Omeprazole-Teva Capsules, 14 pcs., 20 mg, enteric

Omeprazole-Teva Capsules, 14 pcs., 20 mg, enteric

Side effect

From the blood and lymphatic system: rarely - hypochromic microcytic anemia in children; very rare - reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.; From the immune system: very rarely - satiety, increased body temperature, angioedema, narrowing of the bronchi, allergic vasculitis, fever, anaphylactic shock.; From the nervous system: often - headache, dizziness, insomnia, drowsiness, lethargy (the listed side effects tend to worsen with long-term therapy): rarely - paresthesia, confusion, hallucinations, especially in elderly patients or in severe cases of the disease; very rarely - anxiety, depression, especially in elderly patients or in severe cases of the disease.; From the organ of vision: infrequently - visual disturbances, incl. reduction of visual fields, decrease in the acuity and clarity of visual perception (usually disappear after cessation of therapy); From the organ of hearing and labyrinthine disorders: infrequently - disorders of auditory perception, incl. “ringing in the ears” (usually disappears after cessation of therapy); From the gastrointestinal tract: often - nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with continued therapy); infrequently - taste perversion (usually disappears after cessation of therapy); rarely - a change in the color of the tongue to brown-black and the appearance of benign cysts of the salivary glands when used simultaneously with clarithromycin (the phenomena are reversible after cessation of therapy); very rarely - dry mouth, stomatitis, candidiasis, pancreatitis; From the liver and biliary tract: infrequently - changes in liver enzymes (reversible); very rarely - hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver diseases.; From the skin and subcutaneous tissues: uncommon - rash, itching, alopecia, erythema multiforme, photosensitivity, increased sweating; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis; From the musculoskeletal and connective tissue side: infrequently - fractures of the vertebrae, wrist bones, femoral head (see section "Special instructions"); rarely - myalgia, arthralgia; very rarely - muscle weakness; From the kidneys and urinary tract: rarely - interstitial nephritis.; General disorders and disorders at the injection site: uncommon - peripheral edema (usually disappears after cessation of therapy); rarely - hyponatremia; very rarely - hypomagnesemia (see section “Special Instructions”), gynecomastia.

Omeprazole-Teva

Omeprazole-Teva

(
Omeprazole-Teva
) is an antiulcer drug, a proton pump inhibitor, which inhibits the secretion of acid by parietal cells and, due to this, reduces gastric acidity.

Composition and release forms of Omeprazole-Teva

In the Russian Federation, three dosage forms of Omeprazole-Teva are approved for use - enteric capsules, differing in the content of the active substance, omeprazole: 10, 20 and 40 mg.
All of them have the appearance of hard white opaque gelatin capsules, on the lid of which is written a black “O”, and on the body - the dosage: “10”, “20” or “40”, respectively. Omepraloz-Teva 10 mg is available from pharmacies without a prescription, the other two (20 and 40 mg) are available with a prescription. Omeprazole-Teva also contains the following excipients: sucrose, starch syrup, sodium carboxymethyl starch type A, sodium lauryl sulfate, povidone K30, sodium phosphate dodecahydrate, sodium hydroxide, hypromellose, methacrylic acid and ethyl acrylic copolymer [1:1], triethyl citrate, titanium dioxide , gelatin, water.

Indications for use, dosage and dosage of the over-the-counter form of Omeprazole-Teva (10 mg)

Omeprazole-Teva 10 mg is recommended for:

• the appearance of symptoms of dyspepsia associated with increased acidity of gastric juice, including symptoms of gastroesophageal reflux disease (heartburn, sour belching)
• long-term maintenance therapy to prevent relapses of heartburn, gastroesophageal reflux disease and duodenal ulcer

Omeprazole-Teva 10 mg is taken once a day, in the morning, with approximately 100 ml of water. Omeprazole-Teva capsules are not chewed or crushed. If symptoms do not decrease within three days, you should consult a doctor. The maximum duration of self-treatment is two weeks.

Indications for use of prescription forms of Omeprazole-Teva (20 and 40 mg)

Omeprazole-Teva 20 and 40 mg is indicated:

• children 3-4 years old and weighing at least 20 kg: for reflux esophagitis, heartburn and sour belching
• children from 5 years of age inclusive and older: for eradication of Helicobacter pylori
  for duodenal ulcer (only as part of complex therapy!)
• adults:
• dyspepsia associated with increased stomach acidity
• reflux esophagitis
• symptomatic treatment of GERD
• treatment and prevention of gastric and duodenal ulcers
• eradication of Helicobacter pylori
  for gastric and duodenal ulcers (only as part of complex therapy!)
• Zollinger-Ellison syndrome

Where to find detailed information about the use of Omeprazole-Teva

The order of administration and dose of Omeprazole-Teva, contraindications, pharmacological properties, place among other proton pump inhibitors and other characteristics of Omeprazole-Teva are determined by its active substance and are described in the article “ Omeprazole
”.

See also the official, approved by the Ministry of Health of Russia on January 15, 2018, Instructions for medical use of the drug Omeprazole-Teva (enteric capsules, 10, 20 and 40 mg), (pdf).

On the website GastroScan.ru in the “Literature” section there is a subsection “Omeprazole”, containing articles for healthcare professionals regarding the treatment of diseases of the gastrointestinal tract with omeprazole.

general information

According to the pharmacological index, Omeprazole-Teva belongs to the group “Proton pump inhibitors”.
For ATC - to the group “Proton pump inhibitors”, code A02BC01. The manufacturer of Omeprazole-Teva is Teva Pharma, S.L.U. (Teva Pharma, SLU), Spain.

Trade names of drugs with the active substance omeprazole

In Russia and other countries - former republics of the USSR, omeprazole is widely available in generic versions.
Prices for generic omeprazole are much lower than prices for original drugs, such as Losek, Losek MAPS, which is important for many patients and often determines the choice of drug. Due to possible differences in the quality of drugs, an objective assessment of their clinical effectiveness is often necessary. Currently, 24-hour monitoring of intragastric acidity is an objective and accessible method for testing antisecretory agents in clinical practice (Alekseenko S.A.). The following drugs are (were) registered in Russia: Bioprazole, Vero-Omeprazole, Gastrozol, Demeprazole, Zhelkizol, Zerotsid, Zolser, Chrismel, Lomak, Losek, Losek MAPS, Omegast, Omez, Omez Insta, Omecaps, Omepar, Omeprazole, Omeprazole pellets . , Pepticum, Pleom-20, Promez, Risek, Romesek, Sopral, Ulzol, Ulkozol, Ultop, Helitsid, Helol, Cisagast.

On the pharmaceutical markets of the countries of the former republics of the USSR, a number of drugs with the active substance omeprazole are presented, which are not registered in Russia, in particular: Gasek (Mepha Lda, Switzerland), Losid (Flamingo Pharmaceutical, India), Omeprazole-Astrapharm (TOV Astrapharm, Ukraine ), Omeprazole-Darnitsa (JSC Pharmaceutical Company Darnitsa, Ukraine), Omeprazole-KMP (JSC Kievmedpreparat, Ukraine), Omeprazole-Lugal (Lugansk Chemical Pharmaceutical Plant, Ukraine), Tserol (Neon Antibiotics Private Limited, India) and others.

A branded medicine with the active ingredient omeprazole on the US and Canadian markets is Prilosec (formerly called Losec). This brand is sold in Russia under the trademarks Losek Maps and Losek, in Germany, Italy and Switzerland - under the trademarks Antra and Antra MUPS. The over-the-counter version of Prilosec is Prilosec OTC.

Omeprazole-Teva has contraindications, side effects and application features; consultation with a specialist is necessary.

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Omeprazole-Teva 40 mg, 28 enteric capsules

Registration Certificate Holder

Teva Pharmaceutical Industries (Israel)

Dosage form

Medicine - Omeprazole-Teva

Description

Enteric capsules

white opaque hard gelatin, No. 0; “O” is written in black ink on the lid and “40” on the body; the contents of the capsules are micropellets from white to white with a yellowish or pinkish tint.

1 caps.

omeprazole 40 mg

Excipients

: granulated sugar [sucrose, starch syrup] - 173.97 mg, sodium carboxymethyl starch type A - 10.20 mg, sodium lauryl sulfate - 12.15 mg, povidone K30 - 19.31 mg, sodium phosphate dodecahydrate - 1.34 mg, sodium hydroxide - 0.29 mg, hypromellose - 28.84 mg , methacrylic acid and ethyl acrylate copolymer [1:1] - 85.05 mg, triethyl citrate - 12.33 mg, titanium dioxide (E171) - 6.62 mg, talc - 0.38 mg.

Composition of the gelatin capsule cap:

titanium dioxide (E171) - 0.74-0.784 mg, water - 5.36-5.684 mg, gelatin - 30.89-37.632 mg.
The composition of the gelatin capsule body:
titanium dioxide (E171) - 1.152-1.18 mg, water - 8.526-8.56 mg, gelatin - 49.098-56.448 mg.
Black ink composition:
shellac - 24-27%, ethanol* - 23-26%, isopropanol* - 1-3%, propylene glycol - 3-7%, butanol* - 1-3%, aqueous ammonia - 1-2%, potassium hydroxide - 0.05-0.1%, water - 15-18%, iron dye black oxide (E172) - 24-28%.

* Ethanol, isopropanol, butanol completely evaporate during the inscription process on the capsules and do not remain on the surface of the capsules.

6 pcs. - blisters (5) - cardboard packs. 7 pcs. - blisters (2) - cardboard packs. 7 pcs. - blisters (4) - cardboard packs. 10 pieces. - blisters (3) - cardboard packs. 14 pcs. — bottles (1) — cardboard packs. 28 pcs. — bottles (1) — cardboard packs. 30 pcs. — bottles (1) — cardboard packs.

Indications

Peptic ulcer of the stomach and duodenum in the acute phase (including those associated with Helicobacter pylori), reflux esophagitis, Zollinger-Ellison syndrome, erosive and ulcerative lesions of the stomach and duodenum associated with taking NSAIDs.

Contraindications for use

Chronic liver diseases (including a history), childhood, hypersensitivity to omeprazole.

pharmachologic effect

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.

Drug interactions

With simultaneous use, cases of the development of symptoms of the toxic effects of benzodiazepines have been described, which is associated with inhibition of the activity of CYP3A isoenzymes and, apparently, CYP2C9.

When used simultaneously with atracurium besylate, the effects of atracurium besylate are prolonged.

When used concomitantly with bismuth tripotassium dicitrate, an undesirable increase in the absorption of bismuth may occur.

When used simultaneously with digoxin, a slight increase in the concentration of omeprazole in the blood plasma is possible.

When used simultaneously with disulfiram, a case of impaired consciousness and catatonia has been described; with indinavir - a decrease in the concentration of indinavir in the blood plasma is possible; with ketoconazole - decreased absorption of ketoconazole.

With prolonged simultaneous use with clarithromycin, the concentrations of omeprazole and clarithromycin in the blood plasma increase.

Cases of decreased excretion of methotrexate from the body in patients receiving omeprazole have been described.

When used simultaneously with theophylline, a slight increase in the clearance of theophylline is possible.

It is believed that with the simultaneous use of omeprazole in high doses and phenytoin, an increase in the concentration of phenytoin in the blood plasma is possible.

Cases of increased concentrations of cyclosporine in blood plasma have been described when used simultaneously with cyclosporine.

When used simultaneously with erythromycin, a case of increased concentration of omeprazole in the blood plasma was described, while the effectiveness of omeprazole decreased.

Dosage regimen

Individual. When taken orally, a single dose is 20-40 mg. Daily dose - 20-80 mg; frequency of use - 1-2 times/day. Duration of treatment is 2-8 weeks.

Side effect

From the digestive system:

rarely - nausea, diarrhea, constipation, abdominal pain, flatulence.

From the side of the central nervous system:

rarely - headache, dizziness, weakness.

From the hematopoietic system:

in some cases - anemia, eosinopenia, neutropenia, thrombocytopenia.

From the urinary system:

in some cases - hematuria, proteinuria.
From the musculoskeletal system:
in some cases - arthralgia, muscle weakness, myalgia.

Allergic reactions:

rarely - skin rash.

special instructions

Before starting therapy, it is necessary to exclude the possibility of a malignant process (especially with a stomach ulcer), because Treatment with omeprazole may mask symptoms and delay correct diagnosis.

The use of omeprazole may distort the results of laboratory tests of liver function and gastrin concentrations in the blood plasma.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution.

During pregnancy and lactation, use is possible depending on the dosage form used.

Use for liver dysfunction

Restrictions for liver dysfunction - Contraindicated.

Contraindicated in chronic liver diseases (including a history).

Use in children

Restrictions for children - Contraindicated.

Due to the lack of experience in clinical use, omeprazole is not recommended for use in children.

Omeprazole-Teva capsules intestinal 20 mg No. 28

Compound

Active substance: omeprazole 20 mg.
Excipients: granulated sugar [sucrose, starch syrup] - 86.98 mg, sodium carboxymethyl starch type A - 5.10 mg, sodium lauryl sulfate - 6.07 mg, povidone K30 - 9.66 mg, sodium phosphate dodecahydrate - 0.67 mg, sodium hydroxide - 0.14 mg, hypromellose - 14.42 mg, methacrylic acid and ethyl acrylate copolymer [1:1] - 42.53 mg, triethyl citrate - 6.17 mg, titanium dioxide (E171) - 3.31 mg, talc - 0.19 mg.

Composition of the gelatin capsule cap: titanium dioxide (E171) - 0.48-0.504 mg, water - 3.48-3.654 mg, gelatin - 20.04-23.912 mg.

Composition of the gelatin capsule body: titanium dioxide (E171) - 0.732-0.78 mg, water - 5.481-5.655 mg, gelatin - 31.563-35.868 mg.

Black ink composition: shellac - 24-27%, ethanol* - 23-26%, isopropanol* - 1-3%, propylene glycol - 3-7%, butanol* - 1-3%, aqueous ammonia - 1-2%, potassium hydroxide - 0.05-0.1%, water - 15-18%, iron dye black oxide (E172) - 24-28%.

* Ethanol, isopropanol, butanol completely evaporate during the inscription process on the capsules and do not remain on the surface of the capsules.

Pharmacokinetics

Suction.
Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration in plasma is reached after 1-2 hours. Absorbed in the small intestine, usually within 3-6 hours. Bioavailability after a single oral dose is approximately 40%; after continuous once-daily dosing, bioavailability increases to 60%. Concomitant food intake does not affect the bioavailability of omeprazole. Distribution. The binding of omeprazole to plasma proteins is about 95%, the volume of distribution is 0.3 l/kg.

Metabolism. Omeprazole is completely metabolized in the liver. The main isoenzymes involved in the metabolic process are CYP2C19 and CYP3A4. Hydroxyomeprazole is the main metabolite formed under the action of the CYP2C19 isoenzyme. Metabolites sulfone and sulfide do not affect the secretion of hydrochloric acid.

Excretion. The half-life is approximately 40 minutes (30-90 minutes). About 80% is excreted in the form of metabolites by the kidneys, the rest through the intestines.

Special groups of patients. In elderly patients (75-79 years old), a slight decrease in the metabolism of omeprazole was noted.

In patients with impaired renal function, no dose adjustment is required. The metabolism of omeprazole in patients with impaired liver function slows down, which leads to an increase in its bioavailability.

When treating children aged 1 year, plasma concentrations of omeprazole were similar to those in adults.

Indications for use

Dosage 10 mg

• Symptoms of dyspepsia associated with increased acidity of gastric juice, incl. symptoms of gastroesophageal reflux disease (heartburn, sour belching).
• Long-term maintenance therapy to prevent relapses of gastroesophageal reflux disease (GERD) (prevention of heartburn relapses).
• Long-term maintenance therapy to prevent relapses of duodenal ulcers.

Dosage 20 and 40 mg

For adults:

• peptic ulcer of the stomach and duodenum (treatment and prevention);
• eradication of Helicobacter pylori for gastric and duodenal ulcers (as part of combination therapy);
• NSAID-associated ulcers and erosions of the stomach and duodenum (treatment and prevention);
• reflux esophagitis; symptomatic gastroesophageal reflux disease (GERD);
• dyspepsia associated with high acidity;
• Zollinger-Ellison syndrome.

Children over 2 years old:

• reflux esophagitis, symptomatic treatment of heartburn and sour belching with GERD in children over 2 years of age and weighing > 20 kg;

Children over 4 years old:

• eradication of Helicobacter pylori in duodenal ulcer (as part of combination therapy).

Contraindications

Dosage 10 mg

• Hypersensitivity to omeprazole or any of the components of the drug;
• fructose intolerance;
• sucrase/isomaltase deficiency;
• glucose-galactose malabsorption;
• simultaneous use with clarithromycin (in patients with liver failure), atazanavir, St. John's wort, erlotinib, posaconazole, simultaneous use with nelfinavir;
• children under 18 years of age.

Dosage 20 and 40 mg

• Hypersensitivity to omeprazole or any of the components of the drug;
• fructose intolerance;
• sucrase/isomaltase deficiency;
• glucose-galactose malabsorption;
• simultaneous use with clarithromycin (in patients with liver failure), atazanavir, St. John's wort, erlotinib, posaconazole;
• children over 2 years of age for indications other than reflux esophagitis and symptomatic gastroesophageal reflux disease;
• children over 4 years of age for indications other than reflux esophagitis, symptomatic gastroesophageal reflux disease and duodenal ulcer caused by Helicobacter pylori;
• children under 18 years of age (for all indications, except for reflux esophagitis and eradication of Helicobacter pylori in duodenal ulcer).

With caution:
liver failure; renal failure; osteoporosis; simultaneous use with clarithromycin, simultaneous use with clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, voriconazole, rifampicin, use with digoxin, St. John's wort preparations; significant spontaneous loss of body weight; repeated vomiting, vomiting with blood; swallowing disorder; change in stool color (tarry stool); and also in the presence of a stomach ulcer (or if its presence is suspected), a malignant neoplasm should be excluded before starting treatment, since treatment may lead to masking of symptoms and delay the correct diagnosis.

Directions for use and doses

Dosage 10 mg The drug is taken orally at a dose of 10 mg once a day.

Capsules are usually taken in the morning, preferably separately from meals, swallowed whole, with half a glass of water. Capsules must not be chewed or crushed. If swallowing is difficult, the contents of the capsule, after opening it, can be mixed with a slightly acidified liquid (juice, yogurt) and used within 30 minutes. If there is no effect within three days, examination by a specialist is necessary. The maximum course of treatment without consulting a doctor is 14 days.

Dosage 20 mg and 40 mg

Capsules are usually taken in the morning, preferably separately from meals, swallowed whole, with half a glass of water. Capsules must not be chewed or crushed. If swallowing is difficult, the contents of the capsule, after opening it, can be mixed with a slightly acidified liquid (juice, yogurt) and used within 30 minutes.

Duodenal ulcer

In case of exacerbation of duodenal ulcer, it is recommended to take the drug 20 mg once a day. Typically, the duration of therapy is 2 weeks; if necessary, it is possible to increase the course of therapy for another 2 weeks. Patients with duodenal ulcer resistant to treatment are usually prescribed the drug 40 mg once a day for 4 weeks. To prevent relapses for patients with duodenal ulcer - 20 mg 1 time per day; in some cases, 10 mg once a day may be sufficient (capsules containing 10 mg of omeprazole must be used). If necessary, the dose can be increased to 40 mg 1 time per day.

Stomach ulcer

For exacerbation of gastric ulcer, the recommended dose of the drug is 20 mg once a day. Duration of therapy is 4 weeks. In cases where complete healing does not occur after the first course of using the drug, a repeat 4-week course of treatment is prescribed. Patients with gastric ulcers resistant to treatment are usually prescribed the drug 40 mg once a day, healing is usually achieved within 8 weeks. To prevent relapses, patients with gastric ulcers are recommended to take the drug at a dose of 20 mg once a day. If necessary, the dose can be increased to 40 mg 1 time per day.

Helicobacter pylori eradication regimens for peptic ulcer disease:

• omeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg simultaneously 2 times a day for 1 week;
• omeprazole 20 mg, clarithromycin 250 mg (alternatively 500 mg), metronidazole 400 mg (or 500 mg or tinidazole 500 mg) simultaneously 2 times a day for 1 week;
• omeprazole 40 mg once a day, as well as amoxicillin 500 mg with metronidazole 400 mg (or 500 mg or tinidazole 500 mg) both 3 times a day for 1 week.

The recommended dose of omeprazole in Helicobacter pylori eradication regimens in pediatric practice is 1-2 mg per kilogram of child body weight per day.

In cases where after treatment the patient is Helicobacter pylori positive, a second course of treatment is possible.

Treatment of ulcerative-erosive lesions of the stomach and duodenum associated with the use of NNVN*.

The recommended dose of omeprazole is 20 mg once a day. The course of treatment is 4 weeks. For patients whose ulcers have not healed, the course can be extended for another 4 weeks.

* (non-steroidal anti-inflammatory drugs)

Prevention of ulcerative-erosive lesions of the stomach and duodenum associated with taking NSAIDs

As a prophylaxis of NSAID-associated ulcerative-erosive lesions of the stomach and duodenum in patients at risk (age over 60 years, history of ulcerative-erosive lesions of the stomach and duodenum, history of bleeding from the upper gastrointestinal tract) recommended dose - 20 mg omeprazole once a day.

Treatment of reflux esophagitis

The recommended dose is 20 mg of omeprazole once a day. The course of treatment is 4 weeks. For patients who have not recovered within this period, the course can be extended by 4 weeks. For severe esophagitis, the recommended dose is 40 mg omeprazole once a day, and the course of treatment is 8 weeks.

For maintenance therapy in patients with reflux esophagitis, the recommended dose of omeprazole is 10 mg once a day (capsules containing 10 mg of omeprazole must be used). If necessary, the dose can be increased to 20-40 mg 1 time per day.

Symptomatic treatment of GERD

The recommended dose is 20 mg per day. Individual dose adjustment is possible. If symptoms persist after 4 weeks of treatment with omeprazole 20 mg daily, further evaluation is required. The recommended dose of omeprazole for the treatment of GERD in pediatric practice is 0.7-3.3 mg per kilogram of child body weight per day. Treatment of non-ulcer dyspepsia

The usual dose is 10 mg (1 capsule) per day. The maximum daily dose of the drug should not exceed 20 mg. The maximum course of treatment is 14 days. If symptoms do not improve within 2 weeks or if they worsen, you should consult a doctor.

Treatment of Zollinger-Ellison syndrome

The dose is set individually. The recommended starting dose is 60 mg once daily. If necessary, the dose is increased to 80-120 mg per day. Doses greater than 80 mg should be divided into two doses.

Use in children over 2 years of age and body weight > 20 kg in the treatment of reflux esophagitis and the symptomatic treatment of heartburn and acid regurgitation in GERD

In children over 2 years of age weighing more than 20 kg, the recommended dose is 20 mg once a day. The dose may be increased to 40 mg once daily if necessary.

The course of treatment for reflux esophagitis is 4-8 weeks, for symptomatic treatment of heartburn and sour belching with GERD - 2-4 weeks. If symptoms persist after 2-4 weeks, the patient requires additional examination.

Treatment of duodenal ulcer caused by H. pylori in children over 4 years of age

When choosing the appropriate combination therapy, official local and national recommendations in terms of bacterial resistance, duration of treatment (most often 7 days, but sometimes up to 14 days may be required) and appropriate antibacterial agents should be taken into account.

Treatment is carried out under the supervision of a specialist.

In children weighing 15-30 kg: use in combination with 2 antibiotics: omeprazole - 10 mg, clarithromycin and amoxicillin in this category of patients are prescribed in a dosage regimen according to the instructions for the use of clarithromycin and amoxicillin (used simultaneously 2 times a day for 1 weeks).

In children weighing 31-40 kg: use in combination with 2 antibiotics: omeprazole - 20 mg, clarithromycin and amoxicillin in this category of patients are prescribed in a dosage regimen according to the instructions for the use of clarithromycin and amoxicillin (used simultaneously 2 times a day for 1 weeks).

In children weighing more than 40 kg: use in combination with 2 antibiotics: omeprazole 20 mg, clarithromycin and amoxicillin in this category of patients are prescribed in a dosage regimen according to the instructions for use of clarithromycin and amoxicillin (used simultaneously 2 times a day for 1 week) .

Dosage regimen for special groups of patients

For liver failure, 10-20 mg is prescribed (maximum daily dose 20 mg); in case of impaired renal function and in elderly patients, no dosage adjustment is required.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Best before date

2 years. Do not use after the expiration date stated on the package.

special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract.
because Taking Omeprazole-Teva may mask symptoms and delay the correct diagnosis. Reducing gastric acidity, including when using proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections. Due to decreased secretion of hydrochloric acid, the concentration of chromogranin A (CgA) increases. Increased concentrations of CgA may affect the results of examinations for the detection of neuroendocrine tumors. To prevent this effect, it is necessary to temporarily stop taking omeprazole 5 days before the CgA concentration test. In patients with severe liver dysfunction, it is necessary to regularly monitor liver enzymes during therapy with Omeprazole-Teva.

The drug Omeprazole-Teva contains sucrose and is therefore contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrase/isomaltase deficiency, glucose-galactose malabsorption).

When treating erosive and ulcerative lesions associated with NSAID use, the possibility of limiting or discontinuing NSAID use should be carefully considered to increase the effectiveness of antiulcer therapy.

The drug contains sodium, which should be taken into account in patients on a controlled sodium diet.

The risk-benefit ratio of long-term (more than 1 year) maintenance therapy with Omeprazole-Teva should be regularly assessed. There is evidence of an increased risk of fractures of the vertebrae, wrist bones, and head of the femur, mainly in elderly patients, as well as in the presence of predisposing factors. Patients at risk of developing osteoporosis should ensure adequate intake of vitamin D and calcium.

There are reports of the occurrence of severe hypomagnesemia in patients receiving therapy with proton pump inhibitors, including omeprazole, for more than 1 year.

Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the level of magnesium in the blood plasma (diuretics), require regular monitoring of magnesium levels.

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 who took drugs orally for a long time that reduce the secretion of gastric glands were more likely to develop glandular cysts in the stomach. These phenomena are caused by physiological changes as a result of inhibition of hydrochloric acid secretion, and undergo reverse development as therapy continues.

A decrease in the secretion of hydrochloric acid in the stomach leads to an increase in the growth of normal intestinal microflora, which, in turn, can lead to a slight increase in the risk of developing intestinal infections caused by bacteria of the genus Salmonella spp. and Campylobacter spp., as well as probably Clostridium difficile.

Description

Gastric gland secretion-lowering agent - proton pump inhibitor.

Pharmacodynamics

Omeprazole is a racemic mixture of two enantiomers that reduces the secretion of hydrochloric acid due to specific inhibition of the proton pump of gastric parietal cells. With a single use, it acts quickly and has a reversible inhibition of hydrochloric acid secretion.

Mechanism of action

Omeprazole is a weak base, it becomes active in the acidic environment of the tubules of the cells of the parietal layer of the gastric mucosa, where it is activated and inhibits the H+/K+-ATPase of the proton pump. It has a dose-dependent effect on the last stage of hydrochloric acid synthesis, inhibits both basal and stimulated secretion, regardless of the stimulating factor.

Effect on the secretion of hydrochloric acid in the stomach

After oral administration of omeprazole once a day, there is a rapid and effective decrease in daytime and nighttime secretion of hydrochloric acid, which reaches a maximum within 4 days of treatment.

In patients with duodenal ulcer, 20 mg omeprazole causes a sustained reduction in 24-hour gastric acidity by at least 80%. In this case, a 70% decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin is achieved within 24 hours. Daily oral administration of 20 mg omeprazole in patients with duodenal ulcer maintains pH >3 for an average of 17 hours.

The degree of inhibition of hydrochloric acid secretion is proportional to the area under the tinnitus curve (usually disappears after cessation of therapy).

From the gastrointestinal tract: often - nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with continued therapy), glandular polyps of the fundus of the stomach (benign); rarely - loss of taste, change in color of the tongue to brown-black and the appearance of benign cysts of the salivary glands when used simultaneously with clarithromycin (the phenomena are reversible after cessation of therapy), microscopic colitis; very rarely - dry mouth, stomatitis, candidiasis, pancreatitis.

From the liver and biliary tract: infrequently - changes in the activity of liver enzymes (reversible); very rarely - hepatitis, jaundice, liver failure, encephalopathy in patients with underlying liver diseases.

From the skin and subcutaneous tissues: infrequently - urticaria, rash, itching, alopecia, erythema multiforme, photosensitivity, increased sweating; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the musculoskeletal and connective tissue side: infrequently - fractures of the vertebrae, wrist bones, femoral head (see section "Special instructions"); rarely - myalgia, arthralgia; very rarely - muscle weakness.

From the kidneys and urinary tract: rarely - interstitial nephritis.

General disorders and disorders at the injection site: infrequently - peripheral edema (usually disappears after cessation of therapy); rarely - hyponatremia; very rarely - gynecomastia; frequency unknown - hypomagnesemia (see section "Special instructions").

Use during pregnancy and breastfeeding

Research results indicate no adverse effects on the course of pregnancy, the health of the fetus and newborn child.
Omeprazole can be used with caution during pregnancy. Omeprazole is excreted in breast milk. However, when used in therapeutic doses, the effect on a child is unlikely.

Interaction

Active substances with pH-dependent absorption
A decrease in gastric acidity when using omeprazole can increase or decrease the absorption of pharmacologically active substances.

Nelfinavir, atazanavir

When used concomitantly with omeprazole, a significant decrease in plasma concentrations of atazanavir and nelfinavir may be observed.

The simultaneous use of omeprazole and nelfinavir is contraindicated. Concomitant use of omeprazole (40 mg daily) reduces nelfinavir exposure by approximately 40% and mean exposure to the pharmacologically active metabolite M8 is reduced by 75-90%. The interaction may involve a mechanism of CYP1C19 inhibition. Concomitant use of omeprazole with atazanavir is not recommended.

Coadministration of omeprazole (40 mg daily) and atazanavir 300 mg/ritonavir 100 mg in healthy volunteers resulted in a 75% reduction in atazanavir exposure. Increasing the atazanavir dose to 400 mg does not compensate for the effect of omeprazole on atazanavir exposure. Administration of 20 mg omeprazole per day with 400 mg atazanavir and 100 mg ritonavir to healthy volunteers resulted in an approximately 30% reduction in atazanavir exposure and was comparable to exposure with a single dose of 300 mg atazanavir and 100 mg ritonavir.

Digoxin

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy volunteers increased the bioavailability of digoxin by 10%. Although glycoside toxicity with omeprazole is not a common event, increased monitoring is necessary, especially when treating elderly patients.

Clopidogrel

In a crossover clinical study, the duration of taking clopidogrel in combination with clopidogrel and omeprazole at a dose of 80 mg was 5 days. Exposure to the active metabolite of clopidogrel was reduced by 46% (on day 1) and 42% (on day 5) when clopidogrel and omeprazole were co-administered. The mean time to platelet aggregation inhibition was reduced by 47% (24 hours) and 30% (day 5) when clopidogrel and omeprazole were co-administered. Another study showed that taking clopidogrel and omeprazole at different times did not prevent their interaction, which is likely due to the inhibitory effect of omeprazole on CYP2C19. Observational and clinical studies have provided conflicting data on the clinical impact of these PK/PD interactions on the development of severe cardiovascular events.

Other medicines

The absorption of posaconazole, erlotinib, ketaconazole and itraconazole is significantly reduced, and their clinical effectiveness is accordingly impaired. Avoid co-administration of omeprazole with posaconazole or erlotinib.

Medicines metabolized by the CYP2C19 isoenzyme

Omeprazole moderately inhibits CYP2C19, the main enzyme in the metabolism of omeprazole. Therefore, the metabolism of other drugs also metabolized by CYP2C19 may be reduced and their systemic exposure increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol, diazepam and phenytoin.

Cilostazol

In a crossover clinical study, administration of omeprazole 40 mg to healthy volunteers increased the Cmax and AUC of cilostazol by 18% and 26%, respectively, and one of the active metabolites of cilostazol by 29% and 69%, respectively.

Phenytoin

Monitoring plasma concentrations of phenytoin is recommended during the first two weeks after initiation of omeprazole therapy and in case of dose adjustment of phenytoin; Monitoring and subsequent dose adjustment of phenytoin should be carried out until the end of treatment with omeprazole.

Unknown mechanism of interaction

Saquinavir

Coadministration of omeprazole and saquinavir/ritonavir is well tolerated in HIV-infected patients and also results in a reduction in plasma concentrations of saquinavir by approximately 70%.

Tacrolimus

Coadministration with omeprazole reduces the serum concentration of tacrolimus. Increased monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be carried out, with tacrolimus dose adjustments if necessary.

The influence of other drugs on the pharmacokinetics of omeprazole

Inhibitors of the isoenzyme CYP2C19 and/or CYP3A4 Given the metabolism of omeprazole with the participation of the isoenzymes CYP2C19 and CYP3A4, drugs that can inhibit these enzymes (such as clarithromycin and voriconazole) may reduce the serum concentration of omeprazole, increasing the rate of its metabolism.

No effect on metabolism

Omeprazole does not affect the metabolism of drugs metabolized by the CYP3A4 isoenzyme, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

No interaction of omeprazole with the following drugs has been identified: antacids, caffeine, theophylline, S-warfarin, piroxicam, diclofenac, naproxen, metoprolol, propranolol and ethanol.

Overdose

Symptoms: vomiting, abdominal pain, diarrhea, dizziness, depression, blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

Treatment: symptomatic therapy, hemodialysis is not effective enough. A specific antidote is not known.

Impact on the ability to drive vehicles and operate machinery

Considering the possibility of undesirable effects on the central nervous system and the organ of vision, during treatment with omeprazole, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.