De-nol coated pills 120mg N112
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Active ingredients
Bismuth tri-potassium dicitrate
Release form
Pills
Composition
1 tablet contains: Active substance: bismuth tri-potassium dicitrate 304.6 mg, which corresponds to the bismuth oxide content of 120 mg. Auxiliary substances: corn starch - 70.6 mg, povidone K30 - 17.7 mg, potassium polyacrylate - 23.6 mg, macrogol 6000 - 6 mg, magnesium stearate - 2 mg. The composition of the shell: opadry OY-S-7366 (hypromellose 5 MPa · s - 3.2 mg, macrogol 6000 - 1.1 mg).
Pharmacological effect
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 precipitate, and also chelate compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions. Increasing the synthesis of prostaglandin E, the formation of mucus and the secretion of bicarbonate, 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
The absorption and distribution of bismuth tri-potassium dicitrate is practically not absorbed from the gastrointestinal tract. Withdrawal Excreted mainly with feces. An insignificant amount of bismuth entering the plasma is excreted by the kidneys.
Indications
decompensated renal failure; pregnancy; lactation period; children up to 4 years; hypersensitivity to the drug.
Contraindications
decompensated renal failure; pregnancy; lactation period; children up to 4 years; hypersensitivity to the drug.
Use during pregnancy and lactation
De-Nol is contraindicated for use during pregnancy and lactation.
Dosage and administration
Adults and children over 12 years old are prescribed 1 tablet each. 4 times / day for 30 minutes before meals and at night 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 meals. Children aged 4 to 8 years prescribed at a dose of 8 mg / kg / day; Depending on the body weight of the child, 1-2 pills per day are prescribed (respectively, 1-2 doses per day).In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day). Tablets are taken 30 minutes before a meal, washed down with a small amount of water. Duration of treatment is 4-8 weeks. Over the next 8 weeks 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 activity.
Side effects
On the part of the digestive system: possible nausea, vomiting, increased stool, constipation. These effects are not harmful to health and are temporary. Allergic reactions: skin rash, itchy skin. On the part of the central nervous system: with long-term use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.
Overdose
Symptoms: with prolonged use in doses exceeding the recommended, possibly impaired renal function (fully reversible with drug withdrawal). Treatment: gastric lavage, the appointment of activated carbon and saline laxatives. In the future, conduct symptomatic therapy. For violations of kidney function, accompanied by a high level of bismuth in the blood plasma, chelating agents can be administered (D-penicillamine, unitiol). In the case of pronounced renal impairment, hemodialysis is indicated.
Interaction with other drugs
While taking other medicines, as well as food and liquids, in particular, antacids, milk, fruit and fruit juices, it is possible to change the effectiveness of De-Nol (it is not recommended to take orally for 30 minutes before and after taking De-Nol). The combined use of De-nola with tetracyclines reduces the absorption of the latter.
special instructions
The drug should not be used for more than 8 weeks. During treatment, it is not recommended to exceed the prescribed daily doses for adults and children. During the period of treatment De-Nol should not use other drugs containing bismuth. 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 feces in black. Color: due to the formation of bismuth sulfide. Sometimes there is a slight darkening of the tongue.Impact on the ability to drive vehicles and control mechanisms Data on the effect of the drug De-nol on the ability to drive vehicles and mechanisms is missing.