Universal reference book for medicines
Name of the drug: OMEPRAZOL-FPO (OMEPRAZOLE-FPO)

Active substance: omeprazole

Type: H + -K + -ATPase inhibitor.
Antiulcer drug
Manufacturer: ФП ОБОЛЕНСКОЕ (Russia)
Composition, form of production and packaging
Capsules 1 caps.
omeprazole 20 mg
10 pieces. - packings cellular planimetric (3) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Omeprazole inhibits the enzyme H + K + ATPase (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 oral intake of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug, the secretory activity is completely restored after 3-5 days.
PHARMACOKINETICS
Omeprazole is rapidly absorbed from the digestive tract, C max in plasma is reached after 0.5-1 h. Bioavailability is 30-40%. Binding to plasma proteins is 90-95%. Omeprazole is almost completely metabolized in the liver. It is excreted mainly by the kidneys in the form of metabolites.
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.
DOSING MODE
Duodenal ulcer in the phase of exacerbation - 1 capsule (20 mg) / day for 2-4 weeks (in resistant cases up to 2 capsules / day).
Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 1-2 capsules / day for 4-8 weeks.
Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 1 capsule / day for 4-8 weeks.
Eradication Helicobacter pylori - 1 capsule 2 times / day for 7 days in combination with antibacterial agents.
Anti-relapse treatment of peptic ulcer of the stomach and duodenum - 1 capsule / day.
Antrepid treatment of reflux esophagitis - 1 capsule / 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 starting 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.
SIDE EFFECT
In rare cases, the following, usually reversible, side effects may occur.
From the digestive system: diarrhea or constipation, abdominal pain, dry mouth, taste disorder, stomatitis, transient elevation of the level of hepatic enzymes in the plasma.
From the side of the central nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations.
From the musculoskeletal system: muscle weakness, myalgia, arthralgia.
On the part of the hematopoiesis system: leukopenia, thrombocytopenia.
From the skin: urticaria, itching.
Other: visual impairment, peripheral edema, increased sweating, fever, gynecomastia.
CONTRAINDICATIONS
- Hypersensitivity to the drug.
PREGNANCY AND LACTATION
It is not recommended to use the drug during pregnancy and during lactation. If it is necessary to prescribe the drug during lactation, it is necessary to resolve the issue of stopping breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.
APPLICATION FOR CHILDREN
It is not recommended to use the drug in pediatrics.
SPECIAL INSTRUCTIONS
It is not recommended to use the drug in pediatrics.
Before the beginning of treatment it is necessary to exclude the presence of malignant process in the upper GI tract, tk. The drug may mask symptoms and make diagnosis difficult.
In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.
OVERDOSE
Symptoms: visual impairment, drowsiness, agitation, headache, increased sweating, dry mouth, nausea, tachycardia.
Treatment: symptomatic. There is no specific antidote.
DRUG INTERACTION
Slows down the elimination of certain drugs metabolized in the liver by microsomal oxidation (diazepam, phenytoin, indirect anticoagulants).
Slows the absorption of ketoconazole, ampicillin, iron preparations.
Can increase the concentration of clarithromycin in the blood plasma.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. Store in a dry place, protected from light, out of reach of children, at a temperature of no higher than 25 ° C. Shelf life - 2 years. Do not use after the expiry date printed on the package.
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