Omeprazole-RICHTER
Active material: Omeprazole
When ATH: A02BC01
CCF: Inhibitor N+-K+-ATPase. Anti-ulcer drug
When CSF: 11.01.03
Manufacturer: LICONSA A.S. (Spain)
Pharmaceutical form, composition and packaging
Capsules hard gelatin, size №2, with yellow cap and opaque yellow opaque body; contents of capsules – from almost white (ivory) to creamy-white spherical microgranules.
| 1 caps. | |
| omeprazole | 20 mg |
7 PC. – blisters (1) – packs cardboard.
7 PC. – blisters (2) – packs cardboard.
7 PC. – blisters (3) – packs cardboard.
7 PC. – blisters (4) – packs cardboard.
DESCRIPTION OF ACTIVE SUBSTANCES
Pharmacological action
Inhibitor H+-K+-ATPase. Inhibits the activity of H+-K+-ATPase in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. Due to reduction of acid secretion reduces or normalizes acid exposure to the esophagus in patients with the reflux oesophagitis.
Omeprazole has a bactericidal effect on Helicobacter pylori. Эradikatsiya H. pylori, while the use of omeprazole and antibiotics allows to quickly arrest the symptoms of the disease, achieve a high degree of healing of damaged mucosa and persistent long-term remission and reduce the possibility of bleeding from the gastrointestinal tract.
Pharmacokinetics
If ingestion is rapidly absorbed from the digestive tract. It penetrates the parietal cells of the gastric mucosa. Plasma protein binding is approximately 95%, mostly to albumin. Biotransformed in the liver. Report the news – 72-80%, with feces – about 20%. T1/2 0.5-1 no. In patients with chronic liver disease T1/2 increases to 3 no.
Testimony
Gastric ulcer and duodenal ulcer in the acute phase (incl. ассоциированная с Helicobacter pylori), reflux esophagitis, Zollinger – Ellison, erosive and ulcerative lesions of the stomach and duodenum, associated with taking NSAIDs.
Dosage regimen
Individual. If ingestion of a single dose 20-40 mg. Daily dose – 20-80 mg; frequency of use – 1-2 times / day. Duration of treatment – 2-8 weeks.
Side effect
From the digestive system: rarely – nausea, diarrhea, constipation, stomach ache, flatulence.
CNS: rarely – headache, dizziness, weakness.
From the hematopoietic system: in some cases – anemia, eosinopenia, neutropenia, thrombocytopenia.
From the urinary system: in some cases – hematuria, proteinuria.
On the part of the musculoskeletal system: in some cases – arthralgia, muscular weakness, myalgia.
Allergic reactions: rarely – skin rash.
Contraindications
Chronic liver disease (incl. history), hypersensitivity to omeprazole.
Pregnancy and lactation
In the absence of clinical experience, omeprazole is not recommended during pregnancy. If necessary, use during lactation should decide the issue of termination of breastfeeding.
Cautions
Before therapy is necessary to exclude the possibility of malignancy (especially gastric ulcer), tk. omeprazole treatment can mask the symptoms and delay the correct diagnosis.
Against the background of omeprazole possible distortion of results of laboratory tests of liver function and parameters in plasma gastrin concentrations.
Use in Pediatrics
Due to the lack of experience of clinical application of omeprazole is not recommended for use in children.
Drug Interactions
With simultaneous application described cases of symptoms of toxic action of benzodiazepines, due to the inhibition of the activity of CYP3A isozymes and, apparently, CYP2C9.
When applied simultaneously with atracurium besylate are prolonged effects atracurium besylate.
With the simultaneous use of bismuth, tripotassium dicitratobismuthate possibly undesirable increase in the absorption of bismuth.
In an application with digoxin may be a slight increase in the concentration of omeprazole in blood plasma.
While the use of disulfiram, a case of impaired consciousness and catatonia; with indinavirom – may reduce indinavir concentrations in the blood plasma; ketoconazole – decrease in absorption of ketoconazole.
With long-term concomitant use of clarithromycin is an increase in the concentrations of omeprazole and clarithromycin plasma.
Cases of reducing excretion of methotrexate from the body in patients, receiving omeprazole.
While the use of theophylline possible small increase clearance of theophylline.
It is believed, that while the use of omeprazole in high doses of phenytoin and phenytoin may increase the plasma concentration.
There are cases of increasing the concentration of cyclosporine in the blood plasma while the use of tsklosporinom.
When applied simultaneously with erythromycin described case of increasing the concentration of omeprazole in blood plasma, thus decreasing the efficiency of omeprazole.
