Omez capsules 20 mg 30 pcs
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Omeprazole
Release form
Capsules
Composition
Each capsule contains: Active ingredient: omeprazole 20 mg.; Excipients: Granules: mannitol 143.567 mg, lactose 10.14 mg, sodium lauryl sulfate 0.545 mg, sodium hydrogen phosphate 0.923 mg, sucrose 8.951 mg, sucrose (25/30) 25.524 mg, hypromellose 6 cps 0.139 mg; Coverage: hypromellose 6 cps 10,49 mg.; Enteric coating: methacrylic acid and methyl methacrylate copolymer [1: 1] (methacrylic acid copolymer [type C]) 37.8 mg, sodium hydroxide 0.504 mg, macrogol-6000 4.536 mg, talc 4.41 mg, titanium dioxide 3.15 mg .
Pharmacological effect
Mechanism of action; Omeprazole is a weak base. Concentrates 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 + -ATP-azu .; The effect of omeprazole on the last stage of the process of formation of hydrochloric acid in the stomach is dose-dependent and provides highly effective inhibition of basal and stimulated secretion of hydrochloric acid, regardless of the stimulating factor .; Effect on the secretion of gastric juice; Omeprazole with daily oral administration 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 in a dose of 20 mg causes a steady decrease in 24-hour gastric acidity of not less than 80%. When this is achieved a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% within 24 hours; In patients with duodenal ulcer, omeprazole 20 mg with daily oral administration maintains the value of pH ≥ 3 in the intragastric medium for an average of 17 hours per day .; Inhibition of the secretion of hydrochloric acid depends on the area under the concentration-time pharmacokinetic curve (AUC) of omeprazole, and not on the plasma concentration of the drug at a given time .; The effect on Helicobacter pylori; Omeprazole has a bactericidal effect on Helicobacter pylori in vitro .; Eradication of Helicobacter pylori when using omeprazole together with antibacterial agents is accompanied by the rapid elimination of symptoms,a high degree of healing of gastrointestinal mucous membrane defects and long-term remission of peptic ulcer disease, which reduces the likelihood of complications such as bleeding as effectively as constant maintenance therapy .; Other effects associated with inhibition of the secretion of hydrochloric acid; In patients taking drugs that lower the secretion of the gastric glands for a long period of time, the formation of glandular cysts in the stomach is more common; benign cysts and pass independently on the background of continued therapy. Reduced 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 serum increases. Owing to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A increases (see the section “Special Instructions”).
Pharmacokinetics
Absorption; Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration (Cmax) of omeprazole in the blood plasma is reached in 0.5–1 hour. Bioavailability after a single ingestion is 30–40%, after constant administration 1 time per day bioavailability increases to 60%. Eating does not affect the bioavailability of omeprazole .; Distribution; The indicator of the binding of omeprazole to plasma proteins is about 95%, the volume of distribution is 0.3 l / kg .; Metabolism; A part of omeprazole undergoes a presystemic hepatic metabolism involving CYP2C19 and CYP3A4 isoenzymes with the formation of inactive sulfone, sulfide, and hydroxy-omeprazole metabolites. Omeprazole, not included by the parietal cells in the process of formation of active metabolites, is completely metabolized in the liver also with the participation of CYP2C19 and CYP3A4 isoenzymes .; Total plasma clearance is 0.3-0.6 l / min; Withdrawal; The half-life is about 40 minutes (30-90 minutes). About 80% is excreted in the form of metabolites by the kidneys, and the rest - by the intestines .; Special groups of patients; No significant changes in the bioavailability of omeprazole were observed 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
Adults; Peptic ulcer disease of the stomach and duodenum (including prevention of relapse) .; Gastroesophageal reflux disease (GERD) .; Hypersecretory states (Zollinger-Ellison syndrome, stressful ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis) .; Eradication of Helicobacter pylori in infected patients with gastric ulcer and duodenal ulcer (as part of combination therapy) .; Prevention and treatment of injuries of the mucous membrane of the stomach and duodenum caused by taking nonsteroidal anti-inflammatory drugs (NSAIDs-gastropathy): dyspepsia, erosion of the mucous membrane, 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: during the treatment of gastroesophageal reflux disease; ; over the age of 4 years, weighing more than 20 kg: in the treatment of duodenal ulcers caused by Helicobacter pylori .; Safety and efficacy in other indications in pediatric patients has not been established.
Contraindications
Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the drug .; Surase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sucrose in the formulation) .; Concomitant use with erlotinib, posaconazole, nelfinavir and atazanavir .; Omeprazole is contraindicated in children, except as indicated: gastroesophageal reflux disease for children over 2 years old and duodenal ulcer caused by Helicobacter pylori for children over 4 years old (see the section "Administration and Dosage").
Use during pregnancy and lactation
Studies have shown no side effects of omeprazole on the health of pregnant women, on the fetus or on the newborn .; Omeprazole is excreted in breast milk, however, when used in therapeutic doses, the effect on the child is unlikely .; Omeprazole is approved for use during pregnancy and during breastfeeding.
Dosage and administration
Drain down with enough water (the contents of the capsule cannot be chewed), 30 minutes before a meal .; 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 into carbonated drinks or milk.The resulting mixture should be ingested immediately after preparation .; Adults; For gastric ulcer and duodenal ulcer (including for the prevention of relapse) - 20 mg 1 time per day; Patients who are resistant to treatment with other anti-ulcer drugs are prescribed at a dose of 40 mg / day, a course of treatment for duodenal ulcer is 2 weeks, if necessary up to 4 weeks; with gastric ulcer - 4-8 weeks .; When 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 carried out in the smallest effective dose, including on demand and intermittent courses. The duration of maintenance therapy is determined by the doctor .; In hypersecretory conditions (Zollinger-Ellison syndrome, stressful ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis) - 60 mg; if necessary, increase the dose 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 ulcer and duodenal ulcer 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 administer Omez in 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 .; The second line (four-component); It is used in case of failure of the standard triple therapy, or in case of intolerance of the penicillin group. Bismuth tri-potassium 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 treatment options are assigned based on the study of the individual sensitivity of H. pylori to antibacterial drugs. ; - For the prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by nonsteroidal anti-inflammatory drugs (NSAIDs-gastropathy), such as dyspepsia, erosion of the mucous membrane, peptic ulcer,for the purpose of prevention, Omez is prescribed in a dose of 20 mg daily 30 minutes before breakfast during the entire course of NSAID treatment; for the purpose of treatment, in 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, weighing more than 20 kg: for 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 pound of baby’s body weight per day); ; over the age of 4 years, weighing more than 20 kg: with a duodenal ulcer caused by Helicobacter pylori, at a dose of 20 mg once a day in combination with antibacterial drugs (the recommended dose of omeprazole in Helicobacter pylori eradication schemes in pediatric practice is 1 -2 mg per pound of baby’s body weight per day) .; Use of the drug in special cases; Impaired renal function. Dose adjustment is not required .; Liver dysfunction. In patients with impaired liver function, bioavailability and clearance of omeprazole increase. In this regard, the therapeutic dose should not exceed 20 mg per day .; Elderly age. The rate of metabolism of omeprazole in the elderly is reduced, but dose adjustment is not required.
Side effects
The frequency of undesirable drug reactions is described in accordance with the following gradation: very often (> 1/10); often (≥1 / 100, Disorders of the blood and lymphatic system: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia, eosinophilia; Disorders of the immune system: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock .; Metabolic and nutritional disorders: rarely - hyponatremia; frequency unknown - hypomagnesaemia, which in severe cases can lead to hypocalcemia, hypokalemia. Psychiatric disorders: infrequently - sleeplessness Itza, rare - anxiety, depression, reversible mental confusion, very rarely - aggression, hallucinations .; disorders of the nervous system: often - headache, rare - dizziness, paresthesia,drowsiness; rarely - a violation of taste .; Violations on the part of the organ of vision: infrequently - visual disturbances, including reduction of visual fields, decrease in sharpness and clarity of visual perception (usually disappear after cessation of therapy) .; Disturbances on the part of the organ of hearing and labyrinth disorders: infrequently - impaired hearing, including “ringing in the ears” (usually disappear after cessation of therapy), vertigo (feeling of circling your own body or surrounding objects) .; Violations of the respiratory system, chest and mediastinal organs: rarely - bronchospasm .; Disorders of the gastrointestinal tract: often - abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, discoloration of the tongue to brownish black and the appearance of benign salivary gland cysts, while being used with clarithromycin (the effects are reversible after cessation of therapy); isolated cases - the formation of gastric glandular cysts during prolonged treatment and with simultaneous use with clarithromycin (a consequence of the inhibition of the secretion of hydrochloric acid, is benign, reversible) .; Disorders of the liver and biliary tract: infrequently - increased activity of "liver" enzymes and alkaline phosphatase (reversible); rarely, hepatitis (with or without jaundice); very rarely - liver failure, encephalopathy in patients with previous severe liver diseases .; Violations of the skin and subcutaneous tissues: rarely - dermatitis, pruritus, skin rash, urticaria; rarely - alopecia, photosensitivity reactions such as reddening of the skin after ultraviolet irradiation, erythema multiforme exudative, toxic epidermal necrolysis, Stevens-Johnson syndrome (severe erythema, characterized by the appearance of spots and blisters on the skin and mucous membranes against the background of high temperature and pain in the joints) .; Disorders of the musculoskeletal and connective tissues: infrequently - fractures of the vertebrae, wrist bones, femoral head, associated with osteoporosis (see section "Special instructions"), rarely - arthralgia, myalgia,muscle weakness .; Kidney and urinary tract disorders: rarely interstitial nephritis .; Violations of the genital organs and breast: rarely - gynecomastia .; General disorders and disorders at the injection site: infrequently - malaise, peripheral edema; rarely, increased sweating; In the case of side effects that are not listed in this manual, you should immediately consult a doctor.
Overdose
Symptoms: dizziness, confusion, apathy, drowsiness, headache, blurred vision, dilatation of vessels, tachycardia, nausea, vomiting, flatulence, diarrhea, increased sweating, "dryness" in the mouth .; Treatment: symptomatic. If necessary - gastric lavage, the appointment of activated carbon. Hemodialysis is not effective enough.
Interaction with other drugs
You must consult with your doctor before taking Omez if you are receiving treatment with one or more of the drugs indicated in this section. A decrease in the secretion of hydrochloric acid in the stomach during treatment with omeprazole and other proton pump inhibitors may lead to a decrease or increase in the absorption of other drugs, the absorption of which depends on the acidity of the medium .; Substances with pH-dependent absorption; Like other drugs that reduce the acidity of gastric juice, treatment with omeprazole may reduce the absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron and cyanocobalamin. Their joint use with omeprazole should be avoided .; Digoxin; Digoxin bioavailability with simultaneous use with omeprazole increases by 10% (correction of digoxin dosing regimen may be required). Caution should be exercised with the simultaneous use of these drugs in elderly patients .; Clopidogrel; According to research results, an interaction between clopidogrel (loading dose 300 mg, maintenance dose 75 mg / day) and omeprazole (80 mg / day inside) decreases the exposure of the active metabolite of clopidogrel and reduces the inhibition of platelet aggregation. Probably, the observed effect is due to the inhibitory effect of omeprazole on the CYP2C19 isoenzyme.Therefore, the simultaneous use of omeprazole and clopidogrel should be avoided .; Antiretroviral drugs; Increasing the pH value during therapy with omeprazole may affect the absorption of antiretroviral drugs. Interaction at the level of an isoenzyme CYP2C19 is also possible. With the joint use of omeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their concentration in serum is observed during therapy with omeprazole. With simultaneous use with omeprazole, the area under the concentration-time pharmacokinetic curve of atazanavir decreases by 75%. In this regard, the combined use of omeprazole with antiretroviral drugs, such as atazanavir and nelfinavir, is contraindicated .; With simultaneous use with omeprazole, an increase in the plasma concentration of saquinavir / ritonavir up to 70% is noted, while the tolerance of treatment by patients with HIV infection does not worsen .; Tacrolimus; With simultaneous use of omeprazole and tacrolimus, an increase in serum tacrolimus concentration was observed, which may require correction of its dose. It is necessary to control creatinine clearance and tacrolimus concentration in blood plasma when it is combined with omeprazole .; Methotrexate; With the combined use of methotrexate with proton pump inhibitors, some patients showed a slight increase in the concentration of methotrexate in the blood plasma. When treating with high doses of methotrexate, you should temporarily stop taking omeprazole. Formulations in metabolism involving isozyme CYP2C19; While the use of omeprazole may increase the plasma concentration and increase the half-life of warfarin (R-warfarin), diazepam, phenytoin, cilostazol, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs, metabolized in the liver with the participation of CYP2C19 isoenzyme (may require a reduction in the dose of these drugs). However, taking omeprazole 20 mg per day does not affect the concentration of phenytoin in the blood plasma of patients who take phenytoin for a long time. When omeprazole is used by patients receiving warfarin or other vitamin K antagonists, monitoring of the international normalized ratio is necessary.At the same time, concomitant treatment with omeprazole at a daily dose of 20 mg does not lead to a change in the coagulation time in patients who take warfarin for a long time .; Inhibitors of isoenzymes CYP2C19 and / or CYP3A4; Simultaneous use with inhibitors of isoenzymes CYP2C19 and / or CYP3A4 slows down the metabolism of omeprazole .; When co-administration of omeprazole with clarithromycin or erythromycin, the concentration of omeprazole in the blood plasma increases .; The combined use of voriconazole and omeprazole leads to an increase in the area under the pharmacokinetic curve "concentration-time" of omeprazole .; Dose adjustment of omeprazole when used together with inhibitors of isoenzymes CYP2C19 and / or CYP3A4 may be required in patients with severe hepatic insufficiency in the case of long-term use of omeprazole. With a short joint use of the dose adjustment is not required due to the good tolerability of high doses of omeprazole .; Inductors of isoenzymes CYP2C19 and CYP3A4; Inductors of isoenzymes CYP2C19 and CYP3A4, such as rifampicin, Hypericum perforatum preparations of Hypericum perforatum, when used together with omeprazole can lead to a decrease in the concentration of omeprazole in the plasma of the body by acceleration No effect on metabolism; Joint reception of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma .; There is no established clinically significant interaction of omeprazole with metoprolol, phenacetin, estradiol, budesonide, diclofenac, naproxen, piroxicam, S-warfarin .; No effect of omeprazole on antacid agents, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol was detected.
special instructions
Omeprazole is not intended for use in case of occasional heartburn (heartburn less than 2 times a week) .; Before starting therapy with omeprazole, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, since taking omeprazole may mask the symptoms and delay the correct diagnosis .; It is necessary to consult and supervise the doctor if there are any alarming symptoms, such as significant spontaneous weight loss, frequent vomiting, dysphagia (swallowing disorders), vomiting with blood or melena (black semi-liquid stool),and in the presence of a stomach ulcer (or if a stomach ulcer is suspected) .; Reduced 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 can lead to a slight increase in the risk of intestinal infections caused by bacteria of the genus Salmonella spp., Campylobacter spp., And Clostridium difficile bacteria; A decrease in acidity while taking omeprazole can also lead to a decrease in the absorption of vitamin B12 (cyanocobalamin) .; With simultaneous use of omeprazole with clopidogrel, a decrease in the antiaggregant effect of the latter is observed .; Patients with the risk of osteoporosis or fractures against its background should be under appropriate clinical supervision, although a causal relationship between the use of omeprazole / esomeprazole and fractures against osteoporosis has not been established .; There are reports of the occurrence of severe hypomagnesemia in patients receiving therapy for more than one year with proton pump inhibitors, including omeprazole. Patients receiving therapy with omeprazole for a long time, especially in combination with digoxin or other drugs that reduce the content of magnesium in the blood plasma (diuretics), require regular monitoring of the content of magnesium .; Effect on laboratory tests; Increasing the concentration of chromogranin A (CgA) due to a decrease in the secretion of hydrochloric acid may influence the results of examinations for the detection of neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be suspended 5 days prior to conducting a CgA concentration study.