Omega® JEM (Omez® DSR)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDomperidone + OmeprazoleDomperidone + Omeprazole
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  • Omez® D
    capsules inwards 
    Torrent Pharmaceuticals Co., Ltd.     India
  • Omega® JEM
    capsules inwards 
    Dr. Reddy's Laboratories Ltd.     India
    • Dosage form: & nbspmodified release capsules
    Composition:

    Each capsule contains:

    active ingredients: omeprazole 20 mg (in the form of granules with enteric coating 267 mg) *, domperidone 30 mg (in the formulation of sustained-release granules 100 mg) **;

    Excipients: talc 2 mg.

    * Composition of omeprazole granules:

    active substance: omeprazole 20 mg;

    Excipients: mannitol 137.86 mg, lactose monohydrate 9.66 mg, sodium lauryl sulfate 0.52 mg, sodium hydrogen phosphate 0.89 mg, sucrose (25/30) 24.35 mg, sucrose 8.54 mg, hypromellose 6 cps 0.14 mg;

    coating: hypromellose 6 cps 13 mg;

    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.

    ** Composition of the domperidone pellets:

    active substance: domperidone 30 mg;

    Excipients: sugar grated nonparable 58.98 mg, silicon dioxide colloid 0.48 mg, talc 4.51 mg, hypromellose 5 cps 0.57 mg;

    coating: hypromellose 5 cps 2.34 mg, talc 0.71 mg, iron oxide dye yellow 0.12 mg, iron oxide red oxide 0.04 mg, titanium dioxide 0.47 mg;

    sustained release coating: hypromellose 5 cps 0.40 mg, ethylcellulose 10 cps 1.18 mg, triacetin 0.12 mg, talc 0.086 mg.

    The composition of capsules of gelatinous solid No. 1: gelatin 85.42%, water 14.50%, sodium lauryl sulfate 0.08%.

    Composition of black ink for inscription 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%, ammonia water 1-3%, propylene glycol 0.5-2% .

    Composition of red ink for inscription on the capsule body: ethanol 21-25%, isopropanol 12-16%, butanol 7-10%, shellac 22-27%, dye crimson [Ponso 4R] (E124) 18-24%, titanium dioxide (E171) 5-9%, ammonia water 1-3%, polysorbate 80 0.5-2%, propylene glycol 0.5-2%.

    Description:

    Hard gelatinous transparent colorless capsules No. 1 with black marking on the cap of the capsule and marked with a red "OMEZ-DSR"on the capsule body.Capsule contents: granules from white to grayish-white and from brown to yellowish brown.

    Pharmacotherapeutic group:Reflux-esophagitis treatment agent combined (proton pump inhibitor + dopamine receptor blocker central)
    ATX: & nbsp

    A.02.B.X   Other antiulcer drugs

    Pharmacodynamics:

    Combination of two active substances (domperidone and omeprazole) has a complex effect on the main links of the pathogenesis of gastroesophageal reflux disease (GERD), dyspeptic disorders of various genesis. Domperidone strengthens and synchronizes physiological peristaltic waves, omeprazole reduces basal and stimulated secretion of hydrochloric acid.

    Omeprazole

    Mechanism of action

    Omeprazole is concentrated in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, is activated and inhibits the proton pump - the enzyme H+/TO+-ATPase, which provides a dose-dependent, highly effective inhibition of basal and stimulated hydrochloric acid secretion irrespective of the stimulating factor.

    Effect on gastric acidity

    The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcer omeprazole in a dose of 20 mg causes a steady decrease in 24-hour gastric acidity by at least 80%. At the same time, the average maximum concentration of hydrochloric acid is reduced after pentagastrin stimulation by 70% within 24 hours.In patients with duodenal ulcer omeprazole 20 mg with daily oral administration maintains in the intragastric environment the acidity value at pH> 3 on average for 17 hours per day. Inhibition of the secretion of hydrochloric acid depends on the area under the pharmacokinetic curve "concentration-time" (AUC) omeprazole, and not on the concentration of the drug in the plasma at a given time.

    Action on Helicobacter pylori

    Eradication Helicobacter pylori when omeprazole is used together with antibacterial agents it is accompanied by a rapid elimination of symptoms, a high degree of healing of defects in the gastrointestinal mucosa and a prolonged remission of peptic ulcer, which reduces the likelihood of complications such as bleeding, as effectively as constant maintenance therapy.

    Other effects

    Decrease in secretion of hydrochloric acid in the stomach leads to a slight increase in the risk of developing intestinal infections caused by Salmonella spp., Campylobacter spp. and Clostridium difficile. During treatment with drugs that reduce the secretion of the glands of the stomach, 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 Fig.section "Special instructions").

    Domperidone

    A dopamine antagonist, combines peripheral (gastrokinetic) action and antagonism with dopamine receptors in the trigger zone of the brain (central action), which has 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, strengthens and synchronizes peristaltic waves, thereby accelerating the natural emptying of the stomach and increasing the sphincter pressure of the lower esophagus.

    Pharmacokinetics:

    Omeprazole

    Absorption of omeprazole is high, the time to reach the maximum concentration in the blood plasma (TcmOh) is 0.5-1 hour. Bioavailability - 30-40%, after a constant intake once a day increases to 60%.

    Distribution. The connection with plasma proteins is 90-95%. The volume of distribution is 0.3 l / kg.

    Metabolism. Part of omeprazole undergoes a pre-systemic hepatic metabolism with participation to a greater extent CYP2C19 than CYP3A4 with formation of inactive metabolites. Omeprazole, not included by parietal cells in the formation of active metabolites, is completely metabolized in the liver. The total plasma clearance is 0.3-0.6 l / min.

    Excretion. The half-life (T1/2) of omeprazole is about 40 minutes. It is excreted by the kidneys (70-80%) and with bile (20-30%).

    If liver function is impaired, bioavailability increases and plasma clearance of omeprazole decreases.

    If renal dysfunction or elderly patients there are no changes in the bioavailability of omeprazole.

    Domperidone

    This dosage form provides sustained release of the active substance. In dissolution tests in acidic medium, after 8 hours, 75% to 83% of the nominal content of domperidone in one capsule is determined, and after 12 hours, from 86% to 94%.

    Absorption fasting fast. TcmOh - 30-60 minutes. Low bioavailability (15%) is associated with the metabolism of the first passage in the intestinal wall and liver.

    Distribution. The connection with plasma proteins is 90%. Penetrates into various tissues, it does not pass well through the blood-brain barrier.

    Metabolized in the liver (including due to the effect of the first passage) and in the intestinal wall (by hydroxylation and N-dealkylation) with the participation of isoenzymes CYP3A4, CYP1A2 and CYP2E1.

    Excretion: 66% through the intestine (unchanged - 10%), kidneys - 33% (unchanged 1%) in the form of glucuronides. With severe chronic renal failure T1/2 lengthens.

    Indications:

    - Dyspepsia accompanied by delayed emptying of the stomach, gastroesophageal reflux, esophagitis (a feeling of overfilling in the epigastrium, a feeling of bloating, pain in the upper abdomen, belching, flatulence, nausea, vomiting, heartburn with or without casting gastric contents into the mouth);

    - gastroesophageal reflux disease;

    - nausea, vomiting, heartburn associated with gastroesophageal reflux disease, gastritis, peptic ulcer of the stomach and duodenum, including after eradication therapy.

    Contraindications:

    - Hypersensitivity to the drug components and benzimidazoles;

    - prolactin-secreting pituitary tumor (prolactinoma);

    - lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

    - deficiency of sugar / isomaltase, intolerance to fructose;

    - simultaneous reception of erlotinib, posaconazole, nelfinavir, atazanavir, oral forms of ketoconazole, erythromycin or other inhibitors CYP3A4, causing the lengthening of the interval QT, such as fluconazole, voriconazole, clarithromycin, amiodarone and telithromycin (see section "Interaction with other medicinal products");

    - gastrointestinal bleeding, mechanical obstruction or perforation, i. e. when stimulation of the motility of the gastrointestinal tract can be dangerous;

    - hepatic insufficiency of moderate and severe severity;

    - pregnancy and the period of breastfeeding;

    - children's age till 18 years.

    Carefully:

    - In the presence of a stomach ulcer (or suspected gastric ulcer), a previous surgical intervention on the gastrointestinal tract;

    - in the presence of "alarming" symptoms: significant spontaneous weight loss, repeated vomiting, vomiting with a trace of blood, a change in color of the stool (tarry stool - melena), impaired swallowing;

    - When new symptoms or changes in existing symptoms from the gastrointestinal tract occur;

    - if there are severe electrolyte disorders or heart diseases, such as heart failure).

    - with osteoporosis;

    - with renal failure.

    Pregnancy and lactation:

    The use of Omega® JEM during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    Omega® JEM is taken orally on an empty stomach, 20-30 minutes before meals (the contents of the capsule can not be chewed), with a small amount of water.

    Omez® JEM take one capsule once a day in the morning.

    The maximum daily dose is 1 capsule of Omega® DSR, which corresponds to 20 mg of omeprazole and 30 mg of domperidone.

    Application for violations of liver function. For mild violations of liver function, correction of the dosing regimen is not required.

    Application for violations of kidney function. Correction of a single dose is not required.

    Application in the elderly. Correction of the dosing regimen is not required.

    Side effects:

    Possible side effects are given below for 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 single cases and frequency not known).

    Violations of the blood and lymphatic system

    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.

    Disorders from the metabolism and nutrition

    Omeprazole - rarely: hyponatremia; frequency is unknown: hypomagnesemia, which in severe cases can lead to hypocalcemia, hypokalemia.

    Disorders of the psyche

    Omeprazole - infrequently: insomnia; rarely: increased excitability, depression, reversible confusion; very rarely: aggression, hallucinations. Domperidone - very rarely: agitation, nervousness, increased excitability and irritability.

    Disturbances from the nervous system

    Omeprazole - often: headache; infrequently: dizziness, paresthesia, drowsiness; rarely: a taste disorder. Domperidone - very rarely: extrapyramidal phenomena, seizures, drowsiness, headache.

    Disturbances on the part of the organ of sight

    Omeprazole is infrequent: visual disturbances, including a reduction in visual fields, a reduction in visual acuity and clarity (usually occur after discontinuation of therapy).

    Hearing disorders and labyrinthine disorders

    Omeprazole - infrequent: impairment of auditory perception, including "ringing in the ears" (usually occur after discontinuation of therapy), vertigo (feeling of twisting your own body or surrounding objects).

    Disorders from the cardiovascular system:

    Domperidone - very rarely: lengthening of the interval QT, ventricular tachycardia of the type "pirouette", sudden coronary death (more likely for patients older than 60 years, taking more than 30 mg per day).

    Disturbances from the respiratory system, chest and mediastinal organs:

    Omeprazole - rarely: bronchospasm.

    Disorders from the gastrointestinal tract

    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 brownish-black and the appearance of benign salivary gland cysts with concurrent use with clarithromycin (phenomena are reversible after discontinuation of therapy); single cases: the formation of gastric glandular cysts and during long-term treatment with simultaneous use with clarithromycin (a consequence of inhibiting the secretion of hydrochloric acid, is benign, reversible).

    Disturbances from the liver and bile ducts

    Omeprazole - infrequently: increased activity of "liver" enzymes and alkaline phosphatase (reversible nature); rarely: hepatitis (with jaundice or without), hepatic insufficiency, encephalopathy in patients with previous severe liver diseases.

    Disturbances from the skin and subcutaneous tissues

    Omeprazole - infrequently: dermatitis, itchy skin, skin rash, urticaria; rarely: alopecia, photosensitivity reactions in the form of reddening of the skin after UFD, multiforme exudative erythema, toxic epidermal necrolysis, Stevens-Johnson syndrome (severe erythema, characterized by the appearance of spots and blisters on the skin and mucous membranes amid high fever and joint pain). Domperidone - very rarely: angioedema, hives.

    Disturbances from musculoskeletal and connective tissue

    Omeprazole - infrequently: fractures of the vertebrae, bones of the wrist, head of the femur, associated with osteoporosis; rarely: arthralgia, myalgia, muscle weakness.

    Disorders from the kidneys and urinary tract

    Omeprazole - rarely: interstitial nephritis. Domperidone - very rarely: urinary retention.

    Violations of the genitals and mammary gland

    Omeprazole - rarely: gynecomastia.

    General disorders

    Omeprazole - infrequently: malaise; rarely: increased sweating, peripheral edema.

    Laboratory and instrumental data

    Domperidone is very rare: changes in the parameters of functional liver samples, an increase in the level of prolactin blood.

    In case of side effects not listed in this manual, you should immediately inform your doctor.

    Overdose:

    Symptoms

    Dizziness, confusion, apathy, drowsiness, headache, blurred vision, dilated vessels, tachycardia, nausea, vomiting, flatulence, diarrhea, increased sweating, "dryness" in the mouth. With an increase in the 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 the occurrence of extrapyramidal reactions. Hemodialysis is not effective enough.

    Interaction:

    Special studies of drug interactions Omese® DGD with other drugs have not been conducted.The following drug interactions were noted for individual drugs.

    Substances with pH-dependent absorption

    Like other drugs that reduce the acidity of gastric juice, treatment with omeprazole may lead to a decrease in absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron preparations and cyanocobalamin. Do not share them with Omega® JEM.

    Antacid and antisecretory drugs

    Cimetidine and sodium bicarbonate reduce the oral availability of domperidone.

    Digoxin

    The bioavailability of digoxin when used concomitantly with omeprazole is increased by 10%. Caution should be exercised with the simultaneous use of digoxin and Omega® DGD in elderly patients. The combined use of domperidone and digoxin does not change the concentration of the latter.

    Clopidogrel

    Based on the results of the studies, the interaction between clopidogrel (loading dose 300 mg, maintenance dose 75 mg / day) and omeprazole (80 mg / day inwards), which reduces the exposure of the active metabolite clopidogrel and reduces the inhibition of platelet aggregation.Therefore, simultaneous use of clopidogrel and omeprazole in a dose of 80 mg per day should be avoided.

    Antiretroviral drugs

    An increase in pH on the background of omeprazole therapy may affect the absorption of antiretroviral drugs. It is also possible to interact at the isoenzyme level CYP2C19. In this regard, the combined use of Omese® DGD with antiretroviral drugs, such as atazanavir and nelfinavir, is contraindicated.

    With simultaneous use with omeprazole, an increase in plasma concentrations of saquinavir / ritonavir is observed up to 70%, while tolerability of treatment by patients with HIV infection does not worsen.

    The suppressive effect of HIV protease inhibitors on isoenzyme CYP3A4 can cause an increase in the concentration of domperidone when they are co-administered with Omez® JEM.

    Tacrolimus

    With the simultaneous use of omeprazole and tacrolimus, there was an increase in the concentration of tacrolimus in the blood serum. It is necessary to monitor the clearance of creatinine and the concentration of tacrolimus in the blood plasma when it is used in conjunction with Omega® JEM.

    Methotrexate

    Inhibitors of proton pump can slightly increase the concentration of methotrexate in blood plasma.When treating high doses of methotrexate, Omega® JEM should be temporarily discontinued.

    Drugs metabolized by isoenzyme CYP2C19

    With simultaneous application with omeprazole, an increase in plasma concentration and an increase in the half-life of warfarin (R-varfarin), diazepam, phenytoin, cilostazol, imipramine, clomipramine, citalopram, hexobarbital, disulfiram, as well as other drugs metabolized in the liver with the participation of isoenzyme CYP2C19 (a reduction in the doses of these drugs may be required). However, taking omeprazole 20 mg per day does not affect the concentration of phenytoin in blood plasma in patients taking long-term phenytoin. When using omeprazole by patients receiving warfarin or other antagonists of vitamin K, monitoring of the international normalized relationship 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 long-term warfarin.

    Enzyme Inhibitors CYP2C19 and / or CYP3A4

    Simultaneous application with inhibitors of isoenzymes CYP2C19 and / or CYP3A4 slows the metabolism of omeprazole.

    With the joint administration of omeprazole or domperidone 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 results in an increase in the area under the pharmacokinetic curve of omeprazole. Fluconazole, itraconazole, ketoconazole and voriconazole also increase the concentration of domperidone in plasma.

    The suppressive effect of HIV protease inhibitors on isoenzyme CYP3A4 can cause an increase in the concentration of domperidone when they are co-administered with Omez® JEM.

    Clinical experience and research in vitro show that it is possible to increase the concentration of domperidone in plasma by the combined use of such strong inhibitors CYP3A4, as calcium antagonists (diltiazem and verapamil), nefadozone and amiodarone.

    In addition, with the administration of amiodarone, or with the joint administration of domperidone with ketoconazole, erythromycin may lengthen the interval QT (see section "Special instructions").

    Inductors of enzymes CYP2C19 and CYP3A4

    Inductors of isoenzymes CYP2C19 and CYP3A4, such as rifampicin, preparations of St. John's wort perfumed (Hypericum perforatum), when combined with omeprazole may lead to a decrease in the concentration of omeprazole in the blood plasma due to the acceleration of the metabolism of omeprazole.

    Anticholinergic drugs

    Anticholinergic drugs can neutralize the action of domperidone.

    No effect on metabolism

    The simultaneous administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma.

    There was no clinically significant interaction of omeprazole with metoprolol, phenacetin, estradiol, budesonide, diclofenac, naproxen, piroxicam, S/ RTI & gt;

    There was no effect of omeprazole on antacid agents, theophylline, caffeine, quinidine, lidocaine, propranolol, ethanol.

    The use of domperidone against paracetamol or digoxin did not affect the level of these drugs in the blood.

    Domperidone is compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, L-dopa), because it inhibits their unwanted peripheral effects (nausea and vomiting) and does not affect their central effects.

    Special instructions:

    Lactose

    The granules of omeprazole contain lactose, so do not use Omese® DGD in patients with lactose intolerance, galactosemia and impaired glucose and galactose absorption.

    The 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 older than 60 years with a daily dose of domperidone of more than 30 mg. The use of domperidone and other drugs that lead to lengthening of the interval QT Caution is required in patients with existing conduction abnormalities in elongation QT, severe electrolyte imbalance or congestive heart failure).

    Osteoporosis

    Patients with a risk of developing osteoporosis or fractures against it should be under appropriate clinical supervision, although a causal relationship between omeprazole and fractures against osteoporosis is not established.

    Hypomagnesemia

    There are reports of severe hypomagnesemia in patients receiving 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 magnesium content in the blood plasma (diuretics) require regular monitoring of the magnesium content.

    Impact on laboratory tests

    Increase in the concentration of chromogranin A (CgA) due to a decrease in the secretion of hydrochloric acid) may affect the results of the examinations for the detection of neuroendocrine tumors. To prevent this effect, therapy with proton pump inhibitors should be suspended 5 days before the study concentration CgA.

    Effect on the ability to drive transp. cf. and fur:

    During the period of treatment with Omez® JEM, caution should be exercised when driving vehicles and performing other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Capsules with modified release, 30 mg + 20 mg.
    Packaging:

    For 10 capsules in a blister of (PVC / AL / PA) foil / aluminum foil.

    By 1, 3, 8, 10 blisters together with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003998
    Date of registration:06.12.2016
    Expiration Date:06.12.2021
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.
    Information update date: & nbsp06.06.2017
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