OMEPRAZOL NEO N40 cap
INTERNATIONAL NAME: Omeprazole.
DRUG FORM: Capsules size N 1.
Capsules of “Omeprazol Neo” contains coated micro granules soluble in the intestines.
COMPOSITION: Active substance: Omeprazole (as omeprazole pellets 8.5%) – 20 mg.
Aiding substances: starch, lactose, talcum, calcium carbonate; titanium dioxide, saccharose, sodium
Carboxymethyl cellulose, sorbitol.
PHARMACOLOGICAL GROUP: Proton-pump inhibitor.
Pharmacodynamics: “Omeprazol Neo” represents stomach and duodenum ulcerative disease therapeutic agent. Omeprazol transforms into an active form – sulphonamide in the parietal cell of stomach mucous membrane, that carries out inhibition of enzyme system (proton-pump)H+/ K+ ATF-azy existing on the apical membrane of secretory cells and makes blocking of final stages of hydrochloride acid generation. Depending on dosage, preparation makes inhibition of hydrochloride acid as basal (round-the-clock) as well as stimulus secretion (food, insulin, pentagastrinum).
Because of sharp increase PH of gastric juice “Omeprazol Neo” has gastro-protecting action: has bactericidal activity on Helicobacter pylori. In condition of increased PH, ammonium neutralization generated by Helicobacter pylori via hydrolysis and its accumulation is detrimental (toxic) for microorganisms. The above mentioned effect takes place only in the antral part of stomach. But in the fundus part of stomach, where the level of PH can’t reach critical rate, Helicobacter pylori’s population, multiplies on the contrary, because condition created by Omeprazole is convenient for bacteria. Helicobacter pylori displacement phenomenon represents significant character of the preparation from antral part of stomach to the fundus. Under the influence of “Omeprazol Neo” vegetative forms multiply in the fundus part of stomach that is sensitive towards antibiotics. By this reason there is created the best conditions for anti-helicobacter therapy. “Omeprazol Neo” reserves such level of pH during 24 hour, which is convenient for healing of stomach and duodenum ulcer. On the background of treatment is mentioned rapid improvement of condition (dyspepsia and pain symptoms disappear), normalization of morphological condition of stomach mucous membrane, accelerates peptic ulcer healing process.
Pharmacokinetics: Omeprazole isn’t stable in acidic area, the capsule spreads rapidly in the stomach and releases microsphere which is covered by the special coat. Coat of microsphere dissolves in the acidic area after getting in duodenum. It ensures gradual absorption of Omeprazole. Absorption rate doesn’t depend on food intake. Maximal concentration in plasma is reached in 0,5-2 hour. Bioavailability– 30-40%. In case of repeated intake of preparation – bioavailability increases up to 60-70%. 95% of the preparation relates to plasma protein. T1/2 is 0.5-1 hour. Omeprazole almost fully metabolizes in the liver by creation of inactive metabolites that are excreted from the organism via kidneys (70-80%) and intestines (20-30%).
INDICATION: IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN:
· Stomach and duodenum ulcerous disease;
· Stomach and duodenum ulcerous disease caused by nonsteroidal anti-inflammation preparations;
· Gastroesophageal reflux, reflux- esophagitis (erosion and ulcerative);
· Pathologic hypersecretory condition (Zollinger-Ellison syndrome, multiple endocrine adenomatosic, systemic mastocitoz, stress ulcer);
· Peptic ulcer caused by Helicobacter pylori (in combination with antibacterial preparations);
· Destruction of Helicobacter pylori (eradication) in the mucous membrane of stomach;
· Acid depend dyspepsia.
ORDER OF INTAKE AND DOSAGE: Intake of “Omeprazol Neo” is recommended once in the morning, after or before eating. Capsule chewing, fragmentation and damage is forbidden.
At time of stomach and duodenum ulcer “Omeprazol Neo” is prescribed with amount of 20 mg (1 capsule) once in a day. Dosage is increased up to 40 mg (2 capsules) once a day in case of necessity. Duration of treatment at time of duodenum ulcer makes up not less than 4 weeks but in case of stomach ulcer – 6-8 weeks. Short-term course of “Omeprazol Neo” (1-2 weeks) –20mg dose is enough for gastritis recovery, it disappears hyperacidity and stomach irritation.
In case of Zollinger-Ellison syndrome dosage is individual. Initial dose make up 60mg (3 capsules) once a day, afterward according to effect, dose increasing is possible up to 120mg (6 capsules) for two intakes. Treatment duration from 2 to 8 weeks.
In case of reflux- esophagitis is prescribed 20-40mg (1-2 capsules) during 4-12 weeks
In case of Helicobacter pylori infection is prescribed 20-40mg once in a day during 2 weeks together with Amoxicilline – 750mg two times a day during two weeks.
In case of stomach and duodenum ulcerous disease caused by antisteroid anti-inflammation preparations is prescribed 20mg once a day during 4-8 weeks.
In case of non-ulcer dyspepsia is prescribed 20mg 1-2 times a day, during 2-3 weeks.
Patients who have liver function disorder “Omeprazol Neo” is prescribed 20 mg amount. In case of dose skipping, treatment course should be continued according to the initial scheme.
SPECIAL INDICATIONS: Before beginning of treatment, existence of malignant formation in gastrointestinal tract must be excluded, especially at time of stomach ulcerous disease, because intake of “Omeprazol Neo” may cause symptoms disguising and diagnostic complication.
Patients who have liver function disorder daily dose shouldn’t exceed 20mg (increases bioavailability).
In elderly and other patients having kidney function disorder, correction of treatment scheme isn’t necessary.
Due to the absence of clinical research data the preparation isn’t prescribed for children.
SIDE EFFECTS: “Omeprazol Neo” is usually well-tolerated. Side effects rarely develop, is weakly expressed and reversible nature.
From the side of digestion system: diarrhea and constipation, pain in abdomen, nausea, meteorism.
From the side of nervous system: headache, rarely – sleep disturbance, excitability, sleepiness, paresthesia.
From the side of musculoskeletal system: myalgia, arthralgia, muscle weakness.
From the side of blood formation: leucopenia, thrombocytopenia, agranulocytosis, pancytopenia.
Allergic reactions: rash on the skin, itch, nettle-rash.
CONTRAINDICATION: Hypersensitivity towards components including in the preparation.
RESTRICTIONS OF USE: Liver chronic diseases; pregnancy, lactation period; children’s age (exception – Zollinger-Ellison syndrome).
PREGNANCY AND LACTATION: Due to the absence of clinical research data, usage of “Omeprazol Neo” is permitted during pregnancy period under the doctor’s supervision, only in such case when expected benefit for mother exceeds potential risk of the fetus. In case of necessary use of “Omeprazol Neo” during lactation it is necessary to stop breast feeding.
INTERACTION WITH OTHER PREPARATIONS OR OTHER TYPES OF INTERACTION: “Omeprazol Neo” reduces metabolism of those therapeutic agents, which oxidation currents in the liver by cytochrome P450 enzyme system. Concentration of diazepam, carbamazepine, phenitoin, warfarin increases in plasma and it is necessary to made dosage correction. In case of intake of “Omeprazol Neo” together with warfarin it is recommended to make regular monitoring of anticoagulants concentration in the blood serum or prothrombin level control. “Omeprazol Neo” reinforces operation of coumarins phenytoin. Bioavailability of those therapeutic agents reduce because of stomach acidity lowering, which absorption depends on pH (ketoconazole, iron salt).
Simultaneous intake of “Omeprazol Neo” and Clarithromycin, increases its concentration in plasma. It is recommended to abstain from alcohol and tobacco during treatment period.
Symptoms: sleepiness, headache, dizziness, mouth dryness, nausea, tachycardia, pain in the abdominal area, temperature increase.
Treatment: symptomatic, there isn’t specific antidote, activated charcoal or other absorbent is prescribed.
INFLUENCE ON ABILITY OF DRIVING CARS AND MECHANISMS: In therapeutic doses the preparation doesn’t influence on concentration ability. However, carefulness is necessary for those patients who individually has sleepiness or whose activity needs attention concentration and quick psychomotor action.
VALIDITY: 2 years.
In case of visual defects and expiry of validity date, the preparation can not be used.
STORAGE CONDITIONS: Store at 15-25ºC temperature in a protected from light place, dry place and keep away from children.
ISSUE: III group of a pharmaceutical product, issued without a prescription.
PACKAGE: Primary packing: 10 capsules on a pvc/alu blister.
Secondary packing: 4 blisters are located in a cardboard box with application instruqcion.
MANUFACTURER: Ltd “Neopharmi”.
12th km, David Agmashenebeli alley, Tbilisi, Georgia
Tel/Fax: +995 (032) 259-57-90; 259-64-46.