Омез® D

General characteristics. Structure:

Each solid gelatin capsule contains:
Active agents: домперидон 10 mg, омепразол 10 mg (in the form of the pellets covered with a kishechnorastvorimy cover (8,5% in/in) *; excipients:
microcrystallic cellulose, magnesium stearate, colloid silicon dioxide, sodium carboxymethylstarch, sodium lauryl sulfate, talc.
* Structure of pellets of an omeprazol (8,5% in/in): active agent: омепразол 10 mg;
excipients: Mannitolum, sucrose, sodium hydrophosphate, sodium lauryl sulfate, lactose, calcium carbonate, gipromelloza, propylene glycol, methacrylic acid, polysorbate (Twin-80), diethyl phthalate, sodium hydroxide, cetyl alcohol, starch.
** Structure of an empty solid gelatin capsule: indigo carmine, crimson, titanium dioxide,
methylparahydroxybenzoate (methylparaben), пропилпарагидроксибензоат (propylparaben), sodium lauryl sulfate, gelatin, water.

Description
Solid gelatin capsule No. 2 with a light-violet cover and the white case with a text of "Omez D" and the Dr. REDDYS logo on a cover of the capsule containing white
or almost white pellets, white or almost white particles and powder.

Pharmacological properties:

Pharmacodynamics. Domperidon Uvelichivayet duration of peristaltic reductions of antral department of a stomach and duodenum, accelerates gastric emptying in case of delay
this process, raises a tone of the lower esophageal sphincter, eliminates development of nausea and vomiting. Stimulates release of prolactin from a hypophysis. Antiemetic action, perhaps, is caused by a combination of peripheral (gastrokinetichesky) action and antagonism to dopamine receptors in a trigger zone of a brain. Domperidon has no effect on gastric secretion. Domperidon badly gets
through a blood-brain barrier thanks to what use of a domperidon seldom is followed by development of extrapyramidal side effects, especially at adults.

Omeprazol
Inhibits H+ K enzyme + ATP-ase ("the proton pump") in covering cells of a stomach and
thereby blocks a final stage of synthesis of hydrochloric acid. It leads to decrease in level of basal and stimulated secretion, irrespective of the irritant nature. After a single dose of drug inside action of an omeprazol comes within the first hour and continues within 24 hours, the maximum of effect is reached in 2 hours. After the termination of administration of drug secretory activity is completely recovered in 3 - 5 days.

Pharmakodinamichesky justification of a combination
Omeprazol suppresses secretion of hydrochloric acid, домперидон increases a tone of the lower esophageal sphincter and accelerates gastric emptying, activity of aggressive factors of a gastric juice and throwing of gastric contents in a gullet thereby decrease.

Pharmacokinetics. Domperidon
Absorption
After intake домперидон it is quickly soaked up. Has low bioavailability (about 15%). The lowered acidity of gastric contents reduces absorption of a domperidon. The maximum concentration in plasma is reached in 1 h.
Distribution
Domperidon is widely distributed in various fabrics, in brain tissues its concentration is small. Communication with proteins of plasma makes 91-93%.
Metabolism
Is exposed to intensive metabolism in a wall of intestines and liver.
Removal
It is removed through intestines (66%) and kidneys (33%), in not changed look 10% and 1% of dose size are removed, respectively. The elimination half-life makes 7-9 h, at
the expressed renal failure it is extended.

Omeprazol
Omeprazol is quickly absorbed from digestive tract, the maximum concentration in plasma is reached in 0,5-1 hour. Bioavailability makes 30-40%. Communication with proteins of plasma - about 90%. Omeprazol is almost completely metabolized
in a liver. Is inhibitor of the fermental CYP2C19 system. An elimination half-life - 0,5-1 hour. It is removed by kidneys (70-80%) and with bile (20-30%). At a chronic renal failure removal decreases in proportion to decrease in clearance of creatinine. At
elderly patients removal decreases, bioavailability increases. At a liver failure bioavailability - 100%, an elimination half-life - 3 hours.

Indications to use:

Purpose of a combination of a domperidon and omeprazol is shown at the treatment of dyspepsia and a gastroesophagal reflux which are badly giving in to monotherapy by inhibitors of "the protonew pump" or antagonists of H2 receptors.

Route of administration and doses:

Inside, washing down with a small amount of water, on 1 capsule 2 times a day, in 15-20 minutes prior to food.

Features of use:

Before therapy it is necessary to exclude existence of malignant process since treatment, masking symptomatology, can delay statement of the correct diagnosis.

Side effects:

Domperidon. From the alimentary system: passing enterospasms. From a nervous system: extrapyramidal frustration (at children and persons with a hyperpermeability of a blood-brain barrier).
Allergic reactions: skin rash, small tortoiseshell.
Others: giperprolaktinemiya (galactorrhoea, gynecomastia).

Omeprazol
From digestive organs: diarrhea or a lock, nausea, vomiting, a meteorism, an abdominal pain, dryness in a mouth, taste disturbances, stomatitis, tranzitorny increase in activity of "hepatic" enzymes in plasma; patients with the previous serious illness of a liver have a hepatitis (including with jaundice), an abnormal liver function.
From a nervous system: headache, dizziness, excitement, drowsiness, sleeplessness, paresthesias, depression, hallucinations; at patients with the serious accompanying somatopathies, patients with the previous serious illness of a liver - encephalopathy.
From a musculoskeletal system: muscular weakness, mialgiya, arthralgia. From system of a hemopoiesis: leukopenia, thrombocytopenia; in separate cases agranulocytoses, a pancytopenia.
From integuments: itch, skin rash; in some cases - a photosensitization, a multiformny exudative erythema, an alopecia.
Allergic reactions: small tortoiseshell, Quincke's disease, bronchospasm, intersticial nephrite, acute anaphylaxis, fever.
Others: vision disorder, peripheral hypostases, sweating strengthening, gynecomastia; seldom - formation of gastric glandulyarny cysts during prolonged treatment (a consequence of inhibition of secretion of hydrochloric acid, has high-quality, reversible character).

Interaction with other medicines:

Domperidon
Cimetidinum, Natrii hydrocarbonas, other antiacid and antisecretory drugs reduce bioavailability of a domperidon.
Anticholinergics neutralize action of a domperidon.
Increase concentration of a domperidon in plasma: antifungal means of an azolovy row, antibiotics from group of macroleads, HIV protease inhibitors, нефазодон.
Omeprazol
Can reduce absorption of ethers of ampicillin, salts of iron, an itrakonazol and ketokonazol (омепразол raises рН a stomach). Being P450 cytochrome inhibitor, can increase concentration and reduce removal of diazepam, anticoagulants of indirect action, Phenytoinum (medicines which are metabolized in a liver by means of CYP2C19 cytochrome) that in certain cases can demand reduction of doses of these medicines. Strengthens an inhibiting effect on system of a hemopoiesis of other medicines.

Contraindications:

Hypersensitivity, gastrointestinal bleeding, mechanical impassability,
perforation of a stomach or intestines, prolactin - the cosecreting tumor of a hypophysis (prolaktinom), the lactation period, children's age.
With care - a renal and/or liver failure, pregnancy.

Overdose:

Domperidon
Symptoms: drowsiness, disorientation and extrapyramidal reactions. Treatment: reception of absorbent carbon, at emergence of extrapyramidal reactions - anticholinergic, protivoparkinsonichesky, antihistamines.
Omeprazol
Symptoms: a vision disorder, drowsiness, excitement, confusion of consciousness, a headache, increase in sweating, dryness in a mouth, nausea, arrhythmia. The specific antidote does not exist. Symptomatic treatment. The hemodialysis - is insufficiently effective.

Storage conditions:

To store in the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to apply after the term specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Capsules. 10 capsules in a strip from aluminum foil. 3 strips and the application instruction in a cardboard pack.