Omez Insta, 20 mg, powder for the preparation of suspension for oral administration, 5.885 g, 5 pcs.: instructions for use, reviews and analogues, prices in pharmacies. Buy and deliver to the nearest pharmacy or home in

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.

Content

Characteristics of omez insta (pak.por.d/prig suspension 20mg 5.885g No. 5 (mint))

Composition: Active substance: omeprazole 20 mg.

Pharmacological action: 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.

In patients with duodenal ulcer, 20 mg omeprazole maintains intragastric pH above 3 for 17 hours.

Pharmacokinetics.

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

The half-life is about 0.5-1 hour.

(for liver failure - 3 hours.

); total plasma clearance is from 0.3 to 0.6 l/min.

There is no change in the half-life during treatment.

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 the CYP2C19 isoenzyme.

Excretion by the kidneys (70-80%) and bile (20-30%).

In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.

In elderly patients, excretion decreases and bioavailability increases.

Indications for Use: 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).

Directions for Use: Orally, 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.

For patients with non-erosive GERD - 20 mg 1 time / day.

within 4 weeks.

For patients with an erosive form of GERD (reflux esophagitis) - 20 mg 2 times a day.

for 4-8 weeks, depending on the severity of esophagitis.

To prevent exacerbation of reflux esophagitis - 20 mg/day.

, the duration of maintenance therapy is determined individually.

In case of exacerbation of gastric or duodenal ulcer not associated with Helicobacter pylori - 20 mg in the morning 1 time per day.

within 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.

For the prevention of gastric or duodenal ulcers - 20 mg in the morning 1 time per day.

within 4-8 weeks.

For the treatment of NSAID gastropathy - 20 mg 2 times a day.

for 4-6 weeks, for prevention - 20 mg/day.

for the period of use of NSAIDs in patients with risk factors for the development of NSAID gastropathy.

For hypersecretory conditions - 20 mg in the morning 1 time / day.

within 4-8 weeks.

When treating Zollinger-Ellison syndrome, doses are selected individually, depending on the clinical condition.

The recommended starting dose is 60 mg per 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, it must be divided into 2 administrations.

In elderly patients and with renal failure, there is no need to adjust the dose.

For liver failure, a daily dose of 20 mg may be sufficient.

Interaction: Due to a decrease in the acidity of gastric juice during treatment with omeprazole, the absorption of other drugs may be reduced or increased.

drugs (drugs), the mechanism of absorption of which depends on the pH of gastric juice.

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 the CYP2C19 isoenzyme is also possible.

With the combined use of omeprazole and antiretroviral drugs, such as atazanavir and nelfinavir, during therapy with omeprazole, a decrease in their serum concentrations is observed.

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.

Medicines in which the CYP2C19 isoenzyme is involved in the metabolism, such as diazepam, phenytoin, warfarin, etc.

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 1 time per day did not cause changes in the concentration of phenytoin in the blood plasma.

When using omeprazole in patients receiving warfarin or others.

vitamin K antagonists, monitoring of the international normalized ratio (INR) is necessary; in some cases, it may be necessary to reduce the dose of warfarin or other drugs.

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 once a 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 area under the concentration-time curve (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 that are metabolized by the CYP3A4 isoenzyme, 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.

The isoenzymes CYP2C19 and CYP3A4 are involved in the metabolism of omeprazole.

The combined use of omeprazole and inhibitors of the CYP2C19 and CYP3A4 isoenzymes, such as clarithromycin and voriconazole, may lead to increased plasma concentrations of omeprazole by slowing down 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 the isoenzymes 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.

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

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).

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 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.

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, 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.

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.