ESMOBEES DSR Capsules

Esomeprazole 40 mg + Domperidone 30 mg Sustained Release

ESMOBEES DSR is a prescription gastroenterology formulation containing Esomeprazole Magnesium Trihydrate IP equivalent to Esomeprazole 40 mg as enteric-coated pellets and Domperidone IP 30 mg as sustained-release pellets.

The formulation combines a proton pump inhibitor (PPI) for gastric acid suppression with domperidone, a peripheral dopamine D₂-receptor antagonist with prokinetic and antiemetic effects.

The uploaded artwork shows a 10 × 10 capsule pack.

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1. Product Information

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2. Composition

Each hard gelatin capsule contains:

Esomeprazole Magnesium Trihydrate IP
Equivalent to Esomeprazole — 40 mg
(as enteric-coated pellets)

Domperidone IP — 30 mg
(as sustained-release pellets)

Excipients — q.s.

Colours mentioned on the artwork

• Titanium Dioxide IP
• Sunset Yellow FCF
• Approved colour used in empty hard gelatin capsule shells

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3. What is ESMOBEES DSR?

ESMOBEES DSR contains two pharmacologically different components:

Esomeprazole 40 mg

Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the gastric H⁺/K⁺-ATPase proton pump.

Domperidone 30 mg SR

Domperidone is a peripheral dopamine D₂-receptor antagonist with prokinetic and antiemetic activity. In ESMOBEES DSR, it is supplied as sustained-release pellets.

The formulation therefore combines:

Esomeprazole → gastric acid suppression

Domperidone → peripheral prokinetic/antiemetic activity

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4. Mechanism of Action

Esomeprazole 40 mg

Esomeprazole is the S-isomer of omeprazole and belongs to the proton pump inhibitor class.

It inhibits the H⁺/K⁺-ATPase proton pump in gastric parietal cells.

This blocks the final stage of gastric acid secretion.

Mechanism

Esomeprazole

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Inhibits gastric proton pump

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Reduces gastric acid secretion

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Reduces acid exposure

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Supports control and healing of acid-related gastrointestinal conditions

Esomeprazole delayed-release capsules are established for treatment of GERD and healing of erosive esophagitis. (dailymed.nlm.nih.gov)

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Domperidone 30 mg SR

Domperidone blocks peripheral dopamine D₂ receptors.

Its pharmacological effects include:

• Enhancement of upper-GI motility
• Promotion of gastric emptying
• Peripheral antiemetic activity
• Modulation of upper gastrointestinal function

The ESMOBEES DSR formulation specifically uses sustained-release domperidone pellets.

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5. Combined Action of ESMOBEES DSR

Esomeprazole 40 mg

Reduces gastric acid secretion

Domperidone 30 mg SR

Provides peripheral dopamine-antagonist/prokinetic and antiemetic activity

Combined therapeutic concept

Acid suppression + management of selected associated upper-GI symptoms

The combination should be used only when the prescribing physician considers both components clinically appropriate.

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6. Therapeutic Uses

Esomeprazole has established uses in selected acid-related gastrointestinal disorders, including:

• Gastroesophageal reflux disease (GERD)
• Healing of erosive esophagitis
• Maintenance of healing of erosive esophagitis
• Symptomatic GERD
• NSAID-associated gastric ulcer risk reduction in appropriate patients
• H. pylori eradication regimens as part of combination therapy
• Pathological hypersecretory conditions such as Zollinger-Ellison syndrome

Current prescribing information lists 20 mg or 40 mg once daily for 4–8 weeks for healing erosive esophagitis in adults. (dailymed.nlm.nih.gov)

For ESMOBEES DSR specifically

The exact indication for the 40 mg esomeprazole + 30 mg sustained-release domperidone combination should follow the current approved Indian product information.

A suitable website statement is:

ESMOBEES DSR is intended for physician-directed management of selected gastrointestinal conditions where acid suppression with esomeprazole and an appropriate role for domperidone are clinically considered.

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7. Role of Esomeprazole

Esomeprazole provides the primary acid-suppressive action.

It can help:

• Reduce gastric acid production
• Reduce acid exposure to the oesophagus
• Control acid-related reflux symptoms
• Support healing of erosive esophagitis
• Maintain healing in appropriately selected patients

Esomeprazole 40 mg is an established strength for treatment of erosive esophagitis associated with GERD. (dailymed.nlm.nih.gov)

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8. Role of Domperidone

Domperidone provides:

• Peripheral dopamine D₂ receptor blockade
• Prokinetic activity
• Support for gastric emptying
• Antiemetic effects

However, domperidone has important cardiovascular safety restrictions and should not simply be treated as a routine long-term “gastric” medicine.

The EMA recommends the lowest effective dose for the shortest possible duration, with oral adult dosing generally limited to a maximum of 30 mg/day in its safety recommendations. (ema.europa.eu)

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9. Dosage and Administration

The artwork confirms the strength but does not specify the dosage schedule.

Recommended website wording:

Dosage: Take ESMOBEES DSR exactly as prescribed by the treating physician. Dose and duration depend on the patient’s diagnosis, clinical response, concomitant medicines and individual risk factors.

For esomeprazole alone, approved dosing varies according to the indication. For example, adult erosive esophagitis is commonly treated with 20 mg or 40 mg once daily for 4–8 weeks. (dailymed.nlm.nih.gov)

That does not automatically establish the dosing schedule for ESMOBEES DSR, which contains sustained-release domperidone.

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10. How to Take ESMOBEES DSR

• Take the capsule orally with water.
• Swallow the capsule whole.
• Do not chew or crush the capsule.
• Do not crush or chew the pellets.
• Do not open the capsule unless specifically permitted by the approved product information.
• Follow the prescribed timing and duration.

Because the capsule contains both enteric-coated and sustained-release pellets, manipulation could alter the intended release characteristics.

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11. Missed Dose

If a dose is missed:

• Take it when remembered unless the next dose is close.
• If the next dose is near, skip the missed dose.
• Resume the normal dosing schedule.
• Do not double the dose.

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12. Common Side Effects

Possible side effects may include:

Esomeprazole-related

• Headache
• Abdominal pain
• Diarrhoea
• Nausea
• Flatulence
• Constipation
• Dry mouth

Domperidone-related

• Dry mouth
• Abdominal cramps
• Headache
• Diarrhoea
• Increased prolactin-related effects in some patients

Patients should report persistent or troublesome adverse effects to their physician.

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13. Important Cardiac Safety Warning

Domperidone requires particular caution.

Domperidone has been associated with:

• QT interval prolongation
• Torsades de pointes
• Serious ventricular arrhythmias
• Sudden cardiac death

The risk is particularly relevant in:

• Patients older than 60 years
• Patients receiving oral doses above 30 mg/day
• Patients with underlying cardiac disease
• Patients with electrolyte abnormalities
• Patients taking QT-prolonging medicines
• Patients taking potent CYP3A4 inhibitors

(ema.europa.eu)

Important for ESMOBEES DSR

Each capsule contains Domperidone 30 mg in sustained-release form.

This makes it especially important that the product be prescribed according to its approved product information and that patients with cardiac risk factors are appropriately assessed.

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14. Domperidone Contraindications / Precautions

Domperidone should not be used in patients with relevant contraindications such as:

• Known QT prolongation
• Significant cardiac conduction abnormalities
• Bradycardia
• Significant electrolyte disturbances
• Certain underlying cardiac diseases
• Congestive heart failure
• Moderate or severe hepatic impairment
• Concomitant use of certain QT-prolonging medicines
• Concomitant use of potent CYP3A4 inhibitors

(ema.europa.eu)

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15. Drug Interactions

Patients should inform their physician about all prescription medicines, OTC medicines and supplements.

Important domperidone interactions

Particular attention is required with:

• QT-prolonging medicines
• Certain antiarrhythmics
• Certain macrolide antibiotics
• Certain azole antifungals
• Potent CYP3A4 inhibitors

These combinations may increase domperidone exposure and/or cardiac risk. (ema.europa.eu)

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16. Esomeprazole Drug Interactions

Esomeprazole can interact with medicines through CYP2C19 inhibition and changes in gastric acidity.

Important interactions can include:

• Clopidogrel
• Warfarin
• Diazepam
• Certain antiretroviral medicines
• Methotrexate, particularly at high doses
• Medicines whose absorption depends on gastric acidity

Clopidogrel

Esomeprazole can reduce formation of the active metabolite of clopidogrel through CYP2C19 inhibition. Patients taking clopidogrel should discuss the combination with their physician.

Rilpivirine

Esomeprazole-containing products are contraindicated with rilpivirine-containing medicines under relevant prescribing information because increased gastric pH can significantly reduce rilpivirine exposure.

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17. Long-Term Esomeprazole Considerations

Long-term PPI treatment should be used when clinically justified and periodically reviewed.

Potential concerns associated with prolonged PPI therapy include:

• Hypomagnesemia
• Vitamin B12 deficiency
• Increased risk of certain gastrointestinal infections
• Bone-fracture risk in susceptible patients
• Acute interstitial nephritis

The need for continuing therapy should be periodically reassessed.

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18. Hypomagnesemia

Prolonged PPI therapy has been associated with low magnesium levels in some patients.

Possible symptoms include:

• Muscle spasms
• Tremors
• Weakness
• Dizziness
• Abnormal heart rhythm in severe cases

Patients receiving prolonged therapy may require appropriate clinical monitoring depending on their individual risk factors.

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19. Vitamin B12 Considerations

Long-term gastric acid suppression may affect vitamin B12 absorption in some patients.

Patients receiving prolonged therapy, particularly those with additional risk factors, should discuss appropriate monitoring with their healthcare professional.

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20. Kidney Precautions

Rare cases of acute tubulointerstitial nephritis have been reported with proton pump inhibitors.

Patients with existing renal disease should inform their physician before treatment.

Seek medical evaluation if symptoms suggestive of kidney dysfunction develop.

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21. Liver Precautions

Patients with liver disease should inform their physician before using ESMOBEES DSR.

Domperidone is contraindicated in moderate or severe hepatic impairment under the EMA safety recommendations. (ema.europa.eu)

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22. Pregnancy

If pregnant, planning pregnancy or trying to conceive, consult a healthcare professional before taking ESMOBEES DSR.

The combination should not be self-medicated during pregnancy.

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23. Breastfeeding

Consult a physician before using ESMOBEES DSR while breastfeeding.

The clinician should assess the indication, duration and available alternatives.

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24. Elderly Patients

Extra caution is appropriate in older adults.

Domperidone safety reviews have identified a higher risk of serious cardiac adverse reactions in patients over 60 years of age. (ema.europa.eu)

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25. Pediatric Use

ESMOBEES DSR should not be routinely promoted for pediatric use unless the specific combination, strength and formulation are authorized for the relevant pediatric population.

The established pediatric indications for esomeprazole alone do not automatically establish suitability of this fixed-dose combination.

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26. Driving and Operating Machinery

Patients experiencing:

• Dizziness
• Headache
• Weakness
• Visual disturbance
• Other symptoms affecting alertness

should avoid driving or operating machinery until they know how the medicine affects them.

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27. When to Seek Medical Attention

Patients should seek medical assessment for:

• Persistent or worsening heartburn
• Difficulty swallowing
• Painful swallowing
• Persistent vomiting
• Unexplained weight loss
• Vomiting blood
• Black/tarry stools
• Severe abdominal pain
• Persistent symptoms despite treatment

Urgent medical attention

Seek immediate medical care for:

• Fainting
• Severe dizziness
• Palpitations
• Rapid or irregular heartbeat
• Difficulty breathing
• Facial/lip/tongue swelling
• Severe allergic reaction

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28. Storage

Store ESMOBEES DSR:

• In a cool, dry place.
• Protected from excessive moisture.
• Away from direct sunlight and excessive heat.
• Out of reach of children.

Keep capsules in their original packaging until use.

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29. Key Features of ESMOBEES DSR

Esomeprazole 40 mg

Provides potent gastric acid suppression through proton pump inhibition.

Domperidone 30 mg SR

Provides peripheral dopamine D₂-receptor antagonist activity with prokinetic and antiemetic effects.

Enteric-coated Esomeprazole pellets

Designed to protect esomeprazole from degradation in the acidic stomach environment.

Sustained-release Domperidone pellets

Provides a modified-release delivery system for domperidone.

Dual-component formulation

Combines acid suppression with a second pharmacological action.

Prescription formulation

The artwork carries the Rx symbol.