Coated tablets Gastroesophageal reflux disease: treatment of erosive reflux oesophagitis; prevention of recurrent reflux oesophagitis; symptomatic treatment of gastroesophageal reflux disease. Peptic ulcer coexisting with infectionHelicobacter pylori, in combination with appropriate antibacterial treatment: treatment of duodenal ulcer coexisting with infectionHelicobacter pylori; prevention of recurrent peptic ulcer in patients with peptic ulcer disease caused by infectionHelicobacter pylori. For patients who need long-term NSAID treatment: treatment of stomach ulcers associated with NSAID treatment; prevention of gastric and duodenal ulcers associated with NSAID treatment in patients at risk. Treatment of Zollinger-Ellison syndrome.Oral suspension - it is intended primarily for the treatment of gastroesophageal reflux disease in children aged 1 to 11 years and includes the treatment of erosions confirmed in endoscopic examination in the course of reflux oesophagitis and symptomatic treatment of gastroesophageal reflux disease; It can also be used in patients with difficulty in swallowing dissolved tablets of the preparation.
Composition:
1 tabl enteric contains 20 mg or 40 mg of esomeprazole in the form of a Magnesium trihydrate. 1 sachet contains 10 mg of esomeprazole in the form of magnesium trihydrate. The preparations contain sucrose.
Action:
S-isomer of Omeprazole, a specific proton pump inhibitor (H+/ K+ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of both hydrochloric acid, both basic and stimulated. Reduction of hydrochloric acid excretion increases serum gastrin concentration. Esomeprazole is sensitive to acid, therefore it is administered in the form of coated tablets or enteric granules resistant to its action. It is quickly absorbed from the digestive tract. Bioavailability after a single 20 mg dose is 50%, after repeated administration - 68%; for a 40 mg dose, 64% and 89%, respectively. The maximum concentration in plasma reaches up to 2 hours. In 97% it is bound to plasma proteins. T0,5 in the case of long-term treatment is 1.3 hours. Metabolized by the cytochrome P-450 system (with the participation of CYP2C19 and CYP3A4 isomers), excretion mainly occurs in the urine.
Contraindications:
Hypersensitivity to esomeprazole, benzimidazole derivatives or other components of the preparation. Do not use in patients treated concomitantly with nelfinavir and atazanavir.
Precautions:
Preparation in the form of tabl. powl. do not use in children under 12 years. The granular preparation is not recommended for use in children aged 1 or weighing <10 kg. Due to the content of sucrose in the granules, the preparation should not be used in patients with fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption syndrome.
Pregnancy and lactation:
Due to limited tests, use carefully during pregnancy. The safety of the preparation during breastfeeding has not been established, therefore the preparation should not be administered.
Side effects:
Common: headache, abdominal pain, constipation, diarrhea, bloating, nausea, vomiting. Uncommon: peripheral edema, insomnia, paresthesia, drowsiness, labyrinth-like dizziness, dry mouth, increased activity of liver enzymes, dermatitis, pruritus, rash, urticaria. Rare: leukopenia, thrombocytopenia, hypersensitivity reactions (eg fever, angioneurotic edema and anaphylactic reaction, shock), hyponatraemia, agitation, confusion, depression, dysgeusia, blurred vision, bronchospasm, stomatitis, fungal infection (candidiasis) of the duct alimentary tract, hepatitis with jaundice or without jaundice, alopecia, hypersensitivity to light, joint or muscle aches, unwellness, increased sweating. Very rare: agranulocytosis, pancytopenia, aggression, hallucinations, hepatic failure, encephalopathy in patients with pre-existing liver disease, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, interstitial nephritis, gynecomastia.
Dosage:
Orally. Adults and adolescents over 12 years old. Gastroesophageal reflux disease: erosions in reflux oesophagitis - 40 mg once daily for 4 weeks; if there is no improvement, the treatment can be continued for another 4 weeks; prevention of relapse of reflux oesophagitis: 20 mg once a day; symptomatic treatment of gastroesophageal reflux disease: if esophagitis has been excluded: 20 mg once daily for 4 weeks. In patients whose symptoms persist after 4 weeks of treatment, the diagnosis should be reviewed to reveal another cause of the disease. After the disability, use 20 mg once a day to control the course of the disease (in adults, this dose can be used temporarily, if necessary). In patients treated with NSAIDs who are at risk of gastric and duodenal ulcers, ad hoc administration is not recommended in case of recurrence of symptoms.AdultsPeptic ulcer coexisting with infectionHelicobacter pylori and prevention of relapse: 20 mg twice daily for 7 days in combination with 1 g Amoxicillin and 500 mg of clarithromycin.Long-term treatment of stomach ulcers associated with the use of NSAIDs: 20 mg once daily for 4-8 weeks. Prevention of gastric and duodenal ulcers associated with NSAID treatment in patients at risk: 20 mg once a day.Zollinger-Ellison syndrome: starting dose: 40 mg twice daily, then the dose should be determined individually (the most common doses of 80-160 mg per day are sufficient to control the symptoms). In patients with severe hepatic impairment, the maximum dose is 20 mg once a day. Table. should be swallowed whole and washed down with liquid, they should not be chewed or crushed; in the case of patients who have difficulty swallowing tables. You can dissolve in half a glass of water (do not dissolve in any other liquid, because the cover protecting against the stomach acid can be damaged). The prepared solution, with visible granules, should be drunk within 30 minutes of preparation; undissolved granules should not be chewed or crushed.Children from 1 to 11 years of age weighing ≥ 10 kgGastroesophageal reflux disease - treatment of erosions confirmed in endoscopy in the course of reflux oesophagitis: mc.≥10 - <20 kg: 10 mg once a day for 8 weeks; mc.≥20 kg: 10-20 mg once a day for 8 weeks; symptomatic treatment: 10 mg once daily up to 8 weeks. Doses higher than 1 mg / kg / day have not been studied. In patients with severe hepatic impairment ≥ 12 years of age, the maximum dose is 20 mg. In patients with severe hepatic impairment between 1-11 years, the maximum dose is 10 mg. For the 10 mg dose, pour the contents of the 10 mg sachet into a glass containing 15 ml of non-carbonated water. For a 20-mg dose, add two 10-mg sachets to a glass containing 30 ml of non-carbonated water. Mix and wait a few minutes for the suspension to thicken. Then mix again and drink within 30 minutes of preparation. The granules should not be chewed or crushed.