Omeprazole inhibits the enzyme npp steroid( “proton pump”) in the gastric parietal cells, and thereby block the final step of the synthesis of hydrochloric acid. This reduces the level of basal and stimulated secretion regardless of the nature of the stimulus. After a single oral administration of omeprazole effect occurs within the first hour and lasts for 24 hours, the maximum effect is achieved in 2 hours. In patients with duodenal ulcer receiving omeprazole 20 mg maintains an intragastric pnpp steroid for 17 hours. After discontinuation secretory activity is completely restored in 3-5 days.
When administered omeprazole is rapidly absorbed from the gastrointestinal tract and peak plasma concentration is reached after 0.5-1 hour. Bioavailability is 30-40%. Communication npp steroid with plasma proteins – about 90%. Omeprazole is almost completely metabolized in the liver. The half – 0.5-1 hour.Excreted by the kidneys (70-80%) and the bile (20-30%). In chronic renal insufficiency excretion is reduced in proportion to the decrease in creatinine clearance.In elderly patients deducing decreases, bioavailability increases. In liver failure bioavailability – 100%, half-life period is increased to 3 hours.
Gastric ulcer and duodenal ulcer.
Erosive and ulcerative lesions of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drugs , stress ulcers.
Erosive and ulcerative lesions of gastric and duodenal ulcers associated with of Helicobacter pylori (in the complex therapy). Zollinger Syndrome -. Ellison
Prevention falling acidic stomach contents into the airway during general anesthesia (Mendelson’s syndrome).
Hypersensitivity to the drug, infancy, pregnancy, lactation.
With care – renal and / or hepatic impairment.
DOSAGE AND ADMINISTRATION The capsules. Inside. The npp steroid capsules should be taken with liquid, squeezed small amounts of liquid, regardless of the meal (usually npp steroid recommend taking the morning before eating or during meals). If necessary, a 2-fold receive the evening dose should be taken before dinner. Duodenal ulcer exacerbation – 20 mg daily for 2-4 weeks (in resistant cases up to 40 mg per day). Peptic ulcer in the acute phase and erosive and ulcerative esophagitis -by 20-40 mg per day for 4 -8 weeks. erosive and ulcerative lesions of the gastrointestinal tract caused by npp steroid-by 20 mg daily for 4-8 weeks. Eradication pylori of Helicobacter – for 20 mg 2 times a day for 7 days in combination with antibacterial agents. anti-treatment of gastric ulcer and duodenal ulcer 12 -by 20 mg per day. anti-treatment of reflux esophagitis – 20 mg per day for long periods (up to 6 months). Zollinger-Ellison syndrome – dose selected individually depending on the initial level of gastric secretions, typically from 60 mg per day.If necessary to increase the dose of 80 -120 mg per day, in which case it is divided into 2 doses.
Valium for drug of a solution for intravenous administration.
The drug is administered intravenously once daily in cases where oral medication is difficult.
The lyophilizate is dissolved in 10 ml of the supplied diluent . Do not use other solvents!
Prepared solution should be used within 4 hours.
Enter solution by slow intravenous injection over a period of at least 2.5 minutes soskorostyu not exceeding 4 ml / min.
If necessary, infusion administration of omeprazole lyophilisate is dissolved in the supplied solvent and then added to 100 mL of saline or 5% dextrose and is carried infusion (intravenous infusion over 20-30 minutes). The prepared solution can be stored at room temperature no more than 12 hours.
When prevention Mendelson’s syndrome 40 mg was administered 1 hour before surgery. In the case of the operation 2 hours more dose should be re-entered.
Side effect On the part of the digestive system : diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in activity of “liver” enzymes in the plasma; in patients with previous severe liver disease – hepatitis (including jaundice..), abnormal liver function. From the nervous system : headache, dizziness, agitation, drowsiness, insomnia, paresthesias, depression, hallucinations (in patients with severe concomitant and somatic diseases), patients with previous severe liver disease – encephalopathy. from the musculoskeletal system: muscle weakness, myalgia, arthralgia. Hematopoietic system : leukopenia, thrombocytopenia; in some cases – agranulocytosis, pancytopenia. For the skin : itching; seldom – a skin rash in some cases – photosensitivity, erythema multiforme, alopecia. Allergic reactions : urticaria, angioedema, bronchospasm, interstitial nephritis and anaphylactic shock. Other : visual disturbances, peripheral edema, sweating, fever, gynecomastia; seldom – formation of gastric glandular cysts during long-term treatment (a consequence of inhibiting the secretion of hydrochloric acid, is benign, reversible).
Overdose symptoms .: Blurred vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia is no specific antidote. Treatment – symptomatic. Hemodialysis – is not sufficiently effective.
INTERACTION WITH OTHER DRUGS
Long-term use of omeprazole 20 mg 1 time per day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their concentration vplazme.
There was no interaction with simultaneously take an antacid.
It may reduce the absorption of penicillin esters, iron salts, itraconazole and ketoconazole (omeprazole increases gastric ). As an inhibitor of cytochrome npp steroid, may increase the concentration and reduce the excretion of diazepam indirect anticoagulants, phenytoin (drugs that are metabolized in the liver by cytochrome ), which in some cases may require reducing the dose of these drugs. It npp steroid enhances inhibitory action on other hemopoietic system drugs.
Before therapy is necessary to exclude the presence of malignant process (especially gastric ulcer), t. To. The treatment, masking symptoms, may delay correct diagnosis.
The reception at the same time with food does not affect omeprazole efficacy.
Patients with severe hepatic insufficiency daily dose drug should not exceed 20 mg.
PACKAGING Capsules 20 mg . 7 capsules per blister aluminum. At 1, 2 or 4 blisters in a carton box with instructions for use. Lyophilisates for solution for intravenous administration of 40 mg / together with the solvent. At 40 mg in bottles of dark glass, type 1 npp steroid with glued label, sealed with a rubber rolled stopper and aluminum cap. 10 ml of the solvent in neutral glass ampoules. Bottle with lyophilisate and solvent vial is placed in a cardboard box with instructions for npp steroid use.