Omez® D (Omez D)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDomperidone + OmeprazoleDomperidone + Omeprazole
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  • Omez® D
    capsules inwards 
    Torrent Pharmaceuticals Co., Ltd.     India
  • Omega® JEM
    capsules inwards 
    Dr. Reddy's Laboratories Ltd.     India
    • Dosage form: & nbspcapsules
    Composition:

    Each hard gelatin capsule contains:

    Active substances: domperidone 10 mg, omeprazole 10 mg (in the form of pellets, coated with enteric coating (8.5% w / w) *, excipients:

    microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, sodium carboxymethyl starch, sodium lauryl sulfate, talc.

    * Composition of pellets omeprazole (8.5% w / w): active substance: omeprazole 10 mg;

    auxiliary substances: mannitol, sucrose, sodium hydrophosphate, sodium lauryl sulfate, lactose, calcium carbonate, hypromellose, propylene glycol, methacrylic acid, polysorbate (Tween-80), diethyl phthalate, sodium hydroxide, cetyl alcohol, starch.

    ** Composition of an empty hard gelatin capsule: indigocarmine, carmosine, titanium dioxide, methyl parahydroxybenzoate (methylparaben), propylparahydroxybenzoate (propylparaben), sodium lauryl sulfate, gelatin, water.

    Description:

    Hard gelatin capsule No. 2 with a light purple lid and a white body with an inscription "DOMSTAL On "and a logo (square emblem) on the shell of a capsule containing white or almost white pellets, white or almost white particles and powder.

    Pharmacotherapeutic group:reflux-esophagitis treatment agent (proton pump inhibitor + dopamine receptor blocker central).
    ATX: & nbsp

    A.02.B.X   Other antiulcer drugs

    Pharmacodynamics:

    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 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 the blood-brain barrier, so that the use of domperidone is rarely accompanied by the development of extrapyramidal side effects, especially in adults.


    Omeprazole

    Inhibits the enzyme H + K + ATPase ("proton pump") in parietal cells of the stomach and thereby blocks the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single intake of the drug, omeprazole acts within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.

    Pharmacodynamic justification of combination

    Omeprazole inhibits 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 gastric contents into the esophagus.

    Pharmacokinetics:

    Domperidone

    Suction

    After oral administration domperidone quickly absorbed. It has low bioavailability (about 15%). The decreased acidity of the gastric contents reduces the absorption of domperidone. The maximum concentration in the plasma is achieved after 1 hour.

    Distribution

    Domperidone is widely distributed in various tissues, in the brain tissues its concentration is low. The connection with plasma proteins is 91-93%.

    Metabolism

    It is subjected to intensive metabolism in the wall of the intestine and liver.

    Excretion

    It is excreted through the intestine (66%) and kidneys (33%), in unchanged form, respectively, 10% and 1% of the dose value. The half-life is 7-9 hours, with prolonged renal failure, it lengthens.

    Omeprazole

    Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration in the plasma is reached after 0.5-1 hour. Bioavailability is 30-40%. The connection with plasma proteins is about 90%. Omeprazole almost completely metabolized in the liver. It is an inhibitor of the enzyme system CYP2C19. Half-life is 0.5-1 hour. It is excreted by the kidneys (70-80%) and with bile

    (20-30%). In chronic renal failure, excretion decreases

    in proportion to a decrease in creatinine clearance. In elderly patients excretion decreases, bioavailability increases. With hepatic failure, bioavailability is 100%, half-life is 3 hours.

    Indications:

    The appointment of a combination of domperidone and omeprazole is indicated in the treatment of dyspepsia and gastroesophageal reflux,poorly amenable to monotherapy with "proton pump" inhibitors or H antagonists2receptors.

    Contraindications:

    Hypersensitivity, gastrointestinal bleeding, mechanical

    obstruction, perforation of the stomach or intestine, prolactin-secreting pituitary tumor (prolactinoma), lactation period, children's age.

    Carefully:renal and / or hepatic insufficiency, pregnancy.
    Dosing and Administration:

    Inside, washed down with a small amount of water, 1 capsule 2 times a day, 15-20 minutes before meals.

    Side effects:

    Domperidone

    From the digestive system: transient intestinal spasms.

    From the nervous system: extrapyramidal disorders (in children and people with increased permeability of the blood-brain barrier).

    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 the activity of "liver" enzymes in the plasma; in patients with a previous severe liver disease - hepatitis (incl.with jaundice), a dysfunction of the liver.

    From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitanttheand 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.

    From the skin: itching, skin rash; in some cases -

    photosensitization, multiforme exudative erythema, alopecia.

    Allergic reactions: urticaria, angioedema, bronchospasm,

    interstitial nephritis, anaphylactic shock, fever.

    Other: impaired vision, peripheral edema, increased sweating, gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (the consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible).

    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.

    There is no specific antidote. Treatment is symptomatic. Hemodialysis is not effective enough.

    Interaction:

    Cimetidine, sodium hydrogen carbonate, other antacid and antisecretory drugs reduce the bioavailability of domperidone.

    Anticholinergic drugs neutralize the action of domperidone.

    Increase the concentration of domperidone in plasma: antifungal agents of the azole series, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone. Omeprazole

    Can 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, it can increase concentration and decrease the excretion of diazepam, anticoagulants of indirect action, phenytoin (drugs that are metabolized in the liver via cytochrome CUR2C19), 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.

    Special instructions:Before the beginning of therapy it is necessary to exclude the presence of malignant process, because treatment, masking the symptoms, can delay the formulation of the correct diagnosis.
    Form release / dosage:

    Capsules. 10 capsules per strip of aluminum foil.

    Packaging:3, 5 or 10 strips and instructions for use in a cardboard box. Sample not for sale: 10 capsules in an aluminum foil strip. 1 strip with instructions for use in a cardboard box.
    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001303/08
    Date of registration:29.02.2008
    The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India
    Information update date: & nbsp29.02.2008
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