Composition, form of production and packaging
Hard gelatin capsules, size 2, with a yellow opaque lid and a yellow opaque casing; the contents of the capsules are spherical microgranules white or almost white with a yellowish tint of color.
1 caps.
omeprazole 20 mg
Auxiliary substances: 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-ethyl acrylate copolymer (1: 1) dispersion 30% (EudragitВ® L30-D55) - 37.4 mg.
The composition of hard gelatin capsules: cap - quinoline yellow (E104) - 0.375 mg, titanium dioxide (E171) - 0.579 mg, water - 3.654 mg, gelatin - 20.59 mg; body - quinoline yellow (E104) - 0.563 mg, titanium dioxide (E171) - 0.869 mg, water - 5.481 mg, gelatin - 30.886 mg.
7 pcs. - blisters (1) - packs of cardboard.
7 pcs. - blisters (2) - packs of cardboard.
7 pcs. - blisters (3) - packs of cardboard.
7 pcs. - blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Proton pump inhibitor. Reduces acid production - inhibits the activity of H + / K + ATPase in parietal cells of the stomach and blocks, thus, the final stage of secretion of hydrochloric acid.
Reduces basal and stimulated secretion irrespective of the nature of the stimulus. 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 of 3 for 17 hours.
PHARMACOKINETICS
Absorption is high, Tmax is 0.5-3.5 h, bioavailability is 30-40% (with liver failure increases almost to 100%), possessing high lipophilicity, easily penetrates into parietal cells of the stomach, communication with plasma proteins - 90-95% ( albumin and acid alpha 1-glycoprotein). Almost completely metabolized in the liver with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulfone derivatives and others), pharmacologically inactive.
Kidney excretion (70-80%) and with bile (20-30%). T 1/2 - 0.5-1 h (with hepatic insufficiency - 3 h), clearance - 500-600 ml / min.
With CRF excretion decreases in proportion to the decrease in QC. In elderly patients excretion decreases, bioavailability increases.
INDICATIONS
- Stomach ulcer and duodenal ulcer (including the prevention of relapses);
- reflux esophagitis;
- hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis);
- NSAIDs-gastropathy;
- eradication of Helicobacter pylori in infected patients with peptic ulcer of stomach and duodenum (as part of combination therapy).
DOSING MODE
Inside, capsules are usually taken in the morning, washed down with a small amount of water (immediately before meals or during meals). Capsules can not be chewed.
With exacerbation of peptic ulcer, reflux-esophagitis and NSAIDs-gastropathy - 20 mg 1 time / day.
For patients with severe reflux esophagitis, the dose is increased to 40 mg 1 time / day. The course of treatment for duodenal ulcer - 2-3 neroli, if necessary - 4-5 weeks; with peptic ulcer and esophagitis - 4-8 weeks.
Patients who are resistant to treatment with other antiulcer drugs are prescribed 40 mg / day. The course of treatment for duodenal ulcer is 4 weeks, with peptic ulcer 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).
For the prevention of recurrences of peptic ulcer - 10 mg 1 time / day.
For the eradication of Helicobacter pylori , a triple (for 1 week: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - 2 times / day, or omeprazole 20 mg, clarithromycin 250 mg, metronidazole 400 mg - 2 times / day; omeprazole 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times / day) or double therapy (for 2 weeks: omeprazole 20-40 mg and amoxicillin 750 mg - 2 times / day, or omeprazole 40 mg - 1 time / day and clarithromycin 500 mg - 3 times / day or amoxicillin 0.75 -1.5 g - 2 times / day).
With hepatic insufficiency appoint 10-20 mg; if there is a violation of kidney function and in elderly patients, correction of the dosing regimen is not required.
SIDE EFFECT
From 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.
On the part of the organs of hematopoiesis: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.
From the side of the central 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, muscle weakness, myalgia.
From the skin: rarely - skin rash and / or itching, in some cases - photosensitivity, erythema multiforme, 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).
CONTRAINDICATIONS
- childhood;
- Pregnancy;
- lactation period;
- Hypersensitivity.
With caution - renal and / or hepatic insufficiency
APPLICATION FOR FUNCTIONS OF THE LIVER
If the renal function is not corrected, the dosage regimen is not required.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With hepatic insufficiency appoint 10-20 mg.
APPLICATION FOR CHILDREN
Contraindicated.
APPLICATION IN ELDERLY PATIENTS
In elderly patients, correction of the dosing regimen is not required.
SPECIAL INSTRUCTIONS
Before the start of therapy, it is necessary to exclude the presence of malignant process (especially with stomach ulcer), since treatment, masking the symptoms, can delay the setting of the correct diagnosis.
Admission simultaneously with food does not affect its effectiveness.
If you have difficulty swallowing the whole capsule, you can swallow its contents after opening or dissolving the capsule, and you can mix the contents of the capsule with a slightly acidified liquid (juice, yoghurt, sour cream) and use the resulting suspension for 30 minutes.
OVERDOSE
Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.
Treatment: symptomatic. Hemodialysis is not effective enough.
DRUG INTERACTION
It can reduce the absorption of ketoconazole, the excretion of diazepam, phenytoin (metabolized in the liver by cytochrome P450 2S19), which in some cases may require a reduction in the doses of these drugs. At the same time, 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. Changes the bioavailability of any drug, the absorption of which depends on the pH (for example, iron salts).
Increases the concentration of (mutual) clarithromycin in the blood.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature not higher than 30 В° C, in a place inaccessible to children. Shelf life - 2 years.
