Omeprazol Neo 20mg #40 Caps
Proton-pump inhibitor
International name: UOmeprazole.
ATС Code: AO2BCO1.
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.
Pharmacological operation:
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:
- 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.
Overdose:
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.
