Omez, enteric soluble capsules 40mg 28pcs

Composition

Each 40 mg enteric-soluble capsule contains: Active ingredient:  omeprazole 40 mg. Auxiliary substances: mannitol 236 mg, crospovidone 18 mg, poloxamer (407) 5 mg, hypromellose (1828) 8 mg, meglumin 3 mg. Coverage: povidone (K-30) 26.8 mg. Enteric coating:  methacrylic acid and ethyl acrylate copolymer [1: 1] (methacrylic acid copolymer [type C]) 72 mg, triethyl citrate 7.2 mg, magnesium stearate 4 mg. Composition of gelatin solid capsules size # 0: Body: diamond blue dye (E 133), sunset yellow dye (E 110), charming red dye (E 129), phloxin B dye (Red D & C RED # 28), titanium dioxide (E 171), sodium lauryl sulfate, water, gelatin. Cap: dye iron oxide yellow (E 172), titanium dioxide (E 171), sodium lauryl sulfate, water, gelatin. Black lettering on the capsules: ink S-1-8114: shellac (20% esterified) in ethanol, iron oxide black dye (E 172), n-butanol, propylene glycol (E 1520), indigo carmine dye (E 132), charming red dye (E 129), quinoline yellow dye (E 104), diamond blue dye (E 133); ink S-1-8115: shellac (20% esterified) in ethanol, iron oxide black dye (E 172), ethanol, methanol, indigo carmine dye (E 132), charming red dye (E 129), quinoline yellow dye (E 104), diamond blue dye (E 133).

Pharmacological action

Pharmacodynamicmechanism of action Omeprazole is a weak base. It is concentrated in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, is activated and inhibits the proton pump-the enzyme H+/K+ – ATPASE. The effect of omeprazole on the last stage of the formation of hydrochloric acid in the stomach is dose-dependent and provides highly effective inhibition of basal and stimulated hydrochloric acid secretion, regardless of the stimulating factor. Effect on gastric juice secretion Omeprazole with daily oral use provides rapid and effective inhibition of day and night secretion of hydrochloric acid. The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcer, omeprazole at a dose of 20 mg causes a steady decrease in 24-hour gastric acidity by at least 80%. In this case, the average maximum concentration of hydrochloric acid after stimulation with pentagastrin is reduced by 70% within 24 hours. In patients with duodenal ulcer, omeprazole 20 mg with daily oral use maintains an intragastric acidity value of pH ≥ 3 for an average of 17 hours per day. Inhibition of hydrochloric acid secretion depends on the area under the concentration–time pharmacokinetic curve (AUC) of omeprazole, and not on the drug’s plasma concentration at a given time. Action on Helicobacter Pyloriomeprazole has a bactericidal effect on Helicobacter pylori in vitro. Eradication of Helicobacter pylori when using omeprazole together with antibacterial agents is accompanied by rapid elimination of symptoms, a high degree of healing of defects in the gastrointestinal mucosa and long-term remission of peptic ulcer disease, which reduces the likelihood of complications such as bleeding, as effective as constant maintenance therapy. Other effects associated with inhibition of hydrochloric acid secretionin patients taking drugs that lower the secretion of gastric glands, for a long period of time, the formation of glandular cysts in the stomach is more often noted; cysts are benign and pass independently against the background of continuing therapy. A decrease in the secretion of hydrochloric acid in the stomach leads to a slight increase in the risk of intestinal infections caused by Salmonella spp., Campylobacter spp. and Clostridium difficile. During treatment with drugs that lower the secretion of gastric glands, the concentration of gastrin in the blood serum increases. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A increases (see the section “Special instructions”). Pharmacokineticsabsorption Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration (Cmax) of omeprazole in blood plasma is reached after 0.5-1 hour. Bioavailability after a single oral dose is 30-40%, after a constant intake of 1 time a day, bioavailability increases to 60%. Food intake does not affect the bioavailability of omeprazole. Distribution The binding rate of omeprazole to plasma proteins is about 95%, the volume of distribution is 0.3 l / kg. Metabolism Part of omeprazole undergoes presystemic hepatic metabolism with the participation of CYP2C19 and CYP3A4 isoenzymes with the formation of inactive metabolites of sulfone, sulfide and hydroxy-omeprazole. Omeprazole, which is not involved in the formation of active metabolites by parietal cells, is completely metabolized in the liver also with the participation of isoenzymes CYP2C19 and CYP3A4. The total plasma clearance is 0.3-0.6 l / min. Elimination The elimination half-life is about 40 minutes (30-90 minutes). About 80% is excreted as metabolites by the kidneys, and the rest is excreted by the intestines. Special patient groups There were no significant changes in the bioavailability of omeprazole in elderly patients or in patients with impaired renal function. In patients with impaired liver function, there is an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance.

Indications

Adult gastric and duodenal ulcer disease (including relapse prevention). Gastroesophageal reflux disease (GERD). Hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis). Eradication of Helicobacter pylori in infected patients with peptic ulcer of the stomach and duodenum (as part of combination therapy). Prevention and treatment of gastric and duodenal mucosal injuries caused by nonsteroidal anti-inflammatory drugs (NSAIDs-gastropathy): dyspepsia, mucosal erosions, peptic ulcer. Prevention of Mendelssohn’s syndrome (aspiration pneumonitis). Children Over the age of 2 years, with a body weight of more than 20 kg: in the treatment of gastroesophageal reflux disease;over the age of 4 years, with a body weight of more than 20 kg: in the treatment of duodenal ulcer caused by Helicobacter pylori. Safety and efficacy for other indications in paediatric patients have not been established.

Use during pregnancy and lactation

The results of the studies showed no side effects of omeprazole on the health of pregnant women, on the fetus or on the newborn. Omeprazole is excreted in breast milk, but when used in therapeutic doses, the effect on the child is unlikely. Omeprazole is approved for use during pregnancy and lactation.

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the drug. Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sucrose in the preparation). Concomitant use with erlotinib, posaconazole, nelfinavir and atazanavir. Omeprazole is contraindicated in children, except for the following indications: gastroesophageal reflux disease for children over 2 years of age and duodenal ulcer caused by Helicobacter pylori for children over 4 years of age (see the section “Dosage and use”). Before using the drug, you should consult your doctor in the following cases: :

• in the presence of a previously diagnosed peptic ulcer of the stomach; severe liver disease, accompanied by hepatic insufficiency; renal failure; jaundice; previous surgery on the gastrointestinal tract;
• in the presence of “alarm” symptoms: significant spontaneous reduction of body weight, repeated vomiting, vomiting blood, change in color of stool (black, tar-like stool – melena), impaired swallowing;
• the appearance of new symptoms or modification of already existing symptoms of the gastrointestinal tract;
• while the use of one or more of the following drugs: clopidogrel, digoxin, ketoconazole, Itraconazole, warfarin, Cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampin, St. John’s wort preparations (see section “Interaction with other medicines”).

Osteoporosis. Although a causal relationship between omeprazole use and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision.

Side effects

The frequency of adverse drug reactions is described in accordance with the following gradation: very common (>1/10); common (≥1/100, ><1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (Disorders of the blood and lymphatic system: rarely-leukopenia, thrombocytopenia, hypochromic microcytic anemia in children; very rarely-agranulocytosis, pancytopenia, eosinophilia. Immune system disorders: rarely – hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock. Metabolic and nutritional disorders: rarely-hyponatremia; frequency unknown-hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia. Mental disorders: infrequently-insomnia; rarely-increased excitability, depression, reversible confusion; very rarely-aggression, hallucinations.Nervous system disorders: often-headache; infrequently-dizziness, paresthesia, drowsiness; rarely-taste disorders. Visual disturbances: rarely – blurred vision. Hearing disorders and labyrinth disorders: infrequently-auditory perception disorders, vertigo. Respiratory, thoracic and mediastinal disorders: rarely-bronchospasm. Gastrointestinal disorders: often-abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely-dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis; isolated cases-formation of gastric glandular cysts during long-term treatment with simultaneous use with clarithromycin (a consequence of inhibition of hydrochloric acid secretion, is benign, reversible). Liver and biliary tract disorders: infrequently-increased activity of “liver” enzymes and alkaline phosphatase (reversible); rarely-hepatitis (with or without jaundice), liver failure, encephalopathy in patients with previous severe liver diseases. Skin and subcutaneous tissue disorders: infrequently-dermatitis, pruritus, skin rash, urticaria; rarely-alopecia, photosensitivity reactions in the form of redness of the skin after UV radiation, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome. Musculoskeletal and connective tissue disorders: infrequently-fractures of the vertebrae, wrist bones, and femoral head associated with osteoporosis (see section “Special instructions”); rarely – arthralgia, myalgia, and muscle weakness. Renal and urinary tract disorders: rarely-interstitial nephritis. Genital and breast disorders: rarely-gynecomastia. General disorders: infrequently-malaise; rarely-increased sweating, peripheral edema. In case of side effects that are not specified in these instructions, you should immediately consult a doctor.

Interaction

Slows down the elimination of warfarin, diazepam, and phenytoin.

How to take, course of use and dosage

Inside, with a sufficient amount of water (the contents of the capsule can not be chewed),30 minutes before meals. If the patient cannot swallow the capsule whole, you can mix its contents with a slightly acidified liquid, juice or fruit puree. DO NOT DISSOLVE in carbonated beverages or milk. The resulting mixture should be consumed inside immediately after cooking. Adults with peptic ulcer of the stomach and duodenum – including for the prevention of relapses) – 20 mg 1 time a day; patients resistant to treatment with other anti-ulcer drugs are prescribed at a dose of 40 mg/day, the course of treatment for duodenal ulcer – 2 weeks, if necessary-up to 4 weeks; for gastric ulcer-4-8 weeks. For gastroesophageal reflux disease (GERD), depending on the severity of esophagitis, from 20 mg to 80 mg per day. The duration of the main course also depends on the severity of esophagitis and is 4-8 weeks. Maintenance therapy should be performed at the lowest effective dose, including on-demand and intermittent courses. The duration of maintenance therapy is determined by the doctor. In hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis) – 60 mg; if necessary, the dose is increased to 80-120 mg/day (in this case, it is prescribed in 2-3 doses). For the eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers, according to the recommendations of the Maastricht-4 working group, Omez® can be included in the following treatment regimens:First line (standard triple scheme)Omez ® 20 mg 2 times a day + clarithromycin 500 mg 2 times a day + amoxicillin 1000 mg 2 times a day. To increase the effectiveness of therapy, it is possible to prescribe Omez® at a dose of 40 mg (2 capsules of 20 mg) 2 times a day (doubling the standard dose) and increasing the duration of the course from 7 to 10-14 days. Second line (four-component)It is used when standard triple therapy is ineffective, or when the penicillin group is intolerant. Bismuth tripotassium dicitrate (120 mg 4 times a day) in combination with Omez® 20 mg 2 times a day, tetracycline (500 mg 4 times a day), metronidazole (500 mg 4 times a day) for 10 days. The third line and other alternative therapy options are prescribed based on a study of individual sensitivity of H. pylori to antibacterial drugs. – For the prevention and treatment of damage to the gastric and duodenal mucosa caused by taking nonsteroidal anti-inflammatory drugs (NSAIDs-gastropathy), such as dyspepsia, mucosal erosion, peptic ulcer, for the purpose of prevention, Omez® is prescribed at a dose of 20 mg daily 30 minutes before breakfast during the entire course of NSAID treatment; for the purpose of treatment-at a dose of 20 mg 2 times or once 40 mg per day for 4-8 weeks. – For the prevention of Mendelssohn’s syndrome (aspiration pneumonitis)  – 40 mg once. Children over the age of 2 years, with a body weight of more than 20 kg: with gastroesophageal reflux disease, it is recommended to prescribe Omez® at a dose of 20 mg once a day for 4-8 weeks (the recommended dose of omeprazole for the treatment of gastroesophageal reflux disease in pediatric practice is 0.7-3.3 mg per kilogram of body weight of a child per day);at the age of 4 years, with a body weight of more than 20 kg: with a duodenal ulcer caused by Helicobacter pylori pylori, at a dose of 20 mg once a day in combination with antibacterial drugs (the recommended dose of omeprazole in the eradication regimens of Helicobacter pylori in pediatric practice is 1-2 mg per kilogram of body weight of the child per day). Use of the drug in special cases of impaired renal function. No dose adjustment is required. Impaired liver function. In patients with impaired liver function, the bioavailability and clearance of omeprazole are increased. In this regard, the therapeutic dose should not exceed 20 mg per day. Advanced age. The metabolic rate of omeprazole decreases in the elderly, but no dose adjustment is required.

Overdose

Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.

Treatment: symptomatic. Hemodialysis is not effective enough.

Special instructions

In the presence of any alarming symptoms, such as significant spontaneous weight loss, frequent vomiting, dysphagia, vomiting with blood or melena, as well as in the presence of a stomach ulcer (or if a stomach ulcer is suspected), the possibility of malignancy should be excluded, since treatment with Omez® may smooth out the symptoms and delay the diagnosis. A decrease in the secretion of hydrochloric acid in the stomach under the action of proton pump inhibitors leads to an increase in the growth of normal intestinal microflora and may lead to a slight increase in the risk of intestinal infections caused by Salmonella spp., Campylobacter spp., and Clostridium difficile bacteria. A decrease in the acidity of omeprazole may also lead to a decrease in the absorption of vitamin B12 (cyanocobalamin). With the simultaneous use of omeprazole with clopidogrel, a decrease in the antiplatelet effect of the latter is observed. Patients at risk of developing osteoporosis or fractures associated with it should be under appropriate clinical supervision, although a causal relationship between the use of omeprazole/esomeprazole and fractures associated with osteoporosis has not been established. Severe hypomagnesaemia has been reported in patients treated with proton pump inhibitors, including omeprazole, for more than one year. Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the content of magnesium in blood plasma (diuretics), need regular monitoring of magnesium content. Influence on laboratory tests Lowering the level of hydrochloric acid secretion can lead to an increase in the concentration of chromogranin A (CgA), which affects the results of examinations for detecting neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be suspended 5 days before the CgA concentration study. During treatment with omeprazole, dizziness, drowsiness, and visual impairment may occur, so caution should be exercised when driving vehicles and performing other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children!

Shelf life

3 years

Active ingredient

Omeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Gastrointestinal infections caused by Helicobacter Pylori, Heartburn, Gastric and Duodenal Ulcers, Reflux Esophagitis