GASTRIC RD SR Capsules

Rabeprazole Sodium 20 mg (Enteric Coated) + Domperidone 30 mg (Sustained Release)

GASTRIC RD SR is a prescription gastrointestinal formulation containing Rabeprazole Sodium 20 mg as enteric-coated pellets and Domperidone 30 mg as sustained-release pellets. The combination brings together gastric acid suppression with a prokinetic/antiemetic component.

The uploaded artwork clearly shows 20 × 10 capsules and an Rx symbol.

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1. Product Information

The exact Rabeprazole 20 mg + Domperidone 30 mg sustained-release formulation appears in CDSCO records. A CDSCO FDC record lists Rabeprazole Sodium IP 20 mg as enteric-coated pellets plus Domperidone 30 mg as sustained-release pellets.

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2. Composition

Each hard gelatin capsule contains:

• Rabeprazole Sodium IP – 20 mg
  • As enteric-coated pellets
• Domperidone IP – 30 mg
  • As sustained-release pellets
• Excipients – q.s.

Pack: 20 × 10 Capsules

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3. What is GASTRIC RD SR used for?

GASTRIC RD SR combines:

Rabeprazole → gastric acid suppression

with

Domperidone → gastrointestinal motility/antiemetic activity

The combination may be prescribed for selected gastrointestinal conditions where acid suppression and control of nausea or upper-GI motility symptoms are clinically relevant.

However, the website should not automatically claim that this combination is indicated for routine GERD, heartburn, bloating or long-term dyspepsia solely because rabeprazole itself is used for those conditions.

This distinction is important because regulatory authorities have raised specific safety and benefit-risk considerations regarding domperidone-containing medicines.

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4. How Rabeprazole Works

Rabeprazole Sodium 20 mg

Rabeprazole belongs to the proton-pump inhibitor (PPI) class.

It suppresses gastric acid secretion by inhibiting the H⁺/K⁺-ATPase proton pump in gastric parietal cells.

Simplified mechanism:

Rabeprazole → Proton-pump inhibition → Reduced gastric acid secretion

Reduced acid exposure can help manage acid-related gastrointestinal conditions and support healing of acid-related mucosal injury.

For example, standard rabeprazole labeling includes treatment of erosive/ulcerative GERD and symptomatic GERD, with dosage depending on the indication.

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5. How Domperidone Works

Domperidone 30 mg SR

Domperidone is a dopamine D₂-receptor antagonist with gastrointestinal prokinetic and antiemetic effects.

It can increase upper gastrointestinal motility and promote gastric emptying while reducing nausea and vomiting through its pharmacological action.

Simplified mechanism:

Domperidone → D₂ receptor blockade → increased upper-GI motility → improved gastric emptying

Domperidone has important safety limitations, particularly concerning cardiac rhythm effects, which should be considered when prescribing.

The EMA identified a small increased risk of serious cardiac adverse reactions, including QT prolongation, torsades de pointes and serious ventricular arrhythmias, with higher risk in certain patients and with higher exposure.

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6. Combined Pharmacological Action

Rabeprazole 20 mg

Reduces gastric acid secretion

Domperidone 30 mg SR

Provides prokinetic/antiemetic activity

Overall concept

Acid suppression + gastrointestinal motility modulation

This pharmacological combination may be considered by a physician when both components are clinically appropriate.

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7. Potential Therapeutic Roles

Depending on the physician’s diagnosis and the approved product information, the components may address:

• Acid-related gastrointestinal symptoms
• Gastroesophageal reflux-related acid exposure
• Upper gastrointestinal dyspeptic symptoms
• Nausea associated with gastrointestinal disorders
• Delayed gastric emptying-related symptoms
• Selected upper-GI motility disturbances

Important: These should be presented as potential therapeutic roles of the ingredients, not automatically as approved indications of the specific GASTRIC RD SR brand.

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8. Suggested Dosage

Because the artwork establishes the strength but does not provide a dosage schedule, the safest website wording is:

Dosage and duration should be determined by the treating physician according to the patient’s condition, age, clinical response and concomitant medicines.

Do not publish “one capsule once daily” as a universal instruction for this product unless it is confirmed in the current approved product information.

This is particularly important because the capsule contains Domperidone 30 mg in sustained-release form.

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9. How to Take GASTRIC RD SR

• Take exactly as prescribed.
• Swallow the capsule whole with water.
• Do not crush or chew the capsule.
• Do not open the capsule unless the approved product information specifically permits it.
• Do not take more than the prescribed amount.
• If a dose is missed, follow the prescribing instructions rather than doubling the next dose.

Rabeprazole delayed-release formulations are generally designed to be swallowed whole rather than crushed or chewed.

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10. Important Domperidone Safety Warning

GASTRIC RD SR contains Domperidone 30 mg sustained release.

Domperidone has been associated with a small increased risk of serious cardiac adverse effects.

Risk may be higher in:

• Patients above 60 years of age
• Patients receiving higher daily doses
• Patients with cardiac conduction abnormalities
• Patients with certain heart diseases
• Patients with significant electrolyte disturbances
• Patients taking medicines that prolong the QT interval
• Patients taking potent CYP3A4 inhibitors

EMA recommends using domperidone at the lowest effective dose for the shortest possible duration, and generally limits treatment to short-term use for licensed indications.

Website recommendation

Avoid claims such as:

❌ “Safe for long-term use”
❌ “24-hour guaranteed relief”
❌ “Suitable for all GERD patients”
❌ “No side effects”
❌ “Best acidity medicine”

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11. Common Side Effects

Possible adverse effects may include:

Gastrointestinal

• Dry mouth
• Abdominal discomfort
• Diarrhoea
• Constipation
• Nausea

Neurological

• Headache
• Dizziness
• Drowsiness in some patients

Domperidone-related

• Increased prolactin
• Breast tenderness
• Galactorrhoea
• Menstrual disturbances
• Breast enlargement

Most patients may not experience these effects, but patients should report persistent or troublesome symptoms to their healthcare professional.

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12. Serious Cardiac Symptoms

Patients should seek immediate medical attention if they experience:

• Fainting
• Severe dizziness
• Palpitations
• Rapid or irregular heartbeat
• Chest discomfort
• Sudden loss of consciousness

Domperidone-associated cardiac risks include QT prolongation, torsades de pointes and serious ventricular arrhythmias.

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13. Who Should Avoid or Use It With Particular Caution?

The physician should be informed if the patient has:

• Heart rhythm abnormalities
• Prolonged QT interval
• Congestive heart failure or significant cardiac disease
• Severe liver impairment
• Significant electrolyte abnormalities
• Gastrointestinal obstruction
• Gastrointestinal bleeding
• Previous serious reaction to domperidone
• Allergy to rabeprazole or other PPIs

Domperidone is contraindicated in certain cardiac conditions, severe hepatic impairment and with particular QT-prolonging medicines or potent CYP3A4 inhibitors according to EMA safety recommendations.

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14. Drug Interactions

Tell the doctor about all medicines being taken.

Particular attention is required with:

• QT-prolonging medicines
• Potent CYP3A4 inhibitors
• Certain antifungal medicines
• Certain macrolide antibiotics
• Antiarrhythmic medicines
• Other medicines affecting cardiac rhythm
• Other dopamine-antagonist medicines
• Medicines whose absorption is affected by gastric acidity

Because rabeprazole changes gastric acid secretion, it can also affect the absorption of some pH-dependent medicines.

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15. Pregnancy and Breastfeeding

Pregnancy

Use only when considered appropriate by the treating physician.

Breastfeeding

Consult a healthcare professional before using GASTRIC RD SR while breastfeeding.

The physician should consider the individual benefit-risk profile of both components.

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16. Elderly Patients

Particular caution may be appropriate in older patients because domperidone-associated cardiac risk is higher in patients above 60 years in the EMA review.

The physician should review:

• Cardiac history
• Kidney and liver function
• Concomitant medications
• Potential drug interactions
• Treatment duration

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17. Liver and Kidney Impairment

Patients with significant liver or kidney disease should inform their doctor before treatment.

The physician may determine whether an alternative medicine, dose modification or additional monitoring is required.

Severe hepatic impairment is particularly relevant to domperidone safety.

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18. Long-Term Rabeprazole Considerations

Prolonged PPI therapy should be reviewed periodically.

Depending on treatment duration and individual risk factors, long-term PPI therapy may be associated with:

• Hypomagnesemia
• Vitamin B12 deficiency
• Increased fracture risk in susceptible patients
• Certain gastrointestinal infections
• Kidney-related adverse effects

Therefore, treatment should be continued for as long as clinically indicated rather than indefinitely without medical review.

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19. Lifestyle Measures for Acid-Related Symptoms

Patients with reflux symptoms may benefit from individualized lifestyle measures such as:

• Avoiding very large meals
• Avoiding lying down immediately after eating
• Identifying foods that trigger symptoms
• Maintaining a healthy body weight
• Avoiding smoking
• Limiting alcohol where appropriate
• Following the physician’s dietary recommendations

These measures do not replace prescribed treatment.

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20. When to Seek Medical Attention

Consult a doctor promptly for:

• Persistent or worsening symptoms
• Difficulty swallowing
• Painful swallowing
• Recurrent vomiting
• Unexplained weight loss
• Persistent abdominal pain
• Black stools
• Vomiting blood
• New chest pain

Urgent medical attention is required for symptoms suggestive of a serious allergic reaction or cardiac arrhythmia.

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21. Storage

Store GASTRIC RD SR:

• In a cool, dry place
• Away from direct sunlight
• Protected from excessive moisture
• In the original packaging
• Out of reach of children

Do not use after the expiry date.

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22. Key Product Features

GASTRIC RD SR

• Rabeprazole Sodium 20 mg
• Domperidone 30 mg SR
• Enteric-coated rabeprazole pellets
• Sustained-release domperidone pellets
• Hard gelatin capsule
• Prescription formulation
• Pack of 20 × 10 capsules
• Gastrointestinal therapeutic category