Active substanceOmeprazoleOmeprazole
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  • Dosage form: & nbsp
    Powder for suspension for oral administration.
    Composition:Each sachet contains:
    active substance: omeprazole 20 mg,
    Excipients: sodium hydrogen carbonate 1680 mg, xylitol 2000 mg, sucrose 2070 mg, sucralose 30 mg, xanthan gum 55 mg, peppermint flavor 30 mg.
    Description:

    Powder from white to almost white with the smell of mint.

    Pharmacotherapeutic group:The iron of the stomach secretion is a reducing agent - a proton pump inhibitor
    ATX: & nbsp

    A.02.B.C.01   Omeprazole

    Pharmacodynamics:

    Specific proton pump inhibitor: inhibits the activity of H + / K + -ATPase in parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing acid production.

    Omeprazole is a prodrug and is activated in the acidic environment of secretory tubules of parietal cells of the stomach.

    The effect is dose-dependent and provides an effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulating factor.

    Elimination of heartburn after taking the drug occurs within 30 minutes. Inhibition of 50% of the maximum secretion of hydrochloric acid 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 above 3 for 17 hours.

    Pharmacokinetics:

    Absorption is high; time to reach the maximum concentration (TCmax), on average, 30 min (10-90 min), bioavailability - 30-40% (with hepatic insufficiency increases to almost 100%); possessing high lipophilicity, easily penetrates into the parietal cells of the stomach, communication with plasma proteins - 95% (albumin and acid alpha-1 glycoprotein). The half-life (T1 / 2) is about 0.5-1 hour (for hepatic insufficiency - 3 hours); the total plasma clearance is from 0.3 to 0.6 l / min. Changes in T1 / 2 during treatment do not occur.

    Almost completely metabolized in the liver with the participation of the enzymatic system of cytochrome P450 (CYP), with the formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulphonic derivatives, etc.).A significant portion of the metabolism of omeprazole depends on the polymorphically expressed specific isoform CYP2C19 (S-mephenytoin hydroxylase), responsible for the formation of hydroxyomeprazole, the main plasma metabolite. 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:

    - heartburn and other symptoms associated with gastroesophageal reflux disease (GERD);

    - non-erosive and erosive (reflux-esophagitis) forms of GERD;

    - peptic ulcer of the stomach and duodenum (including, prevention of relapses);

    - eradication Helicobacter pylori in infected patients with peptic ulcer of the stomach and duodenum (as part of combination therapy);

    - NSAID-gastropatnja;

    - hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis).

    Contraindications:

    Hypersensitivity, intolerance to fructose, a deficiency of sugar / isomaltase,Glucose-galactose malabsorption (due to the presence of sucrose in the composition of the drug), childhood, pregnancy, lactation.

    The drug should not be used in conjunction with atazanavir and nelfinavir.

    Carefully:

    Renal and / or hepatic insufficiency.

    Pregnancy and lactation:
    Dosing and Administration:
    Inside, 30 minutes before eating. Pour the contents of the sachet into a cup, add 1-2 tablespoons of water (do not use other liquids or food products!), Stir well until a uniform suspension is obtained and immediately drink. If necessary, you can drink a small amount of water.

    For a quick relief of the symptoms of heartburn, a single dose of 20 mg of the drug is sufficient.

    Patients with non-erosive GERD - 20 mg 1 time / day for 4 weeks.

    Patients with erosive form of GERD (reflux esophagitis) - 20 mg 2 times / day for 4-8 weeks, depending on the severity of esophagitis. To prevent exacerbation of reflux esophagitis - 20 mg / day, the duration of maintenance therapy is determined individually.

    When exacerbation of gastric ulcer or 12 duodenal ulcer, not associated with Helicobacter pylori - 20 mg in the morning 1 time / day for 4-8 weeks.

    For eradication Helicobacter pylori use therapy in various combinations: within 7-14 days omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - twice a day; or omeprazole 20 mg, clarithromycin 500 mg, metronidazole 500 mg - twice a day; or omeprazole 20 mg 2 times / day, bismuth preparations in a dose of 120 mg 4 times / day, metronidazole 500 mg 3 times / day and tetracycline 500 mg 4 times / day.

    For the prevention of peptic ulcer of the stomach or duodenum - 20 mg in the morning 1 time / day for 4-8 weeks.

    For the treatment of NSAIDs-gastropathies - 20 mg 2 times / day. for 4-6 weeks, for prophylaxis - 20 mg / day for the period of NSAID use in patients with risk factors for the development of NSAIDs-gastropathy.

    At hypersecretory conditions - on 20 mg in the morning 1 time / sut within 4-8 weeks.

    In the treatment of Zollinger-Ellison syndrome, doses are selected individually, depending on the clinical condition. The recommended initial dose is 60 mg per day. In most patients, the condition is adequately controlled in the dose range of 20-120 mg. If you need a dose of more than 80 mg, you need to divide it into 2 injections.

    In elderly patients and with renal failure, there is no need to adjust the dose. In case of liver failure, a daily dose of 20 mg may be sufficient.

    Side effects:

    In rare cases, the following, usually reversible, side reactions may occur.

    The frequency of side effects is classified according to the incidence of the case: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely from> 1/10000 to <1/1000), very rarely (<1/10000), including individual messages.

    From the hematopoiesis: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia.

    On the part of the digestive system: often - diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; rarely - increased activity of "liver" enzymes, taste disorders; very rarely - dry mouth, stomatitis, candidiasis of the gastrointestinal mucosa. in patients with a previous severe liver disease - hepatitis (including jaundice); very rarely - liver failure, incl. with the development of encephalopathy (in patients with a history of liver disease).

    From the nervous system: often - headache; infrequently - dizziness, paresthesia, drowsiness; rarely - a taste disorder.

    Mental disturbances: infrequently insomnia; rarely - agitation, confusion, depression; very rarely, aggression, hallucinations.

    From the sense organs: infrequently - vertigo; rarely - blurred vision.

    From the musculoskeletal system: rarely - arthralgia, myalgia; very rarely - muscle weakness.

    From the skin: infrequently - dermatitis, itching, rash, hives; rarely alopecia, photosensitization; very rarely - multiforme exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis.

    Allergic reactions: rarely hypersensitivity reactions, including fever, angioedema and anaphylactic reactions (including anaphylactic shock).

    From the genitourinary and reproductive system: rarely - interstitial nephritis, very rarely - gynecomastia.

    Metabolic disorders: rarely - hyponatremia; very rarely - hypomagnesemia.

    Other: infrequent - malaise, peripheral edema, rarely - bronchospasm, increased sweating.

    Overdose:

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

    Treatment: symptomatic. If necessary - gastric lavage, Activated carbon. Hemodialysis is not effective enough.

    Interaction:

    Due to a decrease in the acidity of gastric juice in the treatment with omeprazole, absorption of other medicines may decrease or increase (LC), the absorption mechanism of which depends on the pH of the gastric juice.

    Reduces the absorption of ketoconazole and itraconazole.

    Increases absorption of digoxin. Joint use of omeprazole at a dose of 20 mg 1 time per day and digoxin increases the bioavailability of digoxin by about 10%.

    It was shown that omeprazole interacts with some antiretroviral AC. The mechanisms and the clinical significance of these interactions are not always known. An increase in pH in the stomach with omeprazole therapy may affect the absorption of antiretroviral drugs. It is also possible to interact at the isoenzyme level CYP2C19. When combined with omeprazole and antiretroviral drugs, such as atazanavir and nelfinavir, against the background of therapy with omepazolom, there is a decrease in their concentration in the serum. In this regard, the joint use of omeprazole with atheretroviral drugs, such as atazanavir and nelfinavir, Not recommended.

    With the simultaneous use of omeprazole and saquinavir, an increase in saquinavir concentrations inblood serum.

    Omeprazole inhibits CYP2C19 - the main isoenzyme involved in its metabolism. Joint use of omeprazole with other drugs, in the metabolism of which takes part isoenzyme CYP2C19, such as diazepam, phenytoin, warfarin, other antagonists of vitamin K and cilostazol, can lead to a decrease in the metabolism of these drugs.

    It is recommended to control the concentration of phenytoin in the plasma with simultaneous application of phenytoin and omeprazole; in some cases, a reduction in the dose of phenytoin may be required. At the same time, patients with long-term phenytoin, the combined use of omeprazole at a dose of 20 mg 1 time per day did not cause a change in the concentration of phenytoin in the blood plasma.

    When using omeprazole in patients receiving warfarin or other antagonists of vitamin K, control of the international normalized relationship (INR) is necessary; in some cases it may be necessary to reduce the dose of warfarin or other antagonist of vitamin K. At the same time, in patients taking long-term warfarin, the combined use of omeprazole at a dose of 20 mg 1 time per day did not cause a change in clotting time.

    The use of omeprazole in a dose of 40 mg once a day led to an increase in stachia and area under the curve "concentration-time" (AUC) of cystostaxol by 18% and 26%, respectively; for one of the active metabolites of cilostazol, the increase was 29% and 69%, respectively.

    Omeprazole does not affect the metabolism of drugs that are metabolized by isoenzyme CYP3A4, such as, ciclosporin, lidocaine, quinidine, variety, erythromycin and budesonide.

    With the simultaneous use of omeprazole and tacrolimus, there was an increase in the concentration of tacrolimus in the blood serum.

    In the metabolism of omeprazole, isozymes participate CYP2C19 and CYP3A4. The combined use of omeprazole and isozyme inhibitors CYP2C19 and CYP3A4, such as, clarithromycin and voriconazole, can lead to an increase in the concentration of omeprazole in the blood plasma by slowing the metabolism of omeprazole. The combined use of voriconazole and omeprazole led to more than a twofold increase AUC omeprazole, which however did not require correction of the dose of omeprazole.

    LS inducing isoenzymes CYP2C19 and CYP3A4, such as, rifampicin and preparations of St. John's wort perfumed, when combined with omeprazole may lead to a decrease in the concentration of omeprazole in the blood plasma due to the acceleration of the metabolism of omeprazole.

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

    Omez® insta does not affect the ability to drive vehicles and work with machinery.

    Due to the fact that during dasg treatment with Omez® insta, dizziness and drowsiness may occur, care should be taken when driving vehicles and other mechanisms.

    Form release / dosage:

    Powder for the preparation of a suspension for oral administration.

    Packaging:Powder for the preparation of a suspension for oral administration containing 20 mg of omeprazole. For 5.855 grams of powder in a bag of combined material (low density polyethylene / aluminum foil / low density polyethylene / glassine). By 5,10,20,30 bags together with instructions for use in a pack of cardboard.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000014
    Date of registration:25.10.2010 / 16.11.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India
    Information update date: & nbsp16.09.2015
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