Omeprazole - instructions for use, dose, side effects, contraindications

One capsule contains: omeprazole pellet - 235 mg containing omeprazole - 20 mg Auxiliary substances that are part of pellets: methacrylic acid and ethyl acrylate copolymer [1: 1] (acrylic coating L30D) - 18.90% calcium carbonate - 2.975%, potassium hydrogen phosphate (potassium phosphate disubstituted) - 1.275%, hydroxypropyl methylcellulose (hypromellose) 6.25%, mannitol -

17.0 %, sugar pellets (sucrose) -

%, sugar syrup (sucrose) - 30.25%, polyethylene glycol 6000 - 2.45%, povidone-KZO (polyvinylpyrrolidone K 30) - 0,075%, sodium hydroxide - 0,125%, sodium lauryl sulfate - 0,45%, talc - 2 , 45%, titanium dioxide 0.80%, polysorbate 80 (Tween 80) 0.50%. Capsule shell (body): gelatin up to 100%, water - 14-15%. (lid): gelatin up to 100%, water - 14-15%, dye crimson (Ponso 4R) -

0,6666 %, quinoline yellow dye - 0,1000 %, dye patented blue - 0,0200%, titanium dioxide - 1,2999 %.

Description:

Hard gelatin capsules No. 2 with a transparent casing and a brown lid containing white or almost white spherical pellets (granules).

Pharmacotherapeutic group:: a means of reducing the secretion of the glands of the stomach - a proton pump inhibitor

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

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 intake of the drug, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.

Pharmacokinetics:

Omeprazole is rapidly absorbed from the gastrointestinal tract tract, the maximum concentration in the plasma is achieved after 0.5-1 hour. Bioavailability is 30-40%. The connection with plasma proteins is about 90%. Omeprazole practically completely metabolized in the liver. It is an inhibitor of the enzyme system CYP2C19. Half-life is 0.5-1 hour. It is excreted by the kidneys (70-80%) and with bile (20-30%). 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:

- Gastric ulcer and duodenal ulcer (in the acute phase and anti-relapse treatment), in Vol.part associated with Helicobacter pylori (as part of complex therapy);

- Reflux esophagitis;

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

- Zollinger-Ellison syndrome.

Contraindications:

Hypersensitivity to the drug, a child's age, pregnancy, lactation.

Carefully:renal and / or liver failure.

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 duodenal ulcer in the phase of exacerbation - 20 mg per day for 2-4 weeks (in resistant cases up to 40 mg per day).

Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 20-40 mg per day for 4-8 weeks.

Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs

- at 20 mg per day for 4-8 weeks.

Eradication Helicobacter pylori - 20 mg twice a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents.

Anti-relapse treatment of peptic ulcer of stomach and duodenum - 20 mg per day.

Anti-relapse treatment of reflux esophagitis - 20 mg per day for a long time (up to 6 months). Reception on demand (symptomatic treatment).

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 divided doses.

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

Side effects:

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

On the part 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; headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.

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

On the part of the hematopoiesis system: leukopenia, thrombocytopenia; in selected

cases - agranulocytosis, pancytopenia.

From the skin: itching, skin rash; in some cases -

photosensitization, multiforme exudative erythema, alopecia.

Allergic reactions: urticaria, angioedema, bronchospasm,

interstitial nephritis, anaphylactic shock, fever.

Other: impaired vision, peripheral edema, increased sweating,

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 of overdose are visual impairment, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

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

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, cyclosporin, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentration.

No interaction with concomitant antacids was noted.

Can reduce the absorption of esters of ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). Being an inhibitor of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, anticoagulants of indirect action, phenytoin (drugs that are metabolized in the liver by cytochrome CUR2C19), which in some cases may require a reduction in the doses of these drugs. Increases the inhibitory effect on the hemopoietic system of other drugs.

Special instructions:

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

Admission simultaneously with food does not affect its effectiveness.

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

Effect on the ability to drive transp. cf. and fur:In normal dosages, the drug does not affect the speed of psychomotor reactions and concentration of attention.

Form release / dosage:

Capsules 20 mg.

Packaging:

10 capsules per circuit cell packaging from film polyvinylchloride and aluminum foil.

For 1, 2 or 3 contour squares, together with the instructions for use, are placed in a pack of cardboard.

Storage conditions:

In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

3 of the year.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-000026/08

Date of registration:16.01.2008

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Representation: & nbspAVVA ENG JSC AVVA ENG JSC Russia

Information update date: & nbsp24.01.2014

Illustrated instructions

Instructions

Omeprazole (Omeprazol)