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

    1 capsule contains enteric-soluble granules (sucrose, corn starch), giprolase, magnesium carbonate, heavy, sucrose, corn starch, sodium lauryl sulfate.

    Wood pellets: methacrylic acid and Pellets:

    Core pellets:

    Active substance: omeprazole 20.00 mg Excipients: sugar

    granules (sucrose, corn starch) 80,00 mg, giprolase 4.80 mg, magnesium carbonate, heavy 20.00 mg, sucrose 32.20 mg, corn starch 26.50 mg, sodium lauryl sulfate 2.50 mg.

    Sheath of pellets. methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion1 31.00 mg, talc 6.00 mg, macrogol 6000 3.10 mg, titanium dioxide 1,90, sodium hydroxide 0.21 mg.

    1 is represented as the dry polymer weight Capsule shell composition:

    CASE Capsule: iron dye red oxide E172 0,0875 %, titanium dioxide E171 3 %, gelatin up to 100 %. LETTER Capsules: iron dye red oxide E172 0,6153 %, titanium dioxide E171 2%, gelatin up to 100 %.

    Description:

    Two-color capsules: the case of a capsule of light pink color, cap of a capsule of brownish color. Capsules contain white to white pellets with a yellowish or pinkish hue.

    Pharmacotherapeutic group:reducing the secretion of the gastric glands means - a 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. The drug is a prodrug and is activated in the acidic environment of the secretory tubules of parietal cells. 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 secretory activity is completely restored after 3-5 days. Basal gastric secretion is reduced to 94% after taking 40 mg of omeprazole. The acidity of gastric juice within 24 hours is reduced by 80 - 97% with the intake of 20 mg of omeprazole and by 92 - 94% with the intake of 40 mg. Inhibition of 50% of maximum secretion lasts 24 hours.

    Pharmacokinetics:

    Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration in the plasma is reached after 0.5-1 hour. Bioavailability is 30-40 %. Bioavailability increases somewhat in the elderly and patients with impaired liver function, and to a large extent in patients with chronic hepatic insufficiency (up to 100%). The connection with plasma proteins is about 90% - 95%. Omeprazole almost completely metabolized in the liver with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.), pharmacologically inactive. It is an inhibitor of the enzyme system CYP2C19. Half-life is 0.5-1 hour. 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. With hepatic failure half-life

    - 2 - 3 hours.

    The total clearance is 500 - 600 ml / min.

    Indications:

    - Peptic ulcer of stomach and duodenum (in the phase of exacerbation and anti-relapse treatment), incl. associate with Helicobacter pylori (as part of combination therapy);

    - Gastroesophageal reflux disease (GERD), including reflux-esophagitis and non-erosive forms of reflux disease (NERD);

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

    - Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

    Contraindications:

    - Hypersensitivity to omeprazole or other components of the drug;

    - Children's age (effectiveness and safety in children is not proven);

    - Pregnancy;

    - Lactation period.

    Carefully:

    renal and / or hepatic impairment, hereditary fructose intolerance, glucose malabsorption syndrome and / or galactose, or sucrose / isomaltose deficiency.

    Pregnancy and lactation:

    The safety of use during pregnancy and lactation of breastfeeding has not been studied. Therefore, it is not recommended to prescribe a drug during pregnancy. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside, before eating, 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: for 20 - 40 mg per day for 4-8 weeks.

    Gastroesophageal reflux disease (GERD): patients with moderate inflammation 1 capsule 20 mg once a day in the morning, before breakfast for 4-8 weeks. To ensure the following dosing regimen, it is possible to take the drug at another registered dosage (Ultop, capsules 40 mg). Patients with severe course of GERD, resistant to conventional therapy: 40 mg (2 capsules Ultopa 20 mg or 1 capsule Ultopa 40 mg) once a day in the morning, before breakfast. The duration of the main course of treatment is usually 4-8 weeks. After healing of erosive esophagitis, supportive treatment for 26-52 weeks is shown, with severe esophagitis - for life. In cases of recurrence of severe GERD or resistant GERD, the treatment can be extended to 4-8 weeks.

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

    Eradication Helicobacter pylori: 20 mg twice a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents. Anti-relapse treatment of peptic ulcer of stomach and duodenum: on 10-20 mg a day.To ensure the following dosing regimen, it is possible to take the drug at another registered dosage (Ultop, capsules 10 mg).

    Antiretroviral treatment of GERD: 20 mg per day for a long time. The safety and efficacy of twelve-month maintenance therapy has been proven. Possible reception on request.

    Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion: 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 2-3 doses.

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

    Side effects:

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

    On the part of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, heartburn, dry mouth, taste disorders, stomatitis, pancreatitis (including fulminant), loss of appetite, fecal color changes, esophageal candidiasis, atrophy of the tongue mucosa,transient increase in the activity of "hepatic" enzymes and bilirubin in plasma; in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function or hepatic encephalopathy.

    From the central or peripheral nervous system: headache,

    dizziness, aggressiveness, apathy, nervousness, agitation, drowsiness, insomnia, tremor, vertigo, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.

    From the cardiovascular system: angina pectoris, tachycardia, bradycardia,

    palpitation, arterial hypertension, vasculitis, peripheral edema.

    From the genitourinary system: interstitial nephritis, urinary tract infections, leukocyturia, proteinuria, hematuria, glucosuria, increased serum creatinine concentration, gynecomastia, testicular pain.

    From the musculoskeletal system: muscular weakness, myalgia, arthralgia, ossalgia (pain in the bones), muscle cramps.

    On the part of the hematopoiesis system: pancytopenia, agranulocytosis, anemia (including hemolytic anemia), neutropenia, thrombocytopenia, leukocytosis, and leukopenia.

    From the skin: skin itching, skin rash; in some cases - photosensitivity, multiforme exudative erythema, hair loss, alopecia, petechiae, dry skin, epidermal necrosis, Stevens-Johnson syndrome.

    On the part of the respiratory system: cough, nosebleeds.

    From the sense organs: ringing in the ears, perversion of taste, unexpressed impairment of sight and hearing.

    Allergic reactions: urticaria, angioedema, bronchospasm,

    interstitial nephritis, anaphylactic shock, fever.

    Laboratory indicators: hypoglycemia, hyponatremia.

    Other: pain in the back, visual impairment, peripheral edema, increased sweating, gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible), increased sweating, general fatigue, general weakness, weight gain.

    Overdose:

    Symptoms: abdominal pain, drowsiness, headache, dizziness, dry mouth, tachycardia, arrhythmia, blurred vision, agitation, confusion, increased sweating, nausea; in rare cases: convulsions, dyspnea, hypothermia.

    Treatment symptomatic. There is no specific antidote. Hemodialysis is ineffective.

    Interaction:

    Long-term use of omeprazole at a dose of 20 mg once daily in combination with caffeine, theophylline, digoxin, amoxicillin, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, lidocaine, quinidine and estradiol did not lead to a change in their concentration in the plasma.

    No interaction with simultaneously accepted antacids.

    Can reduce the absorption of esters ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). Being an inhibitor of cytochrome P450, it can increase concentration and decrease excretion diazepam, anticoagulants of indirect action, phenytoin, nifedipine, warfarin and disulfiram, which in some cases may require a reduction in the doses of these drugs.

    Efficiency prednisone and cyclosporine can be reduced, which in some cases may require correction of the dose of cyclosporine.

    With the simultaneous intake of increased absorption of omeprazole and clarithromycin, which leads to an increase in their concentration in the plasma.

    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.

    The intake of food slows the absorption of omeprazole, so the drug is recommended to be taken before meals.

    In special cases, if there are difficulties with 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 acidic liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

    Caution is necessary to take Ultop in patients with cirrhosis; the daily dose should not exceed 20 mg.

    Also with caution, it is necessary to take Ultop in patients with renal insufficiency. In patients on dialysis, the pharmacokinetic parameters of omeprazole do not change.

    Ultop contains sucrose, so the drug is not recommended for patients with glucose malabsorption syndrome and / or galactose, or sucrose / isomaltose deficiency.
    The capsule of the hydrogen sorbent, soldered in the lid of the vial, should not be swallowed!
    Effect on the ability to drive transp. cf. and fur:

    in normal dosages, the drug does not affect the speed of psychomotor reactions and concentration of attention.

    Form release / dosage:

    Capsules enteric in solution 20 mg.

    In production at AO "KRKA, dd, Novo mesto ", Slovenia:

    Packaging:

    To 14 or 28 capsules are placed in a polyethylene foam box with a polypropylene screw cap with a first opening control and a capsule hydrogen sorbent.

    1 pencil case in a pack of cardboard along with instructions for use.

    Storage conditions:

    List B.

    In a dry 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.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014514 / 01
    Date of registration:22.10.2008
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp28.11.2013
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