Omeprazole-Akrikhin capsules intestinal 20 mg No. 30
Compound
Active substance: omeprazole (in pellet form) 20 mg.
Composition of omeprazole pellets: pellets - 235 mg (active substance: omeprazole - 8.5%; excipients: mannitol - 17%, sucrose - 27.33%, sodium hydrogen phosphate (disubstituted sodium phosphate) - 1.27%, sodium lauryl sulfate - 0.34%, lactose monohydrate - 3.4%, sodium carbonate - 3.4%, hypromellose (hydroxypropyl methylcellulose) - 8.75%, copolymer of methacrylic acid and ethyl acrylate (1:1) - 25%, propylene glycol - 0.81%, diethyl phthalate - 2.5%, cetyl alcohol - 0.75%, sodium hydroxide - 0.15%, polysorbate 80 (Tween 80) - 0.3%, povidone (polyvinylpyrrolidone) - 0.26%, titanium dioxide - 0.18%, talc - 0.06%). Composition of the hard gelatin capsule body: titanium dioxide - 2%, yellow iron oxide - 0.25%, gelatin - up to 100%. Composition of the hard gelatin capsule cap: titanium dioxide - 0.5%, yellow iron oxide - 0.65%, black iron oxide - 0.41%, indigotine - 0.2086%, gelatin - up to 100%.
Pharmacokinetics
When taken orally, it is quickly absorbed from the gastrointestinal tract. Penetrates the parietal cells of the gastric mucosa. Plasma protein binding is about 95%, mainly with albumin. Biotransformed in the liver. Excreted by the kidneys - 72-80%, with feces - about 20%. T1/2 0.5-1 hour. In patients with chronic liver diseases, T1/2 increases to 3 hours.
Indications for use
Adults
- peptic ulcer of the stomach and duodenum (including prevention of relapses);
- reflux esophagitis;
- Zollinger-Ellison syndrome;
- stress ulcers of the gastrointestinal tract (GIT);
- polyendocrine adenomatosis;
- systemic mastocytosis;
- gastropathy caused by taking nonsteroidal anti-inflammatory drugs (NSAID gastropathy);
- eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers (as part of combination therapy);
Children
- gastroesophageal reflux disease in children over 2 years of age;
- duodenal ulcer associated with Helicobacter pylori (as part of combination therapy) in children over 4 years of age.
Contraindications
- Hypersensitivity to omeprazole or other components of the drug;
- simultaneous use with erlotinib, posaconazole, nelfinavir, St. John's wort preparations;
- combined use with clarithromycin in patients with liver failure;
- rare hereditary forms of lactose intolerance, lactase deficiency, sucrase/isomaltase deficiency, glucose-galactose malabsorption, fructose intolerance;
- children under 2 years of age and weighing less than 20 kg (in the treatment of reflux esophagitis, symptomatic treatment of heartburn and sour belching in gastroesophageal reflux disease);
- children under 4 years of age or weighing less than 31 kg (when treating duodenal ulcers caused by Helicobacter pylori);
- children under 18 years of age for all indications except gastroesophageal reflux disease and duodenal ulcer associated with Helicobacter pylori.
With caution:
Renal and/or liver failure; osteoporosis; pregnancy; simultaneous use with atazanavir (the dose of omeprazole should not exceed 20 mg per day), clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin; the presence of “alarming” symptoms: significant weight loss, repeated vomiting, vomiting with blood, difficulty swallowing, change in the color of stool (tarry stools); deficiency of vitamin B12 (cyanocobalamin).
Directions for use and doses
Inside, do not chew. Capsules are usually taken in the morning with a small amount of water (immediately before or during meals).
Adults
For exacerbation of peptic ulcer, reflux esophagitis and NSAID gastropathy - 20 mg 1 time per day. For patients with severe reflux esophagitis, the dose of Omeprazole-Akrikhin is increased to 40 mg once a day. The course of treatment for duodenal ulcer is 2-3 weeks, if necessary - 4-5 weeks; for gastric ulcers and esophagitis - 4-8 weeks.
For patients resistant to treatment with other antiulcer drugs, Omeprazole-Akrikhin is prescribed 40 mg/day. The course of treatment for duodenal ulcer is 4 weeks, for gastric ulcer and reflux esophagitis - 8 weeks.
For Zollinger-Ellison syndrome - 60 mg/day; if necessary, the dose is increased to 80-120 mg/day (in this case it is prescribed in 2-3 doses).
To prevent relapses of peptic ulcer - 20 mg 1 time per day.
To eradicate Helicobacter pylori, “triple” therapy is used (within 1 week: Omeprazole-Akrikhin 20 mg, amoxicillin 1 g, clarithromycin 500 mg - 2 times a day; or Omeprazole-Akrikhin 20 mg, clarithromycin 250 mg, metronidazole 400 mg - 2 times a day; either Omeprazole-Akrikhin 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or “double” therapy (within 2 weeks: Omeprazole-Akrikhin 20-40 mg and amoxicillin 750 mg - 2 times a day, or Omeprazole-Akrikhin 40 mg - 1 time a day and clarithromycin 500 mg - 3 times a day or amoxicillin 0.75-1.5 g - 2 times a day).
Children
For gastroesophageal reflux disease in children over 2 years of age weighing more than 20 kg - 20 mg 1 time per day. If necessary, the dose can be increased to 40 mg 1 time per day. Duration of treatment is 4-8 weeks.
For duodenal ulcer associated with Helicobacter pylori (as part of combination therapy) in children over 4 years of age: Omeprazole-Akrikhin is used 20 mg 2 times a day in combination with clarithromycin and amoxicillin for 1 week. Clarithromycin and amoxicillin are used in the dosage regimen according to the instructions for use of these drugs.
In elderly patients (over 65 years of age), no dose adjustment is required.
In patients with renal failure, no dose adjustment is required.
In patients with liver failure, the maximum daily dose is 20 mg.
Storage conditions
In a dry place, at a temperature not exceeding 25 °C. Keep out of the reach of children.
Best before date
2 years. Do not use the drug after the expiration date.
special instructions
Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because
Treatment, masking symptoms, can delay the correct diagnosis. Increased plasma concentrations of chromogranin A (CgA) may interfere with screening tests for neuroendocrine tumors. To prevent this effect, it is necessary to temporarily stop taking omeprazole 5 days before the CgA concentration test.
The drug should be taken with caution if one of the following symptoms or conditions is present: the presence of “alarming” symptoms - significant weight loss, repeated vomiting, vomiting with blood, difficulty swallowing, change in the color of stool (tarry stools).
Proton pump inhibitors, especially when used in high doses and long-term use (>1 year), may moderately increase the risk of hip, wrist, and vertebral fractures, especially in older patients or those with other risk factors.
Severe hypomagnesemia, manifested by symptoms such as fatigue, delirium, seizures, dizziness and ventricular arrhythmia, has been reported in patients receiving omeprazole for at least three months. In most patients, hypomagnesemia was relieved after discontinuation of proton pump inhibitors and administration of magnesium supplements. In patients who are planning long-term therapy or who are prescribed omeprazole with digoxin or other drugs that can cause hypomagnesemia (for example, diuretics), magnesium levels should be assessed before starting therapy and monitored periodically during treatment.
Omeprazole, like all drugs that reduce acidity, can lead to decreased absorption of vitamin B12 (cyanocobalamin). This must be remembered in patients with a reduced supply of vitamin B12 in the body or with risk factors for impaired absorption of vitamin B12 during long-term therapy.
Patients taking drugs that reduce the secretion of gastric glands for a long time are more likely to experience the formation of glandular cysts in the stomach, which go away on their own with continued therapy. These phenomena are caused by physiological changes resulting from inhibition of hydrochloric acid secretion.
Reduced gastric acid secretion by proton pump inhibitors or other acid-inhibiting agents leads to an increase in the growth of normal intestinal microflora, which in turn may lead to a slight increase in the risk of developing intestinal infections caused by Salmonella spp. and Campylobacter spp., and possibly Clostridium difficile bacteria in hospitalized patients.
Description
Gastric gland secretion-lowering agent - proton pump inhibitor.
Use in children
Due to the lack of experience in clinical use, omeprazole is not recommended for use in children.
Pharmacodynamics
H+-K+-ATPase inhibitor. It inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. Due to a decrease in acid secretion, it reduces or normalizes the effect of acid on the esophagus in patients with reflux esophagitis.
Omeprazole has a bactericidal effect on Helicobacter pylori. Eradication of H. pylori with the simultaneous use of omeprazole and antibiotics allows you to quickly relieve the symptoms of the disease, achieve a high degree of healing of damaged mucosa and stable long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract.
Side effects
The frequency of side effects is classified according to the recommendations of the World Health Organization: very common (≥ 1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000), frequency unknown (it was not possible to determine the frequency of occurrence based on available data).
Disorders of the blood and lymphatic system: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia; frequency unknown - eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions (for example, fever, angioedema, anaphylactic reaction/anaphylactic shock).
Metabolic and nutritional disorders: rarely - hyponatremia; frequency unknown - hypomagnesemia.
Mental disorders: infrequently - insomnia; rarely - agitation, confusion, depression; very rarely - aggression, hallucinations.
Nervous system disorders: often - headache; infrequently - dizziness, paresthesia, drowsiness; rarely - taste disturbance.
Visual disturbances: rarely - blurred vision.
Hearing and labyrinthine disorders: uncommon - vertigo.
Disorders of the respiratory system, chest and mediastinal organs: rarely - bronchospasm.
Gastrointestinal disorders: often - abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely - dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis.
Disorders of the liver and biliary tract: infrequently - increased activity of liver enzymes; rarely - hepatitis (including with jaundice); very rarely - liver failure, encephalopathy in patients with liver disease.
Disorders of the skin and subcutaneous tissues: infrequently - dermatitis, itching, rash, urticaria; rarely - alopecia, photosensitivity; very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders: uncommon - fracture of the hip, wrist bones and vertebrae; rarely - arthralgia, myalgia; very rarely - muscle weakness.
Renal and urinary tract disorders: rarely - interstitial nephritis.
Disorders of the genital organs and breast: very rarely - gynecomastia.
General disorders and disorders at the injection site: rarely - malaise, peripheral edema; infrequently - increased sweating.
Cases of formation of gastric glandular cysts have been reported during long-term treatment with proton pump inhibitors (the consequence of inhibition of hydrochloric acid secretion is benign and reversible).
Use during pregnancy and breastfeeding
Research results indicate no adverse effects on the course of pregnancy, the health of the fetus and newborn child. The drug Omeprazole-Akrikhin is approved for use during pregnancy.
Omeprazole is excreted in breast milk. However, when used in therapeutic doses, the effect on a child is unlikely. The drug can be used during breastfeeding.
Interaction
When used simultaneously with omeprazole, an increase or decrease in absorption of drugs whose bioavailability is largely determined by the acidity of gastric juice (including erlotinib, ketoconazole, itraconazole, posaconazole, iron supplements and cyanocobalamin) may be observed.
When used concomitantly with omeprazole, a significant decrease in plasma concentrations of atazanavir and nelfinavir may be observed.
With simultaneous use with omeprazole, an increase in plasma concentrations of saquinavir/ritonavir is observed up to 70%, while the tolerability of treatment in patients with HIV infection does not deteriorate.
The bioavailability of digoxin when used simultaneously with 20 mg of omeprazole increases by 10%. Caution should be exercised when these drugs are used concomitantly in elderly patients.
When used simultaneously with omeprazole, it is possible to increase the plasma concentration and increase the half-life of warfarin (R-warfarin) or other vitamin K antagonists, cilostazol, diazepam, phenytoin, as well as other drugs metabolized in the liver via the CYP2C19 isoenzyme (a dose reduction of these drugs may be required) .
Concomitant treatment with omeprazole at a daily dose of 20 mg leads to a change in coagulation time in patients taking warfarin for a long time, therefore, when using omeprazole in patients receiving warfarin or other vitamin K antagonists, it is necessary to monitor the International Normalized Ratio (INR); In some cases, it may be necessary to reduce the dose of warfarin or another vitamin K antagonist.
The use of omeprazole at a dose of 40 mg once daily resulted in an increase in the maximum plasma concentration and AUC of cilostazol by 18% and 26%, respectively; for one of the active metabolites of cilostazol, the increase was 29% and 69%, respectively.
The simultaneous use of clopidogrel and omeprazole should be avoided (it is recommended to consider alternative methods of antiplatelet therapy), because when used together, the plasma concentration of clopidogrel decreases by 46% on the first day of use, and by 42% on the 5th day of use.
Omeprazole, when used simultaneously, increases the plasma concentration of tacrolimus, which may require dose adjustment. During combination treatment, tacrolimus plasma concentrations and renal function (creatinine clearance) should be carefully monitored.
Inducers of the isoenzymes CYP2C19 and CYP3A4 (for example, rifampicin, preparations of St. John's wort (Hypericum perforatum)), when used simultaneously with omeprazole, can increase its metabolism, thereby reducing its concentration in plasma.
When methotrexate was co-administered with proton pump inhibitors, a slight increase in plasma methotrexate concentrations was observed in some patients. When treating with high doses of methotrexate, it is recommended to temporarily stop taking Omeprazole-Akrikhin.
When omeprazole is taken together with clarithromycin or erythromycin, the concentration of omeprazole in the blood increases.
The simultaneous use of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood.
Long-term use of the drug Omeprazole-Akrikhin at a dose of 20 mg 1 time per day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentrations.
There was no interaction with concomitantly taken antacids.
Overdose
Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.
Treatment: symptomatic. Hemodialysis is not effective enough.
Impact on the ability to drive vehicles and operate machinery
There is no data on the effect of the drug on the ability to drive a car or use other machinery. However, due to the fact that dizziness, blurred vision and drowsiness may occur during therapy, caution should be exercised when driving or operating machinery that requires increased concentration and speed of psychomotor reactions.
Persons
Alexandra Lukashova
Vice President of Marketing and Sales of Branded and Generic Drugs
Alexey Maltsev
Vice President of OTC Sales and Marketing
Konstantin Paramonov
Vice President of Operations
Irina Redzyuk
Vice President of Regulatory Affairs and New Developments
Olga Smaznaya
Commercial Director
Olga Stepanova
Director of the Center for Scientific Research and Development (CNIiR)
Olga Frolikova
Director of OTC Marketing
Denis Chetverikov
The president
Faiza Yagudina
Director of quality
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