Active substanceOmeprazoleOmeprazole
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  • Dosage form: & nbspcapsules
    Composition:

    Each capsule contains omeprazole 20 mg (in pellets).

    Capsule composition:

    Pellets of omeprazole (omeprazole, methacrylic acid and ethyl acrylate copolymer (acrylic coating L30D), calcium carbonate, potassium hydrogen phosphate (dibasic potassium phosphate), gidrooksipropilmetiltsellyuloza (hypromellose), mannitol, sugar pellets (sucrose) sugar syrup (sucrose), macrogol - 6000 (polyethylene glycol 6000), povidone K-30 (polyvinylpyrrolidone K-30), sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, polysorbate-80 (Tween 80)

    Capsule hard gelatinous: (gelatin, titanium dioxide E171, dye sunset yellow E110 (yellow sunset FCF-FD & C yellow 6 E110), dye quinoline yellow E104 (quinoline yellow E104), water).

    Description:

    Hard gelatin capsules №2 with a case and a cover of yellow color. The contents of the capsules are white or almost white spherical pellets.

    Pharmacotherapeutic group:Proton pump inhibitor
    ATX: & nbsp

    A.02.B.C.01   Omeprazole

    Pharmacodynamics:

    Omeprazole inhibits the enzyme H+/TO+-ATP-asu

    ( "Proton pump") in the gastric parietal cells, and thereby block the final step of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus.After a single intake of the drug, omeprazole acts within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. Have patients with duodenal ulcer 20 mg of omeprazole maintains intragastric pH 3.0 for 17 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.

    Pharmacokinetics:

    Omeprazole is rapidly absorbed from the digestive tract, the peak concentration in the plasma is 0.5-1 hour. Bioavailability is 30-40%. Binding to plasma proteins is about 90%. Omeprazole almost completely metabolized in the liver. Half-life is 0.5-1 hour. It is excreted mainly by the kidneys in the form of metabolites. With CRF excretion decreases in proportion to a decrease in creatinine clearance. In elderly patients excretion decreases, bioavailability increases. With hepatic failure, bioavailability is 100%, half-life is 3 hours.

    Indications:

    - Peptic ulcer of the stomach and duodenum;

    - Reflux esophagitis;

    - Erosive-ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs, stress ulcers;

    - Erosive-ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of complex therapy);

    - Zollinger-Ellison syndrome.

    Contraindications:

    Hypersensitivity to the drug, a child's age, pregnancy, lactation.

    Carefully:

    Renal and / or hepatic insufficiency.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    Inside, squeezed with a small amount of water (the contents of the capsule can not be chewed).

    Peptic ulcer of duodenum in the phase of exacerbation - 1 capsule (20 mg) per day for 2-4 weeks (in resistant cases, up to 2 capsules per day).

    Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 1-2 capsules per day for 4 to 8 weeks.

    Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 1 capsule per day for 4-8 weeks.

    Eradication Helicobacter pylori - 1 capsule 2 times a day for 7 days in combination with antibacterial agents.

    Anti-relapse treatment of peptic ulcer of stomach and duodenum - 1 capsule per day.

    Anti-relapse treatment of reflux esophagitis - 1 capsule per day for a long time (up to 6 months).

    The Zolinger-Ellison Syndrome - the dose is selected individually depending on the initial level of gastric secretion, usually starting at 60 mg per day. If necessary, increase the dose to 80 - 120 mg per day, in this case, it is divided into two doses.

    Side effects:

    In rare cases, the following, usually reversible, side effects may occur:

    From the side of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in the level of "hepatic enzymes in plasma, in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function.

    From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.

    From the side of the musculoskeletal system: muscle weakness, myalgia, arthralgia.

    On the part of the hematopoiesis system: leukopenia, thrombocytopenia, in some cases - agranulocytosis, pancytopenia.

    From the skin: itching; rarely, in some cases - photosensitivity, erythema multiforme, alopecia.

    Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis and anaphylactic shock.

    Other: visual impairment, peripheral edema, increased sweating, fever, gynecomastia; rarely - the formation of gastric grandeur cysts during long-term treatment (consequence of inhibition of hydrochloric acid secretion, is benign reversible).

    Overdose:

    Symptoms of overdose are visual impairment, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

    There is no specific antidote. Treatment is symptomatic.

    Hemodialysis is not effective enough.

    Interaction:

    Long-term use of omeprazole 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their plasma concentration.

    No interaction with concomitant antacids was noted.

    Changes the bioavailability of any drug, the absorption of which depends on the pH value (for example, iron salts).

    Special instructions:

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

    Admission simultaneously with food does not affect its effectiveness.

    If you have difficulty swallowing the whole capsule, you can swallow its contents after opening or dissolving the capsule, and you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

    In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.

    Form release / dosage:

    Capsules of 20 mg.

    Packaging:For 7, 10 capsules in a planar cell package; 2, 3 or 4 contour mesh packages together with instructions for use in a pack of cardboard.
    Storage conditions:

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

    Shelf life:

    2 years. Do not use at the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002333 / 01
    Date of registration:15.07.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:PRODUCTION OF MEDICINES, LTD. PRODUCTION OF MEDICINES, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.06.2017
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