Active substanceOmeprazoleOmeprazole
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  • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance: omeprazole - 20 mg in the form of pellets [omeprazole - 20 mg, mannitol - 39.95 mg, sucrose - 64.22 mg, sodium hydrophosphate (sodium phosphate disubstituted) - 2.98 mg, sodium lauryl sulfate - 0.80 mg, lactose - 7.99 mg, calcium carbonate - 7.99 mg, hydroxypropylmethylcellulose (hypromellose) - 20.56 mg, methacrylic acid and ethyl acrylate copolymer (methacrylic acid copolymer L30D) - 58.75 mg, propylene glycol 1.90 mg, diethyl phthalate 5.88 mg, cetyl alcohol 1.76 mg, sodium hydroxide (sodium hydroxide) 0.35 mg, polysorbate 80 (tween 80) 0 , 70 mg, povidone (polyvinylpyrrolidone) 0.61 mg, titanium dioxide 0.42 mg, talc 0.14 mg] - 235.0 mg

    capsule:

    body: blue patent patent (patent blue V) 0.12% or 0.09 mg, dye azorubin (dye karmazin) 0.0034% or 0.0025 mg, dye floxin B 0.0099% or 0.0075 mg, titanium dioxide - 1.2675% or 0.96 mg, gelatin - up to 100%;

    lid: titanium dioxide - 2,1119% or 1.60 mg, gelatin - up to 100%.
    Description:

    Hard gelatin capsules No. 1, white body with a blue lid. The contents of the capsules are white or white pellets with a cream or yellowish hue.

    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:

    Proton pump inhibitor, reduces acid production - inhibits the activity of the enzyme H+/TO+-ATPase in parietal cells of the stomach and thereby blocking the final stage of hydrochloric acid secretion (HCI). 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 (TCmax) - 0.5-3.5 h, bioavailability - 30-40 % (with hepatic insufficiency increases to almost 100%).Possessing high lipophilicity, it 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) - 0.5-1 h (with hepatic insufficiency - 3 h), clearance - 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 sulfone derivatives, etc.), pharmacologically inactive. Is an inhibitor of isoenzyme CYP2C19. Kidney excretion (70-80%) and with bile (20-30%).

    In chronic renal failure (CRF) excretion decreases in proportion to the decrease in creatinine clearance (CC). In elderly patients excretion decreases, bioavailability increases.

    Indications:

    Peptic ulcer of the stomach and duodenum (including the prevention of relapses), reflux-esophagitis, hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract (GIT), polyendocrine adenomatosis, systemic mastocytosis); NSAIDs are gastropathy. Symptomatic gastroesophageal reflux disease.

    Eradication Helicobacter pylori in infected patients with peptic ulcer of the stomach and duodenum (as part of a combination therapy).

    The drug Omeprazol-SZ is approved for use in children older than 2 years and with a body weight> 20 kg in the treatment of gastroesophageal reflux disease, in children older than 4 years in the treatment of ulcers, duodenal ulcers Helicobacter pylori.

    Contraindications:

    Hypersensitivity to omeprazole, substituted benzimidazoles or any component of the drug.

    Deficiency of lactase, sucrose / isomaltase, lactose intolerance, fructose, glucose-galactose malabsorption.

    Simultaneous reception with erlotinibom, posaconazole.

    Simultaneous reception with atazanavir and nelfinavir.

    Simultaneous reception with clarithromycin in patients with hepatic insufficiency.

    Simultaneous reception with St. John's Wort.

    Children younger than 2 years and with a body weight <20 kg (with the treatment of reflux-esophagitis, symptomatic treatment of heartburn and eructations with acidic in gastroesophageal reflux disease).

    Children younger than 4 years (with treatment of duodenal ulcers caused by Helicobacter pylori).

    Children under 18 years of age for all indications, except for gastroesophageal reflux disease and duodenal ulcer associated with Helicobacter pylori.

    Carefully:

    Renal and / or hepatic insufficiency.

    Patients with osteoporosis.

    Simultaneous use with clopidogrel, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, voriconazole, rifampicip, clarithromycin.

    Pregnancy and lactation:

    The drug Omeprazol-SZ is approved for use in pregnancy and during 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. Capsules are taken before meals. With exacerbation of peptic ulcer, reflux-esophagitis and NSAIDs-gastropathies - 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 - 2-3 weeks, if necessary - 4-5 weeks; with peptic ulcer and esophagitis - 4-8 weeks.

    Patients resistant to treatment with other antiulcer drugs are prescribed 40 mg / day. The course of treatment for duodenal ulcer - 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).

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

    With symptomatic gastroesophageal reflux disease, the recommended dose is 20 mg once a day. The drug provides a rapid elimination of symptoms. Individual dose selection is not excluded. If after 4 weeks of treatment (20 mg once a day) the symptoms do not disappear, an additional examination of the patient is recommended.

    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).

    With hepatic insufficiency appoint 10-20 mg once a day; if there is a violation of kidney function and in elderly patients, correction of the dosing regimen is not required.

    Use in children

    Children older than 2 years and with a body weight > 20 kg

    It is recommended to use the following doses: 20 mg once a day, if necessary, the dose can be increased to 40 mg once a day. Reflux esophagitis: duration of treatment 4-8 weeks. Symptomatic treatment of heartburn and eructations with acidic gastroesophageal reflux disease: duration of treatment 2-4 weeks. If omeprazole is used for 2-4 weeks, the symptoms do not disappear, further examination is recommended.

    Children over 4 years old

    Treatment of duodenal ulcers caused by Helicobacter pylori.

    When choosing an antibiotic for the appropriate combination therapy, individual patient tolerability of the drugs must be considered. The drugs should be prescribed in accordance with the nature of the resistance and treatment guidelines, taking into account the duration of treatment (usually 7 days, sometimes 14 days) and the appropriate use of antibacterial drugs.

    Treatment should be carried out under the supervision of a specialist. The following doses are recommended:

    Body mass

    Dosage

    31-40 kg

    Combination with two antibiotics: 20 mg of omeprazole, 750 mg of amoxicillin and clarithromycin 7.5 mg / kg body weight is applied simultaneously twice a day for one week.

    > 40 kg

    Combination with two antibiotics: 20 mg of omeprazole, 1 g of amoxicillin and 500 mg of clarithromycin are administered concomitantly twice a day for one week.

    Side effects:

    The WHO classification was used to indicate the incidence of adverse events: very frequent (10 %); frequent (≥1% and <10%); infrequent (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (<0.01%); an unknown frequency (according to available data, it is not possible to determine the frequency of occurrence of a side effect).

    From the digestive system: often - diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; rarely - increased activity of "liver" enzymes, taste disorders, microscopic colitis, dry mouth, stomatitis, in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function.

    On the part of the organs of hematopoiesis: rarely - leukopenia, thrombocytopenia, hypochromic microcytic anemia in children; very rarely - agranulocytosis, pancytopenia.

    From the nervous system: in patients with severe concomitant somatic diseases often - headache, infrequently - dizziness, insomnia, vertigo,rarely - agitation, depression, paresthesia, hallucinations; It is very rare in patients with a previous severe liver disease - encephalopathy.

    From the side of the musculoskeletal system: infrequently - fractures of the hip, bones of the wrist and vertebrae; rarely - arthralgia, myasthenia gravis, myalgia.

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

    From the immune system: rarely - anaphylactic reactions / anaphylactic shock, angioedema, fever.

    Disorders from the kidneys and urinary tract: rarely interstitial nephritis.

    Disturbances from the respiratory system, chest and mediastinal organs: rarely - bronchospasm.

    Other: rarely - gynecomastia, malaise, visual impairment, peripheral edema, increased sweating, the formation of gastric glandular cysts during long-term treatment (consequence of inhibition of HCI, is benign, reversible), hypomagnesemia, hyponatremia.

    Overdose:

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

    Treatment: symptomatic, if necessary, gastric lavage, the purpose of activated charcoal. Hemodialysis is not effective enough.

    Interaction:

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

    Being an inhibitor of cytochrome P450, it can increase the concentration and decrease the excretion of diazepam, anticoagulants of indirect action, phenytoin (drugs that are metabolized in the liver by means of the cytochrome isoenzyme CYP2C19), which in some cases may require a reduction in the doses of these drugs.

    It is not recommended the joint use of omeprazole with such drugs as, atazanavir and nelfinavir, as their concentration in the blood plasma is reduced when combined with omeprazole (see section "Contraindications").

    Increases the inhibitory effect on the hemopoietic system of other drugs.

    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.

    Joint reception of omeprazole and digoxin increases the bioavailability of digoxin.

    Omeprazole can reduce the absorption of vitamin B12 for prolonged use.

    Omeprazole should not be used simultaneously with St. John's wort preparations due to the expressed clinically significant interaction.

    With simultaneous application with omeprazole, it is possible to slow the withdrawal of warfarin, diazepam, phenytoin, imipramine, clomipramine, citalopram, hexabarbital, disulfiram.

    No effect of omeprazole on antacid agents was detected, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol, piroxicam, diclofenac, naproxen, metoprolol, ciclosporin, estradiol.

    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.

    Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A (CgA). Increase in concentration CgA in blood plasma 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.

    The drug Omeprazol-SZ should not be taken without supervision by the doctor for renal or hepatic insufficiency.

    Patients at risk for developing osteoporosis should receive treatment in accordance with the latest clinical recommendations.

    Admission simultaneously with food does not affect its effectiveness.

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

    There are no data on the effect of the drug on the ability to drive a car or other mechanisms. However, due to the fact that during therapy there may be dizziness, blurred vision and drowsiness,Care should be taken when driving vehicles or while working with mechanisms that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Capsules 20 mg.

    Packaging:

    10 capsules in a planar cell package.

    For 20 or 30 capsules in a can of polymer or in a polymer vial. Each bank or bottle, 1, 2, 3 contour packs of 10 capsules 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:

    3 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N002595 / 01
    Date of registration:10.03.2009 / 31.03.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspNORTH STAR CJSC NORTH STAR CJSC Russia
    Information update date: & nbsp07.06.2017
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