GASTRIC PD SR Capsules

Pantoprazole 40 mg + Domperidone 30 mg Prolonged Release

GASTRIC PD SR is a prescription gastrointestinal formulation containing Pantoprazole Sodium equivalent to Pantoprazole 40 mg as gastro-resistant pellets and Domperidone 30 mg as sustained/prolonged-release pellets in a hard gelatin capsule.

The formulation combines gastric acid suppression with peripheral dopamine-antagonist/prokinetic activity. Because the product contains 30 mg of oral domperidone in a prolonged-release formulation, its prescribing information and regulatory status should be carefully verified before making broad promotional claims.

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1. Product Information

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2. Composition

Each hard gelatin capsule contains:

• Pantoprazole Sodium IP (as Sesquihydrate)
  Equivalent to Pantoprazole — 40 mg
  (as enteric-coated pellets)
• Domperidone IP — 30 mg
  (as sustained-release pellets)
• Excipients — q.s.

Colours shown on the artwork:

• Brilliant Blue FCF
• Sunset Yellow FCF

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3. What is GASTRIC PD SR?

GASTRIC PD SR combines two medicines with different pharmacological actions.

Pantoprazole 40 mg

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

Domperidone 30 mg SR

Domperidone is a peripheral dopamine D₂-receptor antagonist with antiemetic and prokinetic properties. In this formulation, domperidone is provided as sustained/prolonged-release pellets.

Comparable Indian product information for this same 40 mg + 30 mg formulation describes the combination as Pantoprazole gastro-resistant and Domperidone prolonged-release capsules.

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4. Mechanism of Action

Pantoprazole

Pantoprazole is activated in the acidic environment of gastric parietal cells and inhibits the H⁺/K⁺-ATPase proton pump.

This blocks the final stage of gastric acid secretion and reduces gastric acidity.

Effects include:

• Reduction of gastric acid secretion
• Reduction of acid exposure in the oesophagus
• Support for healing of acid-related mucosal injury
• Control of acid-related reflux symptoms

Pantoprazole is an established treatment component for acid-related disorders including GERD and erosive oesophagitis.

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Domperidone

Domperidone primarily blocks peripheral dopamine D₂ receptors.

Its pharmacological effects include:

• Enhancement of upper GI motility
• Promotion of gastric emptying
• Increased lower oesophageal sphincter tone
• Antiemetic activity

The sustained-release pellet design is intended to provide prolonged delivery of domperidone.

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5. Combined Action

GASTRIC PD SR works through two complementary pharmacological mechanisms:

Pantoprazole 40 mg
↓
Suppresses gastric acid secretion

Domperidone 30 mg prolonged release
↓
Provides peripheral dopamine-antagonist/prokinetic and antiemetic activity

Combined effect
↓
Acid suppression + management of selected associated upper-GI motility/nausea symptoms.

The exact rationale for using the combination should be determined by the treating physician.

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6. Therapeutic Uses

Product information for comparable Pantoprazole 40 mg + Domperidone 30 mg prolonged-release capsules describes use in GERD not adequately responding to pantoprazole alone.

Depending on the approved indication for the specific marketed product, physician-directed use may involve selected acid-related gastrointestinal conditions such as:

• Gastroesophageal reflux disease (GERD)
• Acid reflux associated with upper-GI symptoms
• Selected acid-related dyspeptic symptoms
• Conditions where acid suppression is required together with an appropriately selected prokinetic/antiemetic component

Website recommendation: Avoid describing GASTRIC PD SR as a general treatment for “gas,” “bloating” or routine indigestion without reference to the approved product indication.

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7. Role of Pantoprazole 40 mg

Pantoprazole provides the acid-suppressive component of GASTRIC PD SR.

It can help:

• Reduce gastric acid production
• Reduce acid reflux exposure
• Control acid-related symptoms
• Promote healing of acid-related oesophageal injury
• Maintain acid suppression when clinically indicated

The gastro-resistant formulation protects pantoprazole from degradation in the stomach and allows delivery to the appropriate site.

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8. Role of Domperidone 30 mg SR

Domperidone contributes:

• Peripheral antiemetic action
• Prokinetic activity
• Support for gastric emptying
• Modulation of upper GI motility

The product artwork specifically states that the 30 mg domperidone is provided as sustained-release pellets.

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9. Dosage and Administration

The uploaded artwork does not provide a specific dosage schedule.

Therefore, the safest website wording is:

Dosage: Take GASTRIC PD SR exactly as prescribed by the treating physician. Dose and duration depend on the patient’s diagnosis, clinical response, other medicines and individual risk factors.

Some current Indian product information for the same Pantoprazole 40 mg + Domperidone 30 mg prolonged-release formulation states one capsule once daily, preferably before a meal.

However, for the Amcare GASTRIC PD SR product, I recommend using the wording “as directed by the physician” unless that schedule is specifically present in your approved product literature.

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10. How to Take GASTRIC PD SR

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

Comparable Indian product information specifically instructs patients to swallow the capsule whole and not chew or crush it.

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11. Missed Dose

If a dose is missed:

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

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12. Common Side Effects

Possible adverse effects can include:

Pantoprazole-related

• Headache
• Diarrhoea
• Nausea
• Abdominal discomfort
• Flatulence
• Constipation
• Dizziness

Domperidone-related

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

Individual responses vary.

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13. Important Cardiac Safety Warning

This is particularly important for GASTRIC PD SR.

Domperidone has been associated with:

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

Risk is particularly relevant in people with certain cardiac conditions, in older patients, at higher oral doses, and when domperidone is combined with QT-prolonging medicines or potent CYP3A4 inhibitors.

The EMA review specifically found greater risk in adults taking more than 30 mg/day orally, although the risk is not determined solely by dose.

Important point for this product

GASTRIC PD SR contains 30 mg domperidone in a prolonged-release formulation. Therefore, the product should not be marketed as an ordinary long-term acidity medicine without appropriate regulatory and prescribing review.

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14. Contraindications Related to Domperidone

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

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

These restrictions arise from the recognized cardiac safety profile of domperidone.

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15. Drug Interactions

Particular caution is required with medicines that can increase domperidone exposure or cardiac risk.

These may include:

QT-prolonging medicines

Some:

• Antiarrhythmics
• Certain antibiotics
• Certain antifungals
• Other medicines known to prolong the QT interval

CYP3A4 inhibitors

Strong CYP3A4 inhibitors can increase domperidone exposure.

Patients should provide the physician with a complete list of prescription medicines, OTC medicines and supplements.

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16. Liver Precautions

Patients with liver disease should inform their physician before treatment.

Domperidone is contraindicated in moderate or severe hepatic impairment under the EMA safety recommendations.

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17. Kidney Precautions

Patients with significant renal impairment should inform their physician.

Dose or administration frequency may require individual consideration depending on renal function and the overall treatment regimen.

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18. Long-Term Pantoprazole Considerations

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

Prolonged acid suppression may be associated with issues such as:

• Hypomagnesemia
• Vitamin B12 deficiency with prolonged treatment
• Certain gastrointestinal infections
• Bone-fracture risk in susceptible patients
• Acute interstitial nephritis

The duration of treatment should therefore be based on the underlying diagnosis.

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19. Pregnancy

If pregnant, planning pregnancy or trying to conceive, consult a healthcare professional before using GASTRIC PD SR.

The combination should not be self-medicated during pregnancy.

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20. Breastfeeding

Consult a physician before taking GASTRIC PD SR while breastfeeding.

The physician should assess the potential benefits and risks of the individual treatment.

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21. Elderly Patients

Particular caution is warranted in elderly patients because the risk of serious cardiovascular adverse reactions associated with domperidone is higher in older adults, especially those above 60 years.

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22. Pediatric Use

GASTRIC PD SR should not be promoted for routine pediatric use unless the particular product, strength and formulation are specifically authorized for the relevant pediatric population.

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23. Driving and Machinery

Patients experiencing dizziness or other symptoms that may impair alertness should avoid driving or operating machinery until they know how the medicine affects them.

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24. Seek Immediate Medical Attention If

Patients should seek urgent medical care for:

• Fainting
• Severe dizziness
• Rapid or irregular heartbeat
• Palpitations
• Chest discomfort associated with abnormal heartbeat
• Difficulty breathing
• Facial/lip/tongue swelling
• Severe allergic reaction

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25. Key Features of GASTRIC PD SR

Dual-action gastrointestinal formulation

Pantoprazole 40 mg + Domperidone 30 mg PR

Gastro-resistant Pantoprazole

Pantoprazole is supplied as enteric/gastro-resistant pellets.

Prolonged-release Domperidone

Domperidone is supplied as sustained-release pellets.

Prescription formulation

The artwork carries the Rx designation.

Hard gelatin capsule

Designed to deliver the two components in their respective modified-release forms.