Active substanceOmeprazoleOmeprazole
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  • Dosage form: & nbspcapsules.
    Composition:

    each capsule contains omeprazole pellets of 235.3 mg, including:

    Active substance: omeprazole 20 mg;

    Excipients: manpitol, sucrose, sodium hydrogen phosphate (sodium phosphate disubstituted). sodium lauryl sulfate, lactose, calcium carbonate, methacrylic acid and eqylacrylate copolymer [1: 1] (methacrylic acid copolymer L30D). hypromellose

    hydroxypropyl methyl cellulose), propylene glycol, diethyl phthalate, cetyl alcohol. sodium hydroxide (sodium hydroxide), polysorbate-80 (tween-80), povidone (polyvinylpyrrolidone), titanium dioxide, talc.

    The composition of the capsule is hard gelatinous: body - titanium dioxide, gelatin; cap - titanium dioxide, gelatin, dye quinoline yellow, dye patented blue, dye diamond black.

    Description:

    capsules number 2. consisting of a white body and a lid of green color. The contents of the capsules are white or almost white spherical pellets.

    Pharmacotherapeutic group:Glands of the stomach secretion is a lowering agent - a proton pump inhibitor.
    ATX: & nbsp

    A.02.B.C.01   Omeprazole

    Pharmacodynamics:

    Proton pump inhibitor, reduces acid production - inhibits the activity of H + / K + - adenosine triphosphatase ("proton pump") in parietal cells of the stomach and blocks the final stage of hydrochloric acid secretion.The drug is a prodrug and is activated in the acidic environment of the secretory tubules of parietal cells. Reduces basal and stimulated secretion irrespective of the nature of the stimulus. The antisecretory effect after taking 20 mg occurs within the first hour, a maximum after 2 hours. Inhibition of 50% of maximum secretion lasts 24 hours. A single dose per day provides fast and effective suppression of day and night gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after the end of the admission. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH at level 3 for 17 hours.

    Pharmacokinetics:

    Absorption is high, the time to reach the maximum concentration (TCmah) - 0.5-3.5 hours, bioavailability - 30-40% (with hepatic insufficiency increases almost to 100%); possessing high lipophilicity, easily penetrates into the parietal cells of the stomach, the connection with plasma proteins - 90-95% (albumin and acid alpha-1-glycoprotein). The half-life (T1 / 2) is 0.5-1 hours (with liver failure - 3 hours), the clearance is 500-600 ml / min.Almost completely metabolized in the liver with the participation of the enzyme system CYP2C19, with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulphonic derivatives and others), pharmacologically inactive. Is an inhibitor of isoenzyme CYP2C19. Kidney excretion (70-80%) and with bile (20-30%).

    In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance. In elderly patients excretion decreases, bioavailability increases.

    Indications:

    Stomach ulcer and duodenal ulcer (including the prevention of relapses), reflux esophagitis, hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis). Prevention of aspiration of acidic stomach contents in the respiratory tract during general anesthesia (Mendelssohn syndrome). Gastropathy caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs).

    Eradication Helicobacter pylori in infected patients with peptic ulcer and duodenal ulcer (as part of combination therapy).

    In children older than 12 years in the treatment of gastroesophageal reflux disease and peptic ulcer diseaseof the duodenum associated with Helicobacter pylori (as part of complex therapy).

    Contraindications:

    Hypersensitivity; sugarase / isomaltase deficiency, fructose intolerance, lactase deficiency, lactose intolerance, glucose-galactose malabsorption; simultaneous use with clarithromycin in patients with renal insufficiency, atazanavir, St. John's wort, erlotinib,

    posaconazole.

    Age limit: children under 12 years.

    Carefully:

    Violation of liver and kidney function, osteoporosis, pregnancy, simultaneous use with clarithromycin, clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, voriconazole, rifampicin.

    Pregnancy and lactation:

    Application of the drug Omeprazole When pregnancy is possible, if

    The estimated benefit to the mother exceeds the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.

    Dosing and Administration:

    Inside, capsules are usually taken in the morning, capsules can not be chewed, washed down with a small amount of water (immediately before meals or during meals).

    With exacerbation of peptic ulcer, reflux-esophagitis and NSAID-gastropathy - 20 mg once a day. For patients with severe reflux esophagitis, the dose is increased to 40 mg once a day. The course of treatment for duodenal ulcer is 2-3 weeks, if necessary - 4-5 weeks; with peptic ulcer and esophagitis - 4-8 weeks.

    Patients resistant to treatment with other antiulcer drugs (AC), appoint 40 mg / day. The course of treatment for peptic ulcer 12 weeks - 4 weeks, with peptic ulcer and reflux esophagitis - 8 weeks.

    With Zollinger-Ellison syndrome, 60 mg; if necessary, increase the dose to 80-120 mg / day (in this case, it is prescribed in 2-3 sessions). Prophylaxis of Mendelssohn syndrome - 40 mg 1 hour before surgery (in the case of an operation longer than 2 hours, the required dose of the drug should be re-entered).

    For the prevention of recurrences of peptic ulcer - 10 mg once a day.

    For eradication Helicobacter pylori use "triple" therapy (within 1 week: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - twice a day; or omeprazole 20 mg, clarithromycin 250 mg, metronidazole 400 mg - twice a day; or omeprazole 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or "double" therapy (within 2 weeks: omeprazole 20-40 mg and amoxicillin 750 mg - twice a day, or omeprazole 40 mg - once a day and clarithromycin 500 mg - 3 times a day or amoxicillin 0.75-1.5 g - 2 times a day).

    Children over 12 years of age with chronic gastroduodenal pathology are prescribed omeprazole depending on the body weight (as part of complex therapy): 20 mg / day with a body weight of less than 40 kg, 40 mg / day (20 mg 2 times a day) with a body weight of more than 40 kg.

    Side effects:

    Classification of WHO frequency of development of side effects: very often> 1/10 appointments (> 10%); often from> 1/100 to <1/10 of appointments (> 1% and <10%); infrequently from> 1/1000 to <1/100 of prescriptions (> 0.1% and <1%); rarely from> 1/10000 to <1/1000 appointments (> 0.01% and <0.1%); very rarely <1/10000 prescriptions (<0.01%);

    the frequency is unknown (the frequency can not be determined from the available data).

    Violations of the blood and lymphatic system

    Rarely - Lakopenia, thrombocytopenia, hypochromic microcytic anemia in

    children.

    Rarely agranulocytosis, pancytopenia.

    Immune system disorders

    Rarely - Hypersensitivity reactions (eg, fever, angioedema, anaphylactic reaction / anaphylactic shock).

    Disorders from the metabolism and nutrition Rarely - hyponatremia.

    Unknown frequency hypomagnesemia.

    Mental Disorders Often -lethargy.

    Infrequently - Insomnia.

    Rarely - agitation, confusion, depression, hallucinations.

    Rarely aggression.


    Violations from the nervous system Often - headache.

    Infrequently - dizziness, vertigo, paresthesia, drowsiness.

    Rarely - a violation of taste.

    Disturbance of the organ of vision Rarely blurred vision.

    Hearing disorders and labyrinthine disorders

    Infrequently - impaired auditory perception, including "ringing in the ears."

    Violation of the respiratory system, chest and

    the mediastinum

    Rarely - bronchospasm.

    Disorders from the gastrointestinal tract

    Often - diarrhea, constipation, nausea, vomiting, flatulence, abdominal pain.

    Rarely - dry mouth, stomatitis, candidiasis of the gastrointestinal tract, microscopic colitis, a taste disorder.

    Rarely - pancreatitis.

    Disturbances from the liver and bile ducts - Increased activity of "liver" enzymes.

    Rarely - Hepatitis (with jaundice or without)

    Rarely - hepatic insufficiency, encephalopathy in patients with liver disease.

    Disturbances from the skin and subcutaneous tissues infrequently - dermatitis, itching, rash, hives.

    Rarely - alopecia, photosensitivity.

    Rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

    Disturbances from the musculoskeletal and connective tissue Infrequent -fracture of the hip, bones of the wrist and vertebrae.

    Rarely - Arthralgia, myalgia.

    Rarely - muscle weakness.

    Disorders from the kidneys and urinary tract Rarely-interstitial nephritis.

    Violations from the genitals and breast cancer Very rarely - gynecomastia.

    General disorders and disorders at the site of administration - malaise, peripheral edema.

    Rarely - increased sweating.

    There have been reports of the formation of gastric glandular cysts during prolonged treatment with proton pump inhibitors (the consequence of inhibiting hydrochloric acid secretion is benign reversible).

    Overdose:

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

    Treatment: symptomatic. Hemodialysis is not effective enough.
    Interaction:

    Can reduce the absorption of esters of ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach).

    Omenrazole can reduce the absorption of posaconazole and erlotinib, increases the bioavailability of digoxin.

    Being inhibitors of cytochrome P450, it can increase the concentration and decrease the excretion of warfarin, diazepam, imipramine, clomipramine, citalopram, hexabarbital, disulfiram, anticoagulants of indirect action, phenytoin (AC, which are metabolized in the liver via cytochrome CYP2C19). that in some cases may require a reduction in the doses of these drugs.

    At the same time, long-term use of omeprazole at a dose of 20 mg 1 time per day in combination with caffeine, theophylline. piroxicam, diclofenac. naproxen, metoprolol. propranolol. ethanol, cyclosporin,

    lidocaine. quinidine and estradiol did not lead to a change in their concentration in the plasma.

    Increases the inhibitory effect on the hemopoietic system of other LC. No interaction with concomitant antacids was noted.

    With the combined use of methotrexate with proton pump inhibitors, a slight increase in plasma methotrexate concentration was observed in some patients. When treating high doses of methotrexate, stop taking omeprazole temporarily. When combined with omeprazole with clarithromycin or erythromycin, the concentration of omeprazole in the blood plasma is increased. The simultaneous administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma. No effect of omeprazole on antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol.
    Special instructions:

    Before the start of therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), as treatment, masking the symptoms, can delay the establishment of the correct diagnosis.

    Admission simultaneously with food does not affect its effectiveness.

    Influence on examination

    Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA). Increase in concentration CgA can influence the results of examinations for the detection of neuroendocrine tumors.To prevent this effect, it is necessary to temporarily stop taking omeprazole 5 days before the concentration test CgA.

    Effect on the ability to drive transp. cf. and fur:

    Given the possibility of undesirable effects from the central nervous system and the eye, during treatment with omeprazole, care must be taken when driving vehicles and

    engage in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:Capsules of 20 mg.
    Packaging:

    For 10 or 15 capsules in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered. By 1,2, 3 contour packs of 10 capsules or 1, 2, 3, 4 contour squares of 15 capsules together with the instructions for use will be prevented in a pack of cardboard.

    Storage conditions:

    List B. Store in a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002773 / 01
    Date of registration:14.07.2009
    The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia
    Information update date: & nbsp11.03.2015
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