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Active ingredients
Domperidone + Omeprazole
Release form
Capsules
Composition
Active ingredient: Omeprazole (Omeprazole), Domperidone (Domperidone) Active ingredient concentration (mg): 20
Pharmacological effect
Combined preparation comprising domperidone - dopamine receptor blocker and central action omeprazol - an inhibitor of proton nasosa.DomperidonUvelichivaet duration of peristaltic contractions of the antrum and duodenum, accelerates gastric emptying, when the retardation of the process, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting. Stimulates the secretion of prolactin from the pituitary gland. The antiemetic effect is probably due to a combination of peripheral (gastrokinetic) action and antagonism of the dopamine receptors in the trigger zone of the brain. Domperidone has no effect on gastric secretion. Domperidone poorly penetrates the BBB, due to this domperidone use is rarely accompanied by the development of extrapyramidal side effects, especially in adults. OmeprazoleInhibits the enzyme H + -K + -ATP-azu (proton pump) in the parietal cells of the stomach and thereby blocks the final stage of secretion of hydrochloric acid. This leads to a decrease in basal and stimulated secretion, regardless of the nature of the stimulus. After a single dose of the drug inside omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After stopping the drug, secretory activity is fully restored in 3-5 days. The pharmacodynamic justification of the combination Omeprazole suppresses the secretion of hydrochloric acid, domperidone increases the tone of the lower esophageal sphincter and accelerates gastric emptying, thereby reducing the activity of aggressive factors of gastric juice and the casting of the ventricle contents in the esophagus.
Pharmacokinetics
Domperidone Absorption After oral administration, domperidone is rapidly absorbed from the gastrointestinal tract. It has low bioavailability - about 15%. Reduced acidity of gastric contents reduces the absorption of domperidone. Cmax in plasma is reached after 1 hour. Distribution Domoperidone is widely distributed in various tissues, its concentration in brain tissues is low.Plasma protein binding is 91-93%. Metabolism Exposure to intense metabolism in the intestinal wall and liver. Excretion of T1 / 2 is 7-9 hours, with severe renal failure, it lengthens. Excreted through the intestine (66%) and kidneys (33%), unchanged, respectively, output 10% and 1% of the dose. Pharmacokinetics in special clinical situations. In severe renal failure, T1 / 2 is extended. Omeprazole Absorption Omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached in 0.5-1 hours. Biodos upnost 30-40% .RaspredelenieSvyazyvanie to plasma proteins - about 90% .MetabolizmOmeprazol almost completely metabolized in the liver. It is an inhibitor of the CYP2C19 enzyme system. Excretion of T1 / 2 - 0.5-1 h. 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 CC. In elderly patients age, excretion decreases, bioavailability increases. In liver failure, bioavailability is 100%, T1 / 2 - 3 h.
Indications
Peptic ulcer of the stomach and duodenum (including prevention of recurrence), reflux esophagitis, hypersecretory conditions (Zollinger-Ellison syndrome, stressful ulcers of the gastrointestinal tract, polyendocrine adenomatosis, systemic mastocytosis); NPVC-gastropathy; gastric ulcer and duodenal ulcer (as part of combination therapy); prevention of aspiration of the acidic contents of the stomach into the respiratory tract during general anesthesia (Mendelssohn's syndrome).
Contraindications
Hypersensitivity; pregnancy; lactation period; children's age. With care: renal and / or liver failure.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
With caution should use the drug during pregnancy. The use of the drug Omez D during lactation (breastfeeding) is contraindicated.
Dosage and administration
Inside, drinking a small amount of water (the contents of the capsule cannot be chewed), 30 minutes before meals. Exacerbation of gastric ulcer and duodenal ulcer, reflux esophagitis and NPVC-gastropathy - 20 mg 2 times a day.The course of treatment for duodenal ulcer is 2–3 weeks, if necessary, 4–5 weeks; with gastric ulcer and reflux esophagitis - 4–8 weeks. Zollinger-Ellison syndrome - the dose is adjusted individually depending on the initial level of gastric secretion, usually starting at 60 mg / day; if necessary, increase the dose to 80–120 mg / day (in this case, it is prescribed in 2–3 doses). Prevention of Mendelssohn’s syndrome - 40 mg 1 hour before surgery. Prevention of recurrence of gastric ulcer and duodenal ulcer - 10–20 mg 1 once a day. Anti-relapse treatment of reflux esophagitis - 20 mg / day for a long period. Eradication of Helicobacter pylori - 20 mg 2 times a day for 7-14 days (depending on the treatment regimen used) in combination with antibacterial agents. elderly patients dose adjustment is not required.
Side effects
On the part of the blood-forming organs: very rarely - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia. On the part of the digestive system: sometimes - diarrhea, constipation, abdominal pain, nausea, vomiting, flatulence; rarely - increased liver enzymes, taste disorders; very rarely - dry mouth, stomatitis, in patients with previous severe liver disease - hepatitis (including jaundice), impaired liver function. From the nervous system: in patients with severe concomitant somatic diseases - dizziness, headache, excitement, depression; in patients with previous severe liver disease - encephalopathy. From the musculoskeletal system: very rarely - arthralgia, myasthenia, myalgia. From the skin: rarely - skin rash and / or itching; in some cases - photosensitization, erythema multiforme exudative, alopecia. Allergic reactions: often - urticaria; very rarely - angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Others: rarely gynecomastia, malaise, visual impairment, peripheral edema, increased sweating, the formation of gastric glandular cysts during long-term treatment of hydrochloric acid secretion during prolonged treatment (due to inhibition of hydrochloric acid, sweating, the formation of gastric glandular cysts during prolonged treatment). reversible character).
Overdose
Domperidone Symptoms: drowsiness,disorientation and extrapyramidal reactions. Treatment: administration of activated carbon, when extrapyramidal reactions occur - anticholinergic, anti-parkinsonian, antihistamines. : symptomatic therapy. There is no specific antidote. Hemodialysis is not effective enough.
Interaction with other drugs
Domperidone, sodium bicarbonate; ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). Being an inhibitor m isoenzymes of the cytochrome P450 system, can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs that are metabolized in the liver by cytochrome CYP2C19), which in some cases may require a decrease in doses of these drugs. other medicines.
special instructions
Before starting therapy with Omez D, it is necessary to exclude the presence of a malignant process, since treatment masks the symptoms, which may delay the correct diagnosis.