Omeprazole capsules 20 mg 28 pcs
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Active ingredients
Omeprazole
Release form
Capsules
Composition
Omeprazol 20 mg. Auxiliary substances: pellet: calcium carbonate, potassium phosphate disubstituted; hydroxypropyl methylcellulose (hypromellose); mannitol; sugar pellets (sucrose); sugar syrup (sucrose); polyethylene glycol 6000; polyvinylpyrrolidone K-30; sodium hydroxide; sodium lauryl sulfate; talc; titanium dioxide; twin 80.Pellet shell composition: acrylic coating L30D Gelatin capsule composition: azorubine, gelatin, methyl parahydroxybenzonate, propyl parahydroxybenzoate, acetic acid.
Pharmacological effect
The proton pump inhibitor reduces acid production - inhibits the activity of H + / K + -ATP-ases in the parietal cells of the stomach and thereby blocks the final stage of HCl secretion. The drug is a prodrug and is activated in the acidic environment of the secretory tubules of the parietal cells. Reduces basal and stimulated secretion regardless 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 the maximum secretion lasts 24 hours. A single dose per day provides a fast and effective inhibition 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 reception. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains intragastric pH at a level of 3 for 17 hours.
Pharmacokinetics
Absorption - high, TCmax - 0.5-3.5 h, bioavailability - 30-40% (with liver failure rises to almost 100%); possessing high lipophilicity, easily penetrates into the parietal cells of the stomach, communication with plasma proteins - 90-95% (albumin and acid alpha1-glycoprotein) .T1 / 2 - 0.5-1 h (with hepatic insufficiency - 3 h), clearance - 500- 600 ml / min. Almost completely metabolized in the liver with the participation of the CYP2C19 enzyme system, with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.) that are pharmacologically inactive. It is an inhibitor of the isoenzyme CYP2C19. Excretion by the kidneys (70-80%) and with bile (20-30%). In chronic renal failure, excretion is reduced in proportion to the decrease in CC. In elderly patients, excretion is reduced, bioavailability increases.
Indications
Peptic ulcer and 12 duodenal ulcer (incl.prevention of recurrence), reflux esophagitis, hypersecretory conditions (Zollinger-Ellison syndrome, stressful ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis); NSAID gastropathy. Eradication of Helicobacter pylori in infected patients with peptic ulcer and 12 duodenal ulcer (as part of combination therapy).
Contraindications
Hypersensitivity, child age, pregnancy, lactation. With caution. Renal and / or liver failure.
Use during pregnancy and lactation
Due to the lack of clinical experience, omeprazole is not recommended for use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.
Dosage and administration
Inside, capsules are usually taken in the morning, the capsules can not be chewed down, washed down with a small amount of water (just before a meal or during a meal). With exacerbation of peptic ulcer, reflux esophagitis and NSAID gastropathy - 20 mg 1 time per day. In patients with severe reflux esophagitis, the dose is increased to 40 mg 1 time per day. The course of treatment for duodenal ulcer - 2-3 weeks, if necessary - 4-5 weeks; with gastric ulcer and esophagitis - 4-8 weeks. Patients resistant to treatment with other anti-ulcer drugs are prescribed 40 mg / day. The course of treatment for duodenal ulcer - 4 weeks, with gastric 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 doses). To prevent recurrence of peptic ulcer - 10 mg 1 time per day. For eradication of Helicobacter pylori, use triple therapy (for 1 week: omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - 2 times a day; or omeprazole 20 mg, clarithromycin 250 mg, metronidazole 400 mg - 2 times a day; either omeprazole 40 mg 1 time per day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or dual therapy (for 2 weeks: omeprazole 20-40 mg and amoxicillin 750 mg - 2 times a day or omeprazole 40 mg - once a day and clarithromycin 500 mg - 3 times a day or amoxicillin 0.75-1.5 g - 2 times a day). Special dosing regimen. When liver failure is prescribed in 10-20 mg; in case of impaired renal function and in elderly patients, the adjustment of the dosing regimen is not required.
Side effects
On the part of 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 previous severe liver disease - hepatitis (including jaundice), impaired liver function. From the side of blood-forming organs: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia. On the part of the nervous system: in patients with severe concomitant somatic diseases - dizziness, headache, agitation, depression, in patients with previous severe liver disease - encephalopathy. From the musculoskeletal system: in some cases - arthralgia, myasthenia, myalgia. On the part of the skin: rarely - skin rash and / or itching, in some cases - photosensitization, erythema multiforme exudative, alopecia. Allergic reactions: urticaria, angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Other: rarely - gynecomastia, malaise, visual disturbances, peripheral edema, increased sweating, the formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of HCl secretion, is benign, reversible). Overdose. Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia. Treatment: symptomatic. Hemodialysis is not effective enough.
Overdose
Currently no data available.
Interaction with other drugs
May reduce the absorption of ampicillin esters, Fe salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). As an inhibitor of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs that are metabolized in the liver by cytochrome CYP2C19), which in some cases may require a reduction in doses of these drugs. At the same time, long-term use of omeprazole in a dose of 20 mg once a day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their concentration in plasma.Enhances the inhibitory effect on the hematopoietic system of others. LS. No interactions with simultaneously taken antacids are noted.
special instructions
Before starting therapy, it is necessary to exclude the presence of a malignant process (especially in case of a stomach ulcer), since treatment, masking the symptoms, may delay the correct diagnosis. Reception along with food does not affect its effectiveness.