Gastrozol

Gastrozol – inhibitor of the protonew pump, antiulcerous drug.

Form of release and structure

Dosage form – capsules: the size No. 2, firm gelatinous, opaque, the case – light pink color, a lid – pinkish-brown color; contents – pellets of white or almost white color (on 7 or 10 pieces in planimetric bezjyacheykovy packagings, on 1 or 2 packagings in a pack cardboard; on 10, 14 or 28 pieces in polymeric banks, after 1 bank in a pack cardboard).

Active ingredient: омепразол, in 1 capsule – 20 mg.

Additional components: calcium carbonate, sodium hydrophosphate (dinatrium phosphate disubstituted), lactose, sodium lauryl sulfate, gipromelloz (gidroksipropilmetiltsellyuloz), sucrose, methacrylic acid and ethyl acrylate copolymer (copolymer of acid of methacrylic L30D), cetyl alcohol, diethyl phthalate, sodium hydroxide, propylene glycol, polysorbate-80 (twin-80), titanium dioxide, povidone (polyvinylpirrolidone), talc, Mannitolum.

Structure of the capsule (case and lid): gelatin, methylparahydroxybenzoate (methylhydroxybenzoate), titanium dioxide (E171), пропилпарагидроксибензоат (пропилгидроксибензоат), ferrous oxide red (E172); or gelatin, titanium dioxide (E171) and ferrous oxide red (E172).

Indications to use

• Aggravation of a peptic ulcer of a stomach and 12-perstny gut;
• Reflux esophagitis;
• The gastropathy induced by use of non-steroidal anti-inflammatory drugs (NPVP-gastropathy);
• Hyper secretory states (polyendocrine adenomatosis, stressful ulcers of digestive tract, system mastocytosis, Zollingera-Ellison's syndrome);
• Helicobacter pylori infection at patients with a peptic ulcer of a stomach and a 12-perstny gut (as a part of complex therapy).

Also Gastrozol is applied to prevention of a peptic ulcer of a stomach and a 12-perstny gut.

Contraindications

• Children's age;
• Pregnancy;
• Lactation;
• Hypersensitivity to drug.

Gastrozol it is necessary to apply with care at a liver and/or renal failure.

Route of administration and dosage

Drug is accepted inside, swallowing of capsules entirely and washing down with a small amount of water, usually in the morning, just before meal or during food.

The recommended doses depending on indications:

• Aggravation of a peptic ulcer of a 12-perstny gut: on 1 capsule a day within 2-4 weeks, if necessary the dose is increased to 2 capsules;
• Aggravation of a peptic ulcer of a 12-perstny gut and erosive and ulcer esophagitis: on 1-2 capsules a day for 4-8 weeks;
• NPVP-gastropathy: on 1 capsule a day within 4-8 weeks;
• Helicobacter pylori infection: on 1 capsule 2 times a day in a combination with antibacterial agents, a course – 7 days;
• Zollingera-Ellison's syndrome: the dose is established individually depending on the initial level of gastric secretion. The initial dose usually makes 3 capsules a day, in need of it increase up to 4-6 capsules and divide a dose into 2 receptions;
• Prevention of a recurrence of a peptic ulcer of a stomach and 12-perstny gut: on 1 capsule a day;
• Prevention of a recurrence reflux esophagitis: on 1 capsule a day it is long (up to 6 months).

Side effects

• Alimentary system: diarrhea/lock, meteorism, nausea, vomiting, abdominal pain; seldom – taste disturbances, increase in activity of hepatic transaminases, formation of gastric glandulyarny cysts at prolonged treatment (have reversible high-quality character); in some cases – stomatitis, dryness in a mouth; patients with the previous serious illness of a liver have an abnormal liver function, hepatitis (including with jaundice);
• Musculoskeletal system: in some cases – a myasthenia, an arthralgia, a mialgiya;
• Central and peripheral nervous system: patients with the accompanying heavy somatopathies have an excitement, a headache, a depression, dizziness; patients with the previous serious illness of a liver have an encephalopathy;
• System of a hemopoiesis: in some cases – an agranulocytosis, thrombocytopenia, a pancytopenia, a leukopenia;
• Dermatological reactions: seldom – rash and/or an itch of skin; in some cases – an alopecia, a photosensitization, a mnogoformny exudative erythema;
• Allergic reactions: fever, urticaria, bronchospasm, Quincke's disease, acute anaphylaxis, intersticial nephrite;
• Others: vision disorder, indisposition, peripheral hypostases, gynecomastia, sweating strengthening.

Special instructions

Before Gastrozol's appointment it is necessary to conduct examination of the patient to exclude existence of malignant process, especially at a peptic ulcer of a stomach as омепразол can mask symptoms and by that to delay timely statement of the correct diagnosis.

Meal does not influence efficiency of drug.

Medicinal interaction

Omeprazol raises stomach pH therefore can reduce absorption of a ketokonazol, itrakonazol, salts of iron and ethers of ampicillin.

Omeprazol is inhibitor of isoenzymes of system _{of P450 cytochrome} therefore can increase concentration in plasma and reduce removal of the drugs which are metabolized in a liver with the participation of CYP2C19 (for example, Phenytoinum), anticoagulants of indirect action and diazepam. For this reason decrease in doses of these medicines can be required.

Gastrozol strengthens an inhibiting effect of other drugs on system of a hemopoiesis.

Terms and storage conditions

To store at a temperature up to 25 ºС. Not to subject to influence of light and moisture. To protect from children.

Period of validity – 3 years.