Omitox Gastro^® (Capsules) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

Contact Information

Shreya Life Sciences Pvt.Ltd. (India)

ATC Code

A02BC01 (Omeprazole)

Active Substance

Omeprazole (Rec.INN WHO registered)

Dosage Forms

	Omitox Gastro®	Capsules 10 mg: 7, 10, 14, 20, 21, 28, 30, 40 or 100 pcs.
		Capsules 20 mg: 7, 10, 14, 20, 21, 28, 30, 40 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, with a light cream body and a light cream cap; capsule contents – granules of almost white color.

Capsule composition gelatin, maroon, purified water.

10 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

H⁺-K⁺-ATPase inhibitor. Antiulcer drug

Pharmacotherapeutic Group

Gastric secretion reducing agent – proton pump inhibitor

Pharmacological Action

Antiulcer drug. Inhibits the enzyme H⁺-K⁺-ATPase (proton pump) in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. 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, with the maximum effect achieved after 2 hours. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH level of 3 for 17 hours. After discontinuation of the drug, secretory activity is completely restored within 3-5 days.

Pharmacokinetics

Absorption and Distribution

After oral administration, Omeprazole is rapidly absorbed from the gastrointestinal tract, C_max in plasma is reached in 0.5-1 hour.

Bioavailability is 30-40%. Plasma protein binding is about 90%.

Metabolism and Excretion

Omeprazole is almost completely metabolized in the liver.

T_1/2 – 0.5-1 hour. It is excreted mainly in the urine as metabolites.

Pharmacokinetics in Special Clinical Cases

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

In elderly individuals, the excretion of omeprazole decreases, and bioavailability increases.

In hepatic insufficiency, bioavailability is 100%, T_1/2 – 3 hours.

Indications

• Gastric and duodenal ulcer;
• Reflux esophagitis;
• Erosive and ulcerative lesions of the stomach and duodenum associated with NSAID use;
• Erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of combination therapy);
• Zollinger-Ellison syndrome.

ICD codes

Dosage Regimen

For duodenal ulcer in the acute phase, the drug is prescribed at 20 mg once a day for 2-4 weeks. In resistant cases, the dose may be increased to 40 mg/day.

For gastric ulcer in the acute phase and erosive-ulcerative esophagitis – 20-40 mg/day for 4-8 weeks.

For erosive-ulcerative lesions of the gastrointestinal tract caused by NSAID use – 20 mg/day for 4-8 weeks.

For Helicobacter pylori eradication – 20 mg twice a day for 7 days in combination with antibacterial drugs.

For prevention of gastric and duodenal ulcer exacerbation, the drug is prescribed at a dose of 10-20 mg/day.

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

For 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 2 divided doses.

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

The capsules are taken orally with a small amount of water (the capsule contents should not be chewed).

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dry mouth, taste disturbance, stomatitis, transient increase in plasma liver enzyme levels; in patients with pre-existing severe liver disease – hepatitis (including with jaundice), impaired liver function.

From the central and peripheral nervous system headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases or pre-existing severe liver disease – encephalopathy.

From the musculoskeletal system muscle weakness, myalgia, arthralgia.

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

Dermatological reactions itching; in some cases – photosensitivity, erythema multiforme, alopecia.

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

Other peripheral edema, increased sweating, fever, gynecomastia, visual disturbance; rarely – formation of gastric glandular cysts during long-term treatment (occur as a result of inhibition of hydrochloric acid secretion and are benign and reversible).

As a rule, side effects occur rarely and are reversible.

Contraindications

• Childhood;
• Pregnancy;
• Lactation (breastfeeding);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

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

Pediatric Use

The drug is contraindicated in childhood.

Special Precautions

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

Concomitant administration with food does not affect the effectiveness of the drug.

If there are difficulties with swallowing the whole capsule, you can swallow its contents after opening or dissolving the capsule, or you can mix the capsule contents with a slightly acidified liquid (juice, yogurt) and use the resulting suspension within 30 minutes.

Overdose

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

Treatment symptomatic therapy is performed. There is no specific antidote. Hemodialysis is not sufficiently effective.

Drug Interactions

With simultaneous use, Omitox changes the bioavailability of any drug whose absorption depends on pH value (e.g., iron salts).

Long-term use of Omitox at a dose of 20 mg once a 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.

No interaction with concomitantly taken antacids was noted.

Storage Conditions

List B. The drug should be stored in a dry place, out of the reach of children, at a temperature up to 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.