Omitox, 20 mg capsules 30 pcs

Omitox is an anti-ulcer drug. It inhibits the enzyme H+ -K+ -ATPase (proton pump) in the parietal cells of the stomach and thus blocks the final stage of hydrochloric acid synthesis. This leads to a decrease in basal and stimulated secretion regardless of the nature of the stimulus.

After a single oral administration, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is reached after 2 hours. In patients with duodenal ulcer disease, administration of 20 mg of omeprazole maintains intragastric pH=3 for 17 h. After discontinuation of the drug secretory activity is fully restored in 3 to 5 days.

Pharmacokinetics

Intake and distribution

After oral administration, omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5-1 hours.

The bioavailability is 30-40%. Binding to plasma proteins is about 90%.

Metabolism and excretion

Omeprazole is almost completely metabolized in the liver.

The T1/2 is 0.5-1 h. It is excreted mainly in the urine as metabolites.

Pharmacokinetics in special clinical cases

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

In the elderly, the excretion of omeprazole is reduced and bioavailability is increased.

In case of hepatic insufficiency, bioavailability is 100%, T1/2 is 3 hours.

Indications

Active ingredient

Composition

1 capsule contains:

The active ingredient:

omeprazole (in pellets) 20 mg;

Composition of the capsule:

gelatin;

Mareon;

Purified water.

How to take, the dosage

In duodenal ulcer in the acute phase, the drug is prescribed at 20 mg 1 time per day for 2-4 weeks. In resistant cases it is possible to increase the dose to 40 mg/day.

In acute gastric ulcer and erosive-ulcerative esophagitis phases the preparation is prescribed in 20-40 mg/day for 4-8 weeks.

In erosive-ulcerative gastrointestinal lesions caused by taking NSAIDs – 20 mg/day for 4-8 weeks.

For eradication of Helicobacter pylori – 20 mg 2 times per day for 7 days in combination with antibacterial agents.

For prevention of worsening of gastric and duodenal ulcer the drug is prescribed in dose of 10-20 mg per day.

For prevention of relapse of reflux esophagitis – 20 mg/day for a long period of time (up to 6 months).

In Zollinger-Ellison syndrome the dose is adjusted individually depending on the initial level of gastric secretion, usually starting with 60 mg/day. If necessary, the dose is increased to 80-120 mg/day in 2 doses.

In patients with significant liver dysfunction, the daily dose should not exceed 20 mg.

The capsules are taken orally with plain water (the contents should not be chewed).

Interaction

In concomitant use Omitox alters the bioavailability of any drug whose absorption depends on the pH value (e.g., iron salts).

The long-term use of Omitox at a dose of 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol has not resulted in changes in their plasma concentrations.

No interaction with concomitantly taken antacids was noted.

Special Instructions

Before starting therapy, it is necessary to rule out the presence of a malignant process in the upper gastrointestinal tract, because taking Omitox may mask the symptoms and delay the correct diagnosis.

The efficacy of the drug is not affected when taken at the same time as food.

If you have difficulty swallowing the entire capsule, the contents may be swallowed after opening or swallowing the capsule, or the capsule contents may be mixed with a slightly acidified liquid (juice, yogurt) and the resulting suspension may be used within 30 minutes.

Contraindications

Side effects

Digestive system disorders: nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dry mouth, taste disorders, stomatitis, transient increase in plasma liver enzymes; in patients with previous severe liver disease – hepatitis (including jaundice), liver function impairment.

CNS and peripheral nervous system disorders: headache, dizziness, agitation, somnolence, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases or previous severe liver disease – encephalopathy.

Muscular system disorders: muscle weakness, myalgia, arthralgia.

Hematopoietic system: leukopenia, thrombocytopenia; in some cases – agranulocytosis, pancytopenia.

Dermatological reactions: itching; in some cases photosensitization, erythema multiforme, alopecia.

Allergic reactions: urticaria, angioneurotic edema, bronchospasm, interstitial nephritis, anaphylactic shock.

Others: peripheral edema, increased sweating, fever, gynecomastia, visual impairment; rarely – formation of gastric glandular cysts during long-term treatment (occurs as a result of inhibition of hydrochloric acid secretion and is of benign reversible nature).

As a rule, side effects are rare and reversible.

Overdose

Symptoms: visual disturbances, drowsiness, agitation, headache, confusion, increased sweating, dry mouth, nausea, arrhythmia.

Treatment: symptomatic therapy is carried out. There is no specific antidote. Hemodialysis is not effective enough.

Pregnancy use

The drug is contraindicated in pregnancy and lactation.

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