Omez D, 10 mg+10 mg 30 pcs

Combination drug, contains domperidone – dopamine receptor blocker of central action and omeprazole – proton pump inhibitor. Domperidone Increases duration of peristaltic contractions of the antral part of the stomach and duodenum, accelerates gastric emptying if this process is slowed down, increases tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting. Stimulates release of prolactin from the pituitary gland. Antiemetic effect is probably caused by combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in brain trigger zone.

Domperidone has no effect on gastric secretion. Domperidone poorly penetrates through the HEB, due to which 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 the parietal cells of the stomach and thus 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 oral administration of the drug the effect 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 secretory activity is fully restored after 3-5 days. Pharmacodynamic substantiation of the combination Omeprazole inhibits hydrochloric acid secretion, domperidone increases the tone of the lower esophageal sphincter and accelerates gastric emptying, thus reducing the activity of aggressive factors of gastric juice and gastric contents throw into the esophagus.

Indications

Treatment of dyspepsia and gastroesophageal reflux, difficult to respond to monotherapy with proton pump inhibitors or H2 receptor antagonists.

Pharmacological effect

A combined drug containing domperidone, a centrally acting dopamine receptor blocker, and omeprazole, a proton pump inhibitor. Domperidone Increases the duration of peristaltic contractions of the antrum of the stomach and duodenum, accelerates gastric emptying if this process slows down, increases the tone of the lower esophageal sphincter, and 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 of dopamine receptors in the trigger zone of the brain.

Domperidone has no effect on gastric secretion. Domperidone does not penetrate the blood-brain barrier well, so 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 the 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 oral dose of the drug, the effect of omeprazole occurs within the first hour and continues for 24 hours, the maximum effect is achieved after 2 hours. After stopping the drug, secretory activity is completely restored after 3-5 days.
Pharmacodynamic rationale for 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 reflux of gastric contents into the esophagus.

Special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process in the gastrointestinal tract, because Treatment, masking symptoms, can delay the correct diagnosis.

Active ingredient

Domperidone, Omeprazole

Composition

Composition per 1 capsule:

active components:

domperidone – 10 mg;

omeprazole (in enteric-coated pellets) – 10 mg;

auxiliary components:

magnesium stearate,

microcrystalline cellulose,

colloidal silicon dioxide,

sodium lauryl sulfate,

sodium carboxymethyl starch,

talc

excipients of enteric-coated pellets:

sucrose,

mannitol,

sodium lauryl sulfate,

sodium hydrogen phosphate,

calcium carbonate,

lactose,

hypromellose,

methacrylic acid,

propylene glycol,

polysorbate (Tween-80),

sodium hydroxide,

diethyl phthalate,

cetyl alcohol,

starch;

gelatin capsule:

gelatin,

indigo carmine,

titanium dioxide,

methylparaben,

propylparaben,

carmozine,

sodium lauryl sulfate,

water.

Pregnancy

The drug should be used with caution during pregnancy.

Contraindications

– hypersensitivity to the active substance or any of the excipients of Omez DSR,
– gastrointestinal bleeding, mechanical obstruction or perforation, in which stimulation of gastric motility can be dangerous
– prolactin – secreting tumors of the pituitary gland (prolactinoma)
– severe and moderate degree of liver failure
– patients with current or history of conduction disorders, in particular prolongation of the QT interval on the ECG
– patients with severe electrolyte imbalance or serious heart disease (eg, congestive heart failure)
– combined use with drugs that prolong the QT interval
– combined use with drugs that are strong inhibitors of CYP3A4 (regardless of their effect to prolong QT)
– children’s age up to 16 years

Side Effects

Omeprazole From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in the activity of liver enzymes in plasma; in patients with previous severe liver disease – hepatitis (including jaundice), impaired liver function.

Interaction

Domperidone

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

Anticholinergics counteract the effects of domperidone.

Increase the concentration of domperidone in plasma: azole antifungals, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone.

Omeprazole

May reduce the absorption of esters, ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases gastric pH). Being an inhibitor of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs that are metabolized in the liver via cytochrome CYP2C19), which in some cases may require a reduction in their doses. Strengthens the inhibitory effect on the hematopoietic system of other drugs.

Overdose

Omeprazole

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Dr. Reddy’s Laboratories Ltd, India