Composition, form of production and packaging
Hard gelatin capsules, size 2, with a light purple lid and white casing, with the inscription "Omez D" and the logo "DR.REDDY'S" on the shell of the capsule; the contents of the capsules are pellets, particles and powder of white or almost white color.
1 caps.
domperidone 10 mg
omeprazole (in the form of enteric-soluble pellets) 10 mg
Excipients: microcrystalline cellulose, magnesium stearate, silicon dioxide colloid, sodium carboxymethyl starch, sodium lauryl sulfate, talc; in the composition of pellets: mannitol, sucrose, sodium hydrophosphate, sodium lauryl sulfate, lactose, calcium carbonate, hypromellose, diethyl phthalate, propylene glycol, methacrylic acid, polysorbate (Tween-80), diethyl phthalate, sodium hydroxide, cetyl alcohol, starch.
Capsule composition: gelatin, water, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, indigocarmine, carmosine, titanium dioxide.
10 pieces. - Strips (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Combined drug, contains domperidone - blocker of dopamine receptors of central action and omeprazole - proton pump inhibitor.
Domperidone
Increases the duration of peristaltic contractions of the antral part of the stomach and duodenum, accelerates the emptying of the stomach in case of slowing down of this process, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting. Stimulates the release of prolactin from the pituitary gland. The antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the trigger zone of the brain. Domperidone has no effect on gastric secretion. Domperidone poorly penetrates through the BBB, due to this use of domperidone is rarely accompanied by the development of extrapyramidal side effects, especially in adults.
Omeprazole
Inhibits the enzyme H + -K + -ATP-asu (proton pump) in 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. After a single dose of the drug inside the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug, the secretory activity is completely restored after 3-5 days.
Pharmacodynamic justification of combination
Omeprazole suppresses the secretion of hydrochloric acid, domperidone increases the tone of the lower esophageal sphincter and accelerates the emptying of the stomach, thereby reducing the activity of aggressive gastric juice factors and throwing up gastric contents into the esophagus.
PHARMACOKINETICS
Domperidone
Suction
After oral administration, domperidone is rapidly absorbed from the digestive tract. It has low bioavailability - about 15%. The decreased acidity of the gastric contents reduces the absorption of domperidone. C max in plasma is achieved after 1 hour.
Distribution
Domperidone is widely distributed in various tissues, in the brain tissues its concentration is low. Binding to plasma proteins is 91-93%.
Metabolism
It is subjected to intensive metabolism in the wall of the intestine and liver.
Excretion
T 1/2 is 7-9 hours, with pronounced renal failure, it lengthens.
It is excreted through the intestine (66%) and kidneys (33%), in unchanged form, respectively 10% and 1% of the dose value.
Pharmacokinetics in special clinical cases
With severe renal failure, T 1/2 is lengthened.
Omeprazole
Suction
Omeprazole is rapidly absorbed from the gastrointestinal tract, C max in plasma is reached after 0.5-1 h. Bioavailability is 30-40%.
Distribution
Binding to plasma proteins is about 90%.
Metabolism
Omeprazole is almost completely metabolized in the liver. It is an inhibitor of the enzyme system CYP2C19.
Excretion
T 1/2 - 0.5-1 h. It is excreted by the kidneys (70-80%) and with bile (20-30%).
Pharmacokinetics in special clinical cases
In chronic renal failure, excretion decreases in proportion to the decrease in QC.
In elderly patients excretion decreases, bioavailability increases.
With hepatic failure, the bioavailability is 100%, T 1/2 - 3 hours.
INDICATIONS
- treatment of dyspepsia and gastroesophageal reflux, poorly amenable to monotherapy with proton pump inhibitors or antagonists of histamine H2-receptors.
DOSING MODE
Take inwards, squeezed a little water, 1 capsule 2 times / day, 15-20 minutes before meals.
SIDE EFFECT
Domperidone
From the digestive system: transient intestinal spasms.
From the side of the central nervous system: extrapyramidal disorders (in children and people with high permeability of the BBB).
Allergic reactions: skin rash, hives.
Other: hyperprolactinemia (galactorrhea, gynecomastia).
Omeprazole
On the part of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in hepatic enzyme activity in plasma; in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function; rarely - the formation of gastric glandular cysts during long-term treatment (the consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible).
From the central nervous system and peripheral nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.
From the musculoskeletal system: muscle weakness, myalgia, arthralgia.
On the part of the hematopoiesis system: leukopenia, thrombocytopenia; in some cases - agranulocytosis, pancytopenia.
Dermatological reactions: itching, skin rash, increased sweating; in some cases - photosensitivity, multiform exudative erythema, alopecia.
Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.
Other: visual impairment, peripheral edema, gynecomastia.
CONTRAINDICATIONS
- gastrointestinal hemorrhage;
- mechanical obstruction of the stomach or intestines;
- perforation of the stomach or intestines;
- Prolactin-secreting pituitary tumor (prolactinoma);
- the period of lactation (breastfeeding);
- childhood;
- Hypersensitivity to the components of the drug.
With caution should be used in cases of kidney and / or liver failure, during pregnancy.
PREGNANCY AND LACTATION
Caution should be used during pregnancy.
Contraindicated use of the drug Omez В® D during lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be used in cases of kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should be used in cases of liver failure.
APPLICATION FOR CHILDREN
Contraindicated: children's age.
SPECIAL INSTRUCTIONS
Before beginning treatment with Omez В® D, it is necessary to exclude the presence of malignant process, treatment masks the symptoms, which can delay the setting of the correct diagnosis.
OVERDOSE
Domperidone
Symptoms: drowsiness, disorientation and extrapyramidal reactions.
Treatment: reception of activated carbon, when extrapyramidal reactions occur - anticholinergic, anti-Parkinsonian, antihistamines.
Omeprazole
Symptoms: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.
Treatment: symptomatic therapy. There is no specific antidote. Hemodialysis is not effective enough.
DRUG INTERACTION
Domperidone
Cimetidine, sodium hydrogen carbonate, other antacid and antisecretory drugs reduce the bioavailability of domperidone.
Anticholinergic drugs neutralize the action of domperidone.
With simultaneous use of antifungal azole agents, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone increase the concentration of domperidone in plasma.
Omeprazole
Omeprazole is able to reduce the absorption of esters of ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach).
Being an inhibitor of cytochrome P450 isoenzymes, it can increase the concentration and reduce the excretion of diazepam, anticoagulants of indirect action, phenytoin (drugs that are metabolized in the liver via cytochrome CYP2C19), which in some cases may require a reduction in the doses of these drugs.
Increases the inhibitory effect on the hemopoietic system of other drugs.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 2 years.
