Omeprazole | Omez capsules of intestinal solution. 10 mg 10 pcs.
Special Price
$13.58
Regular Price
$22.00
In stock
SKU
BID474038
Description
opaque hard gelatine capsules size № «3», yellow body, light purple cap and black marking “OMEZ 10” on the cap and capsule body. The contents of the capsule are granules from almost white to light yellow.
opaque hard gelatine capsules size № «3», yellow body, light purple cap and black marking “OMEZ 10” on the cap and capsule body. The contents of the capsule are granules from almost white to light yellow.
Description
opaque hard gelatine capsules size № «3», yellow body, light purple cap and black marking “OMEZ 10” on the cap and capsule body. The contents of the capsule are granules from almost white to light yellow.
Packing
10 pcs
Pharmacological action
Pharmacodynamics
Mechanism of action
Omeprazole is a weak base. It is 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 process of 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 acid secretion
Omeprazole with daily oral administration provides fast and effective inhibition of daytime and nighttime hydrochloric acid secretion.
Maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcer, omeprazole at a dose of 20 mg causes a steady decrease in 24-hour gastric acidity by at least 80%. This achieves a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% within 24 hours.
In patients with a duodenal ulcer, does omeprazole 20 mg, with daily oral administration, maintain a pH value in the intragastric medium 3 on average for 17 hours a day.
Inhibition of hydrochloric acid secretion depends on the area under the pharmacokinetic curve “concentration-time” (AUC) of omeprazole, and not on the concentration of the drug in plasma at a given time.
Effect on Helicobacter pylori
Omeprazole has a bactericidal effect on Helicobacter pylori in vitro.
Eradication of Helicobacter pylori with omeprazole in combination with antibacterial agents is accompanied by a rapid elimination of symptoms, a high degree of healing of defects in the mucous membrane of the gastrointestinal tract and prolonged remission of peptic ulcer, which reduces the likelihood of complications such as bleeding, as effectively as continuous maintenance therapy.
Other effects associated with inhibition of hydrochloric acid secretion
In patients taking drugs that lower the secretion of the gastric glands for a long period of time, the formation of glandular cysts in the stomach of the cyst is benign and disappears on its own against the background of 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 lower the secretion of the glands of the stomach, 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 (see the section "Special Instructions").
Pharmacokinetics
Absorption
Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration (Cmax) of omeprazole in the blood plasma is reached after 0.5–1 hours. Bioavailability after a single oral administration is 30–40%, after constant administration once a day, bioavailability increases to 60%. Eating does not affect the bioavailability of omeprazole.
Distribution of
The binding index of omeprazole to plasma proteins is about 95%, the distribution volume is 0.3 l / kg.
Metabolism
A portion of omeprazole undergoes a presystemic hepatic metabolism involving the isoenzymes CYP2C19 and CYP3A4 to form inactive metabolites of sulfone, sulfide and hydroxy-omeprazole. Omeprazole, not included by parietal cells in the formation of active metabolites, is completely metabolized in the liver also with the participation of CYP2C19 and CYP3A4 isoenzymes.
The total plasma clearance is 0.3-0.6 l / min.
Excretion
The elimination half-life is about 40 minutes (30-90 minutes). About 80% is excreted as metabolites by the kidneys, and the rest by the intestines.
Special patient groups
No significant changes in the bioavailability of omeprazole in elderly patients or in patients with impaired renal function. In patients with impaired liver function, an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance are noted.
Indications
Adults
Peptic ulcer of the stomach and duodenum (including prevention of relapse).
Gastroesophageal reflux disease (GERD).
Hypersecretory states (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis).
Helicobacter pylori eradication in infected patients with peptic ulcer and duodenal ulcer (as part of combination therapy).
Prevention and treatment of damage to the mucous membrane of the stomach and duodenum due to the use of non-steroidal anti-inflammatory drugs (NSAIDs-gastropathy): dyspepsia, erosion of the mucous membrane, peptic ulcer.
Prevention of Mendelssohn syndrome (aspiration pneumonitis).
Children
Over the age of 2 years, weighing more than 20 kg: for the treatment of gastroesophageal reflux disease
over the age of 4 years, weighing more than 20 kg: for treating the duodenal ulcer caused by Helicobacter pylori.
Safety and effectiveness for other indications in pediatric patients not established.
Contraindications
Hypersensitivity to omeprazole, substituted benzimidazoles, or other components of the drug.
Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sucrose in the formulation).
Concomitant use with erlotinib, posaconazole, nelfinavir and atazanavir.
The use of omeprazole in children is contraindicated, except as indicated: gastroesophageal reflux disease for children older than 2 years and a duodenal ulcer caused by Helicobacter pylori for children older than 4 years (see section "Dosage and administration").
Before using the drug, it is necessary to consult a doctor in the following cases:
in the presence of a previously diagnosed stomach ulcer of a serious liver disease, accompanied by liver failure of renal failure of jaundice previous surgical intervention on the gastrointestinal tract
in the presence of “disturbing” symptoms: significant spontaneous weight loss body, repeated vomiting, vomiting with an admixture of blood, discoloration of feces (tarry stool - melena), violation of the pharynx
Ia with the appearance of new symptoms or modifying existing symptoms of the gastro-intestinal tract
while the use of one or more of the following drugs: clopidogrel, digoxin, ketoconazole, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, preparations of St. John's wort perforated (see the section "Interaction with other drugs").
Osteoporosis. Although a causal relationship with the use of omeprazole with fractures associated with osteoporosis has not been established, patients with a risk of developing osteoporosis or fractures against its background should be under appropriate clinical supervision.
Use during pregnancy and lactation
Research results have shown that there is no adverse effect 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 baby is unlikely.
Omeprazole is approved for use during pregnancy and during breastfeeding.
Composition
Each enteric-soluble capsule 10 mg contains: Active ingredient: omeprazole 10 mg.
Excipients: mannitol 59 mg, crospovidone 4.5 mg, poloxamer (407) 1.25 mg, hypromellose (1828) 2 mg, meglumine 0.75 mg.
Coating: povidone (K-30) 6.7 mg.
Enteric coating: methacrylic acid and ethyl acrylate copolymer [1: 1] (methacrylic acid copolymer [type C]) 18 mg, triethyl citrate 1.8 mg, magnesium stearate 1 mg.
Composition of gelatin hard capsules size No. 3:
Shell: yellow iron oxide dye (E172), titanium dioxide (E171), sodium lauryl sulfate, water, gelatin.
Cap: blue diamond dye (E133), sunset sunset dye yellow (E110), charming red dye (E129), phloxin B dye (red dye D&C RED # 28), titanium dioxide (E171), sodium lauryl sulfate, water, gelatin.
The inscription is black on capsules: S-1-8114 ink: shellac (20% esterified) in ethanol, black iron oxide dye (E172), n-butanol, propylene glycol (E1520), indigo carmine dye (E132), charming red dye ( E129), quinoline yellow dye (E104), diamond blue dye (E133) S-1-8115 ink: shellac (20% esterified) in ethanol, black iron dye (E172), ethanol, methanol, indigo carmine dye (E132), charming red dye (E129), quinoline yellow dye (E104), brilliant blue dye (E13 3).
Side effects
The frequency of adverse drug reactions is described in accordance with the following gradation: very often (> 1/10) often ( 1/100, < 1/10) infrequently ( 1/1000, <1/100) rarely ( 1/10000, <1/1000) very rarely (<1/10000, including isolated cases).
Disorders from the blood and lymphatic system: rarely - leukopenia, thrombocytopenia, hypochromic microcytic anemia in children is very rare - agranulocytosis, pancytopenia, eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.
metabolic and nutritional disorders: rare - hyponatremia frequency unknown - hypochromic microcytic anemia in children is very rare - agranulocytosis, pancytopenia, eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.
metabolic and nutritional disorders: rare - hyponatremia frequency unknown - hypochromic microcytic anemia in children is very rare - agranulocytosis, pancytopenia, eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.
metabolic and nutritional disorders: rare - hyponatremia frequency unknown -hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia.
Mental disorders: infrequently - insomnia is rare - increased irritability, depression, reversible confusion is very rare - aggression, hallucinations.
Disorders of the nervous system: often - headache infrequently - dizziness, paresthesia, drowsiness rarely - taste disturbance.
Violations of the organ of vision: rarely - blurred vision.
Hearing disorders and labyrinth disorders: infrequently - hearing impairment, vertigo.
Disorders of the respiratory system, chest and mediastinal organs: rarely - bronchospasm.
Disorders of the gastrointestinal tract: 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 prolonged treatment while using it with clarithromycin (due to inhibition of hydrochloric acid secretion, is benign, reversible).
Disorders from 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 in the form of reddening of the skin after UV, multiforme exudative erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Disorders of the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, bones of the wrist, femoral head associated with osteoporosis (see section "Special Instructions") rarely - arthralgia, myalgia, muscle weakness.
Disorders of the kidneys and urinary tract: rarely - interstitial nephritis.
Disorders from the genitals and mammary gland: rarely - gynecomastia.
General disorders: infrequently - malaise rarely - increased sweating, peripheral edema.
In case of side effects not listed in these instructions, you should immediately consult a doctor.
Drug Interaction
Slows down the elimination of warfarin, diazepam, phenytoin.
Overdose
Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.
Treatment: symptomatic. Hemodialysis is not effective enough.
Storage conditions
At a temperature not exceeding 25 РC.
Keep out of the reach of children!
Shelf suitability
3 Year
Deystvuyuschee
substance omeprazole
Pharmacy
Prescription
dosage form
dosage form
capsules
opaque hard gelatine capsules size № «3», yellow body, light purple cap and black marking “OMEZ 10” on the cap and capsule body. The contents of the capsule are granules from almost white to light yellow.
Packing
10 pcs
Pharmacological action
Pharmacodynamics
Mechanism of action
Omeprazole is a weak base. It is 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 process of 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 acid secretion
Omeprazole with daily oral administration provides fast and effective inhibition of daytime and nighttime hydrochloric acid secretion.
Maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcer, omeprazole at a dose of 20 mg causes a steady decrease in 24-hour gastric acidity by at least 80%. This achieves a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% within 24 hours.
In patients with a duodenal ulcer, does omeprazole 20 mg, with daily oral administration, maintain a pH value in the intragastric medium 3 on average for 17 hours a day.
Inhibition of hydrochloric acid secretion depends on the area under the pharmacokinetic curve “concentration-time” (AUC) of omeprazole, and not on the concentration of the drug in plasma at a given time.
Effect on Helicobacter pylori
Omeprazole has a bactericidal effect on Helicobacter pylori in vitro.
Eradication of Helicobacter pylori with omeprazole in combination with antibacterial agents is accompanied by a rapid elimination of symptoms, a high degree of healing of defects in the mucous membrane of the gastrointestinal tract and prolonged remission of peptic ulcer, which reduces the likelihood of complications such as bleeding, as effectively as continuous maintenance therapy.
Other effects associated with inhibition of hydrochloric acid secretion
In patients taking drugs that lower the secretion of the gastric glands for a long period of time, the formation of glandular cysts in the stomach of the cyst is benign and disappears on its own against the background of 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 lower the secretion of the glands of the stomach, 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 (see the section "Special Instructions").
Pharmacokinetics
Absorption
Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration (Cmax) of omeprazole in the blood plasma is reached after 0.5–1 hours. Bioavailability after a single oral administration is 30–40%, after constant administration once a day, bioavailability increases to 60%. Eating does not affect the bioavailability of omeprazole.
Distribution of
The binding index of omeprazole to plasma proteins is about 95%, the distribution volume is 0.3 l / kg.
Metabolism
A portion of omeprazole undergoes a presystemic hepatic metabolism involving the isoenzymes CYP2C19 and CYP3A4 to form inactive metabolites of sulfone, sulfide and hydroxy-omeprazole. Omeprazole, not included by parietal cells in the formation of active metabolites, is completely metabolized in the liver also with the participation of CYP2C19 and CYP3A4 isoenzymes.
The total plasma clearance is 0.3-0.6 l / min.
Excretion
The elimination half-life is about 40 minutes (30-90 minutes). About 80% is excreted as metabolites by the kidneys, and the rest by the intestines.
Special patient groups
No significant changes in the bioavailability of omeprazole in elderly patients or in patients with impaired renal function. In patients with impaired liver function, an increase in the bioavailability of omeprazole and a significant decrease in plasma clearance are noted.
Indications
Adults
Peptic ulcer of the stomach and duodenum (including prevention of relapse).
Gastroesophageal reflux disease (GERD).
Hypersecretory states (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis).
Helicobacter pylori eradication in infected patients with peptic ulcer and duodenal ulcer (as part of combination therapy).
Prevention and treatment of damage to the mucous membrane of the stomach and duodenum due to the use of non-steroidal anti-inflammatory drugs (NSAIDs-gastropathy): dyspepsia, erosion of the mucous membrane, peptic ulcer.
Prevention of Mendelssohn syndrome (aspiration pneumonitis).
Children
Over the age of 2 years, weighing more than 20 kg: for the treatment of gastroesophageal reflux disease
over the age of 4 years, weighing more than 20 kg: for treating the duodenal ulcer caused by Helicobacter pylori.
Safety and effectiveness for other indications in pediatric patients not established.
Contraindications
Hypersensitivity to omeprazole, substituted benzimidazoles, or other components of the drug.
Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption (due to the presence of sucrose in the formulation).
Concomitant use with erlotinib, posaconazole, nelfinavir and atazanavir.
The use of omeprazole in children is contraindicated, except as indicated: gastroesophageal reflux disease for children older than 2 years and a duodenal ulcer caused by Helicobacter pylori for children older than 4 years (see section "Dosage and administration").
Before using the drug, it is necessary to consult a doctor in the following cases:
in the presence of a previously diagnosed stomach ulcer of a serious liver disease, accompanied by liver failure of renal failure of jaundice previous surgical intervention on the gastrointestinal tract
in the presence of “disturbing” symptoms: significant spontaneous weight loss body, repeated vomiting, vomiting with an admixture of blood, discoloration of feces (tarry stool - melena), violation of the pharynx
Ia with the appearance of new symptoms or modifying existing symptoms of the gastro-intestinal tract
while the use of one or more of the following drugs: clopidogrel, digoxin, ketoconazole, itraconazole, warfarin, cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, preparations of St. John's wort perforated (see the section "Interaction with other drugs").
Osteoporosis. Although a causal relationship with the use of omeprazole with fractures associated with osteoporosis has not been established, patients with a risk of developing osteoporosis or fractures against its background should be under appropriate clinical supervision.
Use during pregnancy and lactation
Research results have shown that there is no adverse effect 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 baby is unlikely.
Omeprazole is approved for use during pregnancy and during breastfeeding.
Composition
Each enteric-soluble capsule 10 mg contains: Active ingredient: omeprazole 10 mg.
Excipients: mannitol 59 mg, crospovidone 4.5 mg, poloxamer (407) 1.25 mg, hypromellose (1828) 2 mg, meglumine 0.75 mg.
Coating: povidone (K-30) 6.7 mg.
Enteric coating: methacrylic acid and ethyl acrylate copolymer [1: 1] (methacrylic acid copolymer [type C]) 18 mg, triethyl citrate 1.8 mg, magnesium stearate 1 mg.
Composition of gelatin hard capsules size No. 3:
Shell: yellow iron oxide dye (E172), titanium dioxide (E171), sodium lauryl sulfate, water, gelatin.
Cap: blue diamond dye (E133), sunset sunset dye yellow (E110), charming red dye (E129), phloxin B dye (red dye D&C RED # 28), titanium dioxide (E171), sodium lauryl sulfate, water, gelatin.
The inscription is black on capsules: S-1-8114 ink: shellac (20% esterified) in ethanol, black iron oxide dye (E172), n-butanol, propylene glycol (E1520), indigo carmine dye (E132), charming red dye ( E129), quinoline yellow dye (E104), diamond blue dye (E133) S-1-8115 ink: shellac (20% esterified) in ethanol, black iron dye (E172), ethanol, methanol, indigo carmine dye (E132), charming red dye (E129), quinoline yellow dye (E104), brilliant blue dye (E13 3).
Side effects
The frequency of adverse drug reactions is described in accordance with the following gradation: very often (> 1/10) often ( 1/100, < 1/10) infrequently ( 1/1000, <1/100) rarely ( 1/10000, <1/1000) very rarely (<1/10000, including isolated cases).
Disorders from the blood and lymphatic system: rarely - leukopenia, thrombocytopenia, hypochromic microcytic anemia in children is very rare - agranulocytosis, pancytopenia, eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.
metabolic and nutritional disorders: rare - hyponatremia frequency unknown - hypochromic microcytic anemia in children is very rare - agranulocytosis, pancytopenia, eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.
metabolic and nutritional disorders: rare - hyponatremia frequency unknown - hypochromic microcytic anemia in children is very rare - agranulocytosis, pancytopenia, eosinophilia.
Immune system disorders: rarely - hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock.
metabolic and nutritional disorders: rare - hyponatremia frequency unknown -hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia.
Mental disorders: infrequently - insomnia is rare - increased irritability, depression, reversible confusion is very rare - aggression, hallucinations.
Disorders of the nervous system: often - headache infrequently - dizziness, paresthesia, drowsiness rarely - taste disturbance.
Violations of the organ of vision: rarely - blurred vision.
Hearing disorders and labyrinth disorders: infrequently - hearing impairment, vertigo.
Disorders of the respiratory system, chest and mediastinal organs: rarely - bronchospasm.
Disorders of the gastrointestinal tract: 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 prolonged treatment while using it with clarithromycin (due to inhibition of hydrochloric acid secretion, is benign, reversible).
Disorders from 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 in the form of reddening of the skin after UV, multiforme exudative erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome.
Disorders of the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, bones of the wrist, femoral head associated with osteoporosis (see section "Special Instructions") rarely - arthralgia, myalgia, muscle weakness.
Disorders of the kidneys and urinary tract: rarely - interstitial nephritis.
Disorders from the genitals and mammary gland: rarely - gynecomastia.
General disorders: infrequently - malaise rarely - increased sweating, peripheral edema.
In case of side effects not listed in these instructions, you should immediately consult a doctor.
Drug Interaction
Slows down the elimination of warfarin, diazepam, phenytoin.
Overdose
Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.
Treatment: symptomatic. Hemodialysis is not effective enough.
Storage conditions
At a temperature not exceeding 25 РC.
Keep out of the reach of children!
Shelf suitability
3 Year
Deystvuyuschee
substance omeprazole
Pharmacy
Prescription
dosage form
dosage form
capsules
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