- active substance: omeprazole;
- 1 capsule contains omeprazole in the composition of pellets (8.5%) 20 mg;
- excipients: sodium hydrogen phosphate, sodium lauryl sulphate, calcium carbonate, mannitol (E 421), sucrose, hypromellose (hydroxypropylmethylcellulose), methacrylate copolymer (type C), diethyl phthalate, titanium dioxide (E 171);
- the composition of the capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104).
Dosage form. Capsules.
Main physical and chemical properties: hard gelatin capsules № 2, cylindrical with hemispherical ends, body – white, lid – yellow. The contents of the capsules are white or almost white, odorless pellets.
10 capsules in a blister; 1 or 3 blisters in a box.
Benign gastric ulcer and duodenal ulcer, including associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs); eradication of Helicobacter pylori (as part of combination therapy with antibacterial agents); gastroesophageal reflux disease; prevention of aspiration of gastric acid content; Zollinger-Ellison syndrome; relief of symptoms of acid-dependent dyspepsia.
Hypersensitivity to omeprazole, to substituted benzimidazoles, or to any other components of the drug. Omeprazole, like other proton pump inhibitors, should not be taken with nelfinavir and atazanavir.
Apply orally before or during meals, without chewing or damaging the capsule, drinking a small amount of liquid. The dosage regimen depends on the type and severity of the disease and is set by the doctor individually for each patient.
Adults and children from 12 years.
Gastric or duodenal ulcer: daily dose – 1 capsule. Usually, the course of treatment of duodenal ulcer is 4 weeks, gastric ulcer – 8 weeks. If necessary, the daily dose can be increased to 2 capsules.
Treatment and prevention of duodenal and gastric ulcers, as well as gastroduodenal erosion and dyspeptic symptoms associated with the use of NSAIDs: the recommended daily dose is 20 mg. The course of treatment is 4-8 weeks.
For eradication of H. pylori: omeprazole is prescribed in a daily dose of 40 mg (20 mg 2 times a day) as a part of complex therapy according to the approved international schemes:
– triple therapy for duodenal ulcer: for 1 week 2 times a day: amoxicillin 1 g and clarithromycin 500 mg; for 1 week 2 times a day: clarithromycin
250 mg and metronidazole 400 mg (or tinidazole 500 mg); for 1 week 3 times a day: amoxicillin 500 mg and metronidazole 400 mg;
– double therapy for duodenal ulcer: for 2 weeks 2 times a day: amoxicillin 750 mg – 1 g; for 2 weeks 3 times a day: clarithromycin 500 mg;
– double therapy for gastric ulcer: for 2 weeks 2 times a day amoxicillin 750 mg – 1 g
Gastroesophageal reflux disease: daily dose – 1 capsule, course of treatment – 4-8 weeks. Patients with reflux esophagitis resistant to treatment are prescribed 2 capsules daily for 8 weeks.
Prevention of gastric acid aspiration: the recommended dose of omeprazole is 40 mg the night before and 40 mg 2-6 hours before anesthesia.
Zollinger-Ellison syndrome: the initial dose of omeprazole, which is used once in the morning, is 60 mg per day; if necessary, the daily dose is increased to 80-120 mg. The dose should be selected individually based on the body’s response. If the daily dose exceeds 80 mg, it should be divided into 2-3 doses.
Acid-dependent dyspepsia: the daily dose is 10-20 mg once for 2-4 weeks. If after 4 weeks the symptoms do not disappear or reappear quickly, the patient’s diagnosis should be reconsidered. If it is necessary to use omeprazole in a single dose of less than 20 mg, use a drug with a lower content of active substance.
No dose adjustment of omeprazole is required for the elderly or patients with renal impairment.
For patients with hepatic impairment, the maximum daily dose of omeprazole is 20 mg.
Children. In this dosage form, omeprazole should be used in children from 5 years with a bodyweight of at least 20 kg.
At a reflux esophagitis a course of treatment – 4-8 weeks;
in the symptomatic treatment of heartburn and regurgitation of hydrochloric acid in gastroesophageal reflux disease – 2-4 weeks. The daily dose is 20 mg, if necessary, the daily dose can be increased to 40 mg.
If the child cannot swallow the capsule, it should be opened and the contents mixed with a small amount of apple juice or yogurt (approximately 10 ml). Care should be taken to ensure that the child swallows this mixture immediately after cooking.
Omeprazole may be used as part of combination therapy to eradicate H. pylori in children from 5 years of age, but this therapy should be performed with extreme caution under close medical supervision. The course of treatment is 7 days, if necessary, the course of treatment is extended to 14 days.
– children weighing 30-40 kg: omeprazole 20 mg, amoxicillin 750 mg, clarithromycin 7.5 mg/kg body weight 2 times a day for 7 days;
– children weighing more than 40 kg: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg 2 times a day for 7 days.