Omeprazole capsules 20mg №10×3

Name:
Omeprazole caps slow release 20mg in bl. in pack. No. 10х3
Description:
Capsules hard gelatinous cylindrical shape with hemispherical ends, white. The main active ingredient Omeprazole Release form capsules Dosage 20 mg Pharmacodynamics Omeprazole has an antisecretory effect. The mechanism of action is associated with the ability of omeprazole to block the work of the “proton” pump H / K-ATPase. After oral administration, the omeprazole capsule dissolves in the acidic contents of the stomach and releases pellets (microgranules). Pellets enter the duodenum, where omeprazole is isolated in an alkaline environment. After absorption, with the blood flow, omeprazole enters the gastric mucosa and the lumen of the tubules of the parietal cells, where there is an acidic environment (pH<3.0), is oxidized into the active form - sulfenamide-omeprazole (SA-O). SA-O binds the SH-groups of H/K-ATPase in the tubules of parietal cells and irreversibly blocks the work of the enzyme. This leads to a violation of the last stage of the process of formation of hydrochloric acid of gastric juice. Omeprazole dose-dependently reduces the level of basal (fasting) and stimulated (postprandial) secretion of gastric juice. Reduces the total volume of gastric secretion, the release of pepsin. Effectively inhibits both night and day acid production. After a single dose of 20 mg, the maximum plasma concentration is reached after 1-2 hours. Inhibition of stimulated secretion by 50% persists for 24 hours, while the level of intragastric pH> 3.0 persists for 17 hours. A stable decrease in secretion develops to fourth day of therapy. The ability of parietal cells to produce hydrochloric acid is restored 2-3 days after stopping omeprazole. Omeprazole is concentrated in the parietal cells of the gastric glands and has a cytoprotective effect (stimulates the secretion of mucus and bicarbonates, the reproduction of epithelial cells, prevents the back diffusion of protons from the lumen of the stomach into its mucosa). Eradication of Helicobacter pylori with the appointment of omeprazole and antibacterial agents is associated with a high incidence of ulcer healing and long-term remission of peptic ulcer. In the treatment of duodenal ulcers for 4 weeks, scarring of the ulcer occurs in 93% of patients, in the treatment of gastric ulcers for 8 weeks, this figure is 96%, scarring of peptic ulcers of the esophagus is achieved in 90% of patients. 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. Pharmacokinetics After oral administration, it is rapidly and almost completely absorbed in the gastrointestinal tract (GIT). Bioavailability is 30-40% due to the effect of “first pass” through the liver. Simultaneous food intake does not affect bioavailability. After administration at a dose of 40 mg, the maximum plasma concentration is 1.26 ± 0.41 μg / ml and is reached after 1.38 ± 0.32 hours. With repeated injections, bioavailability increases to 60%. In the blood, it is 95% bound to plasma proteins (albumin, acidic α1-glycoprotein). The volume of distribution is 0.2–0.5 l/kg. It is metabolized in the liver with the participation of cytochrome P450 CYP2C19 with the formation of 6 inactive metabolites: hydroxyomeprazole, sulfide and sulfonic derivatives of omeprazole. The R-enantiomer of omeprazole acts as an inhibitor of its own metabolism, reducing the activity of CYP2C19. In the European population, 3-5% of people have defective CYP2C19 genes and slowly metabolize omeprazole. In the Asian population, the proportion of slow metabolizers is 4 times higher. Due to the fact that omeprazole competitively 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 on the main CYP enzymes. It is excreted mainly by the kidneys in the form of metabolites (72-80%) and through the intestines (18-23%). The total clearance is 7.14-8.57 ml / min / kg. The elimination half-life in people with normal liver function is 0.5-1 hour, with chronic liver failure it can increase up to 3 hours. In chronic renal failure, the elimination of omeprazole decreases in proportion to the decrease in creatinine clearance. Elderly patients may slow down the metabolism of omeprazole and increase its bioavailability. Indications for use peptic ulcer of the stomach and duodenum (treatment and prevention of recurrence); eradication therapy of Helicobacter pylori in infected patients with peptic ulcer of the stomach and duodenum (only as part of combination therapy); peptic ulcer of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers (treatment and prevention in patients at risk of their occurrence); reflux esophagitis; long-term treatment of patients with cured reflux esophagitis; gastroesophageal reflux (including symptomatic); 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 old: duodenal ulcer caused by Helicobacter pylori (as part of complex therapy). Method of application and dosesIt is recommended to take capsules in the morning, preferably before meals, swallowing whole with half a glass of water, without chewing or crushing the capsule. For patients with swallowing disorders or children, you can open the capsule and take the contents, after mixing it with a small amount of still water or a slightly acidic liquid (fruit juice, applesauce), drink a little water. The contents of the capsule are mixed with liquid immediately before use or no more than 30 minutes before taking the drug. If the prescribed dose is missed, the capsule should be taken as soon as possible. If the time for taking the next dose is approaching, you should take it as usual and continue taking Omeprazole according to the regimen recommended by your doctor. Do not take a double dose to make up for a missed one. Dosage in adults Treatment of duodenal ulcer in the acute phase The recommended dose is 20 mg / day. The course of treatment averages 2 weeks. In cases where complete scarring does not occur after the first course of taking omeprazole, a second two-week course of therapy is usually prescribed. In case of duodenal ulcer resistant to therapy, 40 mg / day is prescribed; scarring occurs within 4 weeks. Prevention of exacerbations of peptic ulcer of the stomach and duodenum The recommended dose is 20 mg / day. If necessary, the dose can be increased to 40 mg / day. Treatment of gastric ulcer in the acute phase The recommended dose is 20 mg / day. The course of treatment averages 4 weeks. In cases where, after the first course of taking the drug, the ulcer has not completely healed, a repeated 4-week course of treatment is usually prescribed, during which a cure is achieved. With gastric ulcer resistant to therapy, the drug is prescribed at 40 mg / day; recovery usually occurs within 8 weeks. Elimination of Helicobacter pylori in gastric ulcers Various treatment regimens can be used with the choice of antibiotics for a particular patient. Selection should be made in accordance with national, regional and local resistance data and treatment guidelines. In “triple therapy”: omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1000 mg, each taken twice a day for one week, or omeprazole 20 mg + clarithromycin 250 mg or 500 mg + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each taken 2 times a day for one week, or omeprazole 40 mg + amoxicillin 500 mg + metronidazole 400 mg (or 500 mg or tinidazole 500 mg), each taken 3 times a day for one week. After the elimination of Helicobacter pylori, further treatment of gastric ulcer in the acute phase should be carried out according to the standard treatment regimen. In cases where the test for Helicobacter pylori remains positive after therapy, the course of treatment can be repeated. Treatment of NSAID-related gastric and duodenal ulcers The recommended dose is 20 mg/day. Most patients heal within four weeks. In cases where, after the first course of treatment, the ulcer has not completely healed, a repeated 4-week course is usually prescribed. To prevent NSAID-related gastric and duodenal ulcers in patients at risk (age over 60 years, history of gastric and duodenal ulcers, history of gastrointestinal bleeding), the recommended dose is 20 mg / day. Treatment of reflux esophagitis The recommended dose is 20 mg/day. Most patients heal within 4 weeks. In cases where, after the first course of treatment, the ulcer has not completely healed, a repeated 4-week course is usually prescribed. In patients with severe reflux esophagitis, a dose of 40 mg / day is recommended, the course of treatment is an average of 8 weeks. For long-term treatment of patients with healed reflux esophagitis (in remission), 10 mg / day is prescribed as long-term maintenance therapy. If necessary, the dose can be increased to 20-40 mg. For symptomatic treatment of gastroesophageal reflux disease, the dosing regimen is set individually. Assign 10-20 mg / day. The course of treatment is 4 weeks. If after the end of therapy the symptoms do not disappear, it is recommended to change the treatment regimen. Treatment of Zollinger-Ellison syndrome In Zollinger-Ellison syndrome, the dosage regimen is selected individually and treatment is continued according to clinical indications for as long as necessary. The recommended starting dose is 60 mg/day. All patients with severe disease, as well as in cases where other therapeutic methods have not led to the desired result, should be effectively monitored and more than 90% of patients are maintained on a dose of 20-120 mg / day. In cases where the daily dose of omeprazole exceeds 80 mg, the dose should be divided into two doses per day. Dosage in children Clinical experience with omeprazole in children is limited. Treatment should be under the supervision of a specialist. In the case of severe reflux esophagitis resistant to other therapies, children over 2 years of age weighing more than 20 kg are prescribed 20 mg / day (equivalent to about 1 mg / kg / day). The duration of treatment is 4-8 weeks. Children aged 1 to 2 years are prescribed at a dose of 10 mg / day. At the same time, the contents of the capsule are poured into 50 ml of drinking water, after mixing, half of this volume of liquid is measured and given to the child to drink. If necessary, the dose for children from one year to 2 years old can be increased to 20 mg, for children over 2 years old – up to 40 mg. For the treatment of Helicobacter pylori duodenal ulcer in children and adolescents, the choice of treatment regimen should be made in accordance with national, regional and local guidelines regarding bacterial resistance, duration of treatment (usually 7 days, but sometimes up to 14 days), and appropriate use of antibacterial agents. funds. Children weighing 15-30 kg: omeprazole 10 mg + amoxicillin 25 mg/kg + clarithromycin 7.5 mg/kg body weight, each drug 2 times a day for one week. Children weighing 31-40 kg: omeprazole 20 mg + amoxicillin 750 mg + clarithromycin 7.5 mg / kg body weight, each drug 2 times / day for one week. Children weighing more than 40 kg: omeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg, each drug 2 times / day for one week. Special Populations In patients with impaired renal function and elderly patients (over 65 years), no dosage adjustment is required. In patients with impaired liver function, the dose should not exceed 10-20 mg / day. Use in Pregnancy and Lactation Several studies have shown that omeprazole does not adversely affect pregnancy or the health of the fetus/newborn, so omeprazole may be used during pregnancy after careful consideration of the risk/benefit ratio of the drug. Omeprazole is excreted in breast milk, however, when using the recommended therapeutic dosages, it does not adversely affect the child. The benefit to the mother should be assessed based on clinical need and the potential risk to the child. Precautions Before starting the use of omeprazole, the presence of a malignant process (especially with gastric ulcer) should be excluded, since treatment, masking symptoms, may delay the correct diagnosis. Anxiety syndromes include: significant unintentional weight loss, repeated bouts of vomiting, dysphagia, vomiting blood, anemia or melena (shapeless black stools with a characteristic unpleasant odor). 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 from 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. Elevated levels of chromogranin A (CgA) can distort test results when conducting a diagnostic examination to detect 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. Some children with chronic illnesses may need long-term treatment, although this is not recommended. 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 . Long-term use and / or high doses of proton pump inhibitors may increase the risk of fractures of the hip, wrist, spine. With long-term treatment, especially if it is continued for more than 1 year, patients should be under regular medical supervision. The medicinal product contains sodium in an amount of less than 1 mmol (23 mg) per dose, i.e. practically “sodium-free”. Due to the content of parabens, it can cause allergic reactions (possibly delayed), in rare cases – bronchospasm. Due to the presence of sucrose in the composition, this medicinal product is not suitable for patients with rare congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. If you have an intolerance to some sugars, you should consult your doctor before use. The medicinal product contains lactose, therefore patients with congenital galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this medicinal product. Interaction with other drugs When used simultaneously with antacids, no clinically significant interactions were noted. Slows down the absorption of drugs, which depends on the pH – ampicillin, itraconazole, ketoconazole, iron preparations. It slows down the elimination and enhances the effect of drugs metabolized by cytochrome CYP2C19 – warfarin, diazepam, phenytoin. Omeprazole, when used at doses of 40 mg in healthy subjects in a study, increased the Cmax and AUC of cilostazol by 18% and 26%, respectively, and one of its active metabolites by 29% and 69%, respectively. It is recommended that plasma concentrations of phenytoin be monitored during the first two weeks after starting treatment with omeprazole and, if a dose adjustment of phenytoin is made, monitoring and dose adjustment should be carried out after the end of treatment with omeprazole. Since omeprazole is metabolized by the CYP2C19 and CYP3A4 cytochrome system, the use of drugs that inhibit CYP2C19 and CYP3A4 (for example, clarithromycin and voriconazole) may lead to an increase in the concentration of omeprazole in the blood serum due to a decrease in its metabolism. Enhances the hematotoxic effect of chloramphenicol, thiamazole (mercasolil), lithium preparations. Co-administration of omeprazole and clopidogrel leads to a decrease in the therapeutic effect of clopidogrel. The combined use of omeprazole and digoxin can lead to an increase in the bioavailability of digoxin by 10%. Cases of digitalis intoxication have been described. Caution should be exercised when co-prescribing drugs, especially in elderly patients. Plasma levels of nelfinavir and atazanavir decrease when co-administered with omeprazole. Simultaneous reception of omeprazole and nelfinavir is contraindicated (see section “Contraindications”). Due to the significant reduction in absorption of posaconazole and erlotinib, this combination should be avoided when co-administered with omeprazole. With simultaneous use with omeprazole, plasma concentrations of saquinavir / ritonavir increase. With the simultaneous administration of omeprazole and tacrolimus, the concentration of tacrolimus in the blood serum increases. It is necessary to monitor the concentration of tacrolimus in the blood serum and kidney function (creatinine clearance). Inducers of microsomal liver enzymes CYP2C19 and / or CYP3A4 (for example, rifampicin and St. John’s wort) can reduce the concentration of omeprazole in the blood serum due to an increase in its metabolic rate. With the simultaneous use of methotrexate with proton pump inhibitors in some patients, the concentration of the latter increases. At high doses of methotrexate, it may be necessary to temporarily suspend treatment. Contraindications Hypersensitivity to omeprazole or any excipients, children under 1 year of age (body weight less than 10 kg). Omeprazole, like other proton pump inhibitors (PPIs), should not be co-administered with nelfinavir. Composition One capsule contains: active ingredient – omeprazole (in the form of omeprazole pellets 8.5%) – 20 mg; excipients: mannitol, sucrose, calcium carbonate, lactose, disodium hydrogen orthophosphate, sodium lauryl sulfate, hydroxypropyl methylcellulose, methacrylic acid L30D, propylene glycol, cetyl alcohol, sodium hydroxide, polysorbate 80, povidone S-630, titanium dioxide E 171. Capsule composition: gelatin, titanium dioxide E 171, methyl parahydroxybenzoate E 218, propyl parahydroxybenzoate E 216. Omeprazole has low toxicity. When used in doses up to 270 mg / day, omeprazole did not cause the development of intoxication. In patients with severe hepatic insufficiency, when administered in extremely high doses, confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, and arrhythmias may develop. There is no specific antidote. Relief measures include drug withdrawal, supportive and symptomatic therapy aimed at eliminating the disorders that have arisen. Hemodialysis is not effective enough. Side effects Frequency categories are defined according to the following indicators: very often (? 1/10), often (? 1/100 to 1/10), infrequently (? 1/1000 to <1/100), rarely (? 1/10000 <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). Blood and lymphatic system disorders Rare: leukopenia, thrombocytopenia. Very rare: agranulocytosis, pancytopenia. Immune system disorders Rare: Hypersensitivity reactions such as fever, angioedema and anaphylactic reactions/shock. Metabolic and nutritional disorders Rare: hyponatremia. Not known: hypomagnesemia, which in severe cases can lead to hypocalcemia. Hypomagnesemia can also be associated with hypokalemia. Psychiatric disorders Uncommon: insomnia. Rare: agitation, confusion, depression. Very rare: aggression, hallucinations. Nervous system disorders Common: headache. Infrequently: dizziness, paresthesia, drowsiness. Rarely: distortion of taste sensations. Visual disturbances Rare: blurred vision. Hearing and labyrinth disorders Uncommon: vertigo. Gastrointestinal disorders Common: Gastric polyps (benign), abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting. Rare: dry mouth, stomatitis, gastrointestinal candidiasis. Not known: microscopic colitis. Respiratory, thoracic and mediastinal disorders Rare: bronchospasm. Liver and biliary tract disorders Uncommon: elevated liver enzymes. Rare: hepatitis with or without jaundice. Very rare: liver failure, encephalopathy in patients with pre-existing liver disease. Skin and subcutaneous tissue disorders Uncommon: dermatitis, pruritus, rash, urticaria. Rare: alopecia, photosensitivity. Very rare: erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis. Musculoskeletal and connective tissue disorders Uncommon: fractures of the hip, wrist, spine. Rare: arthralgia, sialgia. Very rare: muscle weakness. Renal and urinary tract disorders Rare: interstitial nephritis. Genital and breast disorders Very rare: gynecomastia. General disorders and disorders at the injection site Uncommon: malaise, peripheral edema. Rare: excessive sweating. Children The safety of omeprazole has been evaluated in a total of 310 children aged 0 to 16 years with acid-related disorders. There are limited long-term safety data based on the experience of using omeprazole during a clinical study in 46 children who received maintenance therapy for severe erosive esophagitis for up to 749 days. The adverse event profile was generally the same as in adults with short- and long-term treatment. There are no data on the effect of long-term treatment with omeprazole on puberty and growth. If you experience any of these or any other adverse reactions not listed in this leaflet, you should consult a doctor. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25? Keep out of the reach of children. Buy Omeprazole capsules 20mg No. 10x3 Price for Omeprazole capsules 20mg No. 10x3