Omez Insta, por d/prig suspension d/orally 20 mg No. 5 (Dr. Reddy's Laboratories Ltd., INDIA) buy in an online pharmacy in Nizhny Novgorod from 82.70 rub.

Nosological classification (ICD-10)

D44.8 Neoplasm of undetermined or unknown nature involving more than one endocrine gland
K21 Gastroesophageal reflux
K21.0 Gastroesophageal reflux with esophagitis
K21.9 Gastroesophageal reflux without esophagitis
K25 Stomach ulcer
K26 Duodenal ulcer
K27 Peptic ulcer of unspecified location
K31.8.2* Hyperacidity of gastric juice
K86.8.3* Zollinger-Ellison syndrome
K92.9 Disease of the digestive system, unspecified
R12 Heartburn

Pharmacodynamics

Specific proton pump inhibitor: inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing acid production.

Omeprazole is a prodrug and is activated in the acidic environment of the secretory tubules of the parietal cells of the stomach.

The effect is dose-dependent and provides effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulating factor.

Elimination of heartburn after taking the drug occurs within 30 minutes. Inhibition of 50% of maximum hydrochloric acid secretion lasts 24 hours.

A single dose per 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 the 3-4th day after the end of administration. In patients with duodenal ulcer, 20 mg omeprazole maintains intragastric pH above 3 for 17 hours.

Pharmacokinetics

Absorption - high; Tmax on average is 30 minutes (10–90 minutes), bioavailability is 30–40% (with liver failure it increases to almost 100%); Possessing high lipophilicity, it easily penetrates the parietal cells of the stomach, binding to plasma proteins is 95% (albumin and acidic alpha1-glycoprotein).

T1/2 is about 0.5–1 hour (with liver failure - 3 hours); total plasma clearance is from 0.3 to 0.6 l/min. There is no change in the T1/2 value during treatment.

Almost completely metabolized in the liver with the participation of the cytochrome P450 (CYP) enzyme system, with the formation of six pharmacologically inactive metabolites (including hydroxyomeprazole, sulfide and sulfone derivatives). A significant part of the metabolism of omeprazole depends on the polymorphically expressed specific isoform CYP2C19 (S-mephenytoin hydroxylase), which is responsible for the formation of hydroxyomeprazole, the main plasma metabolite. It is an inhibitor of CYP2C19.

Excretion by the kidneys (70–80%) and bile (20–30%). In chronic renal failure, excretion decreases in proportion to the decrease in creatinine Cl. In elderly patients, excretion decreases and bioavailability increases.

Omez Insta 20 mg N5 powder for suspension

Latin name

Omez Insta

Release form

Powder for suspension for oral administration

Package

5 pieces.

pharmachologic effect

Omez Insta is a proton pump inhibitor.

Pharmacodynamics

Specific proton pump inhibitor: inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing acid production.

Omeprazole is a prodrug and is activated in the acidic environment of the secretory tubules of the parietal cells of the stomach.

The effect is dose-dependent and provides effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulating factor.

Elimination of heartburn after taking the drug occurs within 30 minutes. Inhibition of 50% of maximum hydrochloric acid secretion lasts 24 hours.

Pharmacokinetics

T1/2 is about 0.5–1 hour (with liver failure - 3 hours); total plasma clearance is from 0.3 to 0.6 l/min. There is no change in the T1/2 value during treatment.

Indications

- heartburn and other symptoms associated with gastroesophageal reflux disease (GERD);

- non-erosive and erosive (reflux esophagitis) forms of GERD;

- peptic ulcer of the stomach and duodenum (including prevention of relapses);

— eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers (as part of combination therapy);

- NSAID gastropathy;

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

Contraindications

- hypersensitivity;

- fructose intolerance;

- sucrase/isomaltase deficiency;

- glucose-galactose malabsorption (due to the presence of sucrose in the composition of the drug);

- childhood;

- pregnancy;

- lactation period.

Omez Insta should not be used in combination with atazanavir and nelfinavir.

Carefully:

renal and/or liver failure.

special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because Treatment, masking symptoms, can delay the correct diagnosis.

Taking it with food does not affect its effectiveness.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Omez® Insta does not affect the ability to drive vehicles or operate machinery.

Due to the fact that dizziness and drowsiness may occur during therapy with Omez® Insta, caution should be exercised when driving vehicles and other mechanisms.

Compound

1 sachet contains:

Active substance: omeprazole 20 mg;

Excipients: sodium bicarbonate - 1680 mg; xylitol - 2000 mg; sucrose - 2070 mg; sucralose - 30 mg; xanthan gum - 55 mg; mint flavoring - 30 mg.

Directions for use and doses

Inside, 30 minutes before meals. Pour the contents of the sachet into a cup, add 1-2 tablespoons of water (do not use other liquids or food products!), stir thoroughly until a homogeneous suspension is obtained and drink immediately. If necessary, you can drink it with a small amount of water.

To quickly relieve the symptoms of heartburn, a single dose of 20 mg of the drug is sufficient.

Non-erosive GERD - 20 mg once a day for 4 weeks.

Erosive form of GERD (reflux esophagitis) - 20 mg 2 times a day for 4-8 weeks, depending on the severity of esophagitis.

Prevention of exacerbation of reflux esophagitis - 20 mg/day, the duration of maintenance therapy is determined individually.

Exacerbation of gastric or duodenal ulcer not associated with Helicobacter pylori - 20 mg in the morning once a day for 4-8 weeks.

To eradicate Helicobacter pylori, therapy is used in various combinations: for 7–14 days, omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - 2 times a day; or omeprazole 20 mg, clarithromycin 500 mg, metronidazole 500 mg - 2 times a day; or omeprazole 20 mg - 2 times a day, bismuth preparations at a dose of 120 mg - 4 times a day, metronidazole 500 mg - 3 times a day and tetracycline 500 mg - 4 times a day.

Prevention of gastric or duodenal ulcers - 20 mg in the morning 1 time per day for 4-8 weeks.

Treatment of NSAID gastropathy - 20 mg 2 times a day for 4-6 weeks, for prevention - 20 mg per day for the period of NSAID use in patients with risk factors for the development of NSAID gastropathy.

Hypersecretory conditions - 20 mg in the morning 1 time per day for 4-8 weeks.

Treatment of Zollinger-Ellison syndrome - doses are selected individually, depending on the clinical condition. The recommended starting dose is 60 mg/day. In most patients, the condition is adequately controlled in the dose range of 20–120 mg. If it is necessary to use a dose of more than 80 mg, divide it into 2 administrations.

Special patient groups

In elderly patients and with renal failure, no dose adjustment is required. For liver failure, a daily dose of 20 mg may be sufficient.

Side effects

From the hematopoietic organs:

rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia.

From the digestive system:

often - diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; rarely - increased activity of liver enzymes, taste disturbances; very rarely - dry mouth, stomatitis, candidiasis of the gastrointestinal mucosa; in patients with previous severe liver disease - hepatitis (including jaundice); very rarely - liver failure, incl. with the development of encephalopathy (in patients with a history of liver disease).

From the nervous system:

often - headache; infrequently - dizziness, paresthesia, drowsiness; rarely - taste disturbance.

Mental disorders:

infrequently - insomnia; rarely - agitation, confusion, depression; very rarely - aggression, hallucinations.

From the senses:

infrequently - vertigo; rarely - blurred vision.

From the musculoskeletal system:

rarely - arthralgia, myalgia; very rarely - muscle weakness.

From the skin:

uncommon - dermatitis, itching, rash, urticaria; rarely - alopecia, photosensitivity; very rarely - exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Allergic reactions:

rarely - hypersensitivity reactions, including fever, angioedema and anaphylactic reactions (including anaphylactic shock).

From the genitourinary and reproductive system:

rarely - interstitial nephritis; very rarely - gynecomastia.

Metabolic disorders:

rarely - hyponatremia; very rarely - hypomagnesemia.

Other:

infrequently - malaise, peripheral edema; rarely - bronchospasm, increased sweating.

Drug interactions

Due to a decrease in the acidity of gastric juice during treatment with omeprazole, the absorption of other drugs, the mechanism of absorption of which depends on the pH of the gastric juice, may decrease or increase.

Reduces the absorption of ketoconazole and itraconazole.

Increases the absorption of digoxin. The combined use of omeprazole at a dose of 20 mg 1 time per day and digoxin increases the bioavailability of digoxin by approximately 10%.

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 gastric pH during omeprazole therapy may affect the absorption of antiretroviral drugs.

Interaction at the level of CYP2C19 is also possible. When omeprazole is co-administered with antiretroviral drugs such as atazanavir and nelfinavir, a decrease in their serum concentrations is observed during omeprazole therapy. In this regard, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is not recommended.

When omeprazole and saquinavir were administered concomitantly, an increase in saquinavir serum concentrations was observed.

Omeprazole inhibits CYP2C19, the main isoenzyme involved in its metabolism.

Concomitant use of omeprazole with other drugs in which CYP2C19 is involved in the metabolism, such as diazepam, phenytoin, warfarin, other vitamin K antagonists and cilostazol, may lead to a decrease in the metabolism of these drugs.

It is recommended to monitor plasma phenytoin concentrations during concomitant use of phenytoin and omeprazole; in some cases it may be necessary to reduce the dose of phenytoin. At the same time, in patients taking phenytoin for a long time, co-administration of omeprazole at a dose of 20 mg once a day did not cause changes in the concentration of phenytoin in the blood plasma.

When using omeprazole in patients receiving warfarin or other vitamin K antagonists, INR monitoring is necessary; in some cases, it may be necessary to reduce the dose of warfarin or another vitamin K antagonist. At the same time, in patients taking warfarin for a long time, co-administration of omeprazole at a dose of 20 mg 1 time per day did not cause a change in clotting time.

The use of omeprazole at a dose of 40 mg 1 time per day led to an increase in Cmax and AUC of cilostazol by 18 and 26%, respectively; for one of the active metabolites of cilostazol, the increase was 29 and 69%, respectively.

Omeprazole does not affect the metabolism of drugs, which is carried out through CYP3A4, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted.

CYP2C19 and CYP3A4 are involved in the metabolism of omeprazole. Concomitant use of omeprazole and inhibitors of CYP2C19 and CYP3A4, such as clarithromycin and voriconazole, may lead to increased plasma concentrations of omeprazole by slowing the metabolism of omeprazole. The combined use of voriconazole and omeprazole led to a more than twofold increase in the AUC of omeprazole, which, however, did not require dose adjustment of omeprazole.

Drugs that induce CYP2C19 and CYP3A4, such as rifampicin and St. John's wort preparations, when used together with omeprazole, can lead to a decrease in the concentration of omeprazole in the blood plasma by accelerating the metabolism of omeprazole.

Overdose

Symptoms:

headache, dizziness, lethargy, confusion, tachycardia, arrhythmia, blurred vision, drowsiness, dry mouth, nausea, vomiting, flatulence.

Treatment:

symptomatic. If necessary, gastric lavage and activated charcoal. Hemodialysis is not effective enough.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C.

Best before date

2 years.

Indications of the drug Omez® Insta

heartburn and other symptoms associated with gastroesophageal reflux disease (GERD);

non-erosive and erosive (reflux esophagitis) forms of GERD;

peptic ulcer of the stomach and duodenum (including prevention of relapses);

eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers (as part of combination therapy);

NSAID gastropathy;

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

Omez insta 20 mg 5 pcs. powder for the preparation of suspension for oral administration

pharmachologic effect

Gastric gland secretion inhibitor, proton pump inhibitor.

Composition and release form Omez insta 20 mg 5 pcs. powder for the preparation of suspension for oral administration

Each sachet contains:

active substance: omeprazole 20 mg;
excipients: sodium bicarbonate 1680 mg, xylitol 2000 mg, sucrose 2070 mg, sucralose 30 mg, xanthan gum 55 mg, mint flavor 30 mg.

Powder for oral suspension containing 20 mg omeprazole.

5.885 g of powder per bag made of a combined material (low-density polyethylene / aluminum foil / low-density polyethylene / glassine).

5, 10, 20, 30 sachets along with instructions for use in a cardboard pack.

Description of the dosage form

White to almost white powder with a mint odor.

Ready-to-use suspension: white to almost white suspension.

Directions for use and doses

Inside. Pour the contents of the sachet into a cup, add 1-2 tablespoons of water (do not use other liquids or food products!), stir thoroughly until a homogeneous suspension is obtained and drink immediately. If necessary, you can drink it with a small amount of water.

To ensure the dosage regimens below, it is possible to take the drug in another registered dosage (Omez, capsules, 10 mg, 20 mg and 40 mg; Omez Insta, powder for the preparation of suspension for oral administration, 20 mg; Omez, lyophilisate for the preparation of solution for infusion, 40 mg).

Adults

Heartburn and other symptoms associated with gastroesophageal reflux disease (GERD). To quickly relieve the symptoms of heartburn, a single dose of 20 mg of the drug is sufficient.

Non-erosive and erosive (reflux esophagitis) forms of GERD. Depending on the severity of esophagitis - from 20 mg to 80 mg per day. The daily dose can be divided into 2-3 doses.

The duration of the main course is 4–8 weeks. After healing of the erosion, maintenance treatment is indicated for 26–52 weeks, and for severe esophagitis - for life. To prevent exacerbation of reflux esophagitis – 20 mg/day.

Peptic ulcer of the stomach and duodenum (including prevention of relapses). 20 mg 1 time per day. For patients resistant to treatment with other antiulcer drugs - 40 mg/day. The course of treatment for duodenal ulcer is 2 weeks, if necessary - up to 4 weeks, for gastric ulcer - 4-8 weeks.

Eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers, as well as other diseases that require eradication (as part of combination therapy). According to the recommendations of the Maastricht-4 working group, Omez Insta can be included in the following treatment regimens:

First line (standard triple circuit). Omez Insta 20 mg 2 times a day + clarithromycin 500 mg 2 times a day + amoxicillin 1000 mg 2 times a day. To increase the effectiveness of therapy, it is possible to prescribe Omez Insta 40 mg (2 sachets of 20 mg each) 2 times a day (doubling the standard dose) and increasing the duration of the course from 7 to 10-14 days.
Second line (four-component). It is used when standard triple therapy is ineffective or when penicillin is intolerant. Bismuth tripotassium dicitrate (120 mg 4 times a day) in combination with Omez Insta (20 mg 2 times a day), tetracycline (500 mg 4 times a day), metronidazole (500 mg 4 times a day) for 10 days.
Third line and other alternative therapy options are prescribed based on a study of the individual sensitivity of Helicobacter pylori to antibiotics.

Prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by taking non-steroidal anti-inflammatory drugs (NSAID gastropathy), such as: dyspepsia, erosion of the mucous membrane, peptic ulcer.

For the purpose of prevention, Omez Insta is prescribed at a dose of 20 mg daily before breakfast during the entire course of NSAID treatment; for the purpose of treatment - at a dose of 20 mg 2 times or once 40 mg (2 sachets of 20 mg) per day for 4-8 weeks.

Hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis) – 60 mg/day; if necessary, the dose is increased to 80-120 mg/day (in this case it is prescribed in 2-3 doses).

Children

Age over 2 years, with a body weight of more than 20 kg: for gastroesophageal reflux disease, it is recommended to prescribe Omez Insta at a dose of 20 mg once a day. Duration of treatment – 4-8 weeks;

Over the age of 4 years, with a body weight of more than 20 kg: for duodenal ulcers caused by Helicobacter pylori, at a dose of 20 mg once a day in combination with antibacterial drugs.

Use of the drug in special cases

Renal dysfunction. No dose adjustment is required.

Liver dysfunction. In patients with impaired liver function, the bioavailability and clearance of omeprazole are increased. In this regard, the therapeutic dose should not exceed 20 mg per day.

Elderly age. The rate of metabolism of omeprazole in the elderly is reduced, but no dose adjustment is required.

Pharmacodynamics

Mechanism of action

Omeprazole is a weak base. Concentrated in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, it is activated and inhibits the proton pump - the enzyme H+/K+-ATPase.

The effect of omeprazole on the last stage of the formation of hydrochloric acid in the stomach is dose-dependent and provides highly effective inhibition of basal and stimulated secretion of hydrochloric acid, regardless of the stimulating factor.

Effect on gastric juice secretion

Omeprazole, when administered daily orally, provides rapid and effective inhibition of daytime and nighttime hydrochloric acid secretion.

The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcers, omeprazole at a dose of 20 mg causes a sustained decrease in gastric acidity by at least 80% over 24 hours. In this case, a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% is achieved within 24 hours.

In patients with duodenal ulcers, daily oral administration of 20 mg omeprazole maintains intragastric acidity at pH ≥ 3 for 17 hours.

Inhibition of hydrochloric acid secretion depends on the area under the pharmacokinetic concentration-time curve (AUC) of omeprazole, and not on the plasma concentration of the drug at a given time.

Effect on Helicobacter pylori

Omeprazole in vitro has a bactericidal effect on Helicobacter pylori. Eradication of Helicobacter pylori when using omeprazole in conjunction with antibacterial agents is accompanied by rapid elimination of symptoms, a high degree of healing of defects in the mucous membrane of the gastrointestinal tract and long-term remission of peptic ulcer disease, which reduces the likelihood of complications such as bleeding as effectively as constant maintenance therapy.

Other effects associated with inhibition of hydrochloric acid secretion

Patients taking drugs that reduce the secretion of gastric glands for a long period of time are more likely to experience the formation of glandular cysts in the stomach; The cysts are benign and go away on their own with continued therapy.

A decrease in the secretion of hydrochloric acid in the stomach leads to a slight increase in the risk of developing intestinal infections caused by Salmonella spp., Campylobacter spp. and Clostridium difficile.

During treatment with drugs that reduce the secretion of gastric glands, the concentration of gastrin in the blood serum increases. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A increases.

Pharmacokinetics

Suction

Absorption – high; time to reach maximum concentration (Tcmax), on average - 30 minutes (10-90 minutes), bioavailability - 30-40% (in case of liver failure it increases to almost 100%). Food intake does not affect the bioavailability of omeprazole.

Distribution

The binding rate of omeprazole to plasma proteins is about 95%, the volume of distribution is 0.3 l/kg.

Metabolism

Part of omeprazole undergoes first-pass hepatic metabolism with the participation of isoenzymes CYP2C19 and CYP3A4 with the formation of inactive metabolites sulfone, sulfide and hydroxy-omeprazole. Omeprazole, which is not included by parietal cells in the formation of active metabolites, is completely metabolized in the liver also with the participation of the CYP2C19 and CYP3A4 isoenzymes. The total plasma clearance is 0.3-0.6 l/min.

Removal

The half-life is approximately 40 minutes (30-90 minutes). About 80% is excreted in the form of metabolites by the kidneys, and the rest by the intestines.

Special patient groups

There were no significant changes in the bioavailability of omeprazole in elderly patients or in patients with impaired renal function. In patients with impaired liver function, there is an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance.

Indications for use Omez insta 20 mg 5 pcs. powder for the preparation of suspension for oral administration

Adults

heartburn and other symptoms associated with gastroesophageal reflux disease (GERD);
non-erosive and erosive (reflux esophagitis) forms of GERD;
peptic ulcer of the stomach and duodenum (including prevention of relapses);
eradication of Helicobacter pylori in infected patients with gastric and duodenal ulcers (as part of combination therapy);
prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by taking nonsteroidal anti-inflammatory drugs (NSAID gastropathy): dyspepsia, erosion of the mucous membrane, peptic ulcer;
hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis).

Children

Over the age of 2 years, with a body weight of more than 20 kg: during the treatment of gastroesophageal reflux disease;
Over the age of 4 years, with a body weight of more than 20 kg: for the treatment of duodenal ulcers caused by Helicobacter pylori.

Safety and effectiveness for other indications in pediatric patients have not been established.

Contraindications

Hypersensitivity to omeprazole, substituted benzimidazoles or other components of the drug, fructose intolerance, sucrase/isomaltase deficiency, glucose-galactose malabsorption (due to the presence of sucrose in the drug).

The drug should not be used in combination with atazanavir, nelfinavir, erlotinib, or posaconazole.

The use of omeprazole in children is contraindicated, except as indicated: gastroesophageal reflux disease for children over 2 years old, weighing more than 20 kg and duodenal ulcer caused by Helicobacter pylori, for children over 4 years old, weighing more than 20 kg.

Carefully

Renal failure (no dose adjustment of omeprazole is required).

Liver failure.

Osteoporosis. Although a causal relationship between the use of omeprazole and osteoporotic fractures has not been established, patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision.

Application of Omez insta 20 mg 5 pcs. powder for the preparation of a suspension for oral administration during pregnancy and lactation

The research results showed no side effects of omeprazole on the health of pregnant women, the fetus or the newborn.

Omeprazole is excreted in breast milk, but when used in therapeutic doses, exposure to the child is unlikely.

Omeprazole is approved for use during pregnancy and breastfeeding.

Overdose

Symptoms: headache, dizziness, lethargy, confusion, tachycardia, arrhythmia, blurred vision, drowsiness, dry mouth, nausea, vomiting, flatulence.

Treatment: symptomatic. If necessary, gastric lavage and activated charcoal. Hemodialysis is not effective enough.

Side effects of Omez insta 20 mg 5 pcs. powder for the preparation of suspension for oral administration

The frequency of adverse drug reactions is presented in accordance with the following gradation: very often (>1/10); often (≥1/100,

Disorders of the blood and lymphatic system: rarely - leukopenia, thrombocytopenia, hypochromic microcytic anemia in children; very rarely - agranulocytosis, pancytopenia, eosinophilia.

Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.

Metabolic and nutritional disorders: rarely – hyponatremia; frequency unknown - hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia.

Mental disorders: infrequently – insomnia; rarely - increased excitability, depression, reversible confusion; very rarely – aggression, hallucinations.

Nervous system disorders: often – headache; uncommon – dizziness, paresthesia, drowsiness; rarely – taste disturbance.

Visual disturbances: rarely – blurred vision.

Hearing and labyrinthine disorders: uncommon – hearing loss, vertigo.

Disorders of the respiratory system, chest and mediastinal organs: rarely - bronchospasm.

Gastrointestinal disorders: often – abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely - dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis; isolated cases - the formation of gastric glandular cysts during long-term treatment with simultaneous use with clarithromycin (a consequence of inhibition of hydrochloric acid secretion; it is benign, reversible).

Disorders of the liver and biliary tract: infrequently - increased activity of liver enzymes and alkaline phosphatase (reversible); rarely - hepatitis (with or without jaundice), liver failure, encephalopathy in patients with previous severe liver diseases.

Disorders of the skin and subcutaneous tissues: infrequently - dermatitis, itching, skin rash, urticaria; rarely - alopecia, photosensitivity reactions, exudative erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Musculoskeletal and connective tissue disorders: uncommon – fractures of the vertebrae, wrist bones, femoral head associated with osteoporosis; rarely – arthralgia, myalgia, muscle weakness.

Renal and urinary tract disorders: rarely – interstitial nephritis.

Disorders of the genital organs and breast: rarely – gynecomastia.

General disorders and disorders at the injection site: uncommon – malaise; rarely – increased sweating, peripheral edema.

If side effects not listed in these instructions occur, you should immediately consult a doctor.

Drug interactions

Substances with pH-dependent absorption

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.

Digoxin

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.

Clopidogrel

According to the results of the studies, an interaction was noted between clopidogrel (loading dose 300 mg, maintenance dose 75 mg/day) and omeprazole (80 mg/day orally), which reduces the exposure of the active metabolite of clopidogrel and reduces the inhibition of platelet aggregation. The observed effect is likely due to the inhibitory effect of omeprazole on the CYP2C19 isoenzyme. Therefore, the simultaneous use of omeprazole and clopidogrel should be avoided.

Antiretroviral drugs

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 pharmacokinetic 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 simultaneously with omeprazole, an increase in plasma concentrations of saquinavir/ritonavir is observed up to 70%, while the tolerability of treatment in patients with HIV infection does not deteriorate.

Tacrolimus

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. It is necessary to monitor creatinine clearance and plasma concentrations of tacrolimus when used together with omeprazole.

Methotrexate

When methotrexate was co-administered with proton pump inhibitors, a slight increase in plasma methotrexate concentrations was observed in some patients. When treated with high doses of methotrexate, omeprazole should be temporarily discontinued.

Drugs metabolized by the CYP2C19 isoenzyme

When used simultaneously with omeprazole, it is possible to increase the plasma concentration and increase the half-life of warfarin (R-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 (may dose reduction of these drugs may be required). However, taking omeprazole 20 mg per day does not affect the concentration of phenytoin in the blood plasma in patients taking phenytoin for a long time. When using omeprazole in patients receiving warfarin or other vitamin K antagonists, monitoring of the international normalized ratio is necessary. At the same time, concomitant treatment with omeprazole at a daily dose of 20 mg does not lead to a change in coagulation time in patients taking warfarin for a long time.

Inhibitors of CYP2C19 and/or CYP3A4 isoenzymes

Concomitant use with inhibitors of CYP2C19 and/or CYP3A4 isoenzymes slows down the metabolism of omeprazole.

When omeprazole is taken together with clarithromycin or erythromycin, the concentration of omeprazole in the blood plasma increases.

The combined use of voriconazole and omeprazole leads to an increase in the area under the pharmacokinetic curve of omeprazole.

Dose adjustment of omeprazole when used concomitantly with inhibitors of CYP2C19 and/or CYP3A4 isoenzymes may be required in patients with severe hepatic impairment in case of long-term use of omeprazole. With short-term joint use, correction is not required due to the good tolerance of high doses of omeprazole.

Inducers of CYP2C19 and CYP3A4 isoenzymes

Inducers of the CYP2C19 and CYP3A4 isoenzymes, such as rifampicin, preparations of St. John's wort (Hypéricum perforatum), when used together with omeprazole, can lead to a decrease in the concentration of omeprazole in the blood plasma by accelerating the metabolism of omeprazole.

No effect on metabolism

Co-administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma.

No clinically significant interaction of omeprazole with metoprolol, phenacetin, estradiol, budesonide, diclofenac, naproxen, piroxicam, S-warfarin has been established.

There was no effect of omeprazole on antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol.

Side effects

In rare cases, the following, usually reversible, side effects may occur.

The frequency of side effects is classified depending on the frequency of occurrence of the case: very often (≥1/10); often (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10000 to <1/1000); very rare (<1/10000), including isolated reports.

From the hematopoietic organs: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia.

From the digestive system: often - diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; rarely - increased activity of liver enzymes, taste disturbances; very rarely - dry mouth, stomatitis, candidiasis of the gastrointestinal mucosa; in patients with previous severe liver disease - hepatitis (including jaundice); very rarely - liver failure, incl. with the development of encephalopathy (in patients with a history of liver disease).

From the nervous system: often - headache; infrequently - dizziness, paresthesia, drowsiness; rarely - taste disturbance.

Mental disorders: infrequently - insomnia; rarely - agitation, confusion, depression; very rarely - aggression, hallucinations.

From the senses: infrequently - vertigo; rarely - blurred vision.

From the musculoskeletal system: rarely - arthralgia, myalgia; very rarely - muscle weakness.

From the skin: infrequently - dermatitis, itching, rash, urticaria; rarely - alopecia, photosensitivity; very rarely - exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Allergic reactions: rarely - hypersensitivity reactions, including fever, angioedema and anaphylactic reactions (including anaphylactic shock).

From the genitourinary and reproductive system: rarely - interstitial nephritis; very rarely - gynecomastia.

Metabolic disorders: rarely - hyponatremia; very rarely - hypomagnesemia.

Other: infrequently - malaise, peripheral edema; rarely - bronchospasm, increased sweating.

Omez Insta, por d/prig suspension d/orally 20 mg No. 5 (Dr. Reddy's Laboratories Ltd., INDIA)

Compound.


active substance:
omeprazole	20 mg
excipients: sodium bicarbonate - 1680 mg; xylitol - 2000 mg; sucrose - 2070 mg; sucralose - 30 mg; xanthan gum - 55 mg; mint flavoring – 30 mg

Description of the dosage form.

White to almost white powder with a mint odor.
Pharmachologic effect. Proton pump inhibitor.

Pharmacodynamics.

Specific proton pump inhibitor: inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing acid production.

Omeprazole is a prodrug and is activated in the acidic environment of the secretory tubules of the parietal cells of the stomach.

The effect is dose-dependent and provides effective inhibition of both basal and stimulated acid secretion, regardless of the nature of the stimulating factor.

Elimination of heartburn after taking the drug occurs within 30 minutes. Inhibition of 50% of maximum hydrochloric acid secretion lasts 24 hours.

Pharmacokinetics.

T1/2 is about 0.5–1 hour (with liver failure - 3 hours); total plasma clearance is from 0.3 to 0.6 l/min. There is no change in the T1/2 value during treatment.

Indications.

● heartburn and other symptoms associated with gastroesophageal reflux disease (GERD);

● non-erosive and erosive (reflux esophagitis) forms of GERD;

● peptic ulcer of the stomach and duodenum (including prevention of relapses);

● eradication of Helicobacter pylori

in infected patients with gastric and duodenal ulcers (as part of combination therapy);

● NSAID gastropathy;

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

Contraindications.

● hypersensitivity;

● fructose intolerance;

● sucrase/isomaltase deficiency;

● glucose-galactose malabsorption (due to the presence of sucrose in the drug);

● childhood;

● pregnancy;

● lactation period.

The drug should not be used in combination with atazanavir and nelfinavir.

Carefully:

renal and/or liver failure.

Side effects.

In rare cases, the following, usually reversible, side effects may occur.

From the hematopoietic organs:

rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia.

From the digestive system:

From the nervous system:

often - headache; infrequently - dizziness, paresthesia, drowsiness; rarely - taste disturbance.

Mental disorders:

infrequently - insomnia; rarely - agitation, confusion, depression; very rarely - aggression, hallucinations.

From the senses:

infrequently - vertigo; rarely - blurred vision.

From the musculoskeletal system:

rarely - arthralgia, myalgia; very rarely - muscle weakness.

From the skin:

uncommon - dermatitis, itching, rash, urticaria; rarely - alopecia, photosensitivity; very rarely - exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Allergic reactions:

rarely - hypersensitivity reactions, including fever, angioedema and anaphylactic reactions (including anaphylactic shock).

From the genitourinary and reproductive system:

rarely - interstitial nephritis; very rarely - gynecomastia.

Metabolic disorders:

rarely - hyponatremia; very rarely - hypomagnesemia.

Other:

infrequently - malaise, peripheral edema; rarely - bronchospasm, increased sweating.

Interaction.

Reduces the absorption of ketoconazole and itraconazole.

Increases the absorption of digoxin. The combined use of omeprazole at a dose of 20 mg 1 time per day and digoxin increases the bioavailability of digoxin by approximately 10%.

When omeprazole and saquinavir were administered concomitantly, an increase in saquinavir serum concentrations was observed.

Omeprazole inhibits CYP2C19, the main isoenzyme involved in its metabolism.

Omeprazole does not affect the metabolism of drugs, which is carried out through CYP3A4, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted.

Method of administration and dose.

Inside,

30 minutes before meals. Pour the contents of the sachet into a cup, add 1-2 tablespoons of water (do not use other liquids or food products!), stir thoroughly until a homogeneous suspension is obtained and drink immediately. If necessary, you can drink it with a small amount of water.

To quickly relieve the symptoms of heartburn, a single dose of 20 mg of the drug is sufficient.

Non-erosive GERD - 20 mg once a day for 4 weeks.

Erosive form of GERD (reflux esophagitis) - 20 mg 2 times a day for 4-8 weeks, depending on the severity of esophagitis.

Prevention of exacerbation of reflux esophagitis - 20 mg/day, the duration of maintenance therapy is determined individually.

Exacerbation of gastric or duodenal ulcer not associated with Helicobacter pylori

, - 20 mg in the morning 1 time per day for 4–8 weeks.

For eradication of Helicobacter pylori

therapy is used in various combinations: for 7–14 days, omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - 2 times a day; or omeprazole 20 mg, clarithromycin 500 mg, metronidazole 500 mg - 2 times a day; or omeprazole 20 mg - 2 times a day, bismuth preparations at a dose of 120 mg - 4 times a day, metronidazole 500 mg - 3 times a day and tetracycline 500 mg - 4 times a day.

Prevention of gastric or duodenal ulcers - 20 mg in the morning once a day for 4-8 weeks.

Treatment of NSAID gastropathy - 20 mg 2 times a day for 4-6 weeks, for prevention - 20 mg per day for the period of use of NSAIDs in patients with risk factors for the development of NSAID gastropathy.

Hypersecretory conditions - 20 mg in the morning 1 time per day for 4–8 weeks.

Special patient groups

In elderly patients and with renal failure, no dose adjustment is required. For liver failure, a daily dose of 20 mg may be sufficient.

Overdose.

Symptoms:

headache, dizziness, lethargy, confusion, tachycardia, arrhythmia, blurred vision, drowsiness, dry mouth, nausea, vomiting, flatulence.

Treatment:

symptomatic. If necessary, gastric lavage and activated charcoal. Hemodialysis is not effective enough.

Special instructions.

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because Treatment, masking symptoms, can delay the correct diagnosis.

Taking it with food does not affect its effectiveness.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions.

Omez® Insta does not affect the ability to drive vehicles or operate machinery.

Due to the fact that dizziness and drowsiness may occur during therapy with Omez® Insta, caution should be exercised when driving vehicles and other mechanisms.

Release form.

Powder for oral suspension containing 20 mg omeprazole.

In sachets of combined material (LDPE/aluminum foil/LDPE/glassine) 5.885 g each. 5, 10, 20 or 30 sachets in a cardboard pack.

. India, 7-1-27, Ameerpet, Hyderabad - 500016, Andhra Pradesh.

Manufacturer's address: Dr. Reddy's Laboratories Ltd. India, Plot No. 8/2 and 8/4, Ward-F, Block-4, Adavipolam, Yanam - Puducherry - 533464.

Consumer complaints should be sent to the representative office address: 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1.

Tel., 783-29-01; Fax.

Conditions for dispensing from pharmacies.

On prescription.

Interaction

Reduces the absorption of ketoconazole and itraconazole.

Increases the absorption of digoxin. The combined use of omeprazole at a dose of 20 mg 1 time per day and digoxin increases the bioavailability of digoxin by approximately 10%.

When omeprazole and saquinavir were administered concomitantly, an increase in saquinavir serum concentrations was observed.

Omeprazole inhibits CYP2C19, the main isoenzyme involved in its metabolism.

Omeprazole does not affect the metabolism of drugs, which is carried out through CYP3A4, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted.

Omez® Insta (Omez® Insta)

Substances whose absorption depends on pH (acidity of gastric juice)

Reducing the acidity of gastric juice when using omeprazole can increase or decrease the absorption of pharmacologically active substances.

Nelfinavir, atazanavir

When used concomitantly with omeprazole, a significant decrease in plasma concentrations of atazanavir and nelfinavir may be observed.

The simultaneous use of omeprazole and nelfinavir is contraindicated. Concomitant use of omeprazole (40 mg daily) reduces nelfinavir exposure by approximately 40%. and the average exposure to the pharmacologically active metabolite M8 is reduced by 75-90%. The interaction may involve a mechanism of CYPICI9 inhibition.

Concomitant use of omeprazole with atazanavir is not recommended. Coadministration of omeprazole (40 mg daily) and atazanavir 300 mg/ritonavir 100 mg in healthy volunteers resulted in a 75% reduction in atazanavir exposure. Increasing the atazanavir dose to 400 mg does not compensate for the effect of omeprazole on atazanavir exposure. Administration of 20 mg omeprazole per day with 400 mg atazanavir and 100 mg ritonavir to healthy volunteers resulted in an approximately 30% reduction in atazanavir exposure and was comparable to exposure with a single dose of 300 mg atazanavir and 100 mg ritonavir.

Digoxin

Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy volunteers increased the bioavailability of digoxin by 10%. Despite. that glycoside intoxication while taking omeprazole is not a common event, enhanced monitoring is necessary, especially when treating elderly patients.

Clopidogrel

In a crossover clinical study, the duration of taking clopidogrel at a loading dose of 300 mg (75 mg per day) and the combination of clopidogrel with omeprazole at a dose of 80 mg was 5 days. Exposure to the active metabolite of clopidogrel was reduced by 46% (on day 1) and 42% (on day 5) when clopidogrel was coadministered with omeprazole. The mean time to platelet aggregation inhibition was reduced by 47% (24 hours) and 30% (day 5) when clopidogrel and omeprazole were co-administered. Another study showed that taking clopidogrel and omeprazole at different times did not prevent their interaction, which is likely due to the inhibitory effect of omeprazole on CYP2CI9. Observational and clinical studies have provided conflicting data on the clinical impact of these PK/PD interactions on the development of severe cardiovascular events.

Other medicines

Absorption of posaconazole. erlotinib, ketoconazole and itraconazole are significantly reduced, and their clinical effectiveness deteriorates accordingly. Avoid co-administration of omeprazole with posaconazole or erlotinib.

Medicines metabolized by the CYP2C19 isoenzyme
Omeprazole moderately inhibits
CYP2C19, the main enzyme in the metabolism of omeprazole . Thus, the metabolism of other drugs is also metabolized by CYP2C19. may be reduced and their systemic exposure increased. Examples of such drugs are R-warfarin and other vitamin K antagonists, cilostazol. diazepam and phenytoin.

Cilostazol

In a crossover clinical study, administration of omeprazole 40 mg to healthy volunteers increased the Cmax and AUC of cilostazol by 18% and 26%, respectively. and one of the active metabolites of cilostazol by 29% and 69%, respectively.

Phenytoin

Monitoring plasma concentrations of phenytoin is recommended during the first two weeks after initiation of omeprazole therapy and in case of dose adjustment of phenytoin. Monitoring and subsequent dose adjustment of phenytoin should be carried out until the end of treatment with omeprazole.

Unknown mechanism of interaction

Saquinavir

Coadministration of omeprazole and saquinavir/ritonavir is well tolerated in HIV-infected patients and also results in a reduction in plasma concentrations of saquinavir by approximately 70%.

Tacrolimus

Coadministration with omeprazole increases the serum concentration of tacrolimus. Increased monitoring of tacrolimus concentrations and renal function (creatinine clearance) should be carried out, with tacrolimus dose adjustments if necessary.

The influence of other drugs on the pharmacokinetics of omeprazole

Inhibitors of the isoenzyme
CYP 2 C 19 and or CYP 3 A 4
Considering the metabolism of omeprazole with the participation of the isoenzymes CYP2CI9 and CYP3A4. Drugs that can inhibit these enzymes (such as clarithromycin and voriconazole) may increase serum concentrations of omeprazole, reducing its rate of metabolism.

If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Omez® Insta.

Directions for use and doses

To quickly relieve the symptoms of heartburn, a single dose of 20 mg of the drug is sufficient.

Non-erosive GERD - 20 mg once a day for 4 weeks.

Erosive form of GERD (reflux esophagitis) - 20 mg 2 times a day for 4-8 weeks, depending on the severity of esophagitis.

Prevention of exacerbation of reflux esophagitis - 20 mg/day, the duration of maintenance therapy is determined individually.

Exacerbation of gastric or duodenal ulcer not associated with Helicobacter pylori - 20 mg in the morning once a day for 4-8 weeks.

Prevention of gastric or duodenal ulcers - 20 mg in the morning once a day for 4-8 weeks.

Hypersecretory conditions - 20 mg in the morning 1 time per day for 4–8 weeks.

Special patient groups

In elderly patients and with renal failure, no dose adjustment is required. For liver failure, a daily dose of 20 mg may be sufficient.

Omez Insta

Omez ® Insta

(lat.
Omez Insta
) - an antiulcer drug that reduces acidity in the upper gastrointestinal tract with a complex mechanism of action:

decrease in the production of hydrochloric acid in the parietal cells of the stomach, for which the active substance Omeza Insta omeprazole, which is a proton pump inhibitor, is responsible
chemical neutralization of acid in the esophagus and stomach, which occurs due to the relatively large amount of sodium bicarbonate
(synonyms
sodium bicarbonate
,
baking soda
,
baking soda
).

Omez Insta is a variant of the drug Omez, characterized in that its composition, among the excipients, contains a large amount of sodium bicarbonate. Therefore, the pharmacological and other properties of Omez Insta are largely determined by the characteristics of the active substance Omez - they are set out in the article “Omeprazole”. Baking soda (sodium bicarbonate) is an absorbable antacid that provides rapid acid reduction after consumption. However, a serious disadvantage of baking soda, like other absorbable antacids, is the short duration of action, acid rebound (increased secretion of hydrochloric acid after the end of the drug's effect), the formation of carbon dioxide during their reaction with hydrochloric acid, which stretches the stomach and stimulates gastroesophageal refluxes (Bordin D.S. .). In the figure on the right: a schematic representation of the mechanism of action of Omez Insta (omeprazole/sodium bicarbonate) (O.A. Sablin, A.A. Ledovskaya).

Composition and dosage form of Omez Insta

Omez Insta is available in powder form for the preparation of a suspension for oral administration. One sachet of Omez Insta contains:

formally the only active ingredient is omeprazole - 20 mg
Excipients:
sodium bicarbonate - 1,680 mg
xylitol - 2 g
sucralose - 30 mg
sucrose - 2.7 g
xanthan gum - 55 mg
mint flavoring – 30 mg

Indications for use of Omez Insta

Omez Insta is indicated for the treatment and prevention of the following diseases and conditions and relief of the following symptoms:

heartburn and other symptoms characteristic of gastroesophageal reflux disease
non-erosive and erosive forms of GERD
eradication of Helicobacter pylori
in patients with gastric and/or duodenal ulcers (if necessary and strictly as part of combination therapy)
conditions and diseases of the gastrointestinal tract during therapy with non-steroidal anti-inflammatory drugs
conditions caused by acid hypersecretion: Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis.

Method of use of Omez Insta and dose

The contents of the Omez Insta sachet immediately before use (half an hour before meals) are poured into a vessel, one or two tablespoons of water are added, thoroughly stirred until a homogeneous suspension is obtained and immediately drunk.
It is acceptable to drink a small amount of water. Other liquids for dissolving Omez Insta are not allowed. Dosage and duration of use of Omez Insta:

for quick relief of heartburn - a single dose of Omez Insta packet
for non-erosive GERD - one sachet once a day for 4 weeks
for erosive GERD - one sachet twice a day for 4–8 weeks, depending on the severity of esophagitis
to prevent exacerbation of reflux esophagitis - one sachet once a day, the duration of maintenance therapy is determined individually
in case of exacerbation of a stomach or duodenal ulcer not associated with Helicobacter pylori
- one sachet in the morning once a day for 4-8 weeks
to eradicate Helicobacter pylori,
therapy is used in various combinations: for 7–14 days, omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - twice a day; or omeprazole 20 mg, clarithromycin 500 mg, metronidazole 500 mg - twice a day; or omeprazole 20 mg twice a day, bismuth preparations at a dose of 120 mg 4 times a day, metronidazole 500 mg three times a day and tetracycline 500 mg 4 times a day (see for more details Standards for the diagnosis and treatment of acid-dependent and associated with Helicobacter pylori diseases)
for the prevention of gastric or duodenal ulcers - one sachet in the morning once a day for 4-8 weeks
for the treatment of NSAID gastropathy - one sachet twice a day for 4-6 weeks, for prevention - one sachet per day for the period of NSAID use in patients with risk factors for the development of NSAID gastropathy
for hypersecretory conditions - one sachet in the morning once a day for 4–8 weeks
in the treatment of Zollinger-Ellison syndrome, doses are selected individually, depending on the clinical condition. The recommended starting dose is 3 sachets per day. In most patients, the condition is adequately controlled in the dosage range of one to six sachets. If it is necessary to use a dose of more than 4 sachets, it must be divided into two doses
in elderly patients and with renal failure there is no need to adjust the dose
in case of liver failure, a daily dose of one sachet per day may be sufficient.

pH-grams of the esophagus and stomach after taking Omez Insta

On pH-grams in the body of the stomach with a single dose of a Omez Insta packet, in most cases, an almost immediate increase in pH and the development of a plateau at the level of 4-5 pH units was recorded, and then a further increase in pH over 30-60 minutes to a level of 6.0 –6.5 pH units. The dynamics of intraesophageal pH after taking Omez Insta in most patients was characterized by the disappearance of episodes of pH acidification (Sablin O.A., Ledovskaya A.A.).

Daily pH gram of a patient with GERD before (A) and against the background (B) of a single dose of one Omez Insta sachet (marked with an arrow). Designations:

“Body of the stomach” - pH gram of the body of the stomach
“Esophagus 5 cm” - pH gram at a point in the esophagus located 5 cm above the lower esophageal sphincter
“Esophagus 20 cm” - pH gram at a point in the esophagus located 20 cm above the lower esophageal sphincter (Sablin O.A., Ledovskaya A.A.)

Daily pH-gram of the body of the stomach (upper graphs) and esophagus (lower graphs) of a patient with GERD after taking Omez Insta, pantoprazole and rabeprazole

(from the report of I.G. Pakhomova at the 18th International Medical Slavic-Baltic Scientific Forum “St. Petersburg–Gastro-2016”)

General information

Omez Insta is a prescription medicine
.

Instructions for medical use of the drug Omez Insta (powder for the preparation of suspension for oral administration, 20 mg), (pdf, ).

According to the pharmacological index, Omez Insta belongs to the group “Proton pump inhibitors”. For ATC - to the group “Proton pump inhibitors”, code “A02BC01 Omeprazole”. In the USA and some other countries (but not in Russia), Zegerid, which, like Omez Insta, contains omeprazole and sodium bicarbonate, is approved for use.

In Russia, three more drugs with similar names and similar (but not identical) pharmaceutical effects are approved for use:

“Omez” is “pure” omeprazole, which, unlike Omez Insta, does not contain sodium bicarbonate
"Omez D" and "Omez D" are combination drugs containing, in addition to omeprazole, the prokinetic drug domperidone

Manufacturer of Omeza Insta:
Dr. Reddy's Laboratories Ltd., India.

Materials for healthcare professionals regarding the use of Omez Insta in the treatment of the gastrointestinal tract

Articles and abstracts of reports

Yakovenko E.P., Ivanov A.N., Yakovenko A.V. and others. Proton pump inhibitors: new opportunities for individual selection of therapy in patients with gastroesophageal reflux disease // Attending physician. 2012. No. 6.
Sablin O.A. Ledovskaya A.A. New possibilities for antisecretory therapy of gastroesophageal reflux disease // Experimental and clinical gastroenterology. 2012. No. 6.
Sholomitskaya I.A., Kapralov N.V. Proton pump inhibitor “Omez Insta” in the treatment of acid-related diseases // Medical news. – 2012. – No. 10. pp. 73-76.
Sholomitskaya I.A., Kapralov N.V., Polyanskaya A.V. Efficacy of Omez insta, an immediate-release proton pump inhibitor // Sat. abstracts “XXXIX session “Multidisciplinary approach to gastroenterological problems”. 2013. March 5–6. P. 30.
Kapralov N.V., Sholomitskaya I.A., Polyanskaya A.V. Comparative effectiveness of acid-inhibiting agents in treatment. night acid breakthrough // Sat. abstracts “XXXIX session “Multidisciplinary approach to gastroenterological problems”. 2013. March 5–6. P. 30.
Bulgakov S.A. The phenomenon of nocturnal acid breakthrough during treatment with proton pump inhibitors and its therapeutic correction // Pharmateka. 2012. No. 13.
Simanenkov V.I., Zakharova N.V., Tikhonov S.V. and others. Efficacy and safety of an immediate-release proton pump inhibitor for gastroesophageal reflux disease: results of the INST-PERSPECTIVE study // Attending physician. 2014. No. 8. p. 8.

On the website GastroScan.ru in the “Literature” section there is a subsection “Omeprazole”, containing articles for healthcare professionals discussing the treatment of diseases of the gastrointestinal tract with omeprazole.

Video

Still from video Vovk E.I.
Medicines for the treatment of heartburn and diseases associated with hyperacidity. Clinical pharmacology On the website GastroScan.ru in the “Video” section there is a subsection for patients “Popular Gastroenterology” and subsections “For doctors” and “For medical students and residents”, containing video recordings of reports, lectures, webinars in various areas of gastroenterology for healthcare professionals and medical students.
Omez Insta has contraindications, side effects and application features. Consultation with a specialist is necessary. Back to section

special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because Treatment, masking symptoms, can delay the correct diagnosis.

Taking it with food does not affect its effectiveness.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Omez® Insta does not affect the ability to drive vehicles or operate machinery.

Due to the fact that dizziness and drowsiness may occur during therapy with Omez® Insta, caution should be exercised when driving vehicles and other mechanisms.