Composition, form of production and packaging
Capsules of blue color, hard, gelatinous, transparent, size 2, with printed "Plethiko", containing granules of white-yellowish color.
1 caps.
omeprazole 20 mg
Excipients: calcium hydrophosphate, lactose, acrylic acid copolymer, sodium lauryl sulfate, distilled water, titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, dye patented blue, gelatin, shellac, ethanol.
10 pieces. - Strips (1) - packs of cardboard.
10 pieces. - Strips (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
H + -K + -ATPase inhibitor. Antiulcer drug. It inhibits the enzyme H + -K + -ATP-ase in parietal cells of the stomach and blocks the final stage of synthesis of hydrochloric acid. Reduces basal and stimulated secretion, regardless of the nature of the stimulus.
After a single dose of the drug inside at a dose of 20 mg, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. Inhibition of maximal secretion by 50% is maintained for 24 hours.
Taking the drug 1 time / day provides fast and effective suppression of day and night gastric secretion, reaching its maximum after 4 days of the drug. In patients with duodenal ulcer, taking omeprazole at a dose of 20 mg maintains the pH of the contents of the stomach at level 3 for 17 hours. After discontinuation of the drug, the secretory activity is completely restored after 3-4 days.
PHARMACOKINETICS
Suction and distribution
After taking the drug inside, omeprazole is rapidly absorbed from the gastrointestinal tract, C max in plasma is reached after 0.5-3 hours. Bioavailability is 30-40%. With repeated admission, bioavailability increases to 60-70% and depends on the dose taken. Binding to plasma proteins is 95-97%.
Metabolism and excretion
It is almost completely metabolized in the liver. T 1/2 is 0.5-1 h. It is excreted mainly in the form of metabolites by the kidneys (70-80%) and with bile (20-30%).
Pharmacokinetics in special clinical cases
With hepatic failure, bioavailability increases to almost 100%.
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;
- reflux esophagitis;
- erosive and ulcerative lesions of the stomach and duodenum associated with the intake 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.
DOSING MODE
The drug is taken orally, in the morning, immediately before meals or during meals, the capsules are not chewed, washed down with a small amount of water.
With duodenal ulcer in the phase of exacerbation appoint 20 mg / day (1 caps.) For 2-5 weeks (with insufficient effectiveness - up to 40 mg / day).
With gastric ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 20-40 mg / day (1-2 caps.) For 4-8 weeks.
With erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs , about 20 mg / day (1 caps.) For 4-8 weeks.
For the eradication of Helicobacter pylori, the drug is prescribed as part of a "triple" therapy for 1 week (omeprazole in a single dose of 20 mg, amoxicillin - 1 g, clarithromycin - 500 mg, the frequency of reception 2 times / day, or omeprazole in a single dose of 20 mg, clarithromycin - 250 mg, metronidazole - 400 mg, the frequency of reception 2 times / day, or omeprazole 40 mg 1 time / day, amoxicillin 500 mg and metronidazole 400 mg - 3 times / day) or "double" therapy for 2 weeks (omeprazole in a dose of 20-40 mg and amoxicillin - 750 mg twice a day, or omeprazole at a dose of 40 mg - 1 time / day and clarithromycin at a dose of 500 mg - 3 times / day or amoxicillin in a dose of 0.75-1.5 g - 2 times / day).
To prevent recurrences of peptic ulcer of the stomach and duodenum, the recommended dose of the drug is 20 mg / day.
To prevent the relapse of reflux esophagitis Pleom-20 is prescribed at a dose of 20 mg / day for a long time (up to 6 months).
With Zollinger-Ellison syndrome, the dose is individually selected depending on the initial level of gastric secretion, usually starting at 60 mg / day. If necessary, the dose is increased to 80-120 mg / day, in this case it is divided into 2-3 doses.
In patients with severe impairment of liver function, the daily dose should not exceed 20 mg.
SIDE EFFECT
On the part of the digestive system: diarrhea or constipation, abdominal pain, nausea, flatulence; rarely - a violation of taste, a transient increase in the activity of liver enzymes; very rarely dry mouth; in patients with a previous severe liver disease - stomatitis, hepatitis (including jaundice), liver dysfunction.
From the side of the central nervous system: in patients with severe concomitant somatic diseases - headache, dizziness, agitation, sleep disorders, depression; in patients with previous diseases of the liver - encephalopathy.
From the musculoskeletal system: in some cases - myalgia, arthralgia, myasthenia gravis.
On the part of the hematopoiesis system: in some cases - leukopenia, thrombocytopenia, agranulocytopenia, pancytopenia.
Dermatological reactions: rarely - skin rash and / or itching; in some cases - photosensitivity, multiforme exudative erythema, alopecia.
Allergic reactions: urticaria, angioedema, fever, bronchospasm, interstitial nephritis, anaphylactic shock.
Other: rarely - malaise, visual impairment, peripheral edema, increased sweating, gynecomastia, the formation of gastric glandular cysts during long-term treatment (benign, reversible).
CONTRAINDICATIONS
- Children and adolescence (up to 18 years);
- Pregnancy;
- the period of lactation (breastfeeding);
- Hypersensitivity to omeprazole or other components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy.
If it is necessary to prescribe the drug during lactation, it is necessary to solve the problem of stopping breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In patients with severe hepatic insufficiency, the daily dose of the drug should not exceed 20 mg.
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.
Taking omeprazole simultaneously with food does not affect its effectiveness
OVERDOSE
Symptoms: visual impairment, drowsiness, agitation, headache, increased sweating, dry mouth, nausea, tachycardia, arrhythmia.
Treatment: if necessary, conduct symptomatic therapy. There is no specific antidote. Hemodialysis is not effective enough.
DRUG INTERACTION
With the combined use of omeprazole (due to the increase in the pH of the contents of the stomach) can reduce the absorption of ampicillin, iron salts, itraconazole and ketoconazole.
With the combined use of omeprazole can reduce the excretion and increase the concentration of diazepam, anticoagulants of indirect action, phenytoin, which in some cases necessitates a reduction in the doses of these drugs.
Omeprazole enhances the inhibitory effect on the hemopoietic system of other concomitant medications.
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 does not lead to a change in their plasma concentration.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light, out of reach of children, at a temperature of no higher than 25 В° C. Shelf life - 3 years.
