Manufacturer: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

Pharmaceutical form, composition and packaging

◊ Pills, coated cream white, round, lenticular, with an inscription “gbr 152”, embossed on one side, and a graphic pattern in the form of a square with discontinuous sides and rounded corners, embossed on the other side, odorless or with a slight odor of ammonia.

Excipients: corn starch, povidone K30, potassium polyacrylate, macrogol 6000, magnesium stearate.

The composition of the shell: Opadry OY-S-7366 (gipromelloza, macrogol 6000).

8 PC. – blisters (7) – packs cardboard.
8 PC. – blisters (14) – packs cardboard.

Pharmacological action

Antiulcer drug with bactericidal activity against Helicobacter pylori. Also has anti-inflammatory and astringent action. In the acidic environment of the stomach forms insoluble bismuth oxychloride, and citrate, and chelate compounds are formed from a proteinaceous substrate a protective film on the surface of ulcers and erosions. By increasing the synthesis of prostaglandin E, mucus and bicarbonate secretion, It stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to the action of pepsin, hydrochloric (salt) acid, enzymes and bile salts. It leads to the accumulation of epidermal growth factor in the area of ​​the defect. Reduces the activity of pepsin and pepsinogen.

Pharmacokinetics

Absorption and distribution

Bismuth tripotassium dicitratobismuthate practically not absorbed from the gastrointestinal tract. However, a minor amount of bismuth can enter into the systemic circulation.

Deduction

Write mainly in the faeces. A small amount of bismuth, received by the plasma, excreted by the kidneys.

Testimony

- Gastric ulcer and duodenal ulcer in the acute phase (incl. ассоциированная с Helicobacter pylori);

- Chronic gastritis and gastroduodenitis in the acute phase (incl. associated with Helicobacter pylori);

- Irritable Bowel Syndrome, flowing mostly with symptoms of diarrhea;

- Funktsionalynaya dyspepsia, not related to organic diseases of the digestive tract.

Dosage regimen

Adults and children over 12 years the drug is prescribed for 1 tab. 4 times / day for 30 minutes before meals and at bedtime or 2 tab. 2 times / day for 30 minutes before meals.

Children aged 8 to 12 years appoint 1 tab. 2 times / day for 30 minutes before eating.

Children aged 4 to 8 years administered at a dose of 8 mg / kg / day; the daily dose is divided into 2 admission. Get to 30 minutes before eating.

The tablets should be taken with a little water.

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

To eradication of Helicobacter pylori appropriate use of De-Nol^® in combination with antibacterial agents, having H. pylori activity.

Side effect

From the digestive system: nausea, vomiting, frequent stools, constipation. These effects are transient.

Allergic reactions: skin rash, itch.

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

Contraindications

- Severe renal impairment;

- Pregnancy;

- Lactation;

- Hypersensitivity to the drug.

Pregnancy and lactation

De-zero^® contraindicated during pregnancy and lactation.

Cautions

The drug should not be used more 8 weeks.

During treatment, do not exceed the recommended daily dose for adults and children.

During treatment De nolom^® should not use other drugs, containing bismuth.

Upon completion of a course of treatment at the recommended doses of active agent concentration in the blood plasma does not exceed 3-58 ug / l, and toxicity is observed only at concentrations greater than 100 ug / l.

In the application of De Nol^® possible staining of feces black due to the formation of bismuth sulphide. Sometimes there is a slight darkening of the tongue.

Overdose

Symptoms: long-term use at doses, exceeding recommended, possible impairment of renal function (completely reversible remove the drug).

Treatment: gastric lavage, the appointment of activated charcoal and saline laxatives. In the future, symptomatic therapy. If the kidney function, accompanied by high levels of bismuth in the blood plasma, You can enter complexing – dimerkaptoyantarnuyu and dimerkaptopropansulfonovuyu acid. In the case of severe renal impairment shows hemodialysis.

Drug Interactions

At the same time taking other drugs, as well as food and liquid, in particular, Antacids, milk, fruit and fruit juices may change the effectiveness De Nola^® (It is not recommended to be taken orally for 30 min before and after de-Nol^®).

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 4 year.