OMEZ

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Trade name of the drug: Omez®

Active substance (XPN): omeprazole

dosage form: lyophilisate for solution for infusion

Contents:

Each vial contains:

active substance: omeprazole sodium VR, equivalent to 40 mg omeprazole (buffered);

excipients: anhydrous sodium carbonate, water for injections.

Definition: white or almost white lyophilisate in the form of a homogeneous, porous mass or its fragments, or in the form of a powder.

Pharmacotherapeutic group: a means of reducing pancreatic secretion - a proton pump inhibitor.

Application:

As an alternative to oral therapy:

• in gastric and duodenal ulcers (including in the prevention of recurrences);

• in gastroesophageal reflux disease (GERK);

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

• injuries of the mucous membranes of the stomach and duodenum associated with the reception of nonsteroidal anti-inflammatory drugs (gastropathy): for the prevention and treatment of dyspepsia, mucosal erosion, peptic ulcer;

• during general anesthesia is used to prevent aspiration of gastric acid content into the respiratory tract (Mendelson syndrome).

Methods of administration and dosage

Omez® is administered intravenously for 20-30 minutes. It is recommended to send immediately after the solution for infusion is prepared. Doses are selected individually, sometimes requiring higher doses. If the daily dose is 60 mg, the dose should be divided to take twice.

• As an alternative to oral treatment:in gastric and duodenal ulcers (including prevention of recurrences) it is recommended to prescribe an infusion of Omez® at a dose of 40 mg once a day;

• in gastroesophageal reflux disease (GERK) it is recommended to prescribe an infusion of Omez® to a dose of 40 mg once a day;

• in hypersecretory cases (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis) Omez® is recommended for initial intravenous administration at a dose of 60 mg per day;

• gastric and duodenal mucosal injuries (gastropathy) associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs): for the prevention and treatment of dyspepsia, mucosal erosion, peptic ulcer is recommended to prescribe an infusion of Omez® at a dose of 40 mg once a day.

To prevent aspiration of gastric acid content into the respiratory tract during general anesthesia (Mendelson's syndrome) the drug is prescribed at a dose of 40 mg in the evening and at a dose of 2 mg at least 40 hours before anesthesia / surgery.

Upon completion of parenteral treatment, it is recommended to carry out antisecretory treatment with an oral drug form to attenuate acid secretion (e.g., 20 mg Omez® capsule once daily for 2 weeks for 4 weeks).

Use of the drug in isolated cases

Impaired renal function. No dose adjustment is required.

Impaired liver function. In patients with impaired hepatic function, the bioavailability and clearance of omeprazole are increased. Therefore, the therapeutic dose should not exceed 20 mg per day.

In old age. In elderly people, the rate of metabolism of omeprazole decreases, so no dose adjustment is required.

Instructions for preparing the solution for infusion

The solution for infusion is prepared by mixing the lyophilized powder of omeprazole with 100 ml of 5% solution of dextrose (glucose) for infusion or saline for 100 ml of infusion.

For 5% infusion, dextrose (glucose) solution should be used for 6 hours. Saline solution for infusion should be used for 12 hours. Prior to dispatch, make sure that there are no suspended particles in the solution.

Preparation of solution for infusion in vials

1. A solution for infusion of 5 ml is obtained from the vial with a syringe.

2. For infusion, the solution should be placed in a vial of lyophilized powder of omeprazole, the vial should be shaken well until the drug is completely dissolved.

3. The omeprazole solution is drawn into a syringe.

4. The omeprazole solution is transferred to a vial.

5. The process is repeated 1-4 times to transfer the total drug from the vial.

Prepare the solution for infusion in a soft container

1. A double-sided needle (-conductor) should be used to prepare the solution for infusion. With one end of the needle, the membrane of the infusion sac is perforated, and the other end of the needle is combined with a lyophilized omeprazole vial.

2. The omeprazole powder is dissolved by transferring the infusion solution from the bag to the vial and vice versa.

3. Make sure the powder is completely dissolved, then separate the empty vial and remove the needle from the infusion bag.

Side effects

The frequency of development of adverse drug reactions was described according to the following levels: very common (> 1/10); frequent (≥1 / 100, <1/10); not frequent (≥1 / 1000, <1/100); in rare cases (≥1 / 10000, <1/1000); in very rare cases (<1 / 10000, including individual cases).

Disorders of the skin and subcutaneous tissue: not often - dermatitis, itchy skin, skin rash, hives; in rare cases - alopecia, radiation reactions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Disorders by skeletal muscle and connective tissue: not often - fractures of the hip, wrist, spine; in rare cases - arthralgia, myalgia, muscle relaxation.

Disorders of the central nervous system: often - headache; not often - dizziness, paresthesia, drowsiness; in rare cases - taste disturbance.

Mental Disorders: not often - insomnia; in rare cases - hypersensitivity, aggression, impaired consciousness, depression, hallucinations.

Disorders of the gastrointestinal tract:often - abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; in rare cases - dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis.

Disorders of the liver and bile ducts: infrequently - increased activity of "liver" enzymes; in rare cases - jaundice / jaundice-free hepatitis, liver failure, encephalopathy in patients with previously severe liver disease.

Disorders of the genitals and mammary glands: in rare cases - gynecomastia.

Disorders of the blood and lymphatic systems: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

Disorders of the immune system: in rare cases - hypersensitivity reaction: fever, angioneurotic edema, anaphylactic reaction / anaphylactic shock.

Disorders of the respiratory system, chest and thoracic cavity: in rare cases - bronchospasm.

Disorders of the kidneys and urinary tract: in rare cases - interstitial nephritis.

By hearing organs and maze disorders: not often - Vertigo.

Disorders by visual members: in rare cases - visual uncertainty.

Disorders of metabolism and nutrition: in rare cases - hyponatremia; in very rare cases - hypomagnesemia, hypocalcemia due to severe hypomagnesemia, hypokalemia due to hypomagnesemia.

General disorders: not often - laziness; in rare cases - excessive sweating, peripheral edema.

Contraindications

Hypersensitivity to omeprazole or other components of the drug.

Concomitant use with erlotinib, pozaconazole, nelfinavir and atazanavir.

Breastfeeding period.

It should not be used in children under 18 years of age (efficacy and safety for this dosage form have not been established).

Carefully

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

Liver failure (see section "Method and dosage").

Osteoporosis. Although the causal relationship of omeprazole administration with osteoporosis in osteoporosis has not been established, patients at risk of developing osteoporosis or fractures in osteoporosis should be under appropriate clinical supervision.

Pregnancy.

Caution should be exercised when co-administered with clopidogrel, itraconazole, warfarin, tsilostazole, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampicin, perforated dalachoy drugs.

Drug interactions

Decreased gastric hydrochloric acid secretion during treatment with omeprazole and other proton pump inhibitors may result in decreased or increased absorption of other drugs depending on the acidity of the medium.

Treatment with omeprazole may result in decreased absorption of ketoconazole, itraconazole, pozaconazole, erlotinib, iron, and cyanocobalamins, as well as other drugs that reduce the acidity of gastric juice. The use of these drugs in combination with omeprazole should be avoided.

When taken concomitantly with omeprazole, the bioavailability of digoxin increases by 10% (adjustment of digoxin dosing regimen may be required). Caution should be exercised when using these drugs concomitantly in elderly patients.

When taken concomitantly with omeprazole, warfarin, diazepam, phenytoin, cylostazole, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs that are metabolized in the liver in the presence of the isoenzyme CYP2C19 may be required. possible.

Omeprazole has been shown to interact with some antiretroviral drugs. The mechanisms and clinical significance of these interactions are not always known. Increased pH value in the background of treatment with omeprazole may affect the absorption of antiretroviral drugs. It can also affect CYP2C19 isoenzyme levels. When used in combination with omeprazole and some antiretroviral drugs similar to atazanavir and nelfinavir, a decrease in their serum concentrations is observed against the background of treatment with omeprazole. When used concomitantly with omeprazole, the area below the “concentration-time” pharmacokinetic curve of atazanavir is reduced by 75%. Because of this, omeprazole cannot be used in combination with antiretroviral drugs such as atazanavir and nelfinavir.

When omeprazole is used concomitantly with clopidogrel, a decrease in the antiaggregant effect of the latter is observed.

In some patients, a significant increase in plasma concentrations of methotrexate was observed when proton pump inhibitors were used in combination with methotrexate. Omeprazole should be temporarily discontinued during treatment with high doses of methotrexate.

When omeprazole and tacrolimus are used concomitantly, an increase in serum tacrolimus concentrations has been identified, which may require dose adjustment.

Concomitant use with inhibitors of CYP2C19 and CYP3A4 isoenzymes (such as clarithromycin, erythromycin, voriconazole) may lead to increased plasma concentrations of omeprazole, which may require dose adjustment of omeprazole in long-term use in patients with severe hepatic impairment.

Rifampicin, hole dalachoy (Hypericum perforatum) when omeprazole is co-administered with inducers of CYP2C19 and CYP3A4 isoenzymes, such as drugs, may lead to a decrease in plasma concentrations of omeprazole due to acceleration of the metabolism of omeprazole.

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

Co-administration of omeprazole with amoxicillin or metronidazole does not affect the plasma concentrations of omeprazole.

The effect of omeprazole on antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol has not been determined.

Special instructions

When gastric ulcer is suspected in the early stages, an x-ray or endoscopic examination should be performed to make an accurate diagnosis and prescribe appropriate treatment.

Significant spontaneous weight loss, frequent vomiting, dysphagia, mixed vomiting of blood or any disturbing symptoms such as melena, as well as the possibility of malignant tumors in the presence (or suspicion of peptic ulcer) should be ruled out, as treatment with Omez® may lead to loss of symptoms and delay in diagnosis.

Although the causal relationship of omeprazole / esomeprazole administration with bone fractures in the setting of osteoporosis has not been established, patients at risk of developing osteoporosis or fractures in the setting of osteoporosis should be under appropriate clinical supervision.

The concentration of chromogranin A (CgA) increases due to a decrease in hydrochloric acid secretion. Increased plasma concentrations of CgA may affect the results of examinations for the detection of neuroendocrine tumors. To prevent these effects, treatment with proton pump inhibitors should be discontinued 5 days prior to the CgA concentration test. If during this time the CgA concentration does not return to normal, the test should be repeated.

Use during pregnancy and lactation

The drug can be used during pregnancy when the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding should be discontinued when used during lactation.

Effects on the ability to drive vehicles and perform other types of activities that require concentration and speed of psychomotor reactions. Dizziness, drowsiness, and visual disturbances may occur during treatment with omeprazole, so caution should be exercised when driving and performing other potentially hazardous types of activity that require high concentration and speed of psychomotor reactions.

The drug should be stored out of reach of children and should not be used after the expiration date.

Overdose

According to clinical studies, no dose-related side effects have been reported when the drug is administered intravenously at doses of up to 270 mg per day and up to 650 mg over three days.

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

Treatment: symptomatic. Hemodialysis is not effective enough.

Release Form And Packaging

The 10 ml vial is USP Type-I dark glass, sealed with bromobutyl plugs, sealed with aluminum caps and sealed with a flip off cap. Self-adhesive labels are affixed to the vials.

1 vial is placed in a cardboard box with instructions for use in the state and Russian languages.

Storage conditions

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

Shelf life

2 years.

Order from pharmacies:

According to the recipe.