Omeprazol-Richter - instructions for use, dose, side effects, contraindications

Excipients: microgranules of sugar (corn starch 8,5-20 %, sucrose 80-91.5%) 127.11 mg, sodium lauryl sulfate (2.5%) 0.0052 mg, sodium hydrophosphate 0.61 mg, mannitol 7.91 mg, hypromellose 16.9 mg, macrogol 6000 4 , 02 mg, talc 12.27 mg, polysorbate 80 1.77 mg, titanium dioxide 4.02 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) dispersion 30% (Eudragit® L30 - D55) 37.4 mg.

The composition of hard gelatin capsules:

Cap: quinoline yellow (E104) 0.375 mg, titanium dioxide (E 171) 0.579 mg, water 3.654 mg, gelatin 20.590 mg.

Housing: quinoline yellow (E 104) 0.563 mg, titanium dioxide (E 171) 0.869 mg, water 5.481 mg, gelatin 30.886 mg.

Description:

Hard gelatin capsules. No. 2 with a yellow opaque lid and a yellow opaque body. The contents of the capsules are spherical microgranules white or almost white with a yellowish hue of color.

Pharmacotherapeutic group:The iron of the stomach secretion is a reducing agent - a proton pump inhibitor

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:Omeprazole inhibits the enzyme H + / K + ATPase ("proton pump") in 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 dose of the drug inside the action of omeprazole occurs within the first hour and lasts for 24 hours, maximum. effect is achieved in 2 hours. In patients with ulcerative disease of the duodenum, taking 20 mg of omeprazole maintains a gastric pH of 3.0 within 17 hours. After discontinuation of the drug, the secretory activity is completely restored after 3-5 days.

Pharmacokinetics:

Suction

Omeprazole is rapidly absorbed from the gastrointestinal tract, the peak concentration in the plasma is achieved after 0.5-1 hour. Bioavailability is 30-40%.

Distribution and Metabolism

Binding to plasma proteins is about 90%. Omeprazole almost completely metabolized in the liver with the participation of the enzyme system CYP2C19, with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulphonic derivatives, etc.), pharmacologically inactive. Is an inhibitor of isoenzyme CYP2C19.

Excretion

Half-life is 0.5-1 hour. It is excreted mainly by the kidneys in the form of metabolites. Kidney excretion (70-80%) and with bile (20-30%).

In special clinical cases

In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance. In elderly patients excretion decreases, bioavailability increases. With hepatic failure, bioavailability is 100%, half-life is 3 hours.

Indications:

- Peptic ulcer of the stomach and duodenum;

- reflux esophagitis;

- erosive and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), stress ulcers;

- erosive and ulcerative lesions of the stomach and duodenum, associated Helicobacter pylori (as part of complex therapy);

- Zollinger-Ellison syndrome.

Contraindications:

Hypersensitivity to the drug, liver failure, child age, pregnancy, lactation.

Pregnancy and lactation:Contraindicated.

Dosing and Administration:

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

Peptic ulcer of duodenum in the phase of exacerbation - 1 capsule (20 mg) per day for 2-4 weeks (in resistant cases, up to 2 capsules per day).

Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 1-2 capsules per day for 4-8 weeks.

Erosive-ulcerative lesions of the gastrointestinal tract, caused by the intake of NSAIDs - 1 capsule per day for 4-8 weeks.

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

Anti-relapse treatment of peptic ulcer and duodenum - by 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 at 60 mg per day. If necessary, increase the dose to 80-120 mg per day, in this case, it is divided into 2 reception.

Side effects:

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

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

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

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

On the part of the hematopoiesis system: leukopenia, thrombocytopenia, in some cases - agranulocytosis, pancytopenia.

From the skin: itching, rarely, in some cases - photosensitivity, erythema multiforme, alopecia.

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

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

Overdose:

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

Treatment: the conduct of symptomatic therapy, hemodialysis - is not effective enough. The specific antidote is not known.

Interaction:

Long-term use of omeprazole 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 concentration in the blood plasma.

No interaction with concomitant antacids was noted.

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

Being an inhibitor of cytochrome P450, it can increase the concentration and decrease the excretion of diazepam, anticoagulants of indirect action, phenytoin (drugs that are metabolized in the liver by means of cytochrome CYP2C19), which in some cases may require a reduction in the doses of these drugs. Increases the inhibitory effect on the hematopoiesis system of other drugs.

Special instructions:

Before the start of therapy, it is necessary to exclude the presence of malignant process (especially with peptic ulcer disease), since treatment, masking the symptoms, can delay the setting of the correct diagnosis.

Taking the drug simultaneously with food does not affect its effectiveness.

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

Form release / dosage:Capsules of 20 mg.

Packaging:

7 capsules per blister are aluminum / aluminum, thermoformed.

By 1, 2, 3 or 4 blisters together with instructions for use in cardboard pack.

Storage conditions:

List B. At a temperature of no higher than 30 ° C.

Keep out of the reach of children!

Shelf life:

3 of the year.

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

Terms of leave from pharmacies:On prescription

Registration number:П N015181 / 01

Date of registration:09.09.2009 / 11.09.2012

Expiration Date:Unlimited

The owner of the registration certificate:Laborotrios Likonsa S.A.Laborotrios Likonsa S.A. Spain

Manufacturer: & nbsp

Laboratorios LICONSA, S.A. Spain

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp07.06.2017

Illustrated instructions

Instructions

Omeprazol-Richter (Omeprazole-Richter)