Omez enteric capsules 20mg №10×3

Product DescriptionOmez. Release formCapsules. INNOMeprazol. FTH Proton pump inhibitor. General characteristics Hard transparent gelatin capsules size “2”, with a pink cap and a colorless body, the inscription “OMEZ” on both parts of the capsule. Composition 1 capsule contains: Active substance omeprazole – 20 mg; excipients: mannitol, lactose monohydrate, sodium lauryl sulfate, anhydrous disodium hydrogen phosphate, sucrose, sucrose (25/30), hypromellose (6cps), methacrylic acid copolymer type C, sodium hydroxide, macrogol 6000, purified talc, titanium dioxide (E 171) . Gelatin capsule: water, methyl paraben (E 218), propyl paraben (E 216), gelatin, sodium lauryl sulfate, carmoisine (E 122). Pharmacotherapeutic group Drugs used to treat peptic ulcers and gastroesophageal reflux disease. proton pump inhibitors. Omeprazole. ATC code. A02BC01. Pharmacological properties The use of drugs that suppress the secretion of hydrochloric acid is associated with a response increase in the level of serum gastrin. With a decrease in the acidity of gastric juice, the level of chromogranin A increases, which may distort the results of studies during a diagnostic examination to detect neuroendocrine tumors. Available published data suggest that proton pump inhibitors should be discontinued 5 to 14 days prior to the planned CgA measurement. This allows the level of chromogranin A to normalize to normal values, which can be false positive after taking proton pump inhibitors. Pharmacodynamics Omeprazole is activated in an acidic environment, transforming into a sulfenamide derivative, which irreversibly binds H + K + – ATPase, an enzyme system found on the secretory surface of parietal cells. This blocks the final step of hydrogen ion transport (via exchange for potassium ions), thus inhibiting acid secretion. Omeprazole reduces the level of basal and stimulated secretion, regardless of the form of stimulation. After a single dose of the drug inside, the effect occurs within the first hour and lasts 24 hours, the maximum effect is achieved after 2 hours. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH of 3.0 units. within 17 hours. After stopping the drug, secretory activity is fully restored after 3-5 days. PharmacokineticsAbsorption. Omeprazole is unstable in an acidic environment and is therefore taken orally in the form of enteric granules in capsules or tablets. Omeprazole is rapidly absorbed, with peak plasma concentrations reached approximately 1-2 hours after ingestion. Absorption occurs in the small intestine and is usually completed within 3-6 hours. Simultaneous food intake does not affect bioavailability. After taking a single dose of omeprazole, bioavailability is about 40%, after repeated doses it increases to 60%. Distribution The volume of distribution is about 0.3 l / kg of body weight, the plasma protein binding of omeprazole is about 97%. Metabolism Omeprazole is completely metabolized by cytochrome P450 (CYP). The metabolism of the drug depends on the polymorphic specific isoenzyme CYP2C19, which is responsible for the formation of the main metabolite, hydroxyomeprazole. The metabolism of the remainder depends on another specific isoform, CYP3A4, which is responsible for the formation of omeprazole sulfone. Due to the fact that omeprazole specifically inhibits CYP2C19, there is a risk of metabolic interaction between omeprazole and other substances whose metabolism is associated with CYP2C19. However, due to its low affinity for CYP3A4, omeprazole does not inhibit the metabolism of other CYP3A4 substrates. In addition, omeprazole is characterized by the absence of an inhibitory effect relative to the main ones. About 3% of Caucasians and 15-20% of Asians have a reduced activity of the functional CYP2C19 isoenzyme, which are called “slow metabolizers”, the metabolism of omeprazole probably occurs mainly due to CYP3A4. After a repeated single dose of 20 mg of omeprazole per day, AUC (area according to the “concentration-time” curve) in “slow metabolizers” is 5-10 times higher, and the average Cmax in blood plasma is 3-5 times higher than in study subjects with a functional CYP2C19 enzyme. These results do not affect the choice of omeprazole dosing regimen. Withdrawal The half-life of omeprazole from blood plasma after taking a single dose and repeated doses is usually less than 1 hour. Omeprazole is completely eliminated from the blood plasma in the intervals between doses of the drug, without a tendency to cumulation, after taking a single daily dose. Almost 80% of the oral dose of omeprazole is excreted in the metabolized form in the urine, the rest – with feces, mainly bile secretion. The AUC of omeprazole increases with repeated administration. This increase is dose-dependent and results in a non-linear AUC-dose relationship with multiple doses of the drug. This time and dose dependence is a consequence of a decrease in first-pass metabolism, as well as a decrease in systemic clearance, probably caused by the fact that omeprazole and / or its metabolites (for example, sulfone) inhibit the CYP2C19 enzyme. None of the metabolites of omeprazole affects the secretion of gastric acid. Liver failure. In patients with liver dysfunction, the metabolism of omeprazole is impaired, resulting in an increase in AUC. Omeprazole does not accumulate in the body with a single daily use. Impaired kidney function. In patients with reduced renal function, the pharmacokinetics of omeprazole, including systemic bioavailability and excretion rate, do not change. Elderly patients. (75-79 years old). The rate of metabolism of omeprazole decreases in the elderly. Indications for use Adults: Treatment of gastric and duodenal ulcers. Prevention of recurrence of gastric and duodenal ulcers. Symptomatic treatment of gastroesophageal reflux disease. Treatment of reflux esophagitis, as well as maintenance therapy during remission. Erosive and ulcerative lesions of the stomach and duodenum associated with the use of NCVs, as well as their prevention in patients at risk of their occurrence. Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of complex therapy). Zollinger-Ellison syndrome. Children: Children over 1 year old and weighing at least 10 kg. Treatment of reflux esophagitis. Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease. Children over 4 years of age and weighing ≥31 kg (for enteric capsules 20 mg). Peptic ulcer of the duodenum caused by Helicobacter pylori (as part of complex therapy). Dosage and administration It is recommended to take the capsules in the morning, preferably without food, with a small amount of water (do not chew). Patients with swallowing disorders or children can open the capsule and take the contents by first mixing it with a small amount of still water or a slightly acidic liquid (fruit juice, applesauce) and drinking a small amount of water. Patients should be informed that mixing the contents of the capsule with liquid should be done directly or no more than 30 minutes before taking the drug. The contents of the capsule should not be chewed. Adults: Duodenal ulcer: Acute phase: 20 mg once a day for 2 weeks, if necessary, the course of treatment can be increased up to 4 weeks. With resistance to ongoing therapy, it is possible to increase the dose of the drug to 40 mg once a day. Prevention of relapse: The recommended dose is 10 mg once a day, if necessary, the dose can be increased to 20-40 mg once a day. Gastric ulcer: Acute phase: 20 mg once a day for 4 weeks, if necessary, the course of treatment can be increased up to 8 weeks. With resistance to ongoing therapy, it is possible to increase the dose of the drug to 40 mg once a day. Maintenance therapy: The recommended dose is 20 mg once a day, if necessary, the dose can be increased to 40 mg once a day. Erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs 20 mg once a day for 4 weeks, if necessary, the course of treatment can be increased up to 8 weeks. Prevention of erosive and ulcerative lesions of the gastrointestinal tract caused by NSAIDs In the risk group (patients over 60 years of age, with a history of gastric or duodenal ulcers, history of gastrointestinal bleeding), it is recommended to take omeprazole at a dose of 20 mg once a day. Eradication of Helicobacter pylori The recommended dose of omeprazole is 20 mg 2 times a day or 40 mg 1 time a day for 7 days in combination with antibacterial agents. The choice of antibacterial agents is made individually for each patient in accordance with national, regional and local data on resistance and principles of treatment. In case of ineffectiveness of therapy, a second course is possible. Reflux esophagitis: Acute phase: 20 mg once a day for 4 weeks, if necessary, the course of treatment can be increased up to 8 weeks. In severe cases, as well as with resistance to ongoing therapy, it is possible to increase the dose of the drug to 40 mg once a day. Maintenance therapy: The recommended dose is 10 mg once a day, if necessary, the dose can be increased to 20-40 mg once a day. Symptomatic treatment of gastroesophageal reflux disease It is recommended to take the drug at a dose of 10-20 mg once a day. If there is no improvement after 4 weeks of therapy at a dose of 20 mg, an additional examination is recommended. Zollinger-Ellison syndrome The dose is adjusted individually depending on the initial level of gastric secretion, usually starting with 60 mg per day. If necessary, the dose is increased to 80-120 mg per day, in which case it is divided into 2 doses. The drug is continued as long as the need persists. Children. The following doses are used: Children over 1 year old weighing 10 to 20 kg – 10 mg once a day, if necessary, the dose can be increased to 20 mg once a day. Children over 2 years of age weighing more than 20 kg – 20 mg once a day, if necessary, the dose can be increased to 40 mg 1 time per day. The duration of treatment for reflux esophagitis is 4-8 weeks. The duration of treatment for gastroesophageal reflux disease is 2-4 weeks; if the cure was not achieved within the specified timeframe, an additional examination should be carried out. Eradication of Helicobacter pylori in children and adolescents over 4 years of age and weighing ≥30 kg: The recommended dose of omeprazole for children weighing ≥31 kg is 20 mg 2 times a day for 7 days in combination with antibacterial agents. The choice of antibacterial agents is made individually for each patient in accordance with national, regional and local data on resistance and principles of treatment. Features of the use of the drug in certain categories of patients. Use in patients with impaired liver function: in patients with this pathology, it may be necessary to reduce the dose, since omeprazole is extensively metabolized by the liver and the excretion rate in such patients is reduced compared to patients with preserved liver function. The daily dose should be 10-20 mg in patients with severe liver pathology. Use in elderly patients: there is no need to adjust the dose depending on age. However, the possibility of a slight decrease in the rate of excretion and an increase in the bioavailability of the drug in elderly patients was noted. If the patient has forgotten to take the next dose of Omez, the capsule should be taken as soon as possible. However, if it is time for the next dose, you do not need to take a double dose to make up for the forgotten one. You should continue taking Omez capsules according to the recommended dosing regimen. Side effects The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting. In rare cases, the following, usually reversible, side effects may occur. The frequency of adverse reactions is given as the following gradation: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10000, <1/1000); very rarely (< 1/10000); unknown (frequency not determined). Hematopoietic and lymphatic system: rarely: leukopenia, thrombocytopenia; very rarely: agranulocytosis, pancytopenia. Immune system: rarely: hypersensitivity reactions, such as fever, angioedema and anaphylactic reactions / shock. Metabolism and nutrition: rarely: hyponatremia; unknown: hypomagnesemia, which in severe cases can lead to hypocalcemia. Hypomagnesemia can also be associated with hypokalemia. Mental disorders: infrequently: insomnia; rarely: agitation, confusion, depression; very rarely: aggression, hallucinations. Nervous system: often: headache; infrequently: dizziness, drowsiness, paresthesia; rarely: distortion of taste sensations. Organs of vision: rarely: blurred vision. Organs of hearing and labyrinth system: infrequently: vertigo. Respiratory, thoracic and mediastinal organs: rarely: bronchospasm. Gastrointestinal tract: often: abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting, stomach polyps (benign); rarely: dry mouth, stomatitis, gastrointestinal candidiasis; unknown: microscopic colitis. Hepatobiliary system: infrequently: increased levels of liver enzymes; rarely: hepatitis with or without jaundice; very rarely: liver failure, encephalopathy in patients with pre-existing liver disease. Skin and subcutaneous tissue: infrequently: dermatitis, itching, rash, urticaria; rarely: alopecia, photosensitivity; very rarely: erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis. Musculoskeletal and connective tissue: infrequently: fractures of the hip, wrist, spine; rarely: arthralgia, sialgia; very rare: muscle weakness. Kidneys and urinary tract: rarely: interstitial nephritis. Reproductive system and mammary glands: very rarely: gynecomastia. General disorders and the state of the injection site: infrequently: malaise, peripheral edema; rarely: increased sweating. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in these instructions for use. Contraindications Hypersensitivity to the drug, children's age (under 1 year, body weight less than 10 kg). Omeprazole, like other PPIs, should not be co-administered with nelfinavir. Overdose Overdose symptoms are blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia. There is no specific antidote. Treatment is symptomatic. Due to the fact that a significant part of the drug in plasma is in a protein-bound form, hemodialysis is not effective enough. Precautions If there are any worrisome symptoms (eg, significant unintentional weight loss, repeated bouts of vomiting, dysphagia, hematemesis, anemia, or melena), or if a stomach ulcer is present or suspected, malignancy should be ruled out because treatment may relieve symptoms and delay diagnosis. Co-administration of atazanavir with proton pump inhibitors is not recommended, if such combination therapy is necessary, careful clinical monitoring (for example, viral load) is recommended with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir: the daily dose of omeprazole 20 mg should not be exceeded. Omeprazole, like all drugs that block the secretion of hydrochloric acid, can reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- and achlorhydria. This should be taken into account during long-term therapy in patients with low body weight or with an increased risk of reduced absorption of vitamin B12, or if relevant clinical symptoms are observed. Omeprazole is a CYP2C19 inhibitor. At the beginning or end of treatment with omeprazole, the potential for interactions with drugs that are metabolized via CYP2C19 should be considered. An interaction between clopidogrel and omeprazole has been observed, the clinical significance of which has not been determined. As a precaution, it is recommended to avoid the simultaneous use of omeprazole and clopidogrel. There have been reports of the development of symptomatic and asymptomatic hypomagnesemia in patients taking proton pump inhibitors for at least 3 months, in most cases after 1 year of therapy. Serious side effects include tetany, arrhythmias, and seizures. Most patients required magnesium salts and discontinuation of proton pump inhibitors. Patients in whom long-term use of proton pump inhibitors or concomitant use of digoxin, or other drugs that can cause a decrease in magnesium levels (for example, diuretics), it is necessary to determine the concentration of magnesium in the blood serum before starting the use of proton pump inhibitors and periodically during use . There is evidence of an increased risk of fractures of the vertebrae, wrist bones, femoral head, mainly in elderly patients, as well as in the presence of predisposing factors. According to studies, proton pump inhibitors can increase the overall risk of fractures by 10-40%. Patients at risk of developing osteoporosis should ensure adequate intake of vitamin D and calcium. Interference with laboratory results Elevated levels of chromogranin A (CgA) may interfere with test results for diagnostic testing for neuroendocrine tumors. To avoid this, the use of proton pump inhibitors should be discontinued at least five days before the measurement of serum chromogranin levels. If the levels of CgA and gastrin have not returned to normal values after the initial measurement, the determination of the level of chromogranin should be repeated 14 days after stopping the proton pump inhibitors. The use of proton pump inhibitors may lead to a slight increase in the risk of infectious diseases of the gastrointestinal tract caused by bacteria of the genus Salmonella spp. and Campylobacter spp. Patients taking the drug for a long period (especially more than a year) should be under regular medical supervision. Omez 20 mg contains lactose, therefore patients with congenital galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption should not use this drug. Application features Use during pregnancy and lactation: the results of a number of studies have shown that omeprazole does not adversely affect pregnancy or the health of the fetus / newborn, and therefore omeprazole can be used during pregnancy. Omeprazole is excreted in breast milk, however, when using the recommended therapeutic dosages, it does not adversely affect the child. The use of omeprazole during pregnancy and lactation is possible only after a thorough assessment of the benefit-risk ratio. Influence on the ability to drive a car and control mechanisms: the drug in most cases does not affect the ability to drive a car and control moving mechanisms. However, in rare cases, adverse reactions such as dizziness, visual disturbances may occur. In the event of such violations, the patient should refrain from activities that require increased accuracy and concentration. Interaction with other drugs Omeprazole, by acting on the acid-peptic factor, can affect the bioavailability of drugs, the absorption of which depends on pH, and omeprazole can also prevent the destruction of drugs that are sensitive to acid. Therefore, the simultaneous use of itraconazole or ketoconazole and omeprazole may lead to a decrease in the rate of absorption of other drugs. Omeprazole has a moderate inhibitory effect on CYP2C19 (the main enzyme responsible for the metabolism of omeprazole). Thus, the metabolism of drugs that are also metabolized by CYP2C19 may be slowed down, which may lead to an increase in their clinical effect (warfarin and other vitamin K antagonists, cilostazol, diazepam, phenytoin). Since omeprazole is metabolized by CYP2C19 and CYP3A4, administration of strong inhibitors of these enzymes (eg, clarithromycin and voriconazole) may lead to an increase in serum concentrations of omeprazole. The simultaneous appointment of omeprazole and voriconazole can lead to a two-fold increase in the concentration of omeprazole in the blood serum. With prolonged treatment, as well as in patients with severe hepatic insufficiency, dose adjustment may be required. Drugs that induce CYP2C19 and CYP3A4 (for example, rifampicin, St. John's wort), when used together with omeprazole, can lead to a decrease in the concentration of omeprazole in blood serum. Plasma concentrations of nelfinavir and atazanavir are reduced with concomitant use of omeprazole. Co-administration of omeprazole with nelfinavir is contraindicated. Co-administration of omeprazole (40 mg 1 time per day) reduces the exposure of nelfinavir by an average of approximately 40%, and the pharmacologically active metabolite of nelfinavir M8 to 75-90%. The interaction may be associated with inhibition of CYP2C19. Absorption of posaconazole, erlotinib, ketoconazole, and itraconazole is significantly reduced and thus clinical efficacy may be impaired. Co-administration of posaconazole and erlotinib should be avoided. Mechanism unknown Saquinavir Co-administration of omeprazole with saquinavir/ritonavir resulted in an increase in plasma concentrations of saquinavir of up to 70%, with good tolerability in HIV-infected patients. Tacrolimus Concomitant use of omeprazole may increase the serum concentration of tacrolimus, increased monitoring of tacrolimus concentrations as well as renal function (creatinine clearance) should be carried out, and the dosage of tacrolimus adjusted if necessary. Methotrexate When methotrexate is used with proton pump inhibitors, methotrexate concentrations increase in some patients. At high doses of methotrexate, it may be necessary to temporarily suspend treatment with omeprazole. Storage conditions and shelf life Store at a temperature not exceeding 25 ° C in a place protected from light and moisture. Keep out of the reach of children! Shelf life - 3 years. Do not use after the expiry date stated on the packaging. Conditions of leave By doctor's prescription. Packing: 10 capsules in an aluminum/aluminum blister pack or in an aluminum/aluminum strip. 3 blister packs or 3 strips together with instructions for medical use are placed in a cardboard pack. Buy Omez enteric capsules 20mg No. 10x3