Омизак®

General characteristics. Structure:

Active ingredient: 20 mg of an omeprazol (in the form of the pellets covered with a kishechnorastvorimy cover).

The excipients which are a part of pellets of an omeprazol: Mannitolum, sucrose, sodium dihydrophosphate, sodium lauryl sulfate, lactose, calcium carbonate, gipromelloza, propylene glycol, methacrylic acid, polysorbate (Twin 80), diethyl phthalate, sodium hydroxide, cetyl alcohol, starch.

Structure of an empty solid gelatin capsule: gelatin, ferrous oxide yellow, crimson (azoruby), diamond blue, titanium dioxide; methylparahydroxybenzoate (methylparaben), пропилпарагидроксибензоат (propylparaben).

Pharmacological properties:

Pharmacodynamics. Inhibits H+ K enzyme + ATP-ase ("the proton pump") in covering cells of a stomach and by that blocks a final stage of synthesis of hydrochloric acid. It leads to decrease in level of basal and stimulated secretion, irrespective of the irritant nature. After a single dose of drug inside action of an omeprazol comes within the first hour and continues within 24 hours, the maximum of effect is reached in 2 hours. After the termination of administration of drug secretory activity is completely recovered in 3-5 days.

Pharmacokinetics. Omeprazol is quickly absorbed from digestive tract, the maximum concentration in plasma is reached in 0,5-1 hour. Bioavailability makes 30-40%. Communication with proteins of plasma - about 90%. Omeprazol is almost completely metabolized in a liver. Is inhibitor of the fermental CYP2C19 system. An elimination half-life - 0,5-1 hour. It is removed by kidneys (70-80%) and with bile (20-30%). At a chronic renal failure removal decreases in proportion to decrease in clearance of creatinine. At elderly patients removal decreases, bioavailability increases. At a liver failure bioavailability of-100%, an elimination half-life - 3 hours.

Indications to use:

- A peptic ulcer of a stomach and duodenum (in a phase of an aggravation and antirecurrent treatment), including associated with Helicobacter pylori (as a part of complex therapy);
- Reflux esophagitis;
- The erosive cankers of a stomach and duodenum connected with reception of non-steroidal anti-inflammatory drugs (NPVP);
- Zollingera-Ellison's syndrome.

Route of administration and doses:

Inside, washing down with a small amount of water (contents of the capsule cannot be chewed).

Peptic ulcer of a duodenum in an aggravation phase - on 20 mg a day within 2-4 weeks (in resistant cases to 40 mg a day).

Peptic ulcer of a stomach in a phase of an aggravation and an erosive and ulcer esophagitis - on 20-40 mg a day within 4-8 weeks.

The digestive tract erosive cankers caused by reception of NPVP - on 20 mg a day within 4-8 weeks.

Eradikation Helicobacter pylori - on 20 mg 2 times a day within 7 or 14 days (depending on the applied scheme of treatment) in combination with antibacterial agents.

Antirecurrent treatment of a peptic ulcer of a stomach and 12-perstny gut - on 20 mg a day.

Antirecurrent treatment a reflux esophagitis - 20 mg a day for a long time (up to 6 months). Reception on demand (symptomatic treatment).

Zollingera-Ellison's syndrome - a dose is selected individually depending on the initial level of gastric secretion, usually since 60 mg a day. If necessary the dose is increased to 80 - 120 mg a day, in this case it is divided into 2 receptions.

At patients with a heavy liver failure the daily dose should not exceed 20 mg.

Features of use:

Use during pregnancy. Use of an omeprazol during pregnancy is possible in cases when the expected advantage for mother exceeds potential risk for a fruit.

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.

At emergence of difficulties with a proglatyvaniye of the whole capsule, it is possible to swallow its contents after opening or a rassasyvaniye of the capsule, and also it is possible to mix capsule contents with slightly acidified liquid (juice, yogurt) and to use the received suspension within 30 min.

In usual dosages drug does not exert impact on the speed of psychomotor reactions and concentration of attention.

Side effects:

In rare instances there can be following, usually reversible, side reactions.

From digestive organs: diarrhea or a lock, nausea, vomiting, a meteorism, an abdominal pain, dryness in a mouth, taste disturbances, stomatitis, tranzitorny increase in activity of "hepatic" enzymes in plasma; patients with the previous serious illness of a liver have a hepatitis (including with jaundice), an abnormal liver function.

From a nervous system: headache, dizziness, excitement, drowsiness, sleeplessness, paresthesias, depression, hallucinations; at patients with the serious accompanying somatopathies, patients with the previous serious illness of a liver - encephalopathy.

From a musculoskeletal system: muscular weakness, mialgiya, arthralgia.

From system of a hemopoiesis: leukopenia, thrombocytopenia; in some cases - an agranulocytosis, a pancytopenia.

From integuments: itch, skin rash; in separate cases photosensitization, a multiformny exudative erythema, an alopecia.

Allergic reactions: small tortoiseshell, Quincke's disease, bronchospasm, intersticial nephrite, acute anaphylaxis, fever.

Others: vision disorder, peripheral hypostases, sweating strengthening, gynecomastia; seldom - formation of gastric glandulyarny cysts during prolonged treatment (a consequence of inhibition of secretion of hydrochloric acid, has high-quality, reversible character).

Interaction with other medicines:

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, propranolol, ethanol, cyclosporine, lidocaine, quinidine and oestradiol did not lead to change of their concentration in plasma.

Interaction with at the same time accepted antacids is noted. Can reduce absorption of ethers of ampicillin, salts of iron, an itrakonazol and ketokonazol (омепразол raises рН a stomach).

вляясь P450 cytochrome inhibitor, can increase concentration and reduce removal of diazepam, anticoagulants of indirect action, Phenytoinum (medicines which are metabolized in a liver by means of CYP2C19 cytochrome) that in certain cases can demand reduction of doses of these medicines.

Strengthens an inhibiting effect on system of a hemopoiesis of other medicines.

Contraindications:

Hypersensitivity to drug, children's age, the lactation period.

With care: renal and/or liver failure.

Overdose:

Symptoms of overdose are the vision disorder, drowsiness, excitement, confusion of consciousness, a headache, increase in sweating, dryness in a mouth, nausea, arrhythmia.

The specific antidote does not exist. Symptomatic treatment. The hemodialysis-not enough is effective.

Storage conditions:

To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Capsules of 20 mg. 10 capsules in the blister from aluminum foil. 3 or 5 blisters in a cardboard pack together with the application instruction. A sample not for sale: 10 capsules in the blister from aluminum foil. 1 blister with the application instruction in a cardboard pack.