Omez D (omeprazole) capsules №30

Description

Omez D composition
The main active ingredients of the drug are domperidone and omeprazole.
The list of auxiliary components includes: microcrystalline cellulose, magnesium stearate, sodium starch glycolate, colloidal anhydrous silicon dioxide, talc, sucrose, lactose, mannitol, sodium hydroxide, propylene glycol, hypromellose, cetyl alcohol, corn starch, etc.

Release form
It is produced in the form of capsules, 10 mg of domperidone and 10 mg of omeprazole in one capsule.

Pharmacological properties
This drug Omez D belongs to a group of combined drugs designed to treat peptic ulcer and gastroesophageal reflux disease, based on domperidone and omeprazole.
Domperidone is a dopamine antagonist that has antiemetic properties.
The antiemetic properties of this drug are due to the fact that peripheral (gastrokinetic) action is harmoniously combined in it, as well as antagonism relative to dopamine receptors, in the trigger zone of chemoreceptors, which are outside the blood-brain barrier in the posterior region.
It is known that when used internally, domperidone is able to increase the duration of antral and duodenal contractions, and accelerates bowel movement.
In this case, domperidone has no effect on gastric secretion.
Omeprazole, in turn, belongs to antiulcer drugs that are able to inhibit the basal and stimulated secretion of hydrochloric acid in the cells of the stomach due to a specific effect on the so-called proton pump.

Indications
Omez D is used to treat:

• gastroesophageal reflux disease;
• ulcers of the stomach and duodenal ulcer;
• in the schemes of eradication of Helicobacter pylori;
• delayed evacuation of stomach contents;
• gastroparesis;
• functional dyspepsia.

The mechanism of action is due to the chemical and physical properties of the main active ingredient – domperidone.
This substance is able to penetrate in some amount through the blood-brain barrier.
The use of this drug in rare cases is accompanied by extrapyramidal side effects, especially in adults, but domperidone can also stimulate the release of prolactin from the pituitary gland.
There is also officially documented evidence that low concentrations that were detected in the brain indicate a predominantly peripheral effect of domperidone on dopamine receptors.
The antisecretory effect of omeprazole develops very quickly – within an hour, and lasts for a day. Due to its high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrating in them and produces a cytoprotective effect. Secretory activity returns to normal after 3-4 days of constant intake.
Omeprazole does not affect the motility of the digestive tract.

Contraindications
Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Also use is contraindicated in the case of:

• prolactin-secretory pituitary tumor (prolactinoma);
• liver and / or kidney or liver dysfunctions;
• liver failure;
• in patients who have recorded prolongation of the QT interval, which are the cause of cardiac dysfunction;
• phenylketonuria.

Do not use if vomiting occurs when:

• gastrointestinal bleeding;
• mechanical obstruction;
• perforation;
• motion sickness.

It is not used concomitantly with drugs that prolong the QT interval, erythromycin, fluconazole, ketoconazole, itraconazole, posaconazole, ritonavir, saquinavir, telaprevir, voriconazole, clarithromycin, amiodarone, telithromycin.

Children
Not used in pediatrics.

Application during pregnancy and lactation
This drug Omez D has not been tested in pregnant women, so it is not known what effect it has on the fetus and the woman’s health during this period.
As a consequence, its use during pregnancy can only be used if the risk from use is lower than its health benefits.
If there is a need to use this drug during lactation, then breastfeeding should be suspended.

Method of administration and dosage
The weighted average dosage for adults – the drug Omez D is used – 1 capsule 2-3 times a day. The drug is taken half an hour before meals with water.
If necessary, the dose can be doubled by the attending physician.
The duration of treatment is usually 4-8 weeks. Extension of treatment and dosage is determined by the attending physician.
For eradication therapy, take 2 capsules 2 times a day, combined with antibacterial drugs.
If the patient is diagnosed with renal failure, the frequency of taking the drug should be reduced.

Overdose
An overdose of this drug can be characterized by symptoms such as:

• agitation;
• disturbances of consciousness, convulsions;
• disorientation, drowsiness;
• extrapyramidal reactions.

A specific antidote has not yet been identified.
Recommended gastric lavage within the first hour after poisoning, intake of enterosorbents, symptomatic treatment.
Anticholinergic drugs can be effective in controlling extrapyramidal reactions.

Side effects
When using this drug, side effects have been observed such as:

• allergies, up to anaphylactic shock;
• increased prolactin levels;
• nervousness, dizziness, thirst, depression, convulsions, fatigue, headache, drowsiness, extrapyramidal disorders;
• edema, tachycardia, ventricular arrhythmia, sudden cardiac death;
• dry mouth, short-term intestinal cramps, diarrhea, nausea, heartburn, constipation;
• itching, rash, urticaria, angioedema;
• enlargement, pain, swelling of the mammary glands, gynecomastia, amenorrhea, lactation disorders, irregular menstrual cycle;
• dysuria, frequent urination, asthenia;
• conjunctivitis, stomatitis.

If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.

Storage conditions and periods
Stored for up to 2 years at a temperature not exceeding 25 ° C.