Omeprazol-Teva, 40 mg 28 pcs

Indications

Sour belching, Reflux esophagitis, Heartburn, GI infections caused by Helicobacter pylori, Nausea, Gastric and duodenal ulcers, Pain in the intestinal area

Adults:

• gastric and duodenal ulcer (treatment and prevention);
• eradication of Helicobacter pylori in peptic ulcer disease (as part of combination therapy);
• reflux esophagitis; symptomatic gastroesophageal reflux disease (GERD);
• dyspepsia associated with hyperacidity;
• Zollinger-Ellison syndrome.

Children over 2 years of age:

• reflux esophagitis, symptomatic treatment of heartburn and belching sourness in GERD in children over 2 years of age and with a body weight ≥ 20 kg;

Children over 4 years:

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

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Active ingredient

Omeprazole

Composition

1 capsule contains: the active substance omeprazole 40.00 mg; excipients: sugar grits [sucrose, starch treacle] 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, triethylcitrate 12.33 mg, titanium dioxide (E 171) 6.62 mg, talc 0.38 mg. Gelatin capsule: cap: titanium dioxide (E 171) 0.74-0.784 mg, water 5.36-5.684 mg, gelatin 30.89-37.632 mg; body: titanium dioxide (E 171) 1.152-1.18 mg, water 8.526-8.56 mg, gelatin 49.098-56.448 mg.

How to take, the dosage

The capsules are usually taken in the morning, preferably separated from food, swallowed whole, with half a glass of water. The capsules should not be chewed or crushed. If it is difficult to swallow, the contents of the capsule after opening can be mixed with a slightly acidic liquid (juice, yogurt) and used within 30 minutes.

Duodenal ulcer

In acute cases of duodenal ulcer it is recommended to take the drug in 20 mg 1 time per day. Usually the therapy duration is 2 weeks; if necessary, the therapy course may be increased for 2 more weeks. Patients with duodenal ulcer resistant to treatment are usually prescribed the drug 40 mg once a day, for 4 weeks. For relapse prevention in patients with duodenal ulcer, 20 mg once daily; in some cases, 10 mg once daily may be sufficient (capsules containing 10 mg of omeprazole should be used). If necessary, the dose may be increased to 40 mg once daily.

Gastric ulcer

In acute peptic ulcer disease, the recommended dose of the drug is 20 mg once daily. The duration of therapy is 4 weeks. In cases when after the first course of the drug full healing does not occur, a repeated 4-week course of treatment is prescribed. Patients with gastric ulcer disease resistant to treatment are usually prescribed the drug 40 mg 1 time per day, healing is usually achieved within 8 weeks. For prevention of relapse, patients with peptic ulcer disease are recommended to take the drug in a dose of 20 mg once daily. If necessary, the dose can be increased to 40 mg once a day.

Modes of eradication of Helicobacter pylori in peptic ulcer disease:

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

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

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

Treatment of gastric and 12 duodenal ulcer-erosive lesions associated with taking NSAIDs*.

The recommended dose of omeprazole is 20 mg once daily. The course of treatment is 4 weeks. For patients in whom the ulcer has not healed, the course may be prolonged for another 4 weeks.

* (nonsteroidal anti-inflammatory drugs)

.Prevention of gastric and duodenal ulcerative lesions associated with taking NSAIDs

As prophylaxis of NSAID-associated gastric and duodenal ulcerative erosive lesions in patients at risk (age 60+, history of gastric and duodenal ulcerative erosive lesions, upper GI bleeding history), the recommended dose is 20 mg omeprazole once daily.

Treatment of reflux esophagitis

The recommended dose is 20 mg of omeprazole once daily. The course of treatment is 4 weeks. For patients who are not cured during this period, the course may be prolonged by 4 weeks. For severe esophagitis, the recommended dose is 40 mg omeprazole once daily 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 daily (capsules containing 10 mg omeprazole should be used). If necessary, the dose may be increased to 20-40 mg once daily.

Symptomatic treatment of GERD

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

Treatment of nonulcer 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 within 2 weeks there is no relief of symptoms or they worsen, it is necessary to see 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 daily. A dose of more than 80 mg should be divided into two doses.

Application in children over 2 years of age and body weight ≥ 20 kg in the treatment of reflux esophagitis and symptomatic treatment of heartburn and acid regurgitation in GERD<.

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

The course of treatment in reflux esophagitis – 4-8 weeks, in symptomatic treatment of heartburn and belching sourness in GERD – 2-4 weeks. If the symptoms persist after 2-4 weeks, the patient requires additional examination.

Treatment of duodenal ulcer caused by H. pylori in children older than 4 years

When selecting appropriate combination therapy, official local and national guidelines 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 must be taken into account.

The treatment is under the supervision of a specialist.

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

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

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

Dosing regimen in special groups of patients

In patients with hepatic impairment the dosing regimen is 10-20 mg (maximum daily dose 20 mg); no adjustment is necessary in impaired renal function and in elderly patients.

Interaction

Active substances with pH-dependent absorption

The decrease in gastric acidity with omeprazole may increase or decrease absorption of pharmacologically active substances.

Nelfinavir, atazanavir

Concomitant use with omeprazole may significantly decrease plasma concentrations of atazanavir and nelfinavir.

The concomitant use of omeprazole and nelfinavir is contraindicated. Concomitant use of omeprazole (40 mg daily) reduces exposure to nelfinavir by approximately 40% and the average exposure to the pharmacologically active metabolite M8 is reduced by 75-90%. CYP1C19 inhibition mechanism may be involved in the interaction. Concomitant use of omeprazole with atazanavir is not recommended. Concomitant use 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 did not compensate for the effect of omeprazole on atazanavir exposure. Using 20 mg of omeprazole daily with 400 mg of atazanavir and 100 mg of ritonavir in healthy volunteers resulted in approximately 30% reduction in atazanavir exposure and was comparable to exposure with a single dose of 300 mg of atazanavir and 100 mg of ritonavir.

Digoxin

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

Clopidogrel

In a crossover clinical trial, the duration of clopidogrel at a loading dose of 300 mg (75 mg daily) and the combination of clopidogrel with omeprazole at a dose of 80 mg was 5 days. Exposure to the active metabolite clopidogrel was reduced by 46% (on day 1) and 42% (on day 5) when clopidogrel and omeprazole were taken together. The mean time to inhibit platelet aggregation was reduced by 47% (24 hours) and 30% (day 5) when clopidogrel and omeprazole were taken together. In another study, it was shown that taking clopidogrel and omeprazole at different times did not prevent their interaction, which is probably due to the inhibitory effect of omeprazole on CYP2C19. There are conflicting data from observational and clinical studies on the clinical impact of these FC/FD interactions in terms of the development of severe cardiovascular events.

Other drugs

The absorption of posaconazole, erlotinib, cetaconazole and itraconazole is significantly reduced and their clinical effectiveness is correspondingly impaired. Co-administration of omeprazole with posaconazole or erlotinib should be avoided.

Drugs metabolized by the isoenzyme CYP.2C19

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

Cilostazol

In a cross-sectional clinical trial, taking omeprazole at a dose of 40 mg in healthy volunteers increased C_max and AUC of cilostazol by 18% and 26%, respectively, and one of the active metabolites of cilostazol by 29% and 69%, respectively.

Phenytoin

Phenytoin plasma concentration monitoring is recommended for the first two weeks after initiation of omeprazole therapy and if the phenytoin dose is adjusted; monitoring and subsequent adjustment of the phenytoin dose should be performed until completion of omeprazole treatment.

Unknown mechanism of interaction

Saquinavir

. Co-administration of omeprazole and saquinavir/ritonavir is well tolerated in HIV-infected patients and also results in a decrease in plasma concentration of saquinavir to approximately 70%.

Tacrolimus

The co-administration with omeprazole decreases the serum concentration of tacrolimus. Increased monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be performed with dose adjustments of tacrolimus if necessary.

Influence of other drugs on the pharmacokinetics of omeprazole

Inhibitors of CYP2C19 and/or CYP3A4 isoenzyme

. Given the metabolism of omeprazole involving the CYP2C19 and CYP3A4 isoenzymes, drugs that can inhibit these enzymes (such as clarithromycin and voriconazole) can decrease the serum concentration of omeprazole by increasing its metabolic rate.

No effect on metabolism

. Omeprazole has no effect on the metabolism of drugs metabolized by CYP3A4 isoenzyme, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

Omeprazole has not been found to interact with the following drugs: antacids, caffeine, theophylline, S-warfarin, piroxicam, diclofenac, naproxen, metoprolol, propranolol and ethanol.

Special Instructions

Before starting therapy, the presence of a malignant process in the upper gastrointestinal tract should be excluded, since administration of Omeprazole-Teva may mask the symptoms and delay the correct diagnosis. Decreased gastric acidity, including with proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections.

The decrease in hydrochloric acid secretion increases chromogranin A (CgA) concentrations. Increased concentration of CgA may affect the results of examinations to detect neuroendocrine tumors. To prevent this effect, omeprazole should be temporarily discontinued 5 days prior to the CgA study.

In patients with severe hepatic impairment, liver enzymes should be monitored regularly during therapy with Omeprazole-Teva.

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

In the therapy of erosive ulcerative lesions associated with taking NSAIDs, careful consideration should be given to limiting or discontinuing NSAIDs to increase the effectiveness of antiulcer therapy.

The drug contains sodium, which should be considered in patients on a controlled sodium diet.

The risk-benefit ratio of long-term (>1 year) maintenance therapy with Omeprazole-Teva should be regularly evaluated. There are data on increased risk of vertebral fractures, carpal bones, femoral head mainly in elderly patients, as well as in the presence of predisposing factors. Patients at risk for osteoporosis should have adequate vitamin D and calcium intake.

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

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

Omeprazole, like all acid-lowering drugs, may decrease absorption of vitamin B12 (cyanocobalamin). This should be kept in mind in patients with reduced vitamin B12 stores in the body or with risk factors for impaired absorption of vitamin B12 during long-term therapy.

The formation of glandular cysts in the stomach has been observed more frequently in patients who have taken drugs that reduce gastric secretion orally for a long period of time. These phenomena are due to physiologic changes resulting from inhibition of hydrochloric acid secretion, and are reversed with continuation of therapy.

The decrease in secretion of hydrochloric acid in the stomach leads to increased growth of normal intestinal microflora, which in turn may lead to a slightly increased risk of intestinal infections caused by bacteria of the genus Salmonella spp. and Campylobacter spp, and probably Clostridium difficile.

Influence on the ability to drive vehicles, mechanisms

. Because of the possibility of side effects of the central nervous system and eyesight, during treatment with omeprazole, caution should be exercised while driving motor transport and engaging in potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.

Contraindications

Hypersensitivity to omeprazole or any of the ingredients of the drug; fructose intolerance; sucrose/isomaltase deficiency; glucose-galactose malabsorption; simultaneous use with clarithromycin (in patients with hepatic impairment), atazanavir, Hypericum, erlotinib, posaconazole.

Children over 2 years of age for other indications except reflux esophagitis and symptomatic gastroesophageal reflux disease; Children over 4 years of age for other indications except reflux esophagitis, symptomatic gastroesophageal reflux disease and duodenal ulcer caused by Helicobacter pylori. Children under 18 years of age (for all indications except reflux esophagitis and eradication of Helicobacter pylori in duodenal ulcers).

With caution

Liver function deficiency; renal function deficiency; osteoporosis; concomitant use with clarithromycin; concomitant use with clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, voriconazole, rifampicin; use with digoxin, preparations of Saint John’s wort; significant spontaneous weight loss; recurrent vomiting, vomiting with blood; swallowing disorders; discolored stools (tarry stools); and if peptic ulcer is present (or suspected), malignancy should be excluded before treatment because treatment may mask symptoms and delay correct diagnosis.

Side effects

The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very frequently – at least 10%; frequently – at least 1%, but less than 10%; infrequently – at least 0.1%, but less than 1%; rarely – at least 0.01%, but less than 0.1%; very rarely (including isolated cases) – less than 0.01%.

Blood and lymphatic system disorders: Rarely – hypochromic microcytic anemia in children; very rare – reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.

On the immune system:very rarely – rash, increased body temperature, angioedema, bronchospasm, allergic vasculitis, fever, anaphylactic reactions/shock.

Nervous system disorders: often – headache, drowsiness, lethargy (the listed side effects find a tendency to worsen with long-term therapy); infrequently – insomnia, dizziness; rarely – paresthesias, confusion, hallucinations, especially in elderly patients or in severe course of the disease; very rarely – anxiety, depression, especially in elderly patients or in severe course of the disease.

Overlooking organ: infrequent – visual disturbances, including decreased visual fields, decreased visual acuity and clarity (usually subsides after discontinuation of therapy).

Hearing and labyrinth disorders: infrequent – vertigo, auditory disturbances, including “ringing in the ears” (usually subsides after discontinuation of therapy).

Gastrointestinal tract disorders: often – nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases the severity of the above phenomena increases with the continuation of therapy), glandular polyps of the fundamental region of the stomach (benign); rarely – taste disorder, discoloration of the tongue to brownish-black, and appearance of benign salivary gland cysts when concomitantly used with clarithromycin (the phenomena are reversible after discontinuation of therapy), microscopic colitis; very rarely – dry mouth, stomatitis, candidiasis, pancreatitis.

Hepatic and biliary tract disorders: infrequent – changes in the activity of “liver” enzymes (reversible nature); very rare – hepatitis, jaundice, liver failure, encephalopathy in patients with background liver disease.

Skin and subcutaneous tissue disorders: infrequent – urticaria, rash, pruritus, alopecia, erythema multiforme, photosensitization, increased sweating; very rare – Stevens-Johnson syndrome, toxic epidermal necrolysis.

Some cases of skeletal-muscular and connective tissue disorders: frequently – fractures of vertebrae, carpal bones, femoral head (see section “Special indications”); rarely – myalgia and arthralgia; very rarely – muscle weakness.

With regard to the kidneys and urinary tract: rarely – interstitial nephritis.

General disorders and disorders at the site of administration: infrequent – peripheral edema (usually subsides after discontinuation of therapy); rare – hyponatremia; very rare – gynecomastia; frequency unknown – hypomagnesemia (see section “Special Indications”).

Overdose

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

Treatment:conducting symptomatic therapy, hemodialysis is not sufficiently effective. No specific antidote is known.

Pregnancy use

Studies indicate no adverse effects on pregnancy, fetal or newborn health. Omeprazole may be used with caution during pregnancy. Omeprazole is excreted with breast milk. However, when used in therapeutic doses, effects on the child are unlikely.

Similarities

Omez, Omisak, Gastrozol, Losek MAPS, Ultop, Ortanol, Omitox, Omeprazol