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Omez DSR caps with modif release 30 mg+20 mg x30

Trade name: Omez DSR

International name: Domperidone+Omeprazole&, (Domperidone+Omeprazole)

Pharmacological group: reflux esophagitis combined treatment (proton pump inhibitor + dopamine receptor blocker central)

Pharmacological group for ATC: A02BX. Other antiulcer drugs and drugs for the treatment of gastroesophageal reflux (GORD)

Compound:

Each capsule contains:

active ingredients:

omeprazole 20 mg (in enteric-coated granules 267 mg)*,

domperidone 30 mg (in 100 mg extended-release granules)**,

excipients: talc 2 mg.

*Composition of omeprazole granules:

active ingredient: 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 domperidone granules:

active ingredient: domperidone 30 mg,

excipients: nonpareil sugar 58.98 mg, colloidal silicon dioxide 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 yellow 0.12 mg, iron oxide red 0.04 mg, titanium dioxide 0.47 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 hard gelatin capsules No. “1”: gelatin 85.42%, water 14.50%, sodium lauryl sulfate 0.08%.

Composition of black ink for writing on the capsule cap: ethanol 29-33%, isopropanol 9-12%, butanol 4-7%, shellac 24-28%, iron oxide black dye (E172) 24-28%, aqueous ammonia 1- 3%, propylene glycol 0.5-2%.

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

Description:

Hard gelatin transparent colorless capsules No. “1” with black markings “Dr.Reddy’s” on the capsule cap and red markings “OMEZ-DSR” on the capsule body. Capsule contents: white to grayish-white and brown to yellowish-brown granules.

Pharmacodynamics:

The combination of two active ingredients (domperidone 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 is concentrated in the acidic environment of the secretory tubules of the parietal cells of the gastric mucosa, it is activated and inhibits the proton pump - the enzyme H+/K+-ATPase, which provides dose-dependent, highly effective inhibition of basal and stimulated secretion of hydrochloric acid, regardless of the stimulating factor.

Effect on stomach acidity

The maximum effect is achieved within 4 days of treatment. In patients with duodenal ulcers, omeprazole 20 mg causes a sustained reduction in 24-hour gastric acidity by at least 80%. In this case, a decrease in the average maximum concentration of hydrochloric acid after stimulation with pentagastrin by 70% is achieved within 24 hours. In patients with duodenal ulcers, omeprazole 20 mg with daily oral administration maintains the acidity value in the intragastric environment at a pH level >/= 3 on average for 17 hours a day. Inhibition of hydrochloric acid secretion depends on the area under the pharmacokinetic curve ("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 sphincter of the lower esophagus.

Pharmacokinetics:

OMEPRAZOLE

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

Distribution. Communication with plasma proteins is 90-95%. Volume of distribution 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 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. Excreted by the kidneys (70-80%) and bile (20-30%).

If liver function is impaired, bioavailability increases and plasma clearance of omeprazole decreases. In patients with impaired renal function or in elderly patients, no changes in the bioavailability of omeprazole were observed.

DOMPERIDONE

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

Absorption on an empty stomach is rapid. TCmax - 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 various tissues and does not pass well through the blood-brain barrier.

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 isoenzymes CYP3A4, CYP1A2 and CYP2E1.

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

Indications for use:

- dyspepsia, accompanied by delayed gastric emptying, gastroesophageal reflux, esophagitis (a feeling of fullness in the epigastrium, a 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.

Contraindications:

- hypersensitivity to the components of the drug and benzimidazoles,

- prolactin-secreting tumor of the pituitary gland (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 may be dangerous,

- liver failure of moderate and severe severity,

- pregnancy and breastfeeding,

- children under 18 years of age.

Carefully:

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

- in the presence of “alarming” symptoms: significant spontaneous weight loss, repeated vomiting, vomiting mixed with blood, change in the color of stool (tarry stools - melena), difficulty swallowing,

- when new symptoms appear or changes in existing symptoms from the gastrointestinal tract,

- in the presence of severe electrolyte disturbances or heart disease, such as heart failure),

- for osteoporosis,

- in case of renal failure.

Dosage regimen:

Omez DSR is taken orally on an empty stomach, 20-30 minutes before meals (the contents of the capsule cannot be chewed), washed down 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.

Use for liver dysfunction. For mild liver dysfunction, no dosage adjustment is required.

Use for renal dysfunction. No single dose adjustment is required.

Use in the elderly. No dosage adjustment is required.

Side effects:

Possible side effects are listed below by body system and frequency of occurrence for omeprazole and domperidone: very often (>./=1/10), often (>.1/100, <.1/10), infrequently (>./=1 /1000, <.1/100), rare (>./=1/10000, <.1/1000), very rare (<.1/10000, including isolated cases and frequency unknown).

Blood and lymphatic system disorders

Omeprazole - rare: leukopenia, thrombocytopenia, very rare: agranulocytosis, pancytopenia, eosinophilia.

Immune system disorders

Omeprazole - rarely: hypersensitivity reactions: fever, angioedema, anaphylactic reaction/anaphylactic shock.

Domperidone - very rare: anaphylactic reaction/anaphylactic shock, angioedema.

Metabolic and nutritional disorders

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

Mental disorders

Omeprazole - infrequently: insomnia, rarely: increased excitability, depression, reversible confusion, very rarely: aggression, hallucinations.

Domperidone - very rarely: agitation, nervousness, increased excitability and irritability.

Nervous system disorders

Omeprazole - often: headache, infrequently: dizziness, paresthesia, drowsiness, rarely: taste disturbance.

Domperidone - very rarely: extrapyramidal effects, convulsions, drowsiness, headache.

Visual disorders

Omeprazole - infrequently: visual disturbances, including a decrease in visual fields, a decrease in the acuity and clarity of visual perception (usually disappear after cessation of therapy).

Hearing and labyrinth disorders

Omeprazole - uncommon: disturbances in auditory perception, including “ringing in the ears” (usually disappears after cessation of therapy), vertigo (a feeling of spinning of one’s own body or surrounding objects).

Cardiovascular system disorders:

Domperidone - very rare: QT prolongation, torsade de pointes (TdP), sudden coronary death (more likely in patients over 60 years of age taking more than 30 mg per day).

Disorders of the respiratory system, chest and mediastinal organs:

Omeprazole - rarely: bronchospasm.

Gastrointestinal disorders

Omeprazole - often: abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting, rarely: dry oral mucosa, stomatitis, gastrointestinal candidiasis, microscopic colitis, discoloration of the tongue to brown-black and the appearance of benign cysts of the salivary glands when used simultaneously with clarithromycin (the phenomena are reversible after cessation of therapy), isolated cases: the formation of gastric glandular cysts and during long-term treatment with simultaneous use with clarithromycin (a consequence of inhibition of hydrochloric acid secretion, is benign, reversible).

Disorders of the liver and biliary tract

Omeprazole - uncommon: increased activity of liver enzymes and alkaline phosphatase (reversible), rare: hepatitis (with or without jaundice), liver failure, encephalopathy in patients with previous severe liver diseases.

Skin and subcutaneous tissue disorders

Omeprazole - uncommon: dermatitis, itching, skin rash, urticaria, rare: alopecia, photosensitivity reactions in the form of redness of the skin after ultraviolet irradiation, exudative erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome (severe erythema, characterized by the appearance of spots and blisters on the skin and mucous membranes against a background of high fever and joint pain).

Domperidone - very rarely: Quincke's edema, urticaria.

Musculoskeletal and connective tissue disorders

Omeprazole - uncommon: fractures of the vertebrae, wrist bones, femoral head associated with osteoporosis, rare: arthralgia, myalgia, muscle weakness.

Renal and urinary tract disorders

Omeprazole - rare: interstitial nephritis.

Domperidone - very rarely: urinary retention.

Genital and breast disorders

Omeprazole - rare: gynecomastia.

General disorders

Omeprazole - uncommon: malaise, rare: increased sweating, peripheral edema.

Laboratory and instrumental data

Domperidone - very rarely: changes in liver function tests, increased blood prolactin levels.

If side effects not listed in this instruction occur, you should immediately inform your doctor.

Overdose:

Symptoms

Dizziness, confusion, apathy, drowsiness, headache, blurred vision, vascular dilatation, tachycardia, nausea, vomiting, flatulence, diarrhea, increased sweating, dry mouth. As the dose was increased, the rate of drug elimination did not change.

Treatment.

Activated carbon orally, gastric lavage, if necessary, symptomatic therapy and careful observation. Anticholinergics, drugs used to treat parkinsonism, or antihistamines may be effective when extrapyramidal reactions occur. Hemodialysis is not effective enough.

Interaction:

There have been no specific studies of drug interactions between Omez DSR and other drugs. The following drug interactions have been reported for certain medications.

Substances with pH-dependent absorption

Like other drugs that reduce gastric acidity, treatment with omeprazole may lead to decreased absorption of ketoconazole, itraconazole, posaconazole, erlotinib, iron supplements and cyanocobalamin. Their combined use with Omez DSR should be avoided.

Antacid 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 when using digoxin and Omez DSR concomitantly in elderly patients. The combined use of domperidone and digoxin does not change the concentration of the latter.

Clopidogrel

According to the results of the studies, an interaction was noted between clopidogrel (loading dose 300 mg, maintenance dose 75 mg/day) and omeprazole (80 mg/day orally), which reduces the exposure of the active metabolite of clopidogrel and reduces the 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 omeprazole therapy 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.

When used simultaneously with omeprazole, an increase in plasma concentrations of saquinavir/ritonavir is observed up to 70%, while the tolerability of treatment in patients with HIV infection does not deteriorate.

The suppressive effect of HIV protease inhibitors on the CYP3A4 isoenzyme may cause an increase in the concentration of domperidone when 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 monitor creatinine clearance and plasma concentrations of tacrolimus when used together with Omez DSR.

Methotrexate

Proton pump inhibitors may slightly increase plasma concentrations of methotrexate. When treated with high doses of methotrexate, you should temporarily stop taking Omez DSR.

Drugs metabolized by the CYP2C19 isoenzyme

When used simultaneously with omeprazole, it is possible to increase the plasma concentration and increase 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 (may dose reduction of these drugs may be required). However, taking omeprazole 20 mg per day does not affect the concentration of phenytoin in the blood plasma 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

Concomitant use with inhibitors of CYP2C19 and/or CYP3A4 isoenzymes slows down the metabolism of omeprazole.

When taking omeprazole or domperidone together with clarithromycin or erythromycin, the concentration of omeprazole, as well as the concentration of domperidone in the blood plasma increases.

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 concentrations of domperidone.

The suppressive effect of HIV protease inhibitors on the CYP3A4 isoenzyme may cause an increase in domperidone concentrations when coadministered with Omez DSR.

Clinical experience and in vitro studies indicate that plasma concentrations of domperidone may be increased when strong CYP3A4 inhibitors such as calcium antagonists (diltiazem and verapamil), nefadosone and amiodarone are co-administered.

In addition, when taking amiodarone, or when taking domperidone together with ketoconazole, erythromycin, the QT interval may be prolonged (see section "Special Instructions").

Inducers of CYP2C19 and CYP3A4 enzymes

Inducers of the CYP2C19 and CYP3A4 isoenzymes, such as rifampicin, preparations of St. John's wort (Hypyricum perforabtum), when used together with omeprazole, can lead to a decrease in the concentration of omeprazole in the blood plasma by accelerating the metabolism of omeprazole.

Anticholinergic drugs

Anticholinergic drugs may counteract the effects of domperidone.

No effect on metabolism

Co-administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the 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 the use of 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.

Special instructions:

Lactose

Omeprazole granules contain lactose, so you should not use Omez DSR in patients with lactose intolerance, galactosemia and impaired absorption of glucose and galactose.

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 in patients over 60 years of age with a daily dose of domperidone greater than 30 mg. The use of domperidone and other drugs that prolong the QT interval requires caution in patients with existing conduction disturbances due to QT prolongation, severe electrolyte imbalance, or congestive heart failure).

Osteoporosis

Patients at risk of developing osteoporosis or osteoporotic fractures should be under appropriate clinical supervision, although a causal relationship between the use of omeprazole and osteoporotic fractures has not been established.

Hypomagnesemia

There are reports of the occurrence of severe hypomagnesemia in patients receiving therapy 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 level of magnesium in the blood plasma (diuretics), require regular monitoring of magnesium levels.

Effect on laboratory tests

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

USE IN PREGNANCY AND BREASTFEEDING

The use of Omez DSR during pregnancy and breastfeeding is contraindicated.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS

During treatment with Omez DSR, caution should be exercised when driving vehicles and performing other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Best before date:

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

Storage conditions:

At a temperature not higher than 25 degrees C. Keep out of the reach of children!

Update date 01/16/2017

Instructions approved 12/06/2016

s Laboratories Ltd, India

Release forms: modified release capsules 30 mg+20 mg, blisters

Dispensing conditions: by prescription

State data registration: LP-003998 dated 12/06/2016

Status of the registration certificate: expiration date 12/06/2021

Pharmaceutical article number: LP 003998-061216

Characteristics of Omez

Omez is a proton pump inhibitor. Available in two forms: powder, from which a solution for intravenous administration is prepared, and capsules.

Indications for treatment with Omez in adults:

stomach and duodenal ulcers;
prevention of exacerbation of ulcers;
erosions and ulcers due to Helicobacter pylori activity;
erosions and ulcers while taking NSAIDs;
reflux esophagitis;
prevention of ulcers due to stress;
gastritis with reflux of stomach contents into the esophagus;
Zollinger-Ellison syndrome.

Indications for therapy in children:

GERD;
ulcer caused by bacterial activity;
heartburn;
sour belching.

Omez is used for stomach and duodenal ulcers.