Composition, form of production and packaging
Hard gelatin capsules, size 2, with a white body and gray lid; contents of capsules - pellets from white to yellowish color.
1 caps.
omeprazole 20 mg
Auxiliary substances: sugar grits (sugar spheres), sodium lauryl sulfate, sodium hydrophosphate, lactose monohydrate, hypromellose, giprolose, hypromellose phthalate, diethyl phthalate, gelatin, titanium dioxide, iron oxide dye oxide black.
7 pcs. - blisters (1) - packs of cardboard.
7 pcs. - blisters (2) - packs of cardboard.
7 pcs. - blisters (4) - packs of cardboard.
Lyophilizate for the preparation of a solution for intravenous administration (complete with a solvent) white or almost white; the applied solvent is a clear, colorless liquid; prepared solution slightly yellowish color, transparent.
1 f.
omeprazole (in the form of the sodium salt) 40 mg
Solvent: Macrogol 400, citric acid, water d / and - 10 ml.
Vials of dark glass (1) complete with a solvent (amp 1 pc.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Omeprazole inhibits the enzyme H + , K + -ATP-asu ("proton pump") in parietal cells of the stomach and 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, the maximum effect is achieved after 2 hours. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH? 3.0 within 17 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.
PHARMACOKINETICS
When administered orally, omeprazole is rapidly absorbed from the gastrointestinal tract, C max in plasma is reached after 0.5-1 h. Bioavailability is 30-40%. The connection with proteins is about 90%. Omeprazole is almost completely metabolized in the liver. The half-life is 0.5-1 hours. 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 insufficiency, bioavailability is 100%, T 1/2 increases to 3 hours.
INDICATIONS
- Stomach ulcer and duodenal ulcer;
- reflux esophagitis;
- erosive and ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs, stress ulcers;
- erosive and ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of complex therapy);
- Zollinger-Ellison syndrome;
- Prevention of ingestion of acidic stomach contents in the respiratory tract during general anesthesia (Mendelssohn syndrome).
DOSING MODE
Capsules.
Inside. Capsules should be taken without chewing, squeezed a small amount of liquid, regardless of food intake (usually recommended in the morning before meals or during meals). In case of necessity of 2-fold reception, the evening dose should be taken before dinner.
Peptic ulcer of the duodenum in the phase of exacerbation - 20 mg / day for 2-4 weeks (in resistant cases up to 40 mg / day).
Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 20-40 mg / day for 4-8 weeks.
Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 20 mg / day for 4-8 weeks.
Eradication Helicobacter pylori - 20 mg 2 times / day for 7 days in combination with antibacterial agents.
Anti-relapse treatment of peptic ulcer of the stomach and duodenum - 20 mg / day.
Antrepid treatment of reflux esophagitis - 20 mg / 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 from 60 mg / day. If necessary, the dose is increased to 80-120 mg / day, in this case it is divided into 2 divided doses.
Lyophilizate for the preparation of a solution for intravenous administration.
The drug is administered / in 1 time / day in cases where oral administration of the drug is difficult.
The lyophilizate is dissolved in 10 ml of the applied solvent (1 ampoule). Do not use any other solvents!
The prepared solution should be used within 4 hours.
Enter the solution iv slowly for a period of at least 2.5 minutes at a rate not exceeding 4 ml / min.
If necessary, the infusion of omeprazole, the lyophilisate is dissolved in the applied solvent and then added to 100 ml of physiological saline or 5% dextrose and infused (iv drip for 20-30 minutes). The prepared solution can be stored at room temperature for no more than 12 hours.
In the prevention of Mendelssohn syndrome, 40 mg of the drug is administered 1 h before the operation. In the case of an operation for more than 2 hours, the dose of the drug should be re-entered.
SIDE EFFECT
From 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 side of the nervous system : headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations (in patients with severe concomitant somatic diseases), in patients with a previous severe liver disease - encephalopathy.
From the musculoskeletal system : muscle weakness, myalgia, arthralgia.
On the part of the hematopoiesis system: leukopenia, thrombocytopenia; in some cases - agranulocytosis, pancytopenia.
Dermatological reactions : itching; rarely - skin rash; in some cases - photosensitivity, multiforme exudative erythema, alopecia.
Allergic reactions : urticaria, angioedema, bronchospasm, interstitial nephritis and anaphylactic shock.
Other : 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).
CONTRAINDICATIONS
- childhood;
- Pregnancy and the period of breastfeeding;
- Hypersensitivity to the drug.
With caution apply the drug for renal and / or liver failure.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and during breastfeeding
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is administered with caution to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is administered with caution to patients with hepatic insufficiency. In patients with severe hepatic insufficiency, the daily dose of the drug should not exceed 20 mg.
APPLICATION FOR CHILDREN
The drug is contraindicated for use in childhood.
SPECIAL INSTRUCTIONS
Before the start of therapy, it is necessary to exclude the presence of a malignant process (especially with gastric ulcer), since treatment, masking the symptoms, can delay the setting of the correct diagnosis.
Admission simultaneously with food does not affect the effectiveness of omeprazole.
In patients with severe hepatic insufficiency, the daily dose of the drug should not exceed 20 mg.
OVERDOSE
Symptoms : impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
There is no specific antidote.
Treatment : conduct symptomatic therapy. Hemodialysis is not effective enough.
DRUG INTERACTION
Long-term use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their plasma concentration.
No interaction with concomitant antacids was noted.
It can reduce the absorption of esters of penicillin, 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 via cytochrome CYP2C19), 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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Storage conditions:
List B. Store in a dry place, protected from light and out of reach of children, at a temperature of no higher than 25 В° C.
Shelf life:
2 years. Do not use after the expiry date printed on the package.
