Description
Release form
Film-coated tablets.
Pharmacological action
Anti-ulcer 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 precipitate, chelating compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosion. Increasing the synthesis of PGE, the formation of mucus and the secretion of bicarbonate, stimulates the activity of cytoprotective mechanisms, increases the resistance of the gastrointestinal mucosa to pepsin, hydrochloric acid, enzymes and bile salts. It leads to the accumulation of epidermal growth factor in the defect zone. Reduces pepsin activity.
Indications
peptic ulcer of the stomach and duodenum in the exacerbation phase, incl. Helicobacter pylori
associated with chronic gastritis and gastroduodenitis in the acute phase, including associated with Helicobacter pylori
irritable bowel syndrome, occurring mainly with symptoms of
diarrhea, functional dyspepsia, not associated with organic gastrointestinal diseases.
Contraindications
individual intolerance to the drug
severe renal failure (creatinine Cl less than 30 ml / min)
pregnancy
breastfeeding
children under 4 years of age.
Composition
active substance: bismuth tripotassium dicitrate 303.03 mg (equivalent to bismuth oxide 120 mg)
excipients: corn starch – 72.17 mg potassium povidone K30 – 18 mg polycline , 8 mg macrogol 6000 – 6 mg magnesium stearate – 2 mg.
Film sheath: Opadry II transparent (polyvinyl alcohol – 4.505 mg, macrogol 4000 – 2.295 mg) – 8.5 mg of titanium dioxide (E171) – 8.5 mg of talc – 1.7 mg.
Dosage and administration
Inside, 30 minutes before a meal, with a little water.
For adults and children over 12 years of age, Ulkavis is prescribed 1 tablet. 4 times a day and at night or 2 tablets. 2 times a day.
For children from 8 to 12 years old, Ulkavis is prescribed 1 tablet. 2 times a day from 4 to 8 years are prescribed in a dose of 8 mg / kg / day, depending on the body weight of the child, 1-2 tablets per day (respectively, in 1-2 doses per day). In this case, the daily dose should be closest to the calculated dose (8 mg / kg / day).
Duration of treatment 4–8 weeks. Over the next 8 weeks, medications containing bismuth should not be used.
For the eradication of Helicobacter pylori it is advisable to use the drug Ulkavis in combination with other antibacterial agents with anti-Helicobacter pylori activity (on the recommendation of a doctor).
Side effects
From the digestive system: the appearance of nausea, vomiting, more frequent stools, constipation. These phenomena are not hazardous to health and are temporary in nature.
Allergic reactions: skin rash, itchy skin.
With prolonged use in high doses, encephalopathy associated with the accumulation of bismuth in the central nervous system may develop.
Overdose
Symptoms: An overdose of the drug Ulkavis caused by prolonged use of doses exceeding the recommended, can lead to impaired renal function. These symptoms are completely reversible when Ulkavis is discontinued.
Treatment: gastric lavage, administration of activated charcoal and saline laxatives. Further treatment should be symptomatic. In case of impaired renal function, which is accompanied by a high concentration of bismuth in the blood plasma, chelating agents (penicillamine, sodium dimercaptopropanesulfonate) can be prescribed. In case of severe renal impairment, hemodialysis is indicated.
Dispensing conditions from
pharmacies Over-the-counter
dosage form
tablets
KRKA d.d. Novo mesto AO, Slovenia
