Omez DSR modified release capsules №10×1

Name:
Omez DSR caps. with mod. vysv. 20mg/30mg in bl. in pack. No. 10×1
Description:
Modified release hard gelatin capsules, size #1, colorless, transparent, with black marking “DR. REDDY’S” on the capsule cap and red marking “OMEZ-DSR” on the capsule body; the contents of the capsules are granules from white to grayish-white and from brown to yellowish-brown. The main active ingredient Omeprazole, Domperidone Release form Tablets Dosage 20 mg / 30 mg in bl. in pack. No. 10×1 Special instructionsLactose Omeprazole granules contain lactose, so you should not use Omez® DSR in patients with lactose intolerance, galactosemia and malabsorption of glucose and galactose. Cardiovascular system It has been shown that the use of domperidone may be associated with an increased risk of ventricular arrhythmias or sudden coronary death, which is more likely for patients over 60 years of age with a daily dose of domperidone more than 30 mg. The use of domperidone and other drugs that prolong the QT interval requires caution in patients with existing conduction disturbances with QT prolongation, severe electrolyte imbalance, or congestive heart failure). Osteoporosis Patients at risk of developing osteoporosis or fractures due to it should be under appropriate clinical supervision, although a causal relationship between the use of omeprazole and fractures due to osteoporosis has not been established. Hypomagnesemia There have been reports of severe hypomagnesemia in patients treated with proton pump inhibitors, including omeprazole, for more than one year. Patients receiving omeprazole therapy for a long time, especially in combination with digoxin or other drugs that reduce the content of magnesium in the blood plasma (diuretics), require regular monitoring of the magnesium content. Interference with laboratory tests An increase in the concentration of chromogranin A (CgA) due to a decrease in the secretion of hydrochloric acid) may affect the results of examinations for the detection of neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors must be suspended 5 days before the study of CgA concentration. Pharmacological action The combination of two active substances (dommperidone and omeprazole) has a complex effect on the main links in the pathogenesis of gastroesophageal reflux disease (GERD), dyspeptic disorders of various origins. Domperidone enhances and synchronizes physiological peristaltic waves, omeprazole reduces basal and stimulated secretion of hydrochloric acid. Omeprazole Mechanism of action Omeprazole concentrates in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, activates and inhibits the proton pump – the enzyme H + / K + -ATPase, which provides a dose-dependent highly effective inhibition of basal and stimulated secretion of hydrochloric acid, regardless of the stimulating factor. Influence on gastric acidity The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcer, omeprazole at a dose of 20 mg causes a sustained decrease in 24-hour gastric acidity by at least 80%. This achieves a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% within 24 hours. In patients with duodenal ulcer, omeprazole 20 mg, when taken orally daily, maintains an acidity value in the intragastric environment at pH> 3 for an average of 17 hours a day. Inhibition of hydrochloric acid secretion depends on the area under the concentration-time pharmacokinetic curve (AUC) of omeprazole, and not on the plasma concentration of the drug at a given time. Effect on Helicobacter pylori Eradication of Helicobacter pylori when omeprazole is used together with antibacterial agents is accompanied by rapid resolution of symptoms, a high degree of healing of defects in the mucous membrane of the gastrointestinal tract and long-term remission of peptic ulcer, which reduces the likelihood of complications such as bleeding, as effectively as ongoing maintenance therapy. Other effects Reduced secretion of hydrochloric acid in the stomach leads to a slight increase in the risk of intestinal infections caused by Salmonella spp., Campylobacter spp. and Clostridium difficile. During treatment with drugs that reduce the secretion of the gastric glands, the concentration of gastrin in the blood serum increases. Due to a decrease in the secretion of hydrochloric acid, the concentration of chromogranin A increases (see the section “Special Instructions”). Domperidone Dopamine antagonist, combines peripheral (gastrokinetic) action and antagonism to dopamine receptors in the trigger zone of the brain (central action), due to which it has an antiemetic effect, stimulates the release of prolactin from the pituitary gland and eliminates the inhibitory effect of dopamine on the motor function of the gastrointestinal tract, enhances and synchronizes peristaltic waves, thereby accelerating the natural emptying of the stomach and increasing the pressure of the lower esophageal sphincter. PharmacokineticsOmeprazole The absorption of omeprazole is high, the time to reach the maximum plasma concentration (Tmax) is 0.5-1 hour. Bioavailability – 30-40%, after continuous administration 1 time per day increases to 60%. Distribution. Communication with plasma proteins – 90-95%. The volume of distribution is 0.3 l/kg. Metabolism. Part of omeprazole undergoes first pass hepatic metabolism, involving more CYP2C19 than CYP3A4 with the formation of inactive metabolites. Omeprazole, not included by parietal cells in the process of formation of active metabolites, is completely metabolized in the liver. The total plasma clearance is 0.3-0.6 l / min. Withdrawal. The half-life (T1 / 2) of omeprazole is about 40 minutes. Excreted by the kidneys (70-80%) and bile (20-30%). In case of impaired liver function, bioavailability increases and plasma clearance of omeprazole decreases. In case of impaired renal function or in elderly patients, there were no changes in the bioavailability of omeprazole. Domperidone This dosage form provides a sustained release of the active substance. In acid dissolution tests, after 8 hours, from 75% to 83% of the nominal content of domperidone in one capsule is determined, and after 12 hours – from 86% to 94%. Absorption on an empty stomach is fast. Tmax – 30-60 minutes. Low bioavailability (15%) is associated with first pass metabolism in the intestinal wall and liver. Distribution. Communication with plasma proteins – 90%. Penetrates into various tissues, poorly passes through the blood-brain barrier. It is metabolized in the liver (including due to the first pass effect) and in the intestinal wall (by hydroxylation and N-dealkylation) with the participation of CYP3A4, CYP1A2 and CYP2E1 isoenzymes. Excretion: 66% through the intestines (unchanged – 10%), by the kidneys – 33% (unchanged 1%) in the form of glucuronides. With severe chronic renal failure, T1 / 2 lengthens. Indications for use Dyspepsia accompanied by delayed gastric emptying, gastroesophageal reflux, esophagitis (feeling of fullness in the epigastrium, feeling of bloating, pain in the upper abdomen; belching, flatulence; nausea, vomiting; heartburn with or without reflux of gastric contents into the oral cavity ); – gastroesophageal reflux disease; – nausea, vomiting, heartburn associated with gastroesophageal reflux disease, gastritis, peptic ulcer of the stomach and duodenum, including after eradication therapy. Dosage and administration Omez® DSR is taken orally on an empty stomach, 20-30 minutes before meals (the contents of the capsule should not be chewed), with a small amount of water. Omez® DSR is taken one capsule once a day in the morning. The maximum daily dose is 1 capsule of Omez® DSR, which corresponds to 20 mg of omeprazole and 30 mg of domperidone. Application for violations of liver function. With mild violations of liver function, correction of the dosing regimen is not required. Application for violations of kidney function. Single dose adjustment is not required. Use in the elderly. Correction of the dosing regimen is not required. Use during pregnancy and lactation The use of Omez® DSR during pregnancy and during breastfeeding is contraindicated. Precautions In the presence of a stomach ulcer (or suspected gastric ulcer), previous surgical intervention on the gastrointestinal tract; – in the presence of “alarming” symptoms: significant spontaneous weight loss, repeated vomiting, vomiting with blood, discoloration of feces (tarry stools – melena), impaired swallowing; – with the appearance of new symptoms or a change in existing symptoms from the gastrointestinal tract; – in the presence of severe electrolyte disturbances or heart disease, such as heart failure). – with osteoporosis; – with renal failure. Interaction with other drugs Special studies of drug interactions Omez® DSR with other drugs have not been conducted. For individual medicinal products, the following drug interactions have been noted. Substances with pH-dependent absorption Like other drugs that reduce the acidity of gastric juice, treatment with omeprazole may lead to a decrease in the absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron preparations and cyanocobalamin. Their co-administration with Omez® DSR should be avoided. Antacids and antisecretory drugs Cimetidine and sodium bicarbonate reduce the oral availability of domperidone. Digoxin The bioavailability of digoxin when used simultaneously with omeprazole increases by 10%. Caution should be exercised with the simultaneous use of digoxin and Omez® DSR in elderly patients. Co-administration of domperidone and digoxin does not change the concentration of the latter. Clopidogrel Studies have shown an interaction between clopidogrel (loading dose 300 mg, maintenance dose 75 mg/day) and omeprazole (80 mg/day orally), which reduces exposure to the active metabolite of clopidogrel and reduces inhibition of platelet aggregation. Therefore, the simultaneous use of clopidogrel and omeprazole at a dose of 80 mg per day should be avoided. Antiretroviral drugs An increase in pH during therapy with omeprazole may affect the absorption of antiretroviral drugs. Interaction at the level of the CYP2C19 isoenzyme is also possible. In this regard, the combined use of Omez® DSR with antiretroviral drugs such as atazanavir and nelfinavir is contraindicated. With simultaneous use with omeprazole, there is an increase in plasma concentrations of saquinavir / ritonavir up to 70%, while the tolerability of treatment in patients with HIV infection does not worsen. The suppressive effect of HIV protease inhibitors on the CYP3A4 isoenzyme can cause an increase in the concentration of domperidone when they are co-administered with Omez DSR. Tacrolimus: With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted. It is necessary to control the creatinine clearance and the concentration of tacrolimus in the blood plasma when it is used together with Omez® DSR. Methotrexate Proton pump inhibitors may slightly increase methotrexate plasma concentrations. In the treatment of high doses of methotrexate, you should temporarily stop taking Omez® DSR. Drugs in the metabolism of which the CYP2C19 isoenzyme is involved. With simultaneous use with omeprazole, an increase in plasma concentration and an increase in the half-life of warfarin (R-warfarin), diazepam, phenytoin, cilostazol, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs metabolized in the liver with the participation of the CYP2C19 isoenzyme (a decrease in the doses of these drugs may be required). However, taking omeprazole 20 mg per day does not affect the plasma concentration of phenytoin in patients taking phenytoin for a long time. When using omeprazole in patients receiving warfarin or other vitamin K antagonists, monitoring of the international normalized ratio is necessary. At the same time, concomitant treatment with omeprazole at a daily dose of 20 mg does not lead to a change in coagulation time in patients taking warfarin for a long time. Inhibitors of CYP2C19 and / or CYP3A4 enzymes Simultaneous use with inhibitors of CYP2C19 and / or CYP3A4 isoenzymes slows down the metabolism of omeprazole. When omeprazole or domperidone is co-administered with clarithromycin or erythromycin, the concentration of omeprazole, as well as the concentration of domperidone in the blood plasma, increase. The combined use of voriconazole and omeprazole leads to an increase in the area under the pharmacokinetic curve of omeprazole. Fluconazole, itraconazole, ketoconazole and voriconazole also increase plasma domperidone concentrations. The overwhelming effect of HIV protease inhibitors on the CYP3A4 isoenzyme can cause an increase in the concentration of domperidone when they are co-administered with Omez DSR. Clinical experience and in vitro studies show that it is possible to increase the concentration of domperidone in plasma with the combined use of strong CYP3A4 inhibitors such as calcium antagonists (diltiazem and verapamil), nefadozone and amiodarone. In addition, when taking amiodarone, or when co-administering domperidone with ketoconazole, erythromycin may lengthen the QT interval (see section “Special Instructions”). Inducers of CYP2C19 and CYP3A4 enzymes Inducers of CYP2C19 and CYP3A4 isoenzymes, such as rifampicin, St. Anticholinergic drugs Anticholinergic drugs can neutralize the effect of domperidone. No effect on metabolism Co-administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in blood plasma. No clinically significant interaction of omeprazole with metoprolol, phenacetin, estradiol, budesonide, diclofenac, naproxen, piroxicam, S-warfarin has been established. There was no effect of omeprazole on antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol. The use of domperidone while taking paracetamol or digoxin did not affect the level of these drugs in the blood. Domperidone is compatible with taking antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, L-dopa), as it inhibits their undesirable peripheral effects (nausea and vomiting) and does not affect their central effects. Contraindications Hypersensitivity to the components of the drug and benzimidazoles; – prolactin-secreting pituitary tumor (prolactinoma); – lactose intolerance, lactase deficiency, glucose-galactose malabsorption; – sucrase/isomaltase deficiency, fructose intolerance; – concomitant use of erlotinib, posaconazole, nelfinavir, atazanavir, oral forms of ketoconazole, erythromycin or other CYP3A4 inhibitors that cause prolongation of the QT interval, such as fluconazole, voriconazole, clarithromycin, amiodarone and telithromycin (see section “Interaction with other drugs”); – gastrointestinal bleeding, mechanical obstruction or perforation, i.e. when stimulation of gastrointestinal motility can be dangerous; – liver failure of moderate and severe severity; – pregnancy and breastfeeding period; – children’s age up to 18 years. Composition Active substance: omeprazole (in the form of enteric-coated granules) 20 mg domperidone (in the form of sustained-release granules) 30 mg sucrose (25/30) – 24.35 mg; sucrose – 8.54 mg, hypromellose 6 cps – 0.14 mg; 5 cps – 0.57 mg, nonpareil sugar grains – 58.98 mg, colloidal silicon dioxide – 0.48 mg, talc – 4.51 mg. Coating composition: hypromellose 6 cps – 13 mg. The composition of the enteric coating: methacrylic acid and ethyl acrylate copolymer (1:1) (methacrylic acid copolymer (type C) – 40.47 mg; sodium hydroxide – 0.54 mg; macrogol 6000 – 4.85 mg; talc – 4.05 mg ; titanium dioxide – 2.13 mg. Extended release coating: hypromellose 5 cps – 0.40 mg; ethylcellulose 10 cps – 1.18 mg; triacetin – 0.12 mg; talc – 0.086 mg. Composition of gelatin solid capsules No1: gelatin – 85.42% Water – 14.5% Sodium lauryl sulfate – 0.08% Black ink for writing on the cap of the capsule: ethanol – 29-33%, isopropanol – 9-12%, butanol – 4-7% ; shellac – 24-28%; iron dye black oxide (E172) – 24-28%; aqueous ammonia – 1-3%; propylene glycol – 0.5-2%. Red ink for writing on the capsule body: ethanol – 21 -25%; isopropanol – 12-16%; butanol – 7-10%; shellac – 22-27%; crimson dye (Ponso 4R) (E124) – 18-24%; titanium dioxide (E171) – 5-9% , aqueous ammonia – 1-3%, polysorbate 80 – 0.5-2%, propylene glycol – 0.5-2%. symptoms Dizziness, confusion, apathy, drowsiness, headache, blurred vision, vascular dilatation, tachycardia, nausea, vomiting, flatulence, diarrhea, increased sweating, “dryness” in the mouth. With increasing dose, the rate of elimination of the drug did not change. Treatment: activated charcoal inside, gastric lavage; if necessary – symptomatic therapy and careful observation. Anticholinergics, drugs used to treat parkinsonism, or antihistamines may be effective in extrapyramidal reactions. Hemodialysis is not effective enough. Side effects Possible side effects are listed below by body systems and frequency of occurrence for omeprazole and domperidone: very often (> 1/10); often (?1/100, <1/10); infrequently (?1/1000, <1/100); rarely (?1/10000, <1/1000); very rarely (<1/10000, including isolated cases and the frequency is not known). Blood and lymphatic system disorders Omeprazole - rarely: leukopenia, thrombocytopenia; very rarely: agranulocytosis, pancytopenia, eosinophilia. Immune system disorders Omeprazole - rarely: hypersensitivity reactions: fever, angioedema, anaphylactic reaction / anaphylactic shock. Domperidone - very rarely: anaphylactic reaction / anaphylactic shock, angioedema. Metabolic and nutritional disorders Omeprazole - rarely: hyponatremia; frequency unknown: hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia. Mental disorders Omeprazole - infrequently: insomnia; rarely: irritability, depression, reversible confusion; very rarely: aggression, hallucinations. Domperidone - very rarely: agitation, nervousness, irritability and irritability. Nervous system disorders Omeprazole - often: headache; infrequently: dizziness, paresthesia, drowsiness; rarely: taste disturbance. Domperidone - very rarely: extrapyramidal phenomena, convulsions, drowsiness, headache. On the part of the organ of vision Omeprazole - infrequently: visual disturbances, including a decrease in visual fields, a decrease in the sharpness and clarity of visual perception (usually disappear after cessation of therapy). On the part of the organ of hearing and labyrinth disorders Omeprazole - infrequently: disturbances in auditory perception, including ringing in the ears (usually disappear after cessation of therapy), vertigo (a feeling of circling one's own body or surrounding objects). Cardiovascular disorders: Domperidone - very rare: QT interval prolongation, torsades de pointes, sudden coronary death (more likely in patients over 60 years of age taking more than 30 mg per day). Respiratory, thoracic and mediastinal disorders: Omeprazole - rarely: bronchospasm. Gastrointestinal disorders Omeprazole - often: abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; rarely: dryness of the oral mucosa, stomatitis, gastrointestinal candidiasis, microscopic colitis, discoloration of the tongue to brown-black and the appearance of benign salivary gland cysts while using clarithromycin (phenomena are reversible after stopping therapy); isolated cases: the formation of gastric glandular cysts and during long-term treatment with simultaneous use with clarithromycin (a consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible). Liver and biliary tract disorders Omeprazole - infrequently: increased activity of "liver" enzymes and alkaline phosphatase (reversible); rarely: hepatitis (with or without jaundice), liver failure, encephalopathy in patients with previous severe liver disease. Skin and subcutaneous tissue disorders Omeprazole - infrequently: dermatitis, pruritus, skin rash, urticaria; rarely: alopecia, photosensitivity reactions in the form of reddening of the skin after UVI, multiform exudative erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome (severe erythema, characterized by the appearance of spots and blisters on the skin and mucous membranes against the background of high fever and joint pain). Domperidone - very rarely: Quincke's edema, urticaria. Musculoskeletal and connective tissue disorders Omeprazole - infrequently: fractures of the vertebrae, wrist bones, femoral head associated with osteoporosis; rarely: arthralgia, myalgia, muscle weakness. Renal and urinary tract disorders Omeprazole - rarely: interstitial nephritis. Domperidone - very rarely: urinary retention. Violations of the genital organs and mammary gland Omeprazole - rarely: gynecomastia. General disorders Omeprazole - infrequently: malaise; rarely: increased sweating, peripheral edema. Laboratory and instrumental data Domperidone - very rarely: changes in liver function tests, increased blood prolactin levels. In case of side effects not listed in this leaflet, you should immediately inform your doctor. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Buy Omez DSR modified release capsules No. 10x1 Price for Omez DSR modified release capsules No. 10x1 Instructions for use for Omez DSR modified release capsules No. 10x1