Detailed instructions for use are published on this page Omeprazole... The available dosage forms of the drug (capsules or tablets 10 mg, 20 mg, 40 mg), as well as its analogues are listed. Information is provided on the side effects that Omeprazole can cause, on interactions with other medicines. In addition to information about the diseases for the treatment and prevention of which a drug is prescribed (gastritis, ulcer), the intake algorithms, possible dosages for adults, in children are detailed, the possibility of use during pregnancy and lactation is being clarified. Annotation to Omeprazole is supplemented with reviews of patients and doctors.

Instructions for use and dosage regimen

Individual. When taken orally, a single dose is 20-40 mg. The daily dose is 20-80 mg; the frequency of use is 1-2 times a day. The duration of treatment is 2-8 weeks.

Inside, with a small amount of water (the contents of the capsule cannot be chewed).

Duodenal ulcer in the acute phase - 1 capsule (20 mg) per day for 2-4 weeks (in resistant cases - up to 2 capsules per day).

Peptic ulcer in the acute phase and erosive-ulcerative esophagitis - 1-2 capsules per day for 4-8 weeks.

Erosive and ulcerative lesions of the gastrointestinal tract caused by the intake of non-steroidal anti-inflammatory drugs (NSAIDs) - 1 capsule per day for 4-8 weeks.

Eradication of Helicobacter pylori (Helicobacter) - 1 capsule 2 times a day for 7 days in combination with antibacterial agents.

Anti-relapse treatment of gastric ulcer and duodenal ulcer - 1 capsule per day.

Anti-relapse treatment of reflux esophagitis - 1 capsule per day for a long time (up to 6 months).

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

Release forms

Capsules, soluble in the intestine, 10 mg, 20 mg and 40 mg (sometimes mistakenly called tablets).

Omeprazole - proton pump inhibitor. Reduces acid production - inhibits the activity of H / K-ATP-ase in parietal cells of the stomach and thereby blocks the final stage of secretion of hydrochloric acid.

Reduces basal and stimulated secretion regardless of the nature of the stimulus. The antisecretory effect after taking 20 mg occurs within the first hour, maximum - after 2 hours. Inhibition of 50% of the maximum secretion lasts 24 hours.

A single dose per day provides a quick and effective suppression of day and night gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after the end of the intake. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH \u003d 3 for 17 hours.

Pharmacokinetics

Absorption is high. Almost completely metabolized in the liver with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, and others), pharmacologically inactive. Excretion by the kidneys (70-80%) and with bile (20-30%).

Indications

• peptic ulcer of the stomach and duodenum (including prevention of relapse);
• reflux esophagitis;
• hypersecretory states (Zollinger-Ellison syndrome, stress gastrointestinal ulcers, polyendocrine adenomatosis, systemic mastocytosis);
• NSAID gastropathy;
• eradication of Helicobacter pylori in infected patients with gastric ulcer and duodenal ulcer (as part of combination therapy).

Contraindications

• chronic liver disease (including history);
• hypersensitivity to omeprazole.

special instructions

Before starting therapy, it is necessary to exclude the possibility of a malignant process (especially with a stomach ulcer), because omeprazole treatment can mask symptoms and delay correct diagnosis.

Against the background of the use of omeprazole, it is possible to distort the results of laboratory tests of liver function and indicators of the concentration of gastrin in the blood plasma.

Side effect

• nausea;
• diarrhea, constipation;
• stomach ache;
• flatulence;
• headache;
• dizziness;
• weakness;
• anemia, eosinopenia, neutropenia, thrombocytopenia;
• hematuria, proteinuria;
• arthralgia;
• muscle weakness;
• myalgia;
• skin rash.

Drug interactions

When applied simultaneously with atracurium besylate, the effects of atracurium besylate are prolonged.

With simultaneous use with bismuth, tripotassium dicitrate, an undesirable increase in the absorption of bismuth is possible.

With simultaneous use with digoxin, a slight increase in the concentration of omeprazole in the blood plasma is possible.

With simultaneous use with disulfiram, a case of impaired consciousness and catatonia has been described; with indinavir - a decrease in the concentration of indinavir in blood plasma is possible; with ketoconazole - a decrease in the absorption of ketoconazole.

With prolonged simultaneous use with clarithromycin, there is an increase in the concentrations of omeprazole and clarithromycin in the blood plasma.

Cases of a decrease in the excretion of methotrexate from the body in patients receiving omeprazole have been described.

With simultaneous use with theophylline, a slight increase in the clearance of theophylline is possible.

It is believed that with the simultaneous use of omeprazole in high doses and phenytoin, an increase in the concentration of phenytoin in blood plasma is possible.

Cases of an increase in the concentration of cyclosporine in the blood plasma have been described with simultaneous use with cyclosporine.

With simultaneous use with erythromycin, a case of an increase in the concentration of omeprazole in the blood plasma is described, while the effectiveness of omeprazole decreased.

Analogs of the drug Omeprazole

Structural analogues for the active substance:

• Vero Omeprazole;
• Gastrozole;
• Demeprazole;
• Zhelkizole;
• Zerocide;
• Zolser;
• Chrismel;
• Losek;
• Losek MAPS;
• Omez;
• Omez Insta;
• Omezole;
• Omecaps;
• Omeprazole Sandoz;
• Omeprazole Akos;
• Omeprazole Acri;
• Omeprazole Richter;
• Omeprazole FPO;
• Omeprus;
• Omefez;
• Omizak;
• Omipix;
• Omitox;
• Ortanol;
• Ocid;
• Pepticum;
• Pleom-20;
• Promez;
• Romesec;
• Ulsol;
• Ulkozol;
• Ultop;
• Helicide;
• Helol;
• Cisagast.

Application in children

Due to the lack of experience in clinical use, Omeprazole is not recommended for use in children.

Application during pregnancy and lactation

Due to the lack of clinical experience, omeprazole is not recommended for use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Teva Pharma, S.L.U. (Spain)

pharmachologic effect

Pharmacodynamics.

It inhibits the activity of H + / K + -ATPase in the parietal cells of the stomach and thereby blocks the final stage of the secretion of hydrochloric acid.

The effect of omelrazole on the last stage of the hydrochloric acid formation process is dose-dependent and provides effective inhibition of basal and stimulated secretion, regardless of the nature of the stimulating factor.

When taken daily, omeprazole provides rapid and effective inhibition of the day and night secretion of hydrochloric acid.

The maximum effect is achieved within 4 days.

In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric acidity at a pH of more than 3 for 17 hours.

The action of omeprazole together with antibacterial drugs leads to the eradication of Helicobacter pylori, which allows you to quickly stop the symptoms of the disease, achieve a high degree of healing of the damaged mucous membrane and a stable long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract<ЖКТ), а также исчезает необходимость проведения длительной противоязвенной терапии.

Pharmacokinetics.

Absorption and distribution.

After taking the drug inside, omeprazole is rapidly absorbed from the small intestine, the maximum concentration in the blood plasma is reached after 0.5-3.5 hours.

Bioavailability is 30-40%, with liver failure - 100%.

Plasma protein binding (albumin and acid alpha1-glycoprotein) is about 90%.

Metabolism and excretion.

Omeprazole is almost completely metabolized in the liver with the participation of the CYP2C19 enzyme system with the formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.).

It is an inhibitor of the isoenzyme CYP2C19.

The half-life is 0.5-1 hours, with hepatic failure - 3 hours.

Clearance 300-600 ml / min.

It is excreted by the kidneys (70-80%) and through the intestines (20-30%) in the form of metabolites.

Pharmacokinetics in special clinical situations.

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

In the elderly, the excretion of omeprazole decreases, bioavailability increases.

Side effect

On the part of the blood and lymphatic system:

• rarely - hypochromic microcytic anemia in children;
• very rarely - reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.

From the immune system:

• very rarely - rash,
• increase in body temperature,
• angioedema,
• narrowing of the broncho,
• allergic vasculi,
• fever
• anaphylactic shock.

From the nervous system:

• often - headache, dizziness, insomnia, drowsiness, lethargy (the listed side effects tend to worsen with prolonged therapy); rarely - paresthesias, confusion, hallucinations, especially in elderly patients or in severe disease;
• very rarely - anxiety, depression, especially in elderly patients or with a severe course of the disease.

On the part of the organ of vision:

• infrequently - visual impairment,
• incl. reduction of fields of vision,
• decreased acuity and clarity of visual perception (usually disappear after discontinuation of therapy).

From the side of the organ of hearing and labyrinth disorders:

• infrequently - impaired auditory perception,
• incl. "Ringing in the ears" (usually disappears after stopping therapy).

From the gastrointestinal tract:

• often - nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with continued therapy); infrequently - taste perversion (usually disappears after stopping therapy); rarely - a change in the color of the tongue to brown-black and the appearance of benign cysts of the salivary glands with simultaneous use with clarithromycin (the phenomena are reversible after discontinuation of therapy); very rarely - dry mouth, stomatitis, candidiasis, pancreatitis.

From the liver and biliary tract:

• infrequently - changes in indicators of the activity of "liver" enzymes (reversible); very rarely - hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver disease.

On the part of the skin and subcutaneous tissues:

• infrequently - rash, pruritus, alopecia, erythema multiforme, photosensitivity, increased sweating;
• very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the musculoskeletal and connective tissue:

• infrequently - fractures of the vertebrae, wrist bones, femoral head;
• rarely - myalgia, arthralgia;
• very rarely - muscle weakness.

From the kidneys and urinary tract:

• rarely - interstitial nephritis.

General disorders and disorders at the injection site:

• infrequently - peripheral edema (usually disappears after stopping therapy); rarely, hyponatremia;
• very rarely - hypomagnesemia, gynecomastia.

Indications for use

Peptic ulcer of the stomach and duodenum, incl. relapse prevention; gastroesophageal reflux disease (GERD), reflux esophagitis, incl. relapse prevention; erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs); erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy); Zollinger-Ellison syndrome and other pathological conditions associated with increased gastric secretion.

Contraindications

Hypersensitivity to omeprazole or any component of the drug; intolerance to fructose; deficiency of sucrase / isomaltase; glucose-galactose malabsorption; simultaneous use with clarithromycin in patients with hepatic impairment, atazanavir, St. John's wort; period of breastfeeding; age up to 18 years.

Method of administration and dosage

Inside, in the morning before meals or during meals, with a little water; the contents of the capsule must not be chewed.

Adults.

With exacerbation of gastric ulcer, duodenal ulcer and reflux esophagitis.

20 mg once a day.

The course of treatment is 4-8 weeks.

In some cases, it is possible to increase the dose to 40 mg per day.

With maintenance therapy for GERD to prevent relapse.

At 10-20 mg for 26-52 weeks, depending on the clinical effect, with severe esophagitis - for life.

In the treatment of erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs (including for the prevention of relapse).

10-20 mg per day.

With Zollinger-Ellison syndrome.

The dose is set individually.

If necessary, the dose is increased to 80-120 mg per day, in which case it should be divided into two doses.

Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori.

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

In patients with gastric ulcer and / or duodenal ulcer in the acute stage, it is possible to prolong monotherapy with omeprazole.

In elderly patients, dose adjustment is not required.

In patients with insufficient night function, dose adjustment is not required.

In patients with liver failure, the maximum daily dose is 20 mg.

If you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorption of the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension within 30 minutes.

Overdose

Symptoms:

• visual impairment
• drowsiness
• excitement,
• confusion of consciousness
• headache,
• increased sweating,
• dry mouth
• nausea
• arrhythmia.

Treatment:

• carrying out symptomatic therapy,
• hemodialysis is not effective enough.

No specific antidote is known.

Interaction

With simultaneous use with omeprazole, the absorption of ketoconazole may decrease.

With simultaneous use with omeprazole, the bioavailability of digoxin increases by 10% due to an increase in pH.

Omeprazole may reduce the absorption of vitamin B12 with prolonged use.

Omeprazole should not be used simultaneously with St. John's wort preparations due to the pronounced clinically significant interaction.

With the simultaneous use of omeprazole and clarithromycin, their plasma concentrations increase.

When used simultaneously with omeprazole, the area under the concentration-time curve of atazanavir decreases by 75%, therefore their simultaneous use is contraindicated.

With simultaneous use with omeprazole, it is possible to slow down the elimination of warfarin, diazspam and phenytoin, as well as iminramine, clomipramine, citalopram, hexabarbital, disulfiram, since omeprazole is biotransformed in the liver with the participation of the isoenzyme CYP2C19.

Dose reduction of these drugs may be required.

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

special instructions

Carefully.

Lack of liver function; failure of kidney function; pregnancy; simultaneous use with clarithromycin.

Application during pregnancy and during breastfeeding.

The use of the drug during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus.

If necessary, use of the drug during lactation should stop breastfeeding.

Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, because taking the drug can mask the symptoms and delay the correct diagnosis. A decrease in gastric acidity, including when using proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections.

In patients with severe liver failure, it is necessary to regularly monitor the parameters of "liver" enzymes during drug therapy.

The drug contains sucrose and therefore is contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrase / isomaltase deficiency, glucose-galactose malabsorption).

When treating erosive and ulcerative lesions associated with taking NSAIDs, you should carefully consider the possibility of limiting or discontinuing NSAIDs to increase the effectiveness of antiulcer therapy.

The drug contains sodium, which should be taken into account in patients on a controlled sodium diet.

The risk versus benefit ratio of long-term (more than 1 year) maintenance drug therapy should be regularly assessed.

There is evidence of an increased risk of fractures of the vertebrae, wrist bones, and femoral head mainly in elderly patients, as well as in the presence of predisposing factors.

Patients at risk of developing osteoporosis should be provided with adequate intake of vitamin D and calcium. There are reports of severe hypomagnesemia in patients receiving proton pump inhibitor therapy, including omeprazole, for more than 1 year.

Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce plasma magnesium levels (diuretics), require regular monitoring of magnesium levels.

Influence on the ability to drive vehicles and work with equipment.

Given the possibility of undesirable effects on the part of the central nervous system and the organ of vision, during the period of treatment with omeprazole, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Omeprazole is a popular drug from the group of organotropic gastrointestinal agents used in the treatment of inflammatory and destructive diseases of the digestive system. It has an active inhibitory effect on the production of hydrochloric acid in the terminal stage of its synthesis. Omeprazole is included in the standard treatment regimen for peptic ulcer disease.

Pharmacological group: Included in the group of proton pump inhibitors.

Composition of the drug, release form, price

• Basic substance: Omeprazole
• Excipients: Glycerin, nipagin, gelatin, nipazole, sodium lauryl sulfate, titanium dioxide, purified water, E 129 (dye).

Omeprazole is available in opaque hard capsules of 10, 20, 40 mg, consisting of 2 parts: one part is red and the other is white. The contents of the capsules are white or light beige spherical pellets.

10 capsules in a blister contour packaging, 1, 2, 3 packs in a cardboard box. Also available in polymer cans.

• 10 mg No. 28: 65-82 rubles;
• 20 mg No. 10: 29-30 rubles;
• 20 mg No. 20: 41-42 rubles;
• 40 mg No. 28: 131-154 rubles.

pharmachologic effect

Omeprazole is a drug with an active antiulcer effect that inhibits the enzyme H + / K + -adenosine triphosphate (ATP) -phase.

The action of omeprazole is associated with inhibition of the activity of this enzyme, another name for which is the proton pump. Deactivation of the enzyme occurs in the parietal cells of the stomach: the transfer of hydrogen ions necessary for the terminal stage of the synthesis of hydrochloric acid is blocked.

Omeprazole is a prodrug, i.e. acts as an active metabolite. Under the action of the acidic environment of the tubules of gastric parietal cells, omeprazole within 2-4 minutes is biotransformed into sulfenamide, which enters into the reaction of blocking the membrane H + / K + - adenosine triphosphate (ATP) -phase, connecting with the enzyme through a disulfide bridge.

This mechanism of action explains the high selectivity of the drug in relation to parietal cells - they contain the environment necessary for the conversion of omeprazole into an active metabolite. In this case, sulfenamide is not absorbed, since it is a cation.

• Omeprazole has a suppressive effect on the secretion of both basal and hydrochloric acid stimulated by a food irritant.
• Inhibits the production of pepsin and reduces the total volume of gastric secretion.
• In addition, omeprazole has gastroprotective activity of an unclear mechanism.

Does not affect the formation of Castle's internal factor and the speed of passage of the food mass through the stomach into the duodenum; does not act on histamine and acetylcholine receptors.

Microgranules in capsules are covered with a thin shell, the gradual release of which leads to:

• by the beginning of the drug's action approximately 60 minutes after ingestion
• reaching a therapeutic maximum after 120 minutes
• the effect of omeprazole lasts for a day or more
• inhibition of half of the maximum gastric secretion while taking 20 mg of omeprazole continues during the day.

Thus, a single dose of omeprazole during the day quickly and effectively inhibits the daytime and nighttime secretion of hydrochloric acid. The inhibitory effect becomes maximum after 4 days from the start of treatment. In patients with ulcerative lesions of the gastrointestinal mucosa, taking 20 mg of omeprazole leads to the maintenance of pH \u003d 3 inside the stomach for 17 hours. Stopping the intake of omeprazole leads to the restoration of the secretory activity of the stomach after 3-5 days.

Pharmacokinetics

Possesses high absorption. Bioavailability reaches 30-40%, increases in the elderly, and in case of liver failure it reaches 100%. The drug has a high lipophilicity, as a result of which it easily enters the parietal cells. Binds to plasma proteins (albumin and acid alpha1-glycoprotein) up to 90-95%.

The half-life is about 0.5-1 hours, increases to 3 hours with liver failure. Clearance - 500-600 ml / min. It is metabolized in the liver in almost complete volume, forming 6 inactive metabolites. Inhibits the isoenzyme CYP2C19. About 70-80% of the drug is excreted by the kidneys, and 20-30% - by bile.

Chronic renal failure, old age leads to a decrease in the rate of excretion of omeprazole in proportion to a decrease in the rate of creatine clearance.

Indications for the use of Omeprazole

• Gastropathy during treatment with NSAIDs;
• Peptic ulcer and duodenal ulcer, including caused by Helicobacter pylori. It is prescribed as anti-relapse treatment and in the exacerbation phase.
• Reflux esophagitis, including an erosive form.
• Conditions occurring with hypersecretion of gastric juice:
  • polyendocrine adenomatosis;
  • zollinger-Ellison syndrome;
  • ulcers of the gastrointestinal tract against a background of stress;
  • systemic mastocytosis.

Contraindications

It is prescribed with caution in a group of patients with renal or hepatic insufficiency. The instructions for the use of omeprazole indicate the absolute contraindications to treatment:

• Pregnancy;
• Lactation;
• Childhood;
• Hypersensitivity.

Application, dosage

The capsules are intended for oral administration as a whole. Usually they are taken in the morning before meals, without chewing and drinking water. Omeprazole can be taken with food.

Exacerbation of peptic ulcer and 12-bowel disease, gastropathy with NSAIDs, reflux esophagitis

• omeprazole 20 mg once a day.
• severe reflux esophagitis: 40 mg of omeprazole once a day.

A course of treatment:

• : 2-4 weeks, can be extended to 4-5 weeks;
• Peptic ulcer, reflux esophagitis, gastrointestinal lesions during NSAID therapy: 4-8 weeks.

Patients not sensitive to other antiulcer drugs

• 40 mg of omeprazole per day. The course of treatment for ulcerative lesions of the duodenum is 4 weeks,
• Peptic ulcer and reflux esophagitis - 8 weeks.

The use of omeprazole for the treatment of patients with liver failure:

The dose is reduced to 10-20 mg of the drug once a day. In severe forms, the daily dose should not exceed 20 mg.
No dose adjustment is required in patients with renal disease and in the elderly.

Other

• Zollinger-Elysson syndrome: 60 mg daily, an increase in the dose to 80-120 mg is permissible (in this case, it is divided into 2 doses).
• Prevention of exacerbations of peptic ulcer: 10 mg once a day.
• Eradication of the Helicobacter pylori bacteria: 20 mg of omeprazole 2 times a day (with parallel etiotropic therapy).

Side effect

• Digestive organs: abdominal pain, diarrhea or constipation, nausea and vomiting, flatulence. Rarely, the activation of liver enzymes increases, taste perversion, stomatitis, dry mouth mucous membranes appear. Patients with severe liver pathologies may develop hepatitis.
• Nervous system: With concomitant somatic diseases in severe form, dizziness, headaches, depressive conditions, agitation occur. In patients with severe liver pathologies, encephalopathy is possible.
• Musculoskeletal system: rarely develop myasthenia gravis, arthralgia, myalgia.
• Hematopoietic system: rarely - leukopenia, agranulocytosis, thrombocytopenia, pancytopepia.
• Skin: in rare cases - itchy skin or rash, photosensitivity, exudative erythema multiforme, alopecia.
• Allergic reactions: angioedema, urticaria, fever, bronchospasm, anaphylactic shock.
• Other: rarely possible visual impairment, malaise, increased sweating, gynecomastia, the formation of benign gastric glandular cysts of a reversible nature with prolonged treatment.

Drug interactions

• Reduces the absorption of iron salts, ampicillin esters, itraconazole and ketoconazole.
• May increase the concentration in the blood of the following drugs: diazepam, anticoagulants with indirect action, phenytoin, clarithromycin. These groups of drugs are metabolized in the liver by the cytochrome CYP2C19 enzyme, which is inhibited by omeprazole.

special instructions

Before use, gastrointestinal oncopathology is necessarily excluded, since omeprazole can erase the symptoms and thus delay the correct diagnosis.

Overdose

There is confusion, blurred vision, sensation, nausea, arrhythmia, tachycardia, headache. There is no specific antidote, the treatment is symptomatic.

Omeprazole - analogues:

Omeprazole analogs - losek, omez, chelicide, zerocid, romesec, gastrozole, bioprazole, demeprazole, lomac, crismel, zolser, omegast, omezol, zerocid, omitox, omepar, zhelkizol, peptikum, omipix, promez, peptikum, rice, romsek , ultop, cisagast, chelol, orthanol.

Other proton pump inhibitor drugs include:

• Medicines based on pantoprazole - sanpraz, nolpaza, controllers, peptazol.
• Esomeprazole is a nexium.
• Lansoprazole preparations - lanzap, lansofed, helicol, lanzotop, epikur, lancid.
• Based on rabeprazole - zolispan, pariet, zulbeks, ontime, hairabezol, rabelok.

Ortanol 10 mg. 14 pcs 100 rub. 40 mg. 14 pcs 200 rub.	10 mg. 10 pcs 70 rub. 20 mg. 30 pcs. 190 p.	Ultop 10 mg. 14 pcs. 112 RUB 20 mg. 14 pcs. RUB 150	Losek maps 10 mg. 14 pcs 230- 270 rub.	Gastrozole 20 mg. 14 pcs 80 rub. 20 mg. 28 pcs 160 rub.

Catad_pgroup Antisecretory, proton pump inhibitors

Omeprazole-Teva - instructions for use

Registration number:

LP-001970

Trade name: Omeprazole-Teva

International Non-Proprietary Name (INN): omeprazole

Dosage form:

enteric capsules

Composition
Dosage 10 mg
1 capsule contains:
active substance omeprazole 10.00 mg;
excipients: granulated sugar [sucrose, starch syrup] 48.00 mg, sodium carboxymethyl starch type A 2.10 mg, sodium lauryl sulfate 2.99 mg, povidone 4.75 mg, potassium oleate 0.644 mg, oleic acid 0.107 mg, hypromellose 3.00 mg, methacrylic acid and ethyl acrylate copolymer 20.455 mg. triethyl citrate 2.345 mg, titanium dioxide (E171) 0.75 mg talc 0.095 mg.
Cellulose capsule: carrageenan 0.15 mg, potassium chloride 0.2 mg, titanium dioxide (E171) 3.1912 mg, hypromellose 39.96 mg, water 2.30 mg, sunset yellow dye (E110) 0.3588 mg, iron oxide dye red (E172) 0.5888 mg, charming red dye (E129) 0.276 mg.
Dosage 20 mg
1 capsule contains: active substance omeprazole 20.00 mg;
excipients: granulated sugar [sucrose, starch syrup] 96.00 mg, sodium carboxymethyl starch type A 4.20 mg, sodium lauryl sulfate 5.98 mg, povidone 9.50 mg, potassium oleate 1.287 mg, oleic acid 0.214 mg, hypromellose 6.00 mg , melacrylic acid and ethyl acrylate copolymer 40.91 mg, triethyl citrate 4.69 mg, titanium dioxide (E171) 1.50 mg, talc 0.19 mg.
Cellulose capsule: carrageenan 0, 185 mg, potassium chloride 0.265 mg, titanium dioxide (E171) 3.60 mg, hypromellose 52.05 mg, water 3.00 mg, sunset yellow dye (E110) 0.468 mg charming red dye (E129) 0.096 mg , dye brilliant blue (E133) 0.336 mg.
Dose 40 mg
1 capsule contains: active substance omeprazole 40.00 mg:
auxiliary substances: granulated sugar [sucrose, starch syrup] 1912.00 mg, sodium carboxymethyl starch type A 8.40 mg, sodium lauryl sulfate 11.96 mg, povidone 19.00 mg, potassium oleate 2.576 mg, oleic acid 0.428 mg, hypromellose 12.00 mg , methacrylic acid and ethyl acrylate copolymer 81.82 mg triethyl citrate 9.38 mg, titanium dioxide (E171) 3.00 mg, talc 0.38 mg.
Cellulose capsule: carrageenan 0.283 mg, potassium chloride 0.397 mg, titanium dioxide (E171) 5.40 mg, hypromellose 78.07 mg, water 4.50 mg, sunset yellow dye (E110) 0.702 mg, charming red dye (E129) 0.144 mg, dye brilliant blue (E133) 0.504 mg.
The composition of the white ink used to write on the capsules (for all dosages): shellac 11-13%, ethanol 15-18%, isopropanol 15-18%, propylene glycol 1-3%, butanol 4-7%, povidone 10-13%, sodium hydroxide 0, m5-0.1%, titanium dioxide (E 7) -32-36-%.

Description
Dosage 10 mg. Hard opaque cellulose capsules No. 3 with orange body and red cap. Applied in white ink on the cover "O", on the body - "10".
Dosage 20 mg. Hard opaque cellulose capsules No. 2 with an orange body and a blue cap. Applied in white ink on the lid "O", on the body - "20".
Dosage 40 mg. Hard opaque cellulose capsules No. 0 with an orange body and a blue cap. Printed in white ink on the cover "O", on the body - "40".
The contents of the capsules are micropellets from white to white with a yellowish or pinkish shade.

Pharmacotherapeutic group:

gastric glands secretion lowering agent - proton pump inhibitor.

ATX code: A02BC01

Pharmacological properties
Pharmacodynamics.Inhibits the activity of H + / K + -ATP-ase in the parietal cells of the stomach and thereby blocks the final stage of the secretion of hydrochloric acid. The effect of omeprazole on the last stage of the hydrochloric acid formation process is dose-dependent and provides effective inhibition of basal and stimulated secretion, regardless of the nature of the stimulating factor.
When taken daily, omeprazole provides rapid and effective inhibition of the day and night secretion of hydrochloric acid. The maximum effect is achieved within 4 days. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric acidity at a pH of more than 3 for 17 hours.
The action of omeprazole together with antibacterial drugs leads to the eradication of Helicobacter pylori, which allows you to quickly stop the symptoms of the disease, achieve a high degree of healing of the damaged mucous membrane and stable long-term remission and reduce the likelihood of bleeding from the gastrointestinal tract (GIT), and the need for prolonged antiulcer therapy.

Pharmacokinetics
Absorption and distribution... After taking the drug inside, omeprazole is rapidly absorbed from the small intestine, the maximum concentration in the blood plasma (C max) is reached after 0.5-3.5 hours.
Bioavailability is 30-40%, with liver failure - 100%. Plasma protein binding (albumin and acidic aα1-glycoprotein) is about 90%.
Metabolism and excretion... (Omeprazole is almost completely metabolized in the liver with the participation of the CYP2C19 enzyme system to form six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.). It is an inhibitor of the CYP2C19 isoenzyme.
The half-life (T 1/2) is 0.5-1 hours, with hepatic insufficiency -3 hours. Clearance is 300-600 ml / min.
It is excreted by the kidneys (70-80%) and through the intestines (20-30%) in the form of metabolites.
Pharmacokinetics in special clinical situations... In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.
In the elderly, the excretion of omeprazole decreases, bioavailability increases.

Indications for use

peptic ulcer of the stomach and duodenum, incl. relapse prevention;

gastroesophageal reflux disease (GERD), reflux esophagitis, incl. relapse prevention;

erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);

erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy);

zollinger-Ellison syndrome and other pathological conditions associated with resolved gastric secretion. Contraindications
Hypersensitivity to omeprazole or any component of the drug; intolerance to fructose; deficiency of sucrose / isomaltose; glucose-galactose malabsorption; concomitant use with clarithromycin in patients with hepatic insufficiency, atazanavir, St. John's wort; pregnancy, breastfeeding period; age up to 18 years. Carefully
Lack of liver function; failure of kidney function; simultaneous use with clarithromycin. Application during pregnancy and during breastfeeding
The use of omeprazole during pregnancy and breastfeeding is contraindicated due to insufficient data on efficacy and safety in this category of patients. Method of administration and dosage
Inside, in the morning before meals or during meals, with a little water; the contents of the capsule must not be chewed.
Adults
With exacerbation of gastric ulcer, duodenal ulcer and reflux esophagitis
20 mg once a day. The course of treatment is 4-8 weeks. In some cases, it is possible to increase the dose to 40 mg per day.
With maintenance therapy, GERD to prevent relapse
At 10-20 mg for 26-52 weeks, depending on the clinical effect, with severe esophagitis - for life.
In the treatment of erosive and ulcerative lesions of the stomach and duodenum associated with the use of NSAIDs (including for the prevention of relapse)
10-20 mg per day.
With Zollinger-Ellison syndrome
The dose is set individually. The recommended starting dose is 60 mg once a day. If necessary, the dose is increased to 80-120 mg per day, in which case it should be divided into two doses.
Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori
20 mg 2 times a day in combination with antibacterial drugs for 7 days. In patients with gastric ulcer and / or duodenal ulcer in the acute stage, it is possible to prolong monotherapy with omeprazole.
In elderly patients, dose adjustment is not required.
In patients with impaired renal function, dose adjustment is not required.
In patients with liver failure, the maximum daily dose is 20 mg.
If you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorption of the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension within 30 minutes. Side effect
The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often - at least 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.
On the part of the blood and lymphatic system:rarely, hypochromic microcytic anemia in children; very rare - reversible thrombocytopenia, leukopenia, pancytopenia, agranulocytosis.
From the immune system: very rarely - fullness, fever, angioedema, bronchoconstriction, allergic vasculitis, fever, anaphylactic shock.
From the nervous system: often - headache, dizziness, insomnia, drowsiness, lethargy (the listed side effects tend to worsen with prolonged therapy): rarely - paresthesia, confusion, hallucinations, especially in elderly patients or in severe disease; very rarely - anxiety, depression, especially in elderly patients or with severe disease.
On the part of the organ of vision: infrequently - visual impairment, incl. decrease in visual fields, decrease in acuity and clarity of visual perception (usually disappear after stopping therapy).
From the side of the organ of hearing and labyrinth disorders: infrequently - hearing impairment, incl. "ringing in the ears" (usually disappears after stopping therapy).
From the gastrointestinal tract: often - nausea, vomiting, flatulence, constipation, diarrhea, abdominal pain (in most cases, the severity of these phenomena increases with continued therapy); infrequently - taste perversion (usually disappears after stopping therapy); rarely - a change in the color of the tongue to brown-black and the appearance of benign cysts of the salivary glands with simultaneous use with clarithromycin (the phenomena are reversible after discontinuation of therapy); very rarely - dry mouth, stomatitis, candidiasis, pancreatitis.
From the liver and biliary tract: infrequently - changes in the parameters of "liver" enzymes (reversible); very rarely - hepatitis, jaundice, liver failure, encephalopathy, especially in patients with liver disease.
On the part of the skin and subcutaneous tissues: infrequently - rash, pruritus, alopecia, erythema multiforme, photosensitivity, increased sweating; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the musculoskeletal and connective tissue: infrequently - fractures of the vertebrae, wrist bones, femoral head (see the "Special instructions" section); rarely - myalgia, arthralgia; very rarely - muscle weakness.
From the kidneys and urinary tract: rarely, interstitial nephritis.
General disorders and disorders at the injection site:infrequently - peripheral edema (usually disappears after stopping therapy); rarely, hyponatremia; very rarely - hypomagnesemia (see section "Special instructions"), gynecomastia. Overdose
Symptoms: blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: carrying out symptomatic therapy, hemodialysis is not effective enough. No specific antidote is known. Interaction with other medicinal products
With simultaneous use with omeprazole, the absorption of ketoconazole may decrease.
With simultaneous use with omeprazole, the bioavailability of digoxin increases by 10% due to an increase in pH.
Omeprazole may reduce the absorption of vitamin B12 with prolonged use.
Omeprazole should not be used simultaneously with St. John's wort preparations due to the pronounced clinically significant interaction.
With the simultaneous use of omeprazole and clarithromycin, their plasma concentrations increase.
When administered simultaneously with omeprazole, the area of \u200b\u200bmodes of the concentration-time curve of atazanavir decreases by 75%, therefore their simultaneous use is contraindicated.
With simultaneous use with omeprazole, it is possible to slow down the excretion of warfarin, diazepam and phenytoin, as well as imipramine, clomipramine, citalopram, hexabarbital, disulfiram, since omeprazole is biotransformed in the liver with the participation of the isoenzyme CYP2C19. Dose reduction of these drugs may be required. When using omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, erythromycin, phenacetin, estradiol, amoxicillin, naproxen, piroxicam and antacids, no clinically significant interaction has been established. special instructions
Before starting therapy, it is necessary to exclude the presence of a malignant process in the upper gastrointestinal tract, because taking the drug Omeprazole-Teva can mask the symptoms and delay the correct diagnosis.
A decrease in gastric acidity, including with the use of proton pump blockers, increases the number of bacteria in the gastrointestinal tract, which increases the risk of gastrointestinal infections.
In patients with severe liver failure, it is necessary to regularly monitor the parameters of "liver" enzymes during therapy with Omeprazole-Teva.
The drug Omeprazole-Teva contains sucrose and therefore is contraindicated in patients with congenital disorders of carbohydrate metabolism (fructose intolerance, sucrase / isomaltose deficiency, glucose-galactose malabsorption).
When treating erosive and ulcerative lesions associated with taking NSAIDs, you should carefully consider the possibility of limiting or discontinuing NSAIDs to increase the effectiveness of antiulcer therapy.
The drug contains sodium, which should be taken into account in patients on a controlled sodium diet.
The risk and benefit ratio of long-term (more than 1 year) maintenance therapy with Omeprazole-Teva should be regularly assessed. There is evidence of an increased risk of fractures of the vertebrae, wrist bones, and femoral head mainly in elderly patients, as well as in the presence of predisposing factors. Patients at risk of developing osteoporosis should be provided with adequate intake of vitamin D and calcium.
There are reports of severe hypomagnesemia in patients receiving proton pump inhibitor therapy, including omeprazole, for more than 1 year.
A patient receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the plasma magnesium content (diuretics), requires regular monitoring of the magnesium content. Influence on the ability to drive vehicles and work with equipment
Given the possibility of the appearance of undesirable effects on the part of the central nervous system and the organ of vision, during the period of treatment with omeprazole, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. Release form
enteric capsules 10 mg, 20 mg, 40 mg.
6 or 7 capsules in a blister made of aluminum foil / PVC / PVDC and polyamide film / aluminum foil / PVC.
5 blisters of 6 capsules or pi 2 or 4 blisters of 7 capsules together with instructions for use in a cardboard box. Shelf life
2 years.
Do not use after the expiration date printed on the package. Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children. Terms of dispensing from pharmacies
On prescription. The legal entity in whose name the RU was issued:
Teva Pharmaceutical Enterprises Ltd., Israel

Manufacturer:

Teva Pharma, S.L.U., Polygon Industrial Malpica, Calle C, no. 4, 50016 Zaragoza: Spain Claims address:
119049, Moscow, Shabolovka st., 10, bldg. 1