Omeprazol

General characteristics. Structure:

Active ingredient: 20 mg омепразолав to 1 capsule.

Antiulcerous drug.

Pharmacological properties:

Pharmacodynamics. Omeprazol is H+ inhibitor - K+ - ATP-ases (the proton pump) in covering cells mucous a stomach, suppresses a final stage of secretion of hydrochloric acid therefore the level of basal and stimulated secretion irrespective of the irritant nature decreases. After a single dose of drug the pharmacological effect proceeds within 24 hours.

Pharmacokinetics. After absorption in a small intestine омепразол it is transferred by a blood-groove in an inactive form, concentrates in covering cells mucous a stomach where turns into active sulfenamidny derivative, inhibits H+ enzyme - K+ - ATP-ase interacting with SH groups. The elimination half-life makes 0,5-1 hour, at the same time antisecretory action remains within 24 hours. Does not oppress a pepsinia and an internal factor. It is metabolized in a liver, to 75 - 80% of an omeprazol the remained quantity with a stake is distinguished in the form of metabolites with urine.

Indications to use:

- duodenum ulcer;

- an ulcer of a duodenum and stomach ulcer, and also the erosion developing at HIV-positive patients;

- the stomach ulcer caused by Helicobacter pylori;

- ezofagealny reflux;

- symptomatic gastroesophageal reflux;

- kislotozavisimy dyspepsia;

- Zollingera-Ellison's syndrome;

- prevention at patients with probable risk of development of aspiration of gastric contents during an anesthesia.

Route of administration and doses:

Capsules of an omeprazol should be accepted in the morning, to swallow entirely, washing down with a small amount of liquid. Capsules cannot be chewed or split up.

Peptic ulcer of a duodenum in an aggravation phase. Appoint 20 mg within 2-4 weeks once a day (in resistant cases to 40 mg once a day).

Peptic ulcer of a stomach in a phase of an aggravation and an erosive and ulcer esophagitis. Appoint 20-40 mg within 4-8 weeks once a day.

Ulcers and erosion of gastroduodenal department at HIV-positive patients.

To HIV-positive patients with stomach ulcer, an ulcer of a duodenum or erosion of gastroduodenal department appoint 20 mg within 4-8 weeks once a day. Treatment can be carried out against the background of treatment of HIV infection.

The peptic ulcer of a stomach caused by Helicobacter pylori [Нр]. Appoint 20 mg 2 times a day within 7 days in a combination with antibacterial agents.

Ezofagealny reflux and symptomatic gastroesophageal reflux. Appoint 20 mg within 4 weeks once a day. When after the first course of administration of drug full treatment does not come, appoint a repeated 4 weeks course of treatment. To patients with a severe form of an ezofagealny reflux appoint 40 mg daily.

Prevention of a recurrence of stomach ulcer and duodenum and ezofagealny reflyuk. Appoint 20 mg once a day for a long time (up to 6 months).

The GIT erosive cankers caused by reception of non-steroidal anti-inflammatory drugs. Appoint 20 mg within 4-8 weeks once a day.

Kislotozavisimy dyspepsia. For simplification of pains and/or sensations of discomfort in epigastric area and also when pains are followed by heartburn, appoint  20 mg daily within 2 weeks.

Zollinger's syndrome – Ellisona. The dose is selected individually depending on the initial level of gastric secretion - usually 60 mg once a day, if necessary the dose is increased to 80-120 mg once a day. It is necessary to pick up a dose of drug so that secretion level in a stomach was in limits to 10 mmol of HCL/hour (in limits to 5 HCL/hours at the patients who transferred a stomach resection). When the daily dose of drug exceeds 80 mg, the dose should be divided into two parts and to accept twice a day at an interval of 12 hours.

Prevention of aspiration of acid contents of a stomach. Appoint 40 mg in the evening and in the morning before the forthcoming anesthesia.

Use of drug during pregnancy and feeding by a breast.

It is not recommended to appoint омепразол during pregnancy and feeding a breast.

So far there is no sufficient experience for definition of safety of use of an omeprazol for women during pregnancy and feeding by a breast therefore purpose of drug is possible only if the estimated therapeutic effect for mother exceeds potentially possible risk for a fruit or the newborn.

Features of use:

At patients with an abnormal liver function bioavailability and clearance of an omeprazol increases. In this regard the therapeutic dose usually does not exceed 20 mg a day.

Before a course of treatment drug омепразол it is necessary to exclude on the basis of data of an endoscopic research with a biopsy existence of malignant process (especially at stomach ulcer) as treatment by drug can change symptomatology and delay the correct diagnosis.

Drug use омепразол in therapeutic doses does not exert negative impact on the activity demanding the high speed of mental and physical reactions (for example, control of vehicles, service of cars, work at height, etc.).

Side effects:

Possible side effects have easy and reversible temper. Dispepsichesky frustration (feeling of weight in epigastric area, nausea, a meteorism, diarrhea) and a headache are most often noted.

In other cases of the side effects revealed against the background of treatment by drug reliable connection of their emergence with administration of drug was not established.

In rare instances against the background of reception of an omeprazol stomatitis, tranzitorny increase in level of liver enzymes are noted dryness in a mouth; at patients with the previous serious illness of a liver emergence of symptoms of encephalopathy, hepatitis, liver failure, in patients with the serious accompanying somatopathies is possible dizziness, a headache, excitement, a depression are possible.

The arthralgia, mialgiya, muscular weakness are in rare instances noted. Isolated cases of dysfunction of a blood formation, disturbance of endocrine function in the form of a gynecomastia are celebrated.

Allergic reactions in the form of skin rashes, an itch are possible, isolated cases of the raised photosensitization, an erythema, alopecias are celebrated.

Interaction with other medicines:

At combined use of an omeprazol with ketokonazoly absorption of a ketokonazol decreases.

Interaction with amoxicillin was not revealed.

Interaction with food or antiacid drugs was not revealed.

Reception of an omeprazol slows down elimination and can lead to increase in level of concentration in plasma of diazepam, warfarin, Phenytoinum, and also other drugs which are metabolized by oxidation in a liver.

As омепразол is exposed to metabolism in a liver with participation of P450 2C19 cytochrome (CYP2C19), elimination of diazepam, warfarin (R-warfarin) and Phenytoinum can be prolonged. Observation of the patients accepting Phenytoinum and warfarin is recommended; perhaps, the dose decline of these drugs will be required. However the accompanying treatment omeprazoly in a daily dose of 20 mg does not influence concentration of Phenytoinum in plasma at patients, is long accepting drug. Also accompanying treatment omeprazoly in a daily dose of 20 mg does not lead to change of time of coagulation at patients, is long accepting warfarin. Concentration of an omeprazol and a klaritromitsin increase in plasma at combined use of these drugs.

Contraindications:

Hypersensitivity to an omeprazol, other components of drug.

It is not recommended to appoint drug to persons aged up to 18 years.

Overdose:

Signs of overdose (intoxication) omeprazoly in the form of a vision disorder, confusion of consciousness, the increased sweating, drowsiness, dryness in a mouth, a headache, nausea, tachycardias, arrhythmias were noted after reception of a dose ranging from 320 to 900 mg (i.e. 16-45 multiply exceeding the recommended therapeutic dose). Noted symptoms had passing character.

Symptomatic treatment, against the background of control of indicators of the vital functions of an organism. Specific treatment is absent, considering the high level of linkng with proteins of plasma, carrying out dialysis is not rather effective.

Storage conditions:

List B. To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years.

Issue conditions:

According to the recipe

Packaging:

On 14 capsules in cardboard packs in strip packagings.