Omeprazol капс. 0,02 g No. 3/10/20/30

General characteristics. Structure:

Active agent:  омепразол - 20 mg in the form of pellets [омепразол, Mannitolum, sucrose, sodium hydrophosphate (sodium phosphate disubstituted), sodium a lauryl  sulfate,  lactose, calcium   a carbonate,   a gidroksipropilmetiltsellyuloz   (gipromelloz),   methacrylic acid   and   ethyl acrylate   copolymer   (methacrylic   acid      L30D copolymer), propylene glycol,   diethyl phthalate,       cetyl alcohol,    sodium    hydroxide   (sodium a hydroxide), polysorbate-80 (twin-80), povidone (polyvinylpirrolidone), titanium dioxide, talc.
capsule cover: gelatin, titanium dioxide, dye azoruby (dye crimson), dye blue patent (patent blue V), dye phloxine B.

Description. Solid gelatin capsules No. 1, the case of white color with a lid of blue color. Contents of capsules - pellets of color, white or white with a creamy or yellowish shade.

Pharmacological properties:

Pharmacokinetics. Absorption   -  high, TCmax  -  0.5-3.5   h,  bioavailability  -  30-40%  (at   a liver failure increases practically up to  100%); having high lipophilicity, easily gets into covering cells of a stomach, communication with proteins of plasma - 90-95% (albumine and acid an alpha 1 - a glycoprotein). T 1/2 are 0.5-1 h (at a liver failure - 3 h), clearance - 500-600 ml/min. It is almost completely metabolized in a liver with participation of the fermental CYP2C19 system, with formation of 6 metabolites   (гидроксиомепразол,   sulphidic   and   sulfonic   derivatives      , etc.), pharmacological  inactive.  Is      CYP2C19 isoenzyme inhibitor.   Removal by kidneys (70-80%) and with bile (20-30%).
At  HPN  removal  decreases  in proportion to  decrease  in KK.  At  elderly  patients removal decreases, bioavailability increases.

Indications to use:

Peptic ulcer of a stomach and 12-perstny gut (including prevention of a recurrence), a reflux - an esophagitis, hyper secretory states (Zollingera-Ellison's syndrome, stressful ulcers of a GIT, polyendocrine   adenomatosis,   a system   mastocytosis);   NPVP-gastropathy.
Eradikation Helicobacter pylori at the infected patients with a peptic ulcer of a stomach and a 12-perstny gut (as a part of a combination therapy).

Route of administration and doses:

Inside, capsules usually accept in the morning, capsules cannot be chewed, washing down with a small amount of water. Capsules are accepted before food. At an aggravation of a peptic ulcer, a reflux esophagitis and NPVP-gastropathies - 20 mg of 1 times a day.
To patients with a heavy current the reflux esophagitis a dose is increased to 40 mg of 1 times a day.
Course of treatment at a peptic ulcer of a 12-perstny gut - 2-3 weeks, if necessary - 4-5 weeks; at a peptic ulcer of a stomach and an esophagitis - 4-8 weeks.
Sick, resistant to treatment by other antiulcerous JIC, appoint 40 mg/days. A course of treatment at a peptic ulcer of a 12-perstny gut - 4 weeks, at a peptic ulcer of a stomach and a reflux esophagitis - 8 weeks. At    Zollingera-Ellison's syndrome  -  60  mg;    if necessary  the dose  is increased  up to 80-120 mg/days (in this case it is appointed in 2-3 receptions).
For prevention of a recurrence of a peptic ulcer - 10 mg of 1 times a day.
For an eradikation of Helicobacter pylori use "triple" therapy (during 1 week: омепразол 20 mg, amoxicillin of 1 g, кларитромицин 500 mg - on 2 times a day; or омепразол 20 mg, кларитромицин 250 mg, metronidazole of 400 mg - on 2 times a day; or омепразол 40 mg of 1 times a day, amoxicillin of 500 mg and metronidazole of 400 mg - on 3 times a day) or "double" therapy (during 2 weeks: омепразол 20-40 mg and amoxicillin of 750 mg - on 2 times a day or омепразол 40 mg - 1 time a day and кларитромицин 500 mg - 3 times a day or amoxicillin of 0.75-1.5 g - 2 times a day).
At a liver failure appoint 10-20 mg of 1 times a day; at a renal failure and it is not required from elderly patients of correction of the mode of dosing.

Features of use:

Before therapy it is necessary to exclude existence of malignant process (especially at stomach ulcer) since treatment, masking symptomatology, can delay statement of the correct diagnosis. Reception along with food does not influence its efficiency.

Side effects:

- From the alimentary system: diarrhea or locks, abdominal pain, nausea, vomiting, meteorism; in rare instances - increase in activity of "hepatic" enzymes, taste disturbances; in some cases - dryness in a mouth, stomatitis, at patients with the previous serious illness of a liver is hepatitis (including with jaundice), an abnormal liver function.
- From bodies  of a hemopoiesis:    in some cases  - a leukopenia,  thrombocytopenia, an agranulocytosis, a pancytopenia.
-  From  a nervous  system:    patients  with  the serious  accompanying  somatopathies    have a dizziness,    a headache,  excitement,  a depression,    patients  with the previous serious illness of a liver have an encephalopathy.
-  From    a musculoskeletal system:      in some cases  -  an arthralgia.  myasthenia, mialgiya.
- From    integuments:  seldom  -  skin  rash  and/or  an itch,      in some cases  - a photosensitization, a multiformny exudative erythema, an alopecia.
- Allergic   reactions:   small tortoiseshell,   Quincke's   disease,   fever,   bronchospasm, intersticial nephrite and acute anaphylaxis.
- Other: seldom - a gynecomastia, an indisposition, vision disorders, peripheral hypostases, sweating strengthening, formation of gastric glandulyarny cysts  during prolonged treatment (a consequence of inhibition of secretion of NSL, has high-quality, reversible character).

Interaction with other medicines:

Can  reduce  absorption  of ethers  of ampicillin,    Fe salts,  an itrakonazol  and  a ketokonazol (омепразол raises рН a stomach). Being P450 cytochrome inhibitors, can increase concentration and reduce removal of diazepam, anticoagulants of indirect action, Phenytoinum (HP which are metabolized in a liver  by means of    CYP2C19 cytochrome)  that      in certain cases  can  demand reduction of doses of these HP.
At the same time prolonged use of an omeprazol in a dose of 20 mg of 1 times a day in a combination with caffeine,    theophylline,    piroxicam,    diclofenac,    Naproxenum,    metoprololy, pronranololy, ethanol, cyclosporine, lidocaine, quinidine and oestradiol did not lead to change of their concentration in plasma. Strengthens an inhibiting effect on system of a hemopoiesis other. Hp. Interaction with at the same time accepted antacids is noted.

Contraindications:

Hypersensitivity, children's age, pregnancy, lactation period.
With care: Renal and/or liver failure.

Overdose:

Symptoms: confusion of consciousness, a sight illegibility, drowsiness, dryness in a mouth, a headache, nausea, tachycardia, arrhythmia.
Treatment: symptomatic. The hemodialysis is insufficiently effective.

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 3 years. Not to apply after the date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Capsules of 20 mg. On 3 or 10 capsules in a blister strip packaging. On 20, 30 capsules in bank of light-protective glass or bank polymeric or in a bottle polymeric. Each can or a bottle,   1, 2 or 3 blister strip packagings together with the application instruction are placed in a pack from a cardboard.