Trade name of the drug : Omepral

Active ingredient (INN) : omeprazole

Dosage form: capsules

Composition:

each capsule contains:

active substance : omeprazole pellets 7.5%, enteric coated, equivalent to 20 mg;

excipients : sucrose, mannitol, sodium lauryl sulfate, sodium hydrogen phosphate anhydrous, hydroxypropyl methylcellulose E-5, methacrylic acid Co-polymer, sodium hydroxide, PEG-6000, titanium dioxide, purified talc, tween-80, purified water.

Description: hard gelatin capsules No. 2 of a cylindrical shape, consisting of a pink lid and a transparent body.

Pharmacotherapeutic group : Antiulcer drug (inhibitor of H + K + ATP-AZY).

ATX code: A02BC01

 

Pharmacological properties

Omeprazole inhibits the enzyme H + – K + -ATPase (“proton pump”) in the parietal cells of the stomach and thereby blocks the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single oral dose of the drug, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH = 3 for 17 hours. the drug’s secretory activity is fully restored after 3-5 days.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5-1 hours. Bioavailability is 30-40%. Plasma protein binding is about 90%. Omeprazole is almost completely metabolized in the liver. T _1/2 – 0.5-1 h. It is excreted mainly by the kidneys in the form of metabolites. In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance. In elderly patients, excretion decreases, bioavailability increases. With hepatic insufficiency, bioavailability is 100%, T _1/2 – 3 hours.

 

Indications for use

Adults:

– gastric ulcer and duodenal ulcer (treatment and prevention of relapse);

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

– peptic ulcer of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers (treatment and prevention in patients at risk of their occurrence);

– reflux esophagitis;

– gastroesophageal reflux (including symptomatic);

– Zollinger-Ellison syndrome.

Children over 1 year old and weighing at least 10 kg: treatment of reflux esophagitis; Symptomatic treatment of heartburn and acid regurgitation in gastroesophageal reflux disease.

Children over 4 years of age: duodenal ulcer caused by Helicobacter pylori (as part of complex therapy).

 

Method of administration and dosage

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 taking NSAIDs – 1 capsule per day for 4-8 weeks.

Helicobacter pylori eradication – 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.

 

Side effects

In rare cases, the following usually reversible side effects may occur.

From the digestive system : diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in the level of liver enzymes in plasma; in patients with previous severe liver disease – hepatitis (including jaundice), impaired liver function.

From the nervous system : headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, in patients with previous severe liver disease – encephalopathy.

From the musculoskeletal system : muscle weakness, myalgia, arthralgia.

From the hematopoietic system : leukopenia, thrombocytopenia; in some cases – agranulocytosis, pancytopenia.

On the part of the skin : itching; rarely (in some cases) – photosensitization, erythema multiforme, alopecia.

Allergic reactions : urticaria, angioedema, bronchospasm, interstitial nephritis and anaphylactic shock.

Others : blurred vision, peripheral edema, increased sweating, fever, gynecomastia; rarely – the formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible).

Contraindications

• hypersensitivity to the drug;
• childhood;
• pregnancy;
• lactation period.

 

Drug interactions

Long-term use of omeprazole at a dose of 20 mg 1 time per day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentration.

There was no interaction with concomitantly taken antacids.

Changes the bioavailability of any drug, the absorption of which depends on the pH value (for example, iron salts).

 

special instructions

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

Consumption with food does not affect effectiveness.

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.

In patients with severe hepatic impairment, the daily dose should not exceed 20 mg.

Application during pregnancy and lactation :

Contraindicated during pregnancy and lactation.

 

Overdose

Symptoms: blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

Treatment is symptomatic. There is no specific antidote. Hemodialysis is not effective enough.

 

Release form

10 capsules of 20 mg in a blister strip packaging. 3 blister packs, together with instructions for medical use, are placed in a cardboard box.

 

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ° C.

The drug should be kept out of the reach of children.

 

Shelf life

3 years.

Do not use after the expiration date printed on the package.

 

 

Conditions of dispensing from pharmacies

On prescription.