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

    1 capsule contains:

    Active substance: 10 mg 40 mg Omeprazole 10.00 mg 40.00 mg

    Excipients:

    Sugars (sucrose, starch syrup) 40.00 mg 160.00 mg

    Giprolose 2.40 mg 9.60 mg

    Magnesium hydroxycarbonate (magnesium carbonate, heavy) 10.00 mg 40.00 mg

    Sucrose 16.10 mg 64.40 mg

    Corn starch 13.25 mg 53.00 mg

    Sodium lauryl sulfate 1.25 mg 5.00 mg

    Methacrylic acid and ethyl acrylate copolymer (1: 1) 30% dispersion 15.50 mg 62.00 mg

    Talc 3.00 mg 12.00 mg

    Macrogol 6000 1.55 mg 6.20 mg

    Titanium dioxide 0.95 mg 3.80 mg

    Composition of an empty gelatin capsule Cap 10 mg 40 mg

    Gelatin 14.8960 mg 37.2151 mg

    Titanium dioxide (E171)

    0.3040 mg 1.1520 mg

    The iron dye red oxide (E172)

    - 0.0329 mg

    Housing:

    Gelatin 22.0965 mg 56.0936 mg

    Titanium dioxide (E171)

    0.6840 mg 1.1520 mg

    Iron colorant red oxide (E172)

    0.0195 mg 0.3544 mg


    Description:

    Capsules 10mg

    Hard gelatin two-color capsules: body - light pink, cap-white

    colors. Contents of capsules - pellets from white to white with a yellowish or pink tinge

    colors.

    Capsules 40mg

    Hard gelatinous two-color capsules: body - brownish-pink color, cap of light pink color: Contents of capsules - pellets from white to white with a yellowish or pinkish tinge.

    Pharmacotherapeutic group:glands of the stomach secretion of the reducing agent of the proton pump inhibitor.
    ATX: & nbsp

    A.02.B.C.01   Omeprazole

    Pharmacodynamics:

    Inhibits the enzyme H/ K-ATPase ("proton pump") in the parietal cells of the stomach and thereby blocking the final stage of the synthesis of hydrochloric acid. This leads to

    decrease in the level of basal and stimulated secretion, irrespective of the nature of the stimulus. Omeprazole is a prodrug and is activated, in an acidic environment of the secretory tubules of parietal cells. After a single oral intake of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of reception, the secretory activity of omeprazole 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% maximum secretion lasts 24 hours.

    Pharmacokinetics:

    Omeprazole is rapidly absorbed from the gastrointestinal tract (GIT), the maximum concentration in the blood plasma (Stach) is reached after 0.5-1 hour. Bioavailability is 30- V. 40%.Bioavailability is slightly increased in elderly patients 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 is almost completely metabolized in the liver with formation 6 pharmacologically

    inactive metabolites (hydroxyomeprazole sulfide and sulphonic derivatives, etc.). It is an inhibitor of the enzyme system CYP2C19. Half-life (THave2) - 0.5-1 h: Kidney (70-80%) and with bile through the intestine (20-30%).

    In cases of impaired renal function, omeprazole administration declines in proportion to a decrease in creatinine clearance.

    With violations of liver function T1/2 is 2-3 hours.

    The total clearance is 500-600 ml / min.


    Indications:

    Capsules, enteric, soluble, 40 mg

    - 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-ulcerative lesions

    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. '

    Capsules, enteric, soluble 10 mg

    - short-term therapy of non-ulcer dyspepsia;

    - long-term maintenance therapy for the prevention of relapses of gastroesophageal reflux disease (GERD);

    - long-term maintenance therapy to prevent recurrences of gastric and duodenal ulcers.

    Contraindications:Hypersensitivity to omeprazole or other components of the drug, pregnancy, breastfeeding period, children's age, hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sugarase / isomaltase deficiency.
    Carefully:renal and / or liver failure.
    Pregnancy and lactation:

    Safety of Ultopop® during pregnancy and during the period of breastfeeding is not studied, therefore its use during pregnancy is not recommended. If it is necessary to use Ultop® during lactation, breastfeeding should be avoided.to cease.

    Dosing and Administration:

    Inside, before meals (because eating slows down

    absorption of the drug), squeezed small

    amount of water (contents of the capsule

    can not chew). -

    Ulcerative duodenal ulcer

    guts in the exacerbation phase: by 20 mg per day in

    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 of the 1 capsule on 20 mg once a day in the morning, before breakfast for a 4- 8 weeks. To ensure the following dosing regimen, it is possible to take the drug in another registered dosage (Ultop®, capsules

    enteric-soluble 10 mg or 40 mg). The duration of the main course of treatment is usually 4-8 weeks. After healing of erosive esophagitis, supportive treatment is shown for 26 to 52 weeks, with severe esophagitis for life. In cases of relapse of severe GERD or resistant GERD, the treatment can be extended up to 4-8 weeks.

    The Zollinger-Ellison syndrome and other pathological The conditions associated with increased gastric secretion: the dose is selected individually depending on the initial level, gastric secretions 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.

    Eradication Helicobacter pylori: 20 mg twice a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents.

    Non-ulcer dyspepsia: usual dose

    is from 10 mg to 20 mg once a day for 2-4 weeks. If after 4 weeks of taking the drug the condition does not improve, or the symptoms of dyspepsia reappear shortly after discontinuation, to reconsider the diagnosis.

    Prevention of recurrences of peptic ulcer of the stomach and duodenum: by 10-20 mg per day.

    Prevention of relapse of GERD: at 2 0 mg per day for a long time. The safety and efficacy of 12-month maintenance therapy have been proven. Application on demand is possible. Impaired renal function

    For patients with impaired renal function

    correction of the dose is not required.

    Impaired liver function In patients with impaired liver function, the bioavailability and clearance of omeprazole is increased. Concerning

    The therapeutic dose should not exceed 10-20 mg per day.

    Elderly age

    For elderly patients, correction of the treatment regimen is not required.



    Side effects:

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

    From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, pain in the abdomen, irritable bowel syndrome, heartburn, dry mouth, taste disorders, stomatitis, pancreatitis (including fulminant), loss of appetite, color change in feces, candidiasis of the esophagus, atrophy of the tongue mucosa, transient increase in the activity of "liver" 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 nervous system: headache, dizziness, aggression, apathy,

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

    From the cardiovascular system: stenocardia, tachycardia, aetiology, palpitations, increased blood pressure, vasculitis, peripheral edema. From the genitourinary system: interstitial nephritis, urinary tract infections, microscopic pyuria, proteinuria, hematuria, glucosuria, increased serum creatinine concentration, gynecomastia, testicular pain.

    From the musculoskeletal system: muscle weakness, myalgia, arthralgia, ossalgy (pain in the bones), muscle cramp.

    On the part of the hematopoiesis system: pancytopenia, agranulocytosis, anemia (including

    hemolytic anemia), neutropenia, thrombocytopenia, leukocytosis, and leukopenia.

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

    On the part of the respiratory system: sore throat, cough, copious nosebleed.

    From the sense organs: ringing in the ears, unexplained disturbances of sight and hearing.

    Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.

    Laboratory indicators: hypoglycemia, hyponatremia.

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

    Overdose:

    Patients tolerate daily doses of up to 360 mg.

    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 not effective enough.

    Interaction:

    Long-term use of omeprazole at a dose of 20 mg 1 time per day in combination with caffeine, theophylline, digoxin,amoxicillin, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, lidocaine, quinidine and estradiol did not change their plasma concentration

    No interaction with concomitant antacids was observed \

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

    The efficacy of prednisone and cyclosporine may be reduced, which in some cases may require dose adjustment of cyclosporine.

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

    Special instructions:

    Before the beginning of therapy with Ultop® it is necessary to exclude the presence of malignant process (especially with stomach ulcer), since treatment, masking chemotherapy can delay the formulation of the correct diagnosis.

    Food intake slows down the absorption of omeprazole, so Ultop® should be taken before meals.In individual 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 acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

    Also, with caution, it is necessary to take Ultop® to patients with impaired kidney function. In patients on dialysis, pharmacokinetic parameters omeprazole do not change.

    Ultop® contains sucrose, so it is not recommended for patients from syndrome of glucose-galactose malabsorption, a deficiency of sugarase / isomaltase.

    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, Ultop® does not affect the concentration of attention and the speed of psychomotor reactions.
    Form release / dosage:

    Capsules enteric soluble 10 mg and 40 mg.


    Packaging:

    40 mg.

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

    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 of the hydrogen sorbent. In a polyethylene foam box with 28 capsules of 40 mg, place an additional capsule hydrogen sorbent.

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

    When manufactured at OOO Krka-Rus, Russia:

    7 capsules per contour mesh package (blister) from the combined material PVC / PE / PVDC / PE / PVC and aluminum foil or from a combined material OPA / Al / PVC and aluminum foil.

    2 or 4 contour squares (blisters) together with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    In a place protected from moisture, at a temperature of no higher than 25 ° C, in the original packaging. 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:LS-000695
    Date of registration:24.08.2010
    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: & nbsp30.01.2014
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