Омез®

General characteristics. Structure:

Each capsule contains 20 mg of an omeprazol.
Auxiliary ingredients: Mannitolum of 143.567 mg, lactose 10.140mg, sodium a lauryl sulfate 0.545mg, anhydrous hydrophosphate 0.923mg of sodium, sucrose 8.951mg, sucrose (25/30) 25.524mg, a gipromelloza 0.139mg, the purified water, the Internal cover: a gipromelloza 10.490mg, the purified water, the Kishechnorastvorimy covering: methacrylic acid a kopolimer of type C 37.800mg, sodium hydroxide 0.504mg, a macrogoal 6000 4.536mg, the purified talc 4.410mg, titanium dioxide 3.150mg, the purified water

Description: the solid gelatin capsules the 2 size with a pink lid and a text of "OMEZ" on both parts of the capsule filled with white or almost white granules.

Pharmacological properties:

Pharmacodynamics. Omeprazol becomes more active in acid medium, being transformed in derivative sulphenamide which is irreversible connects H+K+ - ATP-ase, the fermental system found on the secretory surface of covering cells. It blocks the final stage of transport of ions of hydrogen (by means of exchange for potassium ions), thus inhibiting acid secretion. Omeprazol reduces the level of basal and stimulated secretion in independence of a stimulation form. After a single dose of drug inside action comes within the first hour and 24 hours proceed, the maximum of effect is reached in 2 hours. At patients with a peptic ulcer of a duodenum reception of 20 mg of an omeprazol supports intragastric pH - 3,0 units within 17 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 concentration maximum in plasma is reached in 0,5-1 hour. Bioavailability makes 30-40%. Linkng with proteins of plasma - about 90%. Omeprazol is almost completely metabolized in a liver by system of enzymes P450 cytochrome. An elimination half-life - 0,5 - 1 hour. The metabolites influencing secretion of hydrochloric acid in an organism are not revealed. Nearly 80% of an intravenous dose of an omeprazol are removed in the form of metabolites with urine, the residual quantity is found in intestines where gets as a result of secretion with bile 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 - 100%, an elimination half-life - 3 hours.

Indications to use:

- Reflux esophagitis
- Peptic ulcer of a stomach and duodenum
- The erosive cankers of a stomach and duodenum connected with reception of NPVS, stressful ulcers
- The erosive cankers of a stomach and duodenum associated with Helicobacter pylori (as a part of complex therapy);
- Zollinger's syndrome - Ellisona.

Route of administration and doses:

To accept inside, washing down with a small amount of water (not to chew).

Peptic ulcer of a duodenum in an aggravation phase - on 1 capsule (20 mg) a day within 2-4 weeks (in resistant cases - to 2 capsules a day).
Peptic ulcer of a stomach in a phase of an aggravation and an erosive and ulcer esophagitis - on 1-2 capsule a day within 4-8 weeks.
The GIT erosive cankers caused by reception of NPVS - on 1 capsule a day within 4-8 weeks.
Eradikation Helicobacter pylori - on 1 capsule 2 times a day within 7 days in combination with antibacterial agents,
Antirecurrent treatment of a peptic ulcer of a stomach and duodenum - on 1 capsule a day.
Antirecurrent treatment a reflux esophagitis - 1 capsule a day for a long time (up to 6 months).
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.

Features of use:

Administration of drug along with food does not influence its efficiency.
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.

Features of use:

Use in pediatrics: Safety and efficiency of an omeprazol for children is not established.
Use at patients of advanced age: There is no need to adjust a dose depending on age. However, the possibility of insignificant reduction in the rate of removal and increase in bioavailability of drug at patients of advanced age is noted.
Use at patients with the broken function of a liver: Patients with this pathology can have a need for a dose decline as омепразол it is extensively metabolized by a liver and removal speed at such patients is reduced in comparison with patients with safe function of a liver. The daily dose has to make 10 - 20 mg to patients with heavy degree of pathology of a liver.
Use at patients with a renal failure: Patients do not have need of individual selection of a dose with a renal failure.
Use during pregnancy and a lactation: Safety and efficiency of an omeprazol for pregnant women and the feeding women is not studied. Therefore омепразол it is not shown to pregnant women and the feeding women.

Side effects:

In rare instances there can be following, usually reversible, by-effects.

From digestive organs: diarrhea or a lock, nausea, vomiting, a meteorism, an abdominal pain, dryness in a mouth, taste disturbance, stomatitis, tranzitorny increase in level 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 somatachesky illness, 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; seldom, in some cases - a fotosensibili-zation, a multiformny erythema, an alopecia.
Allergic reactions: small tortoiseshell, Quincke's disease, bronchospasm, intersticial nephrite and acute anaphylaxis
Others: vision disorder, peripheral hypostases, sweating strengthening, fever, 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:

The possibility of interaction of an omeprazol with other drugs is sharply limited. Nevertheless, as омепразол slows down the microsomal metabolism of drugs which is carried out fermental system of a liver of P450 cytochrome the elimination of other drugs demanding participation of this system of enzymes or high activity of excretory function of a liver, can decrease at a concomitant use of an omeprazol. This effect can reduce the speed of removal of substances, increase concentration of diazepam, Phenytoinum, anticoagulants, such as warfarin, in plasma (control of concentration of drugs in plasma, the prothrombin ratio for anticoagulants is necessary for individual selection of a dose against the background of treatment omeprazoly).
Omeprazol, influencing an acid and peptic factor, can influence bioavailability of drugs which absorption depends from рН, also омепразол can prevent destruction of the drugs sensitive to acid influence. Therefore, the concomitant use of an itrakonazol or a ketokonazol and an omeprazol can lead to reduction in the rate of absorption of other drugs.
Omeprazol does not exert impact on cytochrome P isomers that is confirmed by lack of metabolic reactions with CYP1A2 substrates (caffeine, acetphenetidiene, theophylline), CYP2C9 (S-warfarin, piroxicam, diclofenac, Naproxenum), CYP2D6 (метопролол, propranolol), CYP2E (ethanol), CYP3A (cyclosporine, lidocaine, квинидин, oestradiol, erythromycin, будесонид).

Contraindications:

Hypersensitivity to drug, pregnancy, the lactation period.

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. Because a considerable part of drug in plasma is in the look connected with protein, the hemodialysis is insufficiently effective.

Storage conditions:

List B. In dry, protected from light, the place, unavailable to children, at a temperature up to 25 °C. Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Capsules on 20 mg. On 10 capsules in strips from aluminum foil; 3 strips (30 capsules) together with the application instruction are packed into a cardboard box.