Gastrozol, enteric capsules 10 mg, 28 pcs.

pharmachologic effect

Antiulcer drug, inhibitor of H+-K+-ATPase (proton pump). Omeprazole reduces acid production - inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. The drug is a prodrug and is activated in the acidic environment of the secretory tubules of parietal cells. Reduces the level of basal and stimulated secretion, regardless of the nature of the stimulus. After taking the drug orally at a dose of 20 mg, the antisecretory effect develops within the first hour, maximum after 2 hours. Inhibition of 50% of maximum secretion continues for 24 hours. Taking the drug 1 time per day provides rapid and effective inhibition of day and night gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after stopping the drug. In patients with duodenal ulcer, taking the drug at a dose of 20 mg maintains the intragastric acidity level (pH) at level 3 for 17 hours.

Side effect

From the digestive system: - diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; - rarely - increased activity of liver transaminases, taste disturbances, formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of gastric hydrochloric acid secretion, is benign, reversible); - in some cases - dry mouth, stomatitis; in patients with previous severe liver disease - hepatitis (including jaundice), impaired liver function. From the hematopoietic system: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia. From the central nervous system and peripheral nervous system: - in patients with severe concomitant somatic diseases - dizziness, headache, agitation, depression; - in patients with previous severe liver disease - encephalopathy. From the musculoskeletal system: in some cases - arthralgia, myasthenia, myalgia. Dermatological reactions: - rarely - skin rash and/or itching; - in some cases - photosensitivity, exudative erythema multiforme, alopecia. Allergic reactions: urticaria, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock. Other: rarely - gynecomastia, malaise, blurred vision, peripheral edema, increased sweating.

Mode of application

The drug is taken orally, usually in the morning, the capsules are not chewed and washed down with a small amount of water (immediately before or during meals). For duodenal ulcer in the acute phase, the drug is prescribed at a dose of 20 mg/day for 2-4 weeks; if the effectiveness is insufficient, the dose can be increased to 40 mg/day. For gastric ulcers in the acute phase and erosive-ulcerative esophagitis - 20-40 mg/day for 4-8 weeks. For erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs - 20 mg/day for 4-8 weeks. For the purpose of eradication of Helicobacter pylori, 20 mg is prescribed 2 times a day for 7 days in combination with antibacterial agents. To prevent relapses of gastric and duodenal ulcers - 20 mg/day. To prevent relapses of reflux esophagitis - 20 mg/day for a long time (up to 6 months). For Zollinger-Ellison syndrome, the dose is set individually depending on the initial level of gastric secretion, usually starting from 60 mg/day. If necessary, the dose is increased to 80-120 mg/day, in which case it is divided into 2 doses.

Gastrozol®

Manufacturer: PHARMSTANDARD-LEKSREDSTVA JSC (Russia)

caps. 20 mg: 7, 10, 14, 20 or 28 pcs. Reg. No.: P N000770/01

Clinical and pharmacological group:

H+-K+-ATPase inhibitor. Antiulcer drug

Release form, composition and packaging

Capsules

opaque, hard gelatin, size No. 2, with a light pink body and a pinkish-brown cap; The contents of the capsules are pellets from white to almost white.

Excipients:

mannitol, sucrose, sodium lauryl sulfate, sodium hydrogen phosphate (disodium phosphate disubstituted), calcium carbonate, lactose, hypromellose (hydroxypropyl methylcellulose), methacrylic acid and ethyl acrylate copolymer (methacrylic acid copolymer L30D), propylene glycol, diethyl phthalate, cetyl alcohol, sodium hydroxide, polysorbate-80 (Tween-80), povidone (polyvinylpyrrolidone), titanium dioxide, talc.

Composition of the capsule shell:

iron oxide red (E172), titanium dioxide (E171), methyl parahydroxybenzoate (methylhydroxybenzoate), propyl parahydroxybenzoate (propylhydroxybenzoate), gelatin; or iron oxide red (E172), titanium dioxide (E171), gelatin.

7 pcs. — cellless contour packages (1) — cardboard packs. 7 pcs. — cellless contour packages (2) — cardboard packs. 10 pieces. — cellless contour packages (1) — cardboard packs. 10 pieces. — cellless contour packages (2) — cardboard packs. 10 pieces. — polymer jars (1) — cardboard packs. 14 pcs. — polymer jars (1) — cardboard packs. 28 pcs. — polymer jars (1) — cardboard packs.

Description of the active components of the drug "Gastrozol®"

pharmachologic effect

Antiulcer drug, inhibitor of H+-K+-ATPase (proton pump). Omeprazole reduces acid production - inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. The drug is a prodrug and is activated in the acidic environment of the secretory tubules of parietal cells.

Reduces the level of basal and stimulated secretion, regardless of the nature of the stimulus.

After taking the drug orally at a dose of 20 mg, the antisecretory effect develops within the first hour, maximum after 2 hours. Inhibition of 50% of maximum secretion continues for 24 hours.

Taking the drug once a day provides rapid and effective suppression of daytime and nighttime gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after stopping the drug. In patients with duodenal ulcer, taking the drug at a dose of 20 mg maintains the intragastric acidity level (pH) at level 3 for 17 hours.

Indications

- treatment of gastric and duodenal ulcers;

- prevention of relapses of gastric and duodenal ulcers;

- reflux esophagitis;

- hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis);

- NSAID gastropathy;

— for the purpose of eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers (as part of combination therapy).

Dosage regimen

The drug is taken orally, usually in the morning, the capsules are not chewed and washed down with a small amount of water (immediately before or during meals).

For duodenal ulcer in the acute phase

the drug is prescribed at a dose of 20 mg/day for 2-4 weeks; if the effectiveness is insufficient, the dose can be increased to 40 mg/day.

For gastric ulcers in the acute phase and erosive-ulcerative esophagitis

- 20-40 mg/day for 4-8 weeks.

For erosive and ulcerative lesions of the gastrointestinal tract caused by taking NSAIDs,

- 20 mg/day for 4-8 weeks.

For the purpose of eradication of Helicobacter pylori

prescribed 20 mg 2 times a day for 7 days in combination with antibacterial agents.

To prevent relapses of gastric and duodenal ulcers

- 20 mg/day.

To prevent relapses of reflux esophagitis

- 20 mg/day for a long time (up to 6 months).

For Zollinger-Ellison syndrome

the dose is set individually depending on the initial level of gastric secretion, usually starting from 60 mg/day. If necessary, the dose is increased to 80-120 mg/day, in which case it is divided into 2 doses.

Side effect

From the digestive system:

diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; rarely - increased activity of liver transaminases, taste disturbances, formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of gastric hydrochloric acid secretion, is benign, reversible); in some cases - dry mouth, stomatitis; in patients with previous severe liver disease - hepatitis (including jaundice), impaired liver function.

From the hematopoietic system:

in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the central nervous system and peripheral nervous system:

in patients with severe concomitant somatic diseases - dizziness, headache, agitation, depression; in patients with pre-existing severe liver disease - encephalopathy.

From the musculoskeletal system:

in some cases - arthralgia, myasthenia gravis, myalgia.

Dermatological reactions:

rarely - skin rash and/or itching; in some cases - photosensitivity, exudative erythema multiforme, alopecia.

Allergic reactions:

urticaria, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock.

Other:

rarely - gynecomastia, malaise, blurred vision, peripheral edema, increased sweating.

Contraindications

- pregnancy;

- lactation period (breastfeeding);

- childhood;

- hypersensitivity to the drug.

Carefully _

the drug should be used for renal and/or liver failure.

Pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

The drug should be used with caution in patients with liver failure.

Use for renal impairment

The drug should be used with caution in patients with renal failure.

Application for children

Contraindicated: children's age.

special instructions

Before starting treatment, it is necessary to exclude the presence of a malignant process (especially with gastric ulcer), because taking Gastrozol may mask symptoms and delay the correct diagnosis.

Taking the drug simultaneously with food does not affect its effectiveness.

Overdose

Symptoms:

confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.

Treatment:

carrying out symptomatic therapy. Hemodialysis is not effective enough.

Drug interactions

Gastrozole may reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole, because Omeprazole increases the pH of the stomach.

As an inhibitor of isoenzymes of the cytochrome P450 system, omeprazole can increase plasma concentrations and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs metabolized in the liver with the participation of CYP2C19), which in some cases may require a reduction in the doses of these drugs.

With long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranol, ethanolol, cyclosporine, quinidine and estradiol did not lead to a change in their plasma concentrations.

Gastrozole enhances the inhibitory effect of other drugs on the hematopoietic system.

There was no interaction between omeprazole and concomitantly taken antacids.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored out of the reach of children, in a dry place, protected from light at a temperature not exceeding 25°C. Shelf life: 3 years.

Drug interactions

Gastrozole may reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole, because Omeprazole increases the pH of the stomach.

As an inhibitor of isoenzymes of the cytochrome P450 system, omeprazole can increase plasma concentrations and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs metabolized in the liver with the participation of CYP2C19), which in some cases may require a reduction in the doses of these drugs.

With long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranol, ethanolol, cyclosporine, quinidine and estradiol did not lead to a change in their plasma concentrations.

Gastrozole enhances the inhibitory effect of other drugs on the hematopoietic system.

There was no interaction between omeprazole and concomitantly taken antacids.

Interaction

Gastrozole may reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole, because Omeprazole increases the pH of the stomach. As an inhibitor of isoenzymes of the cytochrome P450 system, omeprazole can increase plasma concentrations and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs metabolized in the liver with the participation of CYP2C19), which in some cases may require a reduction in the doses of these drugs. With long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranol, ethanolol, cyclosporine, quinidine and estradiol did not lead to a change in their plasma concentrations. Gastrozole enhances the inhibitory effect of other drugs on the hematopoietic system. There was no interaction between omeprazole and concomitantly taken antacids.

Gastrozol, enteric capsules 10 mg, 28 pcs.

You should consult your doctor before taking Gastrozol® if you are being treated with one or more of the drugs listed in this section.

A decrease in the secretion of hydrochloric acid in the stomach during treatment with omeprazole and other proton pump inhibitors can lead to a decrease or increase in the absorption of other drugs, the absorption of which depends on the acidity of the environment.

Like other drugs that reduce gastric acidity, treatment with omeprazole may lead to decreased absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron supplements and cyanocobalamin. Their co-administration with omeprazole should be avoided.

The bioavailability of digoxin when used simultaneously with omeprazole increases by 10% (adjustment of the digoxin dosage regimen may be required). Caution should be exercised when these drugs are used concomitantly in elderly patients.

Omeprazole has been shown to interact with some antiretroviral drugs. The mechanisms and clinical significance of these interactions are not always known. An increase in pH during omeprazole therapy may affect the absorption of antiretroviral drugs. Interaction at the level of the CYP2C19 isoenzyme is also possible. When omeprazole is co-administered with certain antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their serum concentrations is observed during omeprazole therapy. When used simultaneously with omeprazole, the area under the concentration-time curve of atazanavir decreases by 75%. In this regard, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is contraindicated. When used concomitantly with omeprazole, an increase in plasma concentrations of saquinavir/ritonavir is observed by up to 70%, while the tolerability of treatment in patients with HIV infection does not deteriorate.

With simultaneous use of omeprazole with clopidogrel, a decrease in the antiplatelet effect of the latter is observed.

When used simultaneously with omeprazole, it is possible to increase the plasma concentration and increase the half-life of warfarin, diazepam, phenytoin, cilostazol, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs metabolized in the liver with the participation of the CYP2C19 isoenzyme (a dose reduction of these drugs may be required ).

With simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted, which may require dose adjustment. In some patients, an increase in methotrexate concentrations was observed during combined use with proton pump inhibitors. When prescribing high doses of methotrexate, the possibility of temporary withdrawal of omeprazole should be considered.

Concomitant use with inhibitors of the CYP2C19 and CYP3A4 isoenzymes (such as clarithromycin and voriconazole) may lead to an increase in the plasma concentration of omeprazole, which may require dose adjustment of omeprazole in patients with severe liver failure, in case of long-term use.

Inducers of the CYP2C19 and CYP3A4 isoenzymes (for example, rifampicin, preparations of St. John's wort (Hypericum perforatum), when used together with omeprazole, can accelerate its metabolism, thereby reducing the concentration of omeprazole in the blood plasma.

No clinically significant interaction of omeprazole with antacids, caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, budesonide, diclofenac, metronidazole, naproxen, piroxicam has been established.

Compound

1 capsule contains: omeprazole 20 mg.
Excipients: mannitol, sucrose, sodium lauryl sulfate, sodium hydrogen phosphate (disodium phosphate disubstituted), calcium carbonate, lactose, hypromellose (hydroxypropyl methylcellulose), methacrylic acid and ethyl acrylate copolymer (methacrylic acid copolymer L30D), propylene glycol, diethyl phthalate, cetyl alcohol, sodium hydroxide, polysorbate-80 (Tween-80), povidone (polyvinylpyrrolidone), titanium dioxide, talc. The capsules are opaque, hard gelatin, size No. 2, with a light pink body and a pinkish-brown cap. The contents of the capsules are white to almost white pellets.

Gastrozol

Gastrozol ®

(lat.
Gastrozol ®
) is an antiulcer drug that reduces stomach acidity, a Russian generic of omeprazole.

Composition and release form of Gastrozol

Gastrozol release form:
opaque capsules No. 2.
The contents of the capsules are white to almost white pellets. Two dosage forms of Gastrozol are approved for use: enteric capsules 10 mg (white body, yellow cap) and 20 mg capsules (light pink body, pinkish-brown cap). Active substance Gastrozole
:
omeprazole (lat. omeprazole
). One capsule contains 10 or 20 mg of omeprazole.

Excipients of Gastrozol:

sodium lauryl sulfate, crystalline disodium phosphate, hydroxypropylcellulose, lactose, hydroxypropylmethylcellulose, corn starch, hydroxypropylmethylcellulose phthalate, sucrose. Or: mannitol, sucrose, sodium disubstituted phosphate, sodium lauryl sulfate, lactose, calcium carbonate, hypromellose, methacrylic acid copolymer L30D, propylene glycol, diethyl phthalate, cetyl alcohol, sodium hydroxide, polysorbate-80, povidone, titanium dioxide, talc.

Composition of the Gastrozol capsule:

iron oxide red, titanium dioxide, methylhydroxybenzoate, propylhydroxybenzoate, acetic acid, gelatin.

The most important advantage of Gastrozol is its low price

.

Indications for taking Gastrozol, order of administration and dose, contraindications, warnings, pharmacological properties, place among other proton pump inhibitors and other characteristics of Gastrozol are determined by its active substance omeprazole and are described in the article omeprazole

.

Professional medical publications concerning treatment of the gastrointestinal tract with Gastrozol

• Vertkin A.L., Zairatyants O.V., Vovk E.I. Continuity in the treatment of acid-related diseases of the stomach and duodenum in the compulsory health insurance system // Consilium Medicum. – 2005. – T. 7. – No. 2.
• Vasiliev Yu.V. Gastroesophageal reflux disease in the stage of reflux esophagitis: diagnosis and therapy // Farmateka. – 2004. – No. 13(90). - With. 1–5.
• Instructions for medical use of the drug Gastrozol (enteric capsules 10 mg), approved by the Ministry of Health of Russia on 01.08.17 (pdf, ).

On the website gastroscan.ru
in the literature catalog there is a section “Omeprazole”, containing medical articles concerning the treatment of diseases of the gastrointestinal tract with omeprazole preparations.

According to the pharmacological index, Gastrozol belongs to the group “Proton pump inhibitors”. For ATC - to the group “Proton pump inhibitors”, code A02BC01.

In Russia and other countries - former republics of the USSR, omeprazole is widely available in generic versions. Prices for generic omeprazole are much lower than prices for original drugs, such as Losek, Losek MAPS, which is important for many patients and often determines the choice of drug. Due to possible differences in the quality of drugs, an objective assessment of their clinical effectiveness is often necessary. Currently, 24-hour monitoring of intragastric acidity is an objective and accessible method for testing antisecretory agents in clinical practice (Alekseenko S.A.).

Gastrozol 10 mg is an over-the-counter drug.

The manufacturer of Gastrozol is Pharmstandard-Leksredstva OJSC, Kursk (previously produced in St. Petersburg).

Trade names of drugs with the active substance omeprazole

The following drugs are (were) registered in Russia: Bioprazole, Vero-Omeprazole, Demeprazole, Zhelkizol, Zerotsid, Zolser, Chrismel, Lomak, Losek, Losek MAPS, Omegast, Omez, Omez Insta, Omecaps, Omepar, Omeprazole, Omeprazole pellets, Omeprazole -AKOS, Omeprazole-Acri, Omeprazole-E.K., Omeprazole-Richter, Omeprazole Sandoz, Omeprazole-FPO, Omeprazole-OBL, Omeprazole-Teva, Omeprol, Omeprus, Omefez, Omizak, Omipix, Omitox, Ortanol, Otsid, Pepticum , Pleom-20, Promez, Risek, Romesek, Sopral, Ulzol, Ulkozol, Ultop, Helitsid, Helol, Cisagast.
A number of drugs with the active substance omeprazole that are not registered in Russia are presented on the pharmaceutical markets of the countries of the former republics of the USSR, in particular: Gasec, Losid, Omeprazole-Astrapharm, Omeprazole-Darnitsa, Omeprazole-KMP, Omeprazole-Lugal, Tserol and others.

A branded medicine with the active ingredient omeprazole on the US and Canadian markets is Prilosec (formerly called Losec). This brand is sold in Russia under the trademarks Losek Maps and Losek, in Germany, Italy and Switzerland - under the trademarks Antra and Antra MUPS. The over-the-counter version of Prilosec is Prilosec OTC.

Gastrozol has contraindications, side effects and application features; consultation with a specialist is necessary.

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