Omez^® D (Capsules) Instructions for Use

Marketing Authorization Holder

Torrent Pharmaceuticals, Ltd. (India)

Manufactured By

Torrent Pharmaceuticals, Ltd. (India)

Contact Information

Dr. Reddy’s Laboratories Ltd. (India)

ATC Code

A02BX (Other drugs for the treatment of gastric and duodenal ulcers and GERD)

Active Substances

Domperidone (Rec.INN registered by WHO)

Omeprazole (Rec.INN registered by WHO)

Dosage Form

Omez® D

Modified-release capsules 10 mg+10 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Modified-release capsules hard gelatin, size No. 2, with a light purple cap and a white body marked “Omez D” and ” on the capsule shell; the capsule contents are white or almost white pellets, white or almost white particles and powder.

Excipients: microcrystalline cellulose (avicel pH), magnesium stearate, colloidal silicon dioxide, sodium carboxymethyl starch, sodium lauryl sulfate, talc.

* Composition of omeprazole pellets, enteric-coated (8.5% w/w): active substance Omeprazole – 10 mg; excipients mannitol, sucrose, sodium phosphate dibasic, sodium lauryl sulfate, lactose, calcium carbonate, hypromellose, propylene glycol, methacrylic acid, polysorbate 80, diethyl phthalate, sodium hydroxide, cetyl alcohol, starch.

Composition of the empty hard gelatin capsule: cap gelatin, water, sodium lauryl sulfate, methylparaben, propylparaben, colorant azorubine (E122), colorant indigo carmine (E132), colorant titanium dioxide (E171); body gelatin, water, sodium lauryl sulfate, methylparaben, propylparaben, colorant titanium dioxide (E171).

10 pcs. – strips made of aluminum foil (3) – cardboard packs.

Clinical-Pharmacological Group

Combined drug that regulates the motor function of the gastrointestinal tract and inhibits the secretion of hydrochloric acid

Pharmacotherapeutic Group

Reflux esophagitis treatment agent combined (proton pump inhibitor + central dopamine receptor blocker)

Pharmacological Action

Combined drug, contains Domperidone – a centrally acting dopamine receptor blocker and Omeprazole – a proton pump inhibitor.

Domperidone

Increases the duration of peristaltic contractions of the antrum of the stomach and duodenum, accelerates gastric emptying in case of its delay, increases the tone of the lower esophageal sphincter, prevents the development of nausea and vomiting. Stimulates the release of prolactin from the pituitary gland. The antiemetic effect is possibly due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the trigger zone of the brain. Domperidone does not affect gastric secretion. Domperidone poorly penetrates the blood-brain barrier, due to this, the use of domperidone is rarely accompanied by the development of extrapyramidal side effects, especially in adults.

Omeprazole

Inhibits the enzyme H⁺-K⁺-ATPase (proton pump) in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid secretion. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single oral dose, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug, secretory activity is completely restored after 3-5 days.

Pharmacodynamic rationale for the combination

Omeprazole suppresses the secretion of hydrochloric acid, Domperidone increases the tone of the lower esophageal sphincter and accelerates gastric emptying, thereby reducing the activity of aggressive factors of gastric juice and the reflux of gastric contents into the esophagus.

Pharmacokinetics

Domperidone

Absorption

After oral administration, Domperidone is rapidly absorbed from the gastrointestinal tract. It has low bioavailability – about 15%. Reduced acidity of gastric contents reduces the absorption of domperidone. C_max in plasma is reached after 1 hour.

Distribution

Domperidone is widely distributed in various tissues, its concentration in brain tissue is low. Plasma protein binding is 91-93%.

Metabolism

It undergoes intensive metabolism in the intestinal wall and liver.

Excretion

T_1/2 is 7-9 hours, in severe renal failure it is prolonged.

It is excreted through the intestines (66%) and by the kidneys (33%), unchanged, 10% and 1% of the dose is excreted, respectively.

Pharmacokinetics in special clinical cases

In severe renal failure, T_1/2 is prolonged.

Omeprazole

Absorption

Omeprazole is rapidly absorbed from the gastrointestinal tract, C_max in plasma is reached after 0.5-1 hour. Bioavailability is 30-40%.

Distribution

Plasma protein binding is about 90%.

Metabolism

Omeprazole is almost completely metabolized in the liver. It is an inhibitor of the CYP2C19 enzyme system.

Excretion

T_1/2 – 0.5-1 hour. It is excreted by the kidneys (70-80%) and with bile (20-30%).

Pharmacokinetics in special clinical cases

In chronic renal failure, excretion decreases in proportion to the decrease in creatinine clearance.

In elderly patients, excretion decreases, bioavailability increases.

In hepatic insufficiency, bioavailability is 100%, T_1/2 – 3 hours.

Indications

• Treatment of dyspepsia and gastroesophageal reflux that are poorly responsive to proton pump inhibitor or histamine H₂-receptor antagonist monotherapy.

ICD codes

Dosage Regimen

Administer orally with a small amount of water.

Take one capsule twice daily, 15-20 minutes before meals.

Do not exceed the prescribed dosage.

Swallow capsules whole; do not crush or chew.

The duration of therapy is determined by the physician based on clinical response.

For dyspepsia and gastroesophageal reflux disease, continue treatment for the prescribed course.

In patients with severe hepatic impairment, use with caution; consider dose adjustment.

In patients with renal impairment, use with caution; monitor for adverse effects.

Discontinue use if symptoms of extrapyramidal reactions occur.

This product contains domperidone; be aware of potential drug interactions with azole antifungals and macrolide antibiotics.

Store in a dry place protected from light at temperatures not exceeding 25°C (77°F).

Keep out of reach of children.

Adverse Reactions

Domperidone

From the digestive system: transient intestinal cramps.

From the CNS: extrapyramidal disorders (in children and persons with increased permeability of the blood-brain barrier).

Allergic reactions: skin rash, urticaria.

Other: hyperprolactinemia (galactorrhea, gynecomastia).

Omeprazole

From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in plasma liver enzyme activity; in patients with pre-existing severe liver disease – hepatitis (including with jaundice), impaired liver function; rarely – formation of gastric glandular cysts during long-term treatment (a consequence of inhibition of hydrochloric acid secretion, is benign, reversible).

From the CNS and peripheral nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe concomitant somatic diseases, patients with pre-existing severe liver disease – encephalopathy.

From the musculoskeletal system: muscle weakness, myalgia, arthralgia.

From the hematopoietic system: leukopenia, thrombocytopenia; in some cases – agranulocytosis, pancytopenia.

Dermatological reactions: itching, skin rash, increased sweating; in some cases – photosensitivity, multiform exudative erythema, alopecia.

Allergic reactions: urticaria, angioedema, bronchospasm, interstitial nephritis, anaphylactic shock, fever.

Other: visual impairment, peripheral edema, gynecomastia.

Contraindications

• Gastrointestinal bleeding;
• Mechanical obstruction of the stomach or intestine;
• Perforation of the stomach or intestine;
• Prolactin-secreting pituitary tumor (prolactinoma);
• Lactation period (breastfeeding);
• Childhood;
• Hypersensitivity to the components of the drug.

With caution the drug should be used in renal and/or hepatic insufficiency, during pregnancy.

Use in Pregnancy and Lactation

The drug should be used with caution during pregnancy.

The use of the drug Omez^® D is contraindicated during lactation (breastfeeding).

Use in Hepatic Impairment

With caution the drug should be used in hepatic insufficiency.

Use in Renal Impairment

With caution the drug should be used in renal insufficiency.

Pediatric Use

Contraindicated: childhood.

Special Precautions

Before starting therapy with Omez^® D, it is necessary to exclude the presence of a malignant process, because treatment masks symptoms, which may delay the correct diagnosis.

Overdose

Domperidone

Symptoms drowsiness, disorientation and extrapyramidal reactions.

Treatment administration of activated charcoal, in case of extrapyramidal reactions – anticholinergic, antiparkinsonian, antihistamine drugs.

Omeprazole

Symptoms visual impairment, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

Treatment symptomatic therapy. There is no specific antidote. Hemodialysis is not sufficiently effective.

Drug Interactions

Domperidone

Cimetidine, sodium bicarbonate, other antacid and antisecretory drugs reduce the bioavailability of domperidone.

Anticholinergic agents neutralize the effect of domperidone.

With simultaneous use, azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone increase the plasma concentration of domperidone.

Omeprazole

Omeprazole can reduce the absorption of ampicillin esters, iron salts, itraconazole and ketoconazole (Omeprazole increases gastric pH).

Being an inhibitor of cytochrome P450 isoenzymes, it may increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs that are metabolized in the liver via cytochrome CYP2C19), which in some cases may require a reduction in the doses of these drugs.

Enhances the inhibitory effect on the hematopoietic system of other drugs.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.