Active substanceOmeprazoleOmeprazole
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  • Dosage form: & nbspenteric-coated capsules
    Composition:

    Composition per one capsule

    Omeprazole pellets - 117.5 mg, containing:

    active substance: omeprazole - 10.0 mg;

    Excipients: Mannitol - 19.97 mg, sucrose - 32.11 mg, disodium hydrogen phosphate - 1.49 mg, sodium lauryl sulfate - 0.40 mg, lactose monohydrate - 4.00 mg, calcium carbonate - 4.00 mg, hypromellose (hydroxypropylmethylcellulose E -5) -10.28 mg, methacrylic acid and ethyl acrylate copolymer [1: 1] (L-30D) -29.37 mg, propylene glycol-0.95 mg, diethyl phthalate-2.94 mg, cetyl alcohol-0.88 mg, sodium hydroxide 0.18 mg, polysorbate-80 0.35 mg, povidone (polyvinylpyrrolidone, povidone K-30) 0.30 mg, titanium dioxide 0.21, talc 0.07 mg.

    The composition of the capsule shell is hard gelatinous:

    body: titanium dioxide (E 171) - 2.0000%, gelatin - up to 100%.

    lid: titanium dioxide (E171) - 1.3333%, dye sunset yellow (E 110) 0.0044%, quinoline yellow (E 104) 0.9197%, gelatin up to 100%.

    Description:

    Opaque capsules number 2. The case is white, the lid is yellow. The contents of capsules are pellets from white to almost white.

    Pharmacotherapeutic group:A drug that reduces the secretion of the glands of the stomach - a proton pump inhibitor
    ATX: & nbsp

    A.02.B.C.01   Omeprazole

    Pharmacodynamics:

    Omeprazole inhibits the enzyme H+TO+-ATP-ase ("proton pump") in parietal cells of the stomach, thereby blocking the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated acid 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. After discontinuation of the drug, the secretory activity is completely restored after 3 to 5 days.

    Pharmacokinetics:

    Suction

    After oral administration omeprazole quickly absorbed from the gastrointestinal tract, the maximum concentration (CmOh) of omeprazole in blood plasma is achieved after 0.5 - 3.5 hours. Bioavailability is 30 - 40%.

    Distribution

    Binding to plasma proteins is about 95%.

    Metabolism

    Omeprazole is almost completely metabolized in the liver with the participation of isoenzyme CYP2C19 with the formation of six pharmacologically inactive metabolites.

    Excretion

    The half-life (T1 / 2) is 0-5-1 hour. It is excreted as metabolites by the kidneys (70 - 80%) and with bile (20 - 30%).

    Pharmacokinetics in special clinical cases

    In patients with hepatic insufficiency, bioavailability increases significantly, and the elimination half-life increases to 3 hours. In elderly patients the rate of excretion decreases, bioavailability increases.

    Indications:Symptoms of gastroesophageal reflux, such as heartburn, acidic eructation.
    Contraindications:

    Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the drug.

    Simultaneous use with drugs of nelfinavir, atazanavir, erlotinib, posaconazole.

    Age to 18 years.

    Carefully:

    Before using the drug, you should consult your doctor in the following cases:

    - if there is a previously diagnosed gastric ulcer; severe liver disease accompanied by hepatic insufficiency; jaundice; previous surgical intervention on the gastrointestinal tract;

    - in the presence of "anxious" symptoms: significant spontaneous loss of body weight, repeated vomiting, vomiting with blood, changes in color of stool (tarry stool - melena), impaired swallowing;

    - When new symptoms or changes in existing symptoms from the gastrointestinal tract occur;

    - in the presence of osteoporosis;

    - on the background of ongoing symptomatic treatment for indigestion or persistent heartburn (for 4 weeks or more);

    - when used concomitantly with one or more of the following drugs: clopidogrel, digoxin, erlotinib, ketoconazole, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, preparations of St. John's wort perfumed (see Interactions with other medicinal products).

    It is also advisable to consult a doctor before using Gastrozol® during pregnancy and breastfeeding (see Application during pregnancy and during breastfeeding.)

    Pregnancy and lactation:

    The results of three prospective epidemiological studies (more than 1000 observations) showed that the use of omeprazole in pregnant women does not adversely affect the course of pregnancy and fetus / newborn health.Nevertheless, before using the drug during pregnancy, it is recommended to consult a doctor.

    Omeprazole penetrates into breast milk. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:

    Inside, squeezed enough water (the contents of the capsule can not be chewed), 30 minutes before eating. If the patient can not swallow the whole capsule, you can dissolve its contents in a small amount of water or fruit juice (not dissolve in carbonated drinks). The resulting solution of the drug should be drunk immediately after preparation, drinking an additional 1/2 cup of water.

    Symptoms of gastroesophageal reflux, such as heartburn, sour belch.

    The usual dose of the drug Gastrozol® is 10 mg (1 capsule) once a day. The maximum daily dose of the drug should not exceed 20 mg. The lowest effective dose should always be used. The maximum course of treatment without a doctor's consultation is 14 days. The interval between 14-day courses of treatment should be at least 4 months.

    If there is no relief of the symptoms within 2 weeks or they become worse, you should consult your doctor!

    Application of the drug in special cases

    The possibility of using the drug Gastrozole® in special cases is evaluated by a doctor.

    Impaired renal function.

    Correction of the dose is not required.

    Violation of the function of the liver.

    In patients with impaired liver function, the bioavailability and clearance of omeprazole is increased. Before use, consult a physician.

    Elderly age.

    Despite the fact that the rate of metabolism of omeprazole in elderly people is decreasing, correction of the dose when using the drug in a daily dose of 20 mg or less is not required.

    Side effects:

    The incidence of side effects is described in accordance with the following gradation: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10000, <1/1000); very rarely (<1/10000).

    Allergic reactions: infrequently - urticaria, skin rash, itchy skin; rarely - fever, urticaria, angioedema, anaphylactoid reactions; very rarely - eosinophilia.

    From the gastrointestinal tract: often - nausea, vomiting, abdominal pain, diarrhea or constipation, flatulence; infrequently - increased activity of "liver" enzymes (transaminases) and alkaline phosphatase (reversible nature), a taste distortion (usually occurs after cessation of therapy); rarely - dry mouth, stomatitis, candidiasis of the gastrointestinal tract,hepatitis (with or without jaundice), microscopic colitis, discoloration of the tongue to brownish-black and the appearance of benign salivary gland cysts with concurrent use with clarithromycin (phenomena are reversible after discontinuation of therapy); very rarely - liver failure (in patients with a previous severe liver disease).

    From the nervous system: often - headache; infrequently - dizziness, paresthesia, drowsiness, insomnia; rarely excitation, reversible confusion, depression; very rarely - aggression, confusion, hallucinations; against a background of severe liver disease - encephalopathy.

    From the skin and subcutaneous tissues: infrequently - dermatitis; rarely - photosensitivity (reddening of the skin), alopecia; very rarely - multiforme exudative erythema, Stevens-Johnson syndrome (severe erythema multiforme, characterized by the appearance of spots and blisters on the skin and mucous membranes against a background of high fever and joint pain), toxic epidermal necrolysis; frequency unknown - subacute cutaneous lupus erythematosus.

    From the side of the organ of vision: infrequently - visual disturbances, including,reduction of visual fields, reduction of acuity and clarity of visual perception (usually occur after discontinuation of therapy).

    From the side of the hearing organ and labyrinthine disturbances: infrequently - impairment of auditory perception, including "ringing in the ears" (usually after the termination of therapy), vertigo.

    From the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, bones of the wrist, head of the femur (see section "Special instructions"); rarely - myalgia (pain in the muscles), arthralgia (joint pain), muscle weakness.

    From the respiratory system: rarely - bronchospasm.

    From the side of the kidneys and urinary tract: rarely - interstitial nephritis.

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

    From the endocrine system: very rarely - gynecomastia.

    Other: infrequent - peripheral edema, malaise; rarely - increased sweating, hyponatremia; very rarely - hypomagnesemia, hypocalcemia due to severe hypomagnesemia.

    There have been reports of cases of the formation of glandular cysts in the stomach in patients taking drugs that reduce the secretion of the glands of the stomach for a long period of time; cysts benign, pass independently on the background of continuation of therapy.

    In case of side effects not listed in this manual, you should immediately contact your doctor.

    Overdose:

    Symptoms: dizziness, confusion, apathy, depression, drowsiness, headache, blurred vision, vascular dilation, tachycardia, nausea, vomiting, flatulence, abdominal pain diarrhea, increased sweating, "dryness" in the mouth.

    Treatment: symptomatic. If necessary - gastric lavage, the appointment of activated charcoal. Hemodialysis is not effective enough.

    Interaction:

    You should consult your doctor before taking Gastrozol® if you are receiving treatment with one or more of the drugs listed in this section.

    The decrease in the secretion of hydrochloric acid in the stomach in the treatment with omeprazole and other inhibitors of the proton pump can lead to a decrease or increase in the absorption of other drugs, the absorption of which depends on the acidity of the medium.

    Like other drugs that reduce the acidity of gastric juice, treatment with omeprazole may lead to a decrease in absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron preparations and cyanocobalamin.They should be avoided together with omeprazole.

    The bioavailability of digoxin when used concomitantly with omeprazole is increased by 10% (correction of the digoxin dosage regimen may be required). Care should be taken when using these drugs at the same time in elderly patients.

    It was shown that omeprazole interacts with some antiretroviral drugs. The mechanisms and the clinical significance of these interactions are not always known. An increase in pH on the background of omeprazole therapy may affect the absorption of antiretroviral drugs. It is also possible to interact at the isoenzyme level CYP2C19. When combined use of omeprazole and some antiretroviral drugs, such as atazanavir and nelfinavir, against the background of therapy with omeprazole there is a decrease in their concentration in serum. When used simultaneously with omeprazole, the area under the concentration-time curve of atazanavir decreases by 75%. In this regard, the joint use of omeprazole with antiretroviral drugs, such as atazanavir and nelfinavir it is contraindicated.With simultaneous use with omeprazole, an increase in plasma concentrations of saquinavir / ritonavir is observed up to 70%, while tolerability of treatment by patients with HIV infection does not worsen.

    With the simultaneous use of omeprazole with clopidogrel, a decrease in the antiplatelet effect of the latter is observed.

    With simultaneous application with omeprazole, an increase in plasma concentration and an increase in the half-life of warfarin, diazepam, phenytoin, cilostazol, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs metabolized in the liver with the participation of isoenzyme CYP2C19 (a reduction in the doses of these drugs may be required).

    With the simultaneous use of omeprazole and tacrolimus, an increase in tacrolimus concentration in serum was noted, which may require correction of its dose. Some patients reported increased concentrations of methotrexate against a background of combined use with proton pump inhibitors. When appointing high doses of methotrexate, consideration should be given to the possibility of a temporary omeprazole withdrawal.

    Simultaneous application with inhibitors of isoenzymes CYP2C19 and CYP3A4 (such as clarithromycin and voriconazole) Can lead to increased plasma concentration of omeprazole, a dose that may require adjustment of omeprazole in patients with severe hepatic failure patients, in case of prolonged use.

    Inductors of isoenzymes CYP2C19 and CYP3A4 (eg, rifampicin, preparations of St. John's wort perfumed (Hypericum perforatum) when combined with omeprazole can accelerate its metabolism, thereby reducing the concentration of omeprazole in blood plasma.

    Not identified clinically significant interactions with omeprazole antacids, caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, budesonide, diclofenac, metronidazole, naproxen, piroxicam.

    Special instructions:

    Omeprazole is not intended for use in case of accidental heartburn (heartburn less often 2 times a week).

    Before therapy with omeprazole is necessary to rule out the presence of malignancy in the upper parts of the gastrointestinal tract, as omeprazole can mask the symptoms and delay the correct diagnosis.

    The decrease in the secretion of hydrochloric acid in the stomach under the influence of proton pump inhibitors leads to an increase in the growth of normal intestinal microflora and can lead to a slight increase in the risk of intestinal infections caused by bacteria of the genus Salmonella spp., Campylobacter spp., as well as bacteria Clostridium difficile. Decreased secretion of hydrochloric acid can lead to an increase in the concentration of chromogranin A (CgA), which influences the results of the examinations for the detection of neuroendocrine tumors, therefore, to prevent this effect, it is necessary to temporarily stop taking omeprazole 5 days before the study of the concentration CgA. If during this time the concentration CgA did not return to the normal value, the study should be repeated.

    The risk-benefit ratio of long-term (more than 1 year) maintenance therapy with omeprazole should be evaluated regularly. There is evidence of an increased risk of vertebral fractures, wrist bones, femoral head, mainly in elderly patients or in the presence of other risk factors. Patients at risk of developing osteoporosis should be provided adequate vitamin intake D and calcium.

    In patients who received omeprazole For at least three months, severe hypomagnesemia, manifested by symptoms such as fatigue, delirium, convulsions, dizziness and ventricular arrhythmia, was documented. In most patients hypomagnesemia was stopped after the withdrawal of proton pump inhibitors and the administration of magnesium preparations. Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the magnesium content in the blood plasma (diuretics) require regular monitoring of the magnesium content.

    Omeprazole, like all drugs that reduce acidity, can lead to a decrease in the absorption of vitamin B12 (cyanocobalamin). This should be remembered for patients with a reduced supply of vitamin B12 for prolonged therapy.

    In patients taking orally for a long time, lowering the secretion of the glands of the stomach, more often the formation of glandular cysts in stomach. These phenomena are caused by physiological changes due to inhibition of hydrochloric acid secretion,and undergo reverse development on the background of continuation of therapy.

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

    During the treatment with omeprazole, dizziness, confusion, drowsiness, and visual impairment may occur, therefore, care should be taken when driving vehicles or controlling other mechanisms and performing other potentially dangerous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:Capsules intestine soluble 10 mg.
    Packaging:

    For 7 or 10 capsules in a contour mesh box made of a polyvinyl chloride or PA / Al / PVC film and aluminum foil.

    1,2, 3 or 4 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 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-004391
    Date of registration:01.08.2017
    Expiration Date:01.08.2022
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp13.09.2017
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