Instructions for Omez DSR hard capsules with modified release, blister No. 30
Composition
active ingredients: omeprazole, domperidone;
1 capsule contains omeprazole 20 mg (in the form of enteric-coated pellets), domperidone 30 mg (in the form of prolonged-release pellets);
excipients of enteric-coated pellets: mannitol (E 421), lactose monohydrate, sodium lauryl sulfate, sodium hydrogen phosphate anhydrous, sucrose, hypromellose, methacrylate copolymer (type C), talc, sodium hydroxide, polyethylene glycol 6000, titanium dioxide (E 171);
Excipients of prolonged-release pellets: nonpareil (sucrose/starch mixture), colloidal anhydrous silicon dioxide, hypromellose, talc, ethylcellulose, triacetin, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).
Dosage form
Modified-release capsules, hard.
Main physicochemical properties: hard gelatin transparent colorless capsules No. "1" with black markings " " and "DR. REDDY'S" on the capsule cap and red markings "OMEZ-DSR" on the capsule body. The contents of the capsules are spherical pellets from almost white to grayish and from yellowish-brown to brown in color.
Pharmacotherapeutic group
Drugs for the treatment of acid-dependent conditions. ATC code A02X.
Pharmacological properties
Pharmacodynamics
A combined medicinal product, the effect of which is due to the components that make up its composition.
Omeprazole belongs to antiulcer drugs that inhibit basal and stimulated secretion of hydrochloric acid in the parietal cells of the stomach due to a specific effect on H+-K+- ATPase (proton pump). The antisecretory effect after taking omeprazole develops very quickly within the first hour and persists throughout the day. Omeprazole, due to its high lipophilicity, easily penetrates the parietal cells of the stomach, concentrates in them and has a cytoprotective effect. The inhibitory effect increases in the first 4 days of administration. Inhibition is dose-dependent. Daily intake of omeprazole in doses of 20 mg and above provides stable and effective acidity control.
Omeprazole does not affect gastrointestinal motility.
Omeprazole (a substituted benzimidazole) inhibits the gastric enzyme H+, K+-ATPase (proton pump), which catalyzes the exchange of H+ and K+ ions. Since this enzyme is considered to be the acid (proton) pump of the gastric mucosa, omeprazole is characterized as a gastric acid (proton) pump inhibitor. Omeprazole effectively inhibits basal and stimulated secretion of hydrochloric acid with a prolonged duration of action. The degree of inhibition of gastric hydrochloric acid secretion by omeprazole correlates with the area under the plasma concentration-time curve and has no direct relationship with the plasma concentration of the drug at any particular time point.
Domperidone is a dopamine antagonist that acts as a prokinetic on the upper gastrointestinal tract, increases the tone of the lower esophageal sphincter and accelerates gastric emptying. The drug does not cause dopamine antagonistic effects on the central nervous system, probably due to the inability to penetrate the blood-brain barrier. Domperidone increases the activity of smooth muscles of the gastrointestinal tract, inhibiting the effects of dopamine. Domperidone effectively enhances esophageal peristalsis and increases lower esophageal sphincter pressure, stimulates gastric motility and peristalsis, improves gastroduodenal coordination, accelerating gastric emptying.
Domperidone blocks peripheral dopamine receptors, eliminates the inhibitory effect of dopamine on the motor function of the gastrointestinal tract and increases the evacuation and motor activity of the stomach. It has an antiemetic effect, soothes hiccups and eliminates nausea. It penetrates poorly through the blood-brain barrier, has practically no effect on dopamine receptors in the brain.
Pharmacokinetics
Omeprazole is rapidly and completely absorbed after oral administration on an empty stomach; absorption may be delayed when taken after a meal. Although the half-life of omeprazole is short (0.5–1.5 hours), the antisecretory effect persists for 24 hours or more. Approximately 90–95% of omeprazole is bound to plasma proteins. A limited amount of omeprazole crosses the blood-brain barrier. The majority (77%) is excreted in the urine as metabolites (of which hydroxyomeprazole and the corresponding carboxylic acid have been identified), the remainder is excreted in the feces (which suggests significant excretion of metabolites with bile).
Omeprazole is sensitive to degradation in the acidic environment of the stomach, therefore, a dosage form of enteric-coated granules in a capsule has been developed for this drug. Food does not affect the bioavailability of the drug. Bioavailability is reported to be about 40% after administration in doses of 20–40 mg. The time to reach maximum plasma concentration is 0.5–3.5 hours. Omeprazole in capsules is completely and rapidly metabolized, as the parent compound was not detected in feces or urine. The main enzyme involved in the metabolism of omeprazole is a polymorphically expressed cytochrome P450 (CYP) isoform – S-mephenytoin hydroxylase, CYP2C19. The plasma half-life does not change significantly after multiple administration. Despite rapid elimination (mean half-life of 0.5 to 1 hour), the antisecretory effect of omeprazole is long-lasting (about 24 hours) due to its strong affinity for the acid pump of parietal cells.
Domperidone is well absorbed after oral administration. It undergoes extensive metabolism in the stomach wall and liver, and has low bioavailability (15%). The maximum concentration in blood plasma is reached 1 hour after administration. Total plasma clearance is about 700 ml/min. Domperidone is secreted into bile mainly in the form of active metabolites. About 30% of the dose is excreted in the urine within 24 hours, almost completely in the form of metabolites, and the rest in the feces within several days (about 10% in the form of unchanged drug). Domperidone is excreted in breast milk in small quantities. A decrease in the acidity of gastric juice reduces the absorption of domperidone. It binds to plasma proteins by 91–93%. The half-life is about 7–9 hours, with severe renal failure the half-life increases.
Indication
Short-term treatment of acid-dependent diseases accompanied by nausea; treatment of gastritis or gastroesophageal reflux disease accompanied by vomiting.
Contraindication
Hypersensitivity to the components of the drug, hypersensitivity to substituted benzimidazoles. Pregnancy and breastfeeding.
Omeprazole, like other proton pump inhibitors (PPIs), should not be used concomitantly with nelfinavir (see Interactions with other medicinal products and other forms of interaction). Severe and moderate hepatic and/or renal impairment; hepatic failure; prolongation of cardiac conduction intervals, in particular the QT interval, underlying cardiac disorders or diseases; severe electrolyte imbalance; prolactin-secreting pituitary tumour (prolactinoma).
Do not use if stimulation of gastric motility may be dangerous, such as in the presence of gastrointestinal bleeding, mechanical obstruction or perforation. Concomitant use of ketoconazole, erythromycin or other potent CYP3A4 inhibitors is contraindicated. Concomitant use of drugs that prolong the QT interval, such as fluconazole, erythromycin, itraconazole, oral ketoconazole, posaconazole, ritonavir, saquinavir, telaprevir, voriconazole, clarithromycin, amiodarone, telithromycin is contraindicated.
Interaction with other medicinal products and other types of interactions
Omeprazole
The likelihood of metabolic interactions between omeprazole and other drugs is very low. However, since omeprazole inhibits the hepatic microsomal metabolism of drugs (cytochrome P450 enzyme system), the elimination of other drugs metabolized by the cytochrome P450 system or those that are largely excreted by the liver may be slowed down during concomitant administration of omeprazole. This effect may lead to slower elimination and increased blood concentrations of diazepam, phenytoin and anticoagulants such as warfarin (monitoring of blood concentrations or prothrombin time is recommended as a basis for dosage adjustment, as the latter may be necessary during treatment with omeprazole).
Omeprazole may increase the half-life and duration of action of diazepam, phenytoin, warfarin. Omeprazole has a potential effect on the bioavailability of drugs whose absorption depends on pH (ketoconazole, itraconazole), and omeprazole may prevent the breakdown of acid-labile drugs. No interactions were observed with any isoforms of the CYP enzyme (phenacetin, caffeine, theophylline), CYP2D6 (metoprolol, propranolol), CYP2E1 (ethanol), CYP3A (cyclosporine, lidocaine, quinidine, estradiol, erythromycin), CYP2C9 (s-warfarin). Omeprazole has no significant effect on the steady-state pharmacokinetics of piroxicam, diclofenac, and naproxen, as confirmed by multiple-dose studies of omeprazole 20 mg in healthy volunteers.
Nelfinavir, atazanavir
Plasma levels of nelfinavir and atazanavir are decreased when co-administered with omeprazole.
Concomitant use of omeprazole with atazanavir is not recommended. Co-administration of omeprazole (40 mg once daily) and atazanavir 300 mg/ritonavir 100 mg in healthy volunteers resulted in a 75% decrease in atazanavir exposure. Increasing the atazanavir dose to 400 mg did not compensate for the effect of omeprazole on atazanavir exposure. Co-administration of omeprazole (20 mg once daily) with atazanavir 400 mg/ritonavir 100 mg in healthy volunteers resulted in an approximately 30% decrease in atazanavir exposure compared to atazanavir 300 mg/ritonavir 100 mg once daily.
Digoxin
Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy volunteers increased the bioavailability of digoxin by 10%. Rare cases of digoxin-induced toxicity have been reported. However, caution should be exercised when prescribing high doses of omeprazole to elderly patients. Therapeutic drug monitoring of digoxin should be intensified.
Clopidogrel
Regarding the simultaneous use of clopidogrel and omeprazole, there are conflicting data on the decrease in the concentration of the active metabolite of clopidogrel and the clinical aspects of this pharmacokinetic/pharmacodynamic interaction in relation to major cardiovascular pathologies.
As a precautionary measure, the concomitant use of omeprazole and clopidogrel should be avoided unless, in the opinion of the physician, the benefit of their concomitant use outweighs the risk.
Medicinal products metabolized by CYP2C19
Omeprazole is a moderate inhibitor of CYP2C19, the main enzyme that metabolizes omeprazole.
Thus, the metabolism of concomitant medications that are also metabolized by CYP2C19 may be reduced and the systemic exposure of these drugs may be increased. Examples of such drugs include R-warfarin and other vitamin K antagonists, cilostazol, diazepam, and phenytoin.
In healthy volunteers, a pharmacokinetic/pharmacodynamic interaction was observed between clopidogrel (loading dose 300 mg/daily maintenance dose 75 mg) and omeprazole (80 mg/day orally, i.e. a dose 4 times the standard daily dose), resulting in a mean 46% decrease in exposure to the active metabolite of clopidogrel and a mean 16% decrease in maximal inhibitory effect on (ADP-induced) platelet aggregation. The clinical significance of this interaction remains unclear. As a precautionary measure, concomitant use of omeprazole and clopidogrel should be avoided unless, in the opinion of the physician, the benefit of their concomitant administration outweighs the risk.
Cilostazol
In healthy volunteers, administration of omeprazole at a dose of 40 mg increased the Cmax and AUC of cilostazol by 18% and 26%, respectively, and of one of its active metabolites by 29% and 69%, respectively.
Phenytoin
Monitoring of phenytoin plasma concentrations is recommended during the first two weeks after starting treatment with omeprazole and, if phenytoin dose adjustment has been made, monitoring and further dose adjustment of the drug should be carried out after the end of treatment with omeprazole.
The mechanism of interaction is unknown.
Saquinavir
Concomitant use of omeprazole with saquinavir/ritonavir resulted in an increase in plasma levels of saquinavir of approximately 70%, which was associated with good tolerability in HIV-infected patients.
Tacrolimus
Increased serum tacrolimus levels have been reported with concomitant use of omeprazole. Increased monitoring of tacrolimus concentrations and renal function (creatinine clearance) is required and the tacrolimus dosage adjusted if necessary.
Methotrexate
Increased methotrexate levels have been reported in some patients when co-administered with proton pump inhibitors. If high doses of methotrexate are required, temporary withdrawal of omeprazole should be considered.
Effect of other drugs on the pharmacokinetics of omeprazole
CYP2C19 and/or CYP3A4 inhibitors
Since omeprazole is metabolised by CYP2C19 and CYP3A4, drugs that inhibit CYP2C19 or CYP3A4 or both (such as clarithromycin and voriconazole) may increase omeprazole serum levels by decreasing its metabolic rate. Concomitant use of voriconazole resulted in a more than two-fold increase in omeprazole exposure. Since high doses of omeprazole were well tolerated, dose adjustment of omeprazole is generally not necessary. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated.
Omeprazole is also partially metabolized by CYP3A4, but does not inhibit this enzyme. Thus, omeprazole does not affect the metabolism of drugs metabolized by CYP3A4, such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin, and budesonide.
CYP2C19 and/or CYP3A4 inducers
Drugs that induce CYP2C19 and/or CYP3A4 activity (such as rifampicin and St. John's wort) may cause a decrease in serum levels of omeprazole as a result of increased metabolism.
Domperidone
Since domperidone causes increased motility of the stomach and small intestine, absorption of drugs in the small intestine may be accelerated, while absorption in the stomach may be slowed down.
Domperidone should be used with caution in combination with monoamine oxidase inhibitors (MAOIs).
The absorption of domperidone was not reduced after administration in combination with antacids or H2-receptor blockers.
The drug should be taken on an empty stomach, 1 hour before a meal, as food affects the bioavailability of omeprazole and domperidone.
Antacids and antisecretory drugs should not be taken simultaneously with the drug, as they reduce its bioavailability after oral administration. Domperidone is metabolized mainly by CYP3A4. According to in vitro studies, concomitant use of drugs that significantly inhibit this enzyme may lead to increased plasma levels of domperidone. When domperidone was used concomitantly with potent CYP3A4 inhibitors that can prolong the QT interval, clinically significant changes in the QT interval were observed. Therefore, concomitant use of domperidone with certain drugs is contraindicated (see section "Contraindications").
Concomitant use of the following drugs with domperidone is contraindicated.
All drugs that prolong the QT interval:
Class IA antiarrhythmics (e.g. disopyramide, hydroquinidine, quinidine); Class III antiarrhythmics (e.g. amiodarone, dofetilide, dronedarone, ibutilide, sotalol); Neuroleptics that prolong the QT interval (e.g. haloperidol, pimozide, sertindole); Antidepressants that prolong the QT interval (e.g. citalopram, escitalopram); Antibiotics that prolong the QT interval (e.g. erythromycin, levofloxacin, moxifloxacin, spiramycin); Antifungals that prolong the QT interval (e.g. pentamidine); Antimalarials that prolong the QT interval (e.g. halofantrine, lumefantrine); Drugs for the treatment of gastrointestinal disorders that prolong the QT interval (e.g. cisapride, dolasetron, prucalopride); Antihistamines that prolong the QT interval (e.g. mequitazine, mizolastine); medicines used in cancer that prolong the QT interval (e.g. toremifene, vandetanib, vincamine); other medicines that prolong the QT interval (e.g. bepridil, diphemanil, methadone); apomorphine, if the benefits of concomitant use do not outweigh the risks, with strict adherence to the recommendations for precautions for concomitant use of these medicines.
Examples of strong CYP3A4 inhibitors (regardless of their effect on QT prolongation) with which the drug is contraindicated are:
azole antifungals such as fluconazole*, itraconazole, ketoconazole* and voriconazole*; macrolide antibiotics such as clarithromycin*, erythromycin*; protease inhibitors*; HIV protease inhibitors such as amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists such as diltiazem and verapamil; amiodarone*; amrepitant; nefazodone; telithromycin*. *prolong the QTc interval.
Concomitant use requires caution.
Use with caution with drugs that cause bradycardia and hypokalemia, as well as with macrolides that can cause QT prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated because it is a potent CYP3A4 inhibitor).
Domperidone should be used with caution when used concomitantly with potent CYP3A4 inhibitors that have not been shown to prolong the QT interval, such as indinavir, and patients should be closely monitored for signs or symptoms of adverse reactions.
The drug can be combined with:
neuroleptics, the effect of which it enhances; dopaminergic agonists (bromocriptine, L-dopa), the undesirable peripheral effects of which, such as indigestion, nausea, vomiting, it suppresses without neutralizing the basic properties.
In separate in vivo pharmacokinetic/pharmacodynamic interaction studies with concomitant oral administration of ketoconazole or erythromycin in healthy volunteers, it was confirmed that these drugs significantly inhibit the CYP3A4-mediated first-pass metabolism of domperidone.
Theoretically, because the drug has a prokinetic effect on the stomach, this may affect the absorption of concomitant oral drugs, in particular prolonged-release or enteric-coated formulations. However, in patients stabilized on digoxin or paracetamol, concomitant use of domperidone did not affect the blood levels of these drugs.
Application features
In the presence of any alarming symptom (e.g. significant weight loss not due to diet, recurrent vomiting, dysphagia, haematemesis or melena), as well as when gastric ulcer is present or suspected, malignant disease should be excluded, as taking the drug may mask its symptoms and delay the establishment of a correct diagnosis.
The drug should be used with caution in patients with mild hepatic and/or renal impairment.
For patients with mild liver dysfunction, the maximum daily dose of the drug should not exceed 1 capsule per day. In patients with liver failure, after taking the usual dose of omeprazole, the half-life may increase by 3 times compared to that in healthy volunteers; therefore, patients with liver dysfunction require dosage adjustment. The dose of omeprazole is selected taking into account the maximum daily dose of 20 mg. In patients with chronic liver diseases, it is necessary to constantly (at least once every 2 weeks) conduct a laboratory blood test for the content of liver enzymes. In case of any changes in these indicators, the drug should be stopped immediately. Patients with moderate and severe liver failure are not recommended to take the drug.
For patients with mild renal impairment, dose adjustment is not required. During long-term therapy, patients should be under regular medical supervision. Omeprazole and its metabolites are excreted by the kidneys; in patients with chronic renal failure, the elimination of the drug is slowed down in proportion to the decrease in creatinine clearance. The plasma half-life is prolonged in patients with severe renal failure.
Not recommended for rocking.
It should be used with caution in elderly patients and in patients with existing or history of heart disease. If signs and symptoms that may be associated with cardiac arrhythmia appear, domperidone treatment should be discontinued and a doctor should be consulted.
Domperidone should be used with caution in patients with risk factors for QT prolongation, including hypokalemia, severe hypomagnesemia, and organic heart disease.
Information regarding the risk of cardiovascular complications caused by medicines containing domperidone should be taken into account:
Some epidemiological studies have shown that domperidone may be associated with serious ventricular arrhythmias or sudden cardiac death; the risk of serious ventricular arrhythmias or sudden cardiac death is higher in patients over 60 years of age or at oral doses of the drug greater than 30 mg per day, as well as in patients who are concomitantly taking drugs that prolong the QT interval or CYP3A4 inhibitors. Therefore, the drug should be used with caution in elderly patients. Patients over 60 years of age should consult a doctor before taking the drug.
The capsules contain lactose, so the drug should not be used in patients with lactase deficiency, galactosemia and glucose/galactose malabsorption.
Concomitant use of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor cannot be avoided, close clinical monitoring (e.g. viral load) is recommended in conjunction with an increase in the dose of atazanavir to 400 mg per 100 mg of ritonavir; the dose of omeprazole should not exceed 20 mg.
Omeprazole, like all drugs that inhibit the secretion of hydrochloric acid in the stomach, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be taken into account in patients with cachexia or risk factors for reduced absorption of vitamin B12 during long-term therapy.
Patients taking proton pump inhibitors, including omeprazole, may develop significant hypomagnesemia for at least three months (in most cases of hypomagnesemia, patients have been taking the drug for about 1 year). Hypomagnesemia can be suspected due to serious manifestations such as fatigue, seizures, delirium, dizziness, ventricular arrhythmias. However, it should be borne in mind that in some cases the manifestations may be masked, which prevents timely recognition of such a complication. In most patients, the manifestations of hypomagnesemia disappear and the condition normalizes after the use of magnesium preparations and the withdrawal of proton pump inhibitors. Prolonged reduction in gastric acidity can lead to an increase in the number of bacteria normally present in the gastrointestinal tract, such as Salmonella and Campylobacter, and in hospitalized patients - also Clostridium difficile.
Treatment with proton pump inhibitors slightly increases the risk of developing gastrointestinal infections caused by Salmonella and Campylobacter.
In healthy volunteers, a pharmacokinetic/pharmacodynamic interaction was observed between clopidogrel (loading dose 300 mg/daily maintenance dose 75 mg) and omeprazole (80 mg/day orally, i.e. a dose 4 times the standard daily dose), resulting in a mean 46% decrease in exposure to the active metabolite of clopidogrel and a mean 16% decrease in the maximum inhibitory effect of [adenosine diphosphate (ADP)-induced] platelet aggregation.
Some evidence suggests that proton pump inhibitor therapy may slightly increase the risk of osteoporosis-related fractures of the hip, wrist, and spine, mainly in the elderly or in the presence of other recognized risk factors. Observational studies suggest that proton pump inhibitors increase the overall risk of fracture in such individuals by 10–40%. This increase may be partly due to other risk factors. Although a causal relationship between omeprazole/esomeprazole and osteoporotic fracture has not been proven, appropriate clinical surveillance and adequate vitamin D and calcium intake are recommended in patients at risk of developing osteoporosis or osteoporotic fracture.
Subacute cutaneous lupus erythematosus (SCL)
The use of proton pump inhibitors may be associated with very rare cases of PSCV. If lesions occur, especially in sun-exposed areas of the skin, accompanied by arthralgia, the patient should seek medical advice immediately and the doctor should consider discontinuing omeprazole. The occurrence of PSCV in patients on previous proton pump inhibitor therapy increases the risk of its development with the use of other proton pump inhibitors.
Impact on research results
During treatment with antisecretory drugs, plasma gastrin concentration increases as a result of decreased hydrochloric acid secretion. Decreased hydrochloric acid secretion increases chromogranin A (CgA) levels. Increased CgA levels may interfere with the results of tests for the detection of neuroendocrine tumors. To avoid this interference, the proton pump inhibitor should be discontinued 5 days before CgA measurement. If CgA and gastrin levels do not return to normal after the initial measurement, the measurement should be repeated 14 days after the end of proton pump inhibitor treatment.
Atrophic gastritis has been reported in patients taking omeprazole for long periods.
In patients taking PPIs concomitantly with digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), magnesium levels should be measured before starting PPI therapy and periodically during treatment. Magnesium levels are also recommended for patients requiring long-term therapy.
With any long-term treatment, especially more than 1 year, the patient should be under regular medical supervision.
Domperidone
Dopamine receptor blockers increase prolactin levels; this increase persists with continued use of these drugs. In patients with a history of prolactin-dependent breast cancer, domperidone should be used with caution. Although galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels in most patients remains unclear.
In patients who develop galactorrhea and/or gynecomastia, discontinuation of the drug results in a reduction of these symptoms.
Cardiovascular effects
Domperidone has been associated with QT prolongation on the ECG. Very rare cases of QT prolongation and torsades de pointes have been reported in post-marketing experience in patients taking domperidone. These reports included patients with electrolyte abnormalities and concomitant medications that may be additional risk factors.
Domperidone should be used at the lowest effective dose.
Domperidone is contraindicated for use with drugs that prolong the QT interval, in particular apomorphine, except in cases where the benefits of concomitant use with apomorphine outweigh the risks and when the recommendations for precautions in the case of concomitant use of these drugs, specified in the instructions for medical use of apomorphine, are strictly followed.
Kidney dysfunction
The half-life of domperidone is prolonged in patients with severe renal impairment. With prolonged use, the frequency of domperidone administration should be reduced to once or twice daily, depending on the severity of renal impairment. A dose reduction may also be necessary.
Antacids or antisecretory drugs should not be taken simultaneously with Omez® DSR, as they reduce the oral bioavailability of domperidone. When used together, Omez® DSR should be taken before meals, and antacids or antisecretory drugs after meals.
Restrictions on use. The dosage and duration of use of domperidone have been reduced. It should be used at the lowest effective dose for the shortest possible period. The daily dose should not exceed 30 mg based on domperidone.
Excipients
Omez® DSR contains lactose, monohydrate, and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment with the drug, caution must be exercised when driving or operating other mechanisms.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy and breastfeeding.
Method of administration and doses
Omez® DSR should be taken orally, 1 capsule per day in the morning, 1 hour before meals. The capsules should be taken whole, without breaking or chewing. The recommended maximum dose for adults should not exceed 30 mg per domperidone (1 capsule).
The course of treatment is determined by the doctor individually depending on the nature and course of the disease. Unless otherwise prescribed by the doctor, Omez® DSR should usually not be used for more than one week.
Children
The efficacy and safety of the drug in children have not been established.
Overdose
In case of an overdose of omeprazole, the following may occur: anxiety, dizziness, visual disturbances, tachycardia, nausea, vomiting, increased sweating, flushing, headache, dry mouth, diarrhea, apathy, depression, confusion. In case of an overdose of domperidone, the following may occur: dizziness, disorientation, extrapyramidal disorders, arrhythmia, increased blood pressure, agitation, impaired consciousness, drowsiness.
Specific antidote is unknown. In case of overdose, symptomatic and supportive treatment is carried out. Hemodialysis is ineffective for removing the drug from the body due to the high degree of binding to blood plasma proteins.
Omeprazole
Overdose of omeprazole has been reported in humans at doses up to 2400 mg (120 times the usual recommended clinical dose). Manifestations included: confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth and other adverse reactions similar to those commonly observed in clinical practice. The symptoms were transient; no serious clinical consequences were observed with omeprazole alone. There is no specific antidote for omeprazole overdose. Omeprazole is highly protein bound and therefore poorly dialysable. Treatment of overdose should be symptomatic and supportive. As in all cases of overdose, the possibility of multiple drug interactions should be considered.
Domperidone
The frequency of overdose with domperidone has not been reported. Given the pharmaceutical properties of domperidone, overdose may be accompanied by the following symptoms: drowsiness, disorientation, extrapyramidal reactions (especially in children), arrhythmia or arterial hypertension. Anticholinergic, antiparkinsonian drugs or antihistamines with anticholinergic properties may be used to reduce extrapyramidal reactions. There is no specific antidote for domperidone, but in case of overdose, gastric lavage and administration of activated charcoal should be considered. Symptomatic and supportive measures are recommended. Symptoms usually resolve within 24 hours.
Adverse reactions
The drug is well tolerated by most patients. Adverse reactions reported during treatment
