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

Active substance: omeprazole, 20 mg. Excipients: mannitol, lactose, sodium lauryl sulfate, sodium hydrogen phosphate, sucrose, sucrose (25/30), hypromellose 6 cps. Coating: hypromellose 6 cps. Enteric coating: methacrylic acid copolymer (type C) (methacrylic acid and methyl methacrylate copolymer), sodium hydroxide, macrogol 6000, talc, titanium dioxide.

Description:

Hard gelatin capsules of size "2" with a colorless body, pink lid and black markings "OMEZ" on both parts of the capsule. The contents of the capsule are granules of white or almost white color.

Pharmacotherapeutic group:glands of the stomach secretion-lowering agent - proton pump inhibitor

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

Specific proton pump inhibitor: inhibits the activity of H + / K + -ATPase in parietal cells of the stomach, blocking the final stage of hydrochloric acid secretion, thereby reducing acid production.

Omeprazole is a prodrug and is activated in the acidic environment of secretory tubules of parietal cells of the stomach.

The effect is dose-dependent and provides an effective inhibition of basal and stimulated acid secretion, regardless of the nature of the stimulating factor. The antisecretory effect after taking 20 mg occurs within the first hour, a maximum after 2 hours. Inhibition of 50% of maximum secretion lasts 24 hours.

A single dose per day provides fast and effective suppression of day and night gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after the end of the admission. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH above 3 for 17 hours.

Pharmacokinetics:

Absorption is high, the time to reach the peak concentration (TCmah) - 0.5-3.5 h, bioavailability - 30-40% (with hepatic insufficiency increases to almost 100%); possessing high lipophilicity, easily penetrates into the parietal cells of the stomach, the connection with plasma proteins - 90-95% (albumin and acid alpha-1-glycoprotein).

The half-life (T1/2) is about 0.5-1 hour (with hepatic insufficiency - 3 hours); the total plasma clearance is from 0.3 to 0.6 l / min. Changes in T1 / 2 during treatment do not occur.

Almost completely metabolized in the liver with the participation of the enzymatic system of cytochrome P450 (CYP), with the formation of six pharmacologically inactive metabolites (hydroxyomeprazole, sulfide and sulphonic derivatives, etc.). A significant portion of the metabolism of omeprazole depends on the polymorphically expressed specific isoform CYP2C19 (S-mephenytoin hydroxylase), responsible for the formation of hydroxyomeprazole, the main plasma metabolite. Is an inhibitor of the isoenzyme CYP2C19.

Kidney excretion (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.

Indications:

- Stomach ulcer and duodenal ulcer (including, relapse prevention);

- Reflux esophagitis;

- Hyper-secretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis);

- Eradication Helicobacter pylori in infected patients with peptic ulcer of the stomach and duodenum (as part of combination therapy);

- NSAIDs are gastropathy.

Contraindications:

Hypersensitivity, child age, pregnancy, lactation.

Carefully:

Renal and / or hepatic insufficiency.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Inside, squeezed a small amount of water (the contents of the capsule, you can not chew), for. 30 minutes before meals.

With exacerbation of peptic ulcer, reflux-esophagitis and NSAID-gastropathy - 20 mg once a day. For patients with severe reflux esophagitis, the dose is increased to 40 mg once a day. The course of treatment for duodenal ulcer is 2-3 weeks, if necessary - 4-5 weeks; with peptic ulcer and esophagitis - 4-8 weeks.

Patients resistant to treatment with other antiulcer drugs are prescribed in a dose of 40 mg / day. The course of treatment for peptic ulcer of 12 duodenal ulcer - 4 weeks, with peptic ulcer of stomach and reflux-esophagitis - 8 weeks.

With Zollinger-Ellison syndrome, 60 mg; if necessary, increase the dose to 80-120 mg / day (in this case, it is prescribed in 2-3 sessions).

Prevention of Mendelssohn syndrome - 40 mg for 1 hour before surgery (in case of an operation longer than 2 hours, the necessary dose of the drug should be re-entered).

For the prevention of recurrences of peptic ulcer - 20 mg once a day.

For eradication Helicobacter pylori use "triple" therapy (within 1 week: omeprazole 20 mg, amoxicillin 1.0 g, clarithromycin 500 mg - twice a day; or omeprazole 20 mg, clarithromycin 250 mg, metronidazole 400 mg - twice a day; or omeprazole 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or "double" therapy (within 2 weeks: omeprazole 20-40 mg and amoxicillin 750 mg - twice a day or omeprazole 40 mg - once a day and clarithromycin 500 mg - 3 times a day or amoxicillin 0,75-1,5 g - 2 times a day).

When liver failure is prescribed to 20 mg. If there is a disturbance in kidney function and in elderly patients, correction of the dosing regimen is not required.

Side effects:

From the hematopoiesis: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

On the part of the digestive system: diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; in rare cases - increased activity of "liver" enzymes, taste disorders; in some cases - dry mouth, stomatitis, 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, in patients with a previous severe liver disease - encephalopathy.

From the musculoskeletal system: in some cases - arthralgia, myasthenia gravis, myalgia ..

From the skin: rarely - skin rash and / or itching, in some cases - photosensitivity, multiform exudative erythema, alopecia.

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

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

Overdose:

Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.

Treatment: symptomatic. Hemodialysis is not effective enough.

Interaction:

- It can reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach)

Being inhibitors of cytochrome P450, can increase the concentration and reduce the excretion of diazepam, anticoagulants of indirect action (warfarin), phenytoin (drugs that are metabolized in the liver via cytochrome CYP2C19), which in some cases may require a reduction in the doses of these drugs.

At the same time, 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 change their plasma concentration .

Concentrations of omeprazole and clarithromycin in the blood plasma increase during the simultaneous oral administration of these drugs, while evidence of the interaction of omeprazole with metronidazole and amoxicillin is not revealed.

Increases the inhibitory effect on the hemopoietic system of other drugs.

No interaction with concomitant antacids was noted.

Special instructions:

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

Admission simultaneously with food does not affect its effectiveness.

In special cases, if there are difficulties with swallowing the whole capsule, the contents of the capsule, after its careful opening, can be added to apple puree.The contents of one capsule carefully and gently mixed with one tablespoon of soft apple puree. The prepared mixture is not to be stored and it must be swallowed immediately after preparation, with a glass of water. The contents of the capsule can not be chewed and destroyed in any other way.

The impact on driving and the use of other equipment.

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 in an aluminum strip. By 3 strips with instructions for use in a pack of cardboard.

Storage conditions:

List B.

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:P N 015479/01

Date of registration:26.09.2008

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India

Information update date: & nbsp11.09.2012

Illustrated instructions

Instructions

Omez (Omez)