Active substanceOmeprazoleOmeprazole
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  • Dosage form: & nbspcapsules
    Composition:

    Each capsule contains 10 mg or 20 mg of omeprazole a (in pellets).

    Structure of the capsule: gelatin, mareon, purified water.

    Description:

    Hard opaque gelatin capsules with a light cream casing and a light cream cap. The contents of capsules are granules of almost white color.

    Pharmacotherapeutic group:proton pump inhibitor
    ATX: & nbsp

    A.02.B.C.01   Omeprazole

    Pharmacodynamics:

    Inhibits the enzyme H + K + ATP-ase ("proton pump") in parietal cells of the stomach and blocks the final stage 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. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric pH-3 for 17 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.

    Pharmacokinetics:

    Omeprazole is rapidly absorbed from the gastrointestinal tract,the maximum concentration in the plasma is achieved after 0.5-1 hour. Bioavailability is 30-40%. The connection with 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. In chronic renal failure, 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:

    - Stomach ulcer and duodenal ulcer;

    -Reflux-esophagitis;

    -Erosis and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers;

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

    -Zollinger's syndrome-Ellison.

    Contraindications:

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

    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 - 20 mg per day for 2-4 weeks (in resistant cases up to 40 mg per day).

    Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 20-40 mg per day for 4-8 weeks.

    Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - at 20 mg per day for 4-8 weeks.

    Eradication Helicobacter pylori - 20 mg twice a day for 7 days in combination with antibacterial agents.

    Anti-relapse treatment of peptic ulcer of stomach and duodenum - on 10-20 mg a day.

    Anti-relapse treatment of reflux esophagitis - 20 mg per day for a long time (up to 6 months).

    Zollinger-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 2 divided doses.

    Side effects:

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

    On the part of the digestive system: diarrhea or constipation, nausea,vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in the level of "liver" enzymes in the 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 musculoskeletal system: muscle weakness, myalgia, arthralgia.

    On the part of the hematopoiesis system: leukopenia, thrombocytopenia; at

    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: impaired vision, peripheral edema, increased sweating, fever, gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (the consequence of inhibition of the secretion of hydrochloric acid, 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 malignant process (especially with gastric ulcer), because treatment, masking the symptoms, can delay the establishment of the correct diagnosis.

    Admission simultaneously with food does not affect its effectiveness.

    If there are difficulties with swallowing an entire 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 10 and 20 mg.
    Packaging:

    10 capsules in aluminum foil strips; 1, 2, 3 or 10 strips complete with instructions for use in a cardboard bundle.

    For 7, 10 capsules in blisters made of PVC-aluminum foil; 1, 2, 3 or 10 blisters complete with instructions for use in a cardboard bundle.


    Storage conditions:

    List B. In a dry place inaccessible to children, at a temperature not higher

    25 ° С

    Shelf life:

    3 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014419 / 01-2002
    Date of registration:09.10.2008
    The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India
    Information update date: & nbsp13.10.2010
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