Ortanol capsules 20mg, No. 28

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

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

reflux esophagitis;

hypersecretory conditions (Zollinger-Ellison syndrome, polyendocrine adenomatosis, systemic mastocytosis, stress gastrointestinal ulcers);

prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the intake of NSAIDs (dyspepsia, erosion of the mucous membrane, peptic ulcer).

Inside. OrtanolЃ capsules are taken before meals (usually in the morning before breakfast). The capsule should be swallowed whole with plenty of liquid. If the patient cannot swallow the OrtanolЃ capsule whole, you can dissolve its contents in a little water or fruit juice (such as apple or orange).

Duodenal ulcer: 20 mg 1 time per day for 2 weeks; if, after the first course of taking the drug, complete scarring does not occur, a repeated 2-week course of therapy is prescribed. In case of duodenal ulcer disease resistant to therapy, OrtanolЃ capsules 40 mg 1 time per day are prescribed, the course of treatment can be extended up to 4 weeks.

Peptic ulcer: 20 mg 1 time per day for 4 weeks; if, after the first course of taking the drug, complete scarring does not occur, a repeated 4-week course of therapy is prescribed. In case of gastric ulcer resistant to therapy, OrtanolЃ capsules 40 mg 1 time per day are prescribed, the course of treatment can be extended up to 8 weeks.

Eradication of Helicobacter pylori in combination therapy: OrtanolЃ capsules 20 mg 2 times a day before meals for 2 weeks in combination with antibacterial drugs.

Reflux esophagitis: 20 mg once a day for 4 weeks; if, after the first course of taking the drug, a complete cure does not occur, a repeated four-week course of therapy is prescribed. In severe forms of esophageal reflux, the course of treatment can be extended up to 8 weeks.

Hypersecretory conditions: the dose of OrtanolЃ and the duration of the course of treatment for patients with Zollinger-Ellison syndrome is selected individually. The recommended starting dose for adults is 60 mg once a day, the maximum is 120 mg / day. When prescribing a dose exceeding 80 mg / day, it is divided into several doses.

Prevention and treatment of damage to the mucous membrane of the stomach and duodenum caused by the intake of NSAIDs: prevention - 1 capsule. OrtanolЃ 20 mg daily before breakfast during the entire course of NSAID treatment. Treatment - 20 mg / day for 4-8 weeks.

The daily dose for patients of the older age group and for patients with severe liver disease should not exceed 20 mg.

No dose adjustment is required for patients with impaired renal function.

active substance: omeprazole - 20 mg

excipients: low-substituted hyprolosis; MCC; anhydrous lactose; croscarmellose sodium; povidone; polysorbate 80; hypromellose phthalate; dibutylsebacat; talcum capsule shell: hypromellose; carrageenan; potassium chloride; titanium dioxide; iron (III) oxide yellow (for a dosage of 40 mg); iron (III) oxide red (for a dosage of 40 mg); water; ink for the inscription - iron (III) oxide black (E172); shellac; ethanol anhydrous; isopropanol anhydrous; propylene glycol; butanol; ammonium hydroxide; potassium hydroxide; purified water

hypersensitivity to omeprazole or other components of the drug;

childhood;

lactation period.

With caution: hepatic and / or renal failure.

Clinical and pharmacological group: N + -K + -ATPase inhibitor. Antiulcer drug

Pharmaco-therapeutic group: Proton pump inhibitor

pharmachologic effect

Inhibitor of H + -K + -ATPase. 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. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. Due to a decrease in acid secretion, it reduces or normalizes the effect of acid on the esophagus in patients with reflux esophagitis.

Omeprazole has a bactericidal effect on Helicobacter pylori. Eradication of H. pylori with the simultaneous use of omeprazole and antibiotics allows you to quickly stop the symptoms of the disease, achieve a high degree of healing of the damaged mucosa and persistent long-term remission, and reduce the likelihood of bleeding from the gastrointestinal tract.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. Penetrates into the parietal cells of the gastric mucosa. Plasma protein binding is about 95%, mainly with albumin. Biotransformed in the liver. It is excreted by the kidneys - 72-80%, with feces - about 20%. T1 / 2 0.5-1 hours. In patients with chronic liver diseases, T1 / 2 increases to 3 hours.

Indications

• Peptic ulcer of the stomach and duodenum in the acute phase (including associated with Helicobacter pylori),

• reflux esophagitis,

• Zollinger-Ellison syndrome,

• erosive and ulcerative lesions of the stomach and duodenum,

• associated with taking NSAIDs.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the 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 / day. The duration of treatment is 2-8 weeks.

Side effect

From the digestive system: rarely - nausea, diarrhea, constipation, abdominal pain, flatulence.

From the side of the central nervous system: rarely - headache, dizziness, weakness.

From the hematopoietic system: in some cases - anemia, eosinopenia, neutropenia, thrombocytopenia.

From the urinary system: in some cases - hematuria, proteinuria.

From the musculoskeletal system: in some cases - arthralgia, muscle weakness, myalgia.

Allergic reactions: rarely - skin rash.

Contraindications for use

Chronic liver disease (including history), childhood, hypersensitivity to omeprazole.

Application during pregnancy and lactation

During pregnancy and lactation, use is possible depending on the dosage form used.

Application for violations of liver function

Contraindicated in chronic liver diseases (including history).

Application in children

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

special instructions

Before starting therapy, it is necessary to exclude the possibility of a malignant process (especially with a stomach ulcer), because treatment with omeprazole 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.

Drug interactions

With simultaneous use, cases of the development of symptoms of the toxic effect of benzodiazepines have been described, which is associated with inhibition of the activity of CYP3A isoenzymes and, apparently, CYP2C9.

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

With the simultaneous use of tripotassium dicitrate with bismuth, 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 the 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 concentration 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.

When used simultaneously with theophylline, a slight increase in the clearance of theophylline is possible.

It is believed that with the simultaneous use of high doses of omeprazole 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 has been described, while the effectiveness of omeprazole decreased.