Omeprazole-Teva
Omeprazole-Teva: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. For violations of liver function
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Omeprazol-Teva
ATX code: A02BC01
Active ingredient: omeprazole (omeprazolum)
Manufacturer: Teva Pharmaceutical Industries (Israel)
Description and photo update: 2018-23-10
Prices in pharmacies: from 40 rubles.
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Omeprazole-Teva is a proton pump inhibitor, a drug that lowers the secretion of gastric glands.
Release form and composition
The dosage form of the drug Omeprazole-Teva - enteric capsules: opaque, hard gelatinous, white and engraved "O" on the capsule cap; at a dosage of 10 mg - size No. 3, with engraving on the body "10"; in a dosage of 20 mg - size 2, with engraving on the body "20"; in a dosage of 40 mg - size No. 0, engraved on the body "40" (6, 7 or 10 capsules in a blister, in a cardboard box 5 blisters of 6 capsules or 2 or 4 blisters of 7 capsules, or 3 blisters of 10 capsules; 14, 28 or 30 capsules in a polyethylene bottle, 1 bottle in a cardboard box).
The composition of the capsule 10/20/40 mg:
- active substance: omeprazole - 10/20/40 mg;
- auxiliary components: sugar grits (sucrose, starch syrup, sodium carboxymethyl starch type A, sodium lauryl sulfate, povidone K-30, sodium phosphate dodecahydrate, sodium hydroxide, hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide, talc;
- capsule: titanium dioxide, gelatin, water;
- engraving ink: shellac, ethanol, isopropanol, propylene glycol, butanol, aqueous ammonia, potassium hydroxide, dye (black iron oxide), water (isopropanol, ethanol and butanol evaporate during the engraving process).
Pharmacological properties
Pharmacodynamics
The action of the drug Omeprazole-Teva is explained by the inhibition of hydrogen-potassium adenosine triphosphatase (H + / K + -adenosine triphosphatase) in the parietal cells of the stomach, which leads to blocking the secretion of hydrochloric acid at the last stage. This effect is dose-dependent and provides effective inhibition of basal and stimulated secretion, regardless of the origin of the stimulating factor.
Daily intake of Omeprazole-Tev provides effective and fairly rapid inhibition of hydrochloric acid, both day and night. Within 4 days, the maximum therapeutic effect of the drug is achieved. In case of ulcerative lesions of the duodenum, taking omeprazole at a dose of 20 mg maintains the acidity of the stomach at a pH 3 for 17 hours.
Taking omeprazole as part of a combination therapy with antibacterial agents ensures the eradication of Helicobacter pylori, quickly relieves the symptoms of the disease, helping to achieve a stable remission, leads to a high degree of healing of the mucous membrane of the stomach and duodenum, and reduces the risk of bleeding from the gastrointestinal tract.
When taking Omeprazole-Tev, there is no need for long-term antiulcer treatment.
Pharmacokinetics
Omeprazole is absorbed in the small intestine. Its maximum concentration (C max) is reached after 0.5–3.5 hours. Bioavailability of omeprazole is 30-40%, in patients with hepatic insufficiency - 100%. Plasma protein binding is approximately 90%.
Omeprazole is metabolized mainly in the liver by means of the CYP2C19 enzyme system, while 6 pharmacologically inactive metabolites are formed. Omeprazole is an inhibitor of the isoenzyme CYP2C19.
The half-life (T 1/2) is 30-60 minutes, with hepatic insufficiency - 3 hours. Clearance - 300-600 ml / min. Omeprazole is excreted mainly (70–80%) by the kidneys, the rest (20–30%) through the intestines in the form of metabolites. In patients with chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.
In elderly patients, the bioavailability of omeprazole increases, and its excretion decreases.
Indications for use
Adult patients:
- ulcerative lesions of the stomach and duodenum (including to prevent relapse);
- gastroesophageal reflux disease, reflux esophagitis (including to prevent relapse);
- erosive and ulcerative diseases of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);
- erosive and ulcerative diseases of the stomach and duodenum associated with Helicobacter pylori (together with antibacterial drugs);
- Zollinger-Ellison syndrome;
- stomach pathologies associated with increased gastric acidity.
In pediatrics:
- gastroesophageal reflux disease (in children over 2 years old);
- ulcerative lesions of the duodenum associated with Helicobacter pylori, together with antibacterial drugs (in children over 4 years old).
Contraindications
- fructose intolerance, sucrase / isomaltase deficiency, glucose-galactose malabsorption (since the drug contains sucrose);
- coadministration with St. John's wort, atazanavir, erlotinib, posaconazole, in patients with hepatic insufficiency - with clarithromycin;
- age under 2 years and body weight less than 20 kg (in the treatment of reflux esophagitis, heartburn, sour eructation, gastroesophageal reflux disease);
- age less than 4 years (in the treatment of duodenal ulcers associated with Helicobacter pylori).
Instructions for use of Omeprazole-Teva: method and dosage
Omeprazole-Teva is taken orally, the capsule is swallowed whole with a small amount of water, before meals or during meals.
Recommended dosage:
- exacerbation of gastric ulcer, duodenal ulcer, reflux esophagitis: 20 mg / day for 4-8 weeks, if necessary, it is possible to increase the dose of the drug to 40 mg / day;
- gastroesophageal reflux disease (maintenance therapy): 10–20 mg / day for 6–12 months, in severe cases, lifelong therapy is possible;
- erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs (including for the prevention of relapse): 10–20 mg / day;
- Zollinger-Ellison syndrome: the recommended initial dose is 60 mg / day per dose; if necessary, it is possible to increase the dose to 80–120 mg (in this case, the dose is divided into 2 doses).
For erosive and ulcerative diseases of the stomach and duodenum associated with Helicobacter pylori, the following combinations are recommended:
- three-component regimen (all drugs are taken simultaneously): Omeprazole-Teva 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg - 2 times a day for 7 days;
- three-component regimen (all drugs are taken simultaneously): Omeprazole-Teva 20 mg + clarithromycin 250 mg (or 500 mg) + metronidazole 400-500 mg (or tinidazole 500 mg) - 2 times a day for 7 days;
- three-component regimen (all drugs are taken simultaneously): Omeprazole-Teva 40 mg + amoxicillin 500 mg + metronidazole 400-500 mg (or tinidazole 500 mg) - 2 times a day for 7 days;
- two-component regimen (the dose should be divided into parts): Omeprazole-Teva 40–80 mg + amoxicillin 1500 mg - taken daily for 2 weeks;
- two-component regimen: Omeprazole-Teva 40 mg (1 time per day) + clarithromycin 500 mg (3 times a day), the duration of treatment is 2 weeks.
In pediatrics:
- gastroesophageal reflux disease (for children over 2 years of age and weighing ˃ 20 kg): 20 mg / day; if necessary, it is possible to increase the dose to 40 mg / day, the duration of treatment is 4–8 weeks;
- duodenal ulcer in children over 4 years of age with a body weight of 15-30 kg (combination therapy, all drugs are taken simultaneously): Omeprazole-Teva 10 mg + amoxicillin 25 mg / kg + clarithromycin 7.5 mg / kg - 2 times a day for 7 days;
- duodenal ulcer in children over 4 years old weighing 31-40 kg (combination therapy, all drugs are taken simultaneously): Omeprazole-Teva 20 mg + amoxicillin 750 mg + clarithromycin 7.5 mg / kg - 2 times a day for 7 days;
- duodenal ulcer in children over 4 years old with a body weight of ˃ 40 kg (combination therapy, all drugs are taken simultaneously): Omeprazole-Teva 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg - 2 times a day for 7 days.
In cases where the patient finds it difficult to swallow a whole capsule, it is allowed to swallow its contents by opening it or absorbing it. You can also stir the contents of the capsule into a small amount of a slightly acidified liquid (juice or yogurt). The resulting mixture is recommended to be consumed within 30 minutes.
Side effects
- Gastrointestinal tract: abdominal pain, diarrhea, taste disturbance, microscopic colitis, discoloration of the tongue (darkening), the appearance of benign cysts of the salivary glands (when taken together with clarithromycin), dry mouth, stomatitis, candidiasis, pancreatitis;
- liver and biliary tract: changes in the activity of liver enzymes, jaundice, hepatitis, liver failure, encephalopathy (mainly in patients with impaired liver function);
- skin and subcutaneous tissues: rash, itching, urticaria, alopecia, erythema multiforme, photosensitivity, increased sweating, Stevens-Johnson syndrome, toxic epidermal necrolysis;
- musculoskeletal and connective tissue: fractures of the vertebrae, wrist bones, femoral head, myalgia, arthralgia, muscle weakness;
- hematopoietic system: anemia, eosinopenia, neutropenia, thrombocytopenia;
- kidneys and urinary tract: interstitial nephritis, hematuria, proteinuria;
- other disorders, as well as local disorders: peripheral edema, hyponatremia, gynecomastia, hypomagnesemia.
Overdose
In case of an overdose of Omeprazole-Teva, the following symptoms are possible: drowsiness, blurred vision, agitation, headache, confusion, increased sweating, dry mouth, arrhythmia, nausea.
The specific antidote is unknown. In case of overdose, symptomatic treatment is recommended. Dialysis is ineffective.
special instructions
Taking omeprazole can complicate the diagnosis of malignant processes in the upper gastrointestinal tract, and therefore, before starting therapy, you should make sure that these diseases are absent. Due to a decrease in the acidity of gastric juice in the gastrointestinal tract, the number of bacteria increases, which can increase the risk of gastrointestinal infections.
5 days before the examination for the presence of neuroendocrine tumors, carried out by studying the concentration of CgA, it is recommended to interrupt the intake of omeprazole, as it may distort the results of this study.
In the treatment of erosions and ulcers associated with taking NSAIDs, the possibility of discontinuing NSAIDs or reducing their dose should be considered in order to increase the effectiveness of antiulcer therapy.
Patients on a controlled sodium diet should take into account the presence of sodium in the composition of the drug Omeprazole-Teva.
With long-term maintenance treatment with omeprazole, the benefit / risk ratio should be considered, as there is evidence of an increased risk of fractures (especially in elderly patients and in the presence of risk factors). When osteoporosis is at risk, adequate intake of vitamin D and calcium is recommended. Also, with the duration of therapy with proton pump inhibitors for more than 12 months, episodes of severe hypomagnesemia were observed, and therefore in these cases, as well as when omeprazole is taken together with drugs that lower the magnesium content in blood plasma, regular monitoring of the magnesium content should be carried out.
Influence on the ability to drive vehicles and complex mechanisms
When using the drug Omeprazole-Teva, there is a risk of developing undesirable effects on the part of the nervous system and the organ of vision, and therefore, care should be taken when driving vehicles, working with complex mechanisms, as well as when engaging in other potentially hazardous activities that require the speed of psychomotor reactions.
Application during pregnancy and lactation
Available data show that omeprazole does not have undesirable effects on the course of pregnancy, as well as the condition of the fetus and newborn.
According to the instructions, Omeprazole-Teva is excreted in breast milk, however, when used in recommended doses, an undesirable effect on the child is unlikely.
For violations of liver function
In case of severe impairment of liver function during the period of taking the drug Omeprazole-Teva, it is necessary to monitor the indicators of liver enzymes. The daily dose of the drug should not exceed 20 mg.
Use in the elderly
In elderly patients, dose adjustment of Omeprazole-Teva is not required.
Drug interactions
The combined use of omeprazole and St. John's wort, atazanavir, erlotinib, posaconazole is contraindicated.
There was no clinically significant interaction between omeprazole and the following drugs and substances: amoxicillin, metronidazole, caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, phenacetin, estradiol, budesonide, diclofenac, naproxen, piroxicam, antacids, ethanol.
Omeprazole interacts with the following drugs:
- ketoconazole, itraconazole: reduces their absorption;
- digoxin: increases its absorption;
- vitamin B 12: when taken together for a long time, it reduces its absorption;
- warfarin, diazepam, phenytoin, imipramine, clomipramine, citalopram, hexobarbital, disulfiram: slows down their excretion, which may require dose adjustment of these drugs;
- methotrexate: omeprazole can in some cases slightly increase its concentration in blood plasma. If you need to take high doses of methotrexate, you must temporarily stop taking omeprazole.
Clarithromycin and erythromycin increase the concentration of omeprazole in the blood plasma.
Analogs
Analogs of Omeprazole-Teva are: Gastrozol, Zhelkizol, Losek, Losek MAPS, Omal, Omez, Omez Insta, Omizak, Omitox, Ortanol, Pleom-20, Promez, Ultop, Ulkozol, Helicid, Tsisagast.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Omeprazole-Teva
Reviews of Omeprazole-Teva are mostly positive. Patients note the effectiveness of the drug in the fight against gastrointestinal problems, such as gastric ulcer, reflux disease. It is especially emphasized that it quickly reduces the acidity of gastric juice. Among the pluses, the relatively low cost of the drug is also noted. Negative reviews are rare and pay attention to a large number of excipients, as well as side effects, although it is mentioned that after the drug is discontinued, undesirable effects disappear in a short period of time.
Price for Omeprazole-Teva in pharmacies
The approximate price for Omeprazole-Teva in pharmacies is 95 rubles. per package containing 28 capsules of 20 mg.
Omeprazole-Teva: prices in online pharmacies
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Drug name Price Pharmacy |
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Omeprazole-Teva 20 mg enteric capsules 14 pcs. RUB 40 Buy |
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Omeprazole-Teva capsules p.o. enteric solution. 20mg 14 pcs. RUB 48 Buy |
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Omeprazole-Teva 20 mg enteric capsules 28 pcs. RUB 61 Buy |
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Omeprazole-Teva 10 mg enteric capsules 28 pcs. RUB 70 Buy |
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Omeprazole-Teva capsules p.o. enteric solution. 10mg 28 pcs. 82 RUB Buy |
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Omeprazole-Teva capsules enteric solution. 20mg 28 pcs. 89 RUB Buy |
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Omeprazole-Teva 40 mg enteric capsules 28 pcs. 130 RUB Buy |
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Omeprazole-Teva capsules enteric solution. 40mg 28 Pcs. 144 RUB Buy |
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Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
