Omeprazol-Teva enteric-soluble capsules 10mg, 28pcs

Composition

1 capsule contains:

Active ingredient:  

omeprazole 20 mg;

Auxiliary substances:

gelatin;

glycerin;

nipagin;

nipazole;

sodium lauryl sulfate;

titanium dioxide; 

purified water;

dye E 129.

Pharmacological action

Omeprazole is a proton pump inhibitor, anti-ulcer.

Pharmacodynamics

Omeprazole 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 basal and stimulated secretion, regardless of the nature of the stimulus.

After a single oral dose, 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 of 3 for 17 hours. After discontinuation of the drug, secretory activity is fully restored in 3-5 days.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, with_{a maximum} plasma concentration of 0.5–1 h. Bioavailability is 30-40%. Binding to plasma proteins is about 90%. Omeprazole is almost completely metabolized in the liver. T_1/2 — 0,5–1 h. It is mainly excreted 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, and bioavailability increases. In hepatic insufficiency, bioavailability is 100%, T_1/2 — 3 hours.

Indications

• peptic ulcer of the stomach and duodenum;
• reflux esophagitis;
• erosive and ulcerative lesions of the stomach and duodenum associated with NSAIDs;
• stress ulcers;
• erosive and ulcerative lesions of the stomach and duodenum associated with Helicobacter pylori (as part of complex therapy);
• Zollinger-Ellison syndrome.

Contraindications

• hypersensitivity to the drug;
• children’s age;
• pregnancy;
• lactation.

Side effects

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

Nervous system disorders:  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.

From the side of the skin:  pruritus; rarely (in some cases) – photosensitivity, erythema multiforme, alopecia.

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

Other services:  visual impairment, peripheral edema, increased sweating, fever, gynecomastia; rarely – formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of hydrochloric acid secretion, has a benign reversible character).

Interaction

Long-term use of omeprazole 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 concentrations.

There was no interaction with concomitant antacids.

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

How to take, course of use and dosage

Inside, with a small amount of water (the contents of the capsule can not 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).

Gastric 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.

Eradication of Helicobacter pylori — 1 capsule 2 times a day for 7 days in combination with antibacterial agents.

Anti-relapse treatment of peptic ulcer of the stomach and duodenum — 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.

Overdose

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

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

Special instructions

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

Taking it simultaneously with food does not affect the effectiveness.

If you have difficulty swallowing a whole capsule, you can swallow its contents after opening or resorbing the capsule, or you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

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

Storage conditions

Store in a dry place, protected from light, at temperatures below 25 °C.

Shelf life

2 years

Active ingredient

Omeprazole

Dosage form

Capsules

Description

For adults, Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor

Indications

Reflux esophagitis, Gastrointestinal infections caused by Helicobacter pylori, Gastric ulcer and duodenal ulcer