GASTRIC PD Tablets

Pantoprazole Sodium 40 mg + Domperidone 10 mg

GASTRIC PD is a prescription fixed-dose combination containing Pantoprazole Sodium equivalent to Pantoprazole 40 mg and Domperidone 10 mg in an enteric-coated tablet. The product is positioned for physician-directed management of selected gastrointestinal conditions where acid suppression and control of associated nausea or upper-GI motility symptoms are clinically appropriate.

---

1. Product Information

Composition

Each enteric-coated tablet contains:

• Pantoprazole Sodium IP equivalent to Pantoprazole — 40 mg
• Domperidone IP — 10 mg
• Excipients — q.s.

---

2. What is GASTRIC PD?

GASTRIC PD combines two pharmacologically different medicines:

Pantoprazole 40 mg

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

Domperidone 10 mg

A dopamine D₂-receptor antagonist that has antiemetic and prokinetic effects. It acts predominantly outside the central nervous system because it has limited penetration across the blood-brain barrier.

The combination therefore provides two different pharmacological actions: reduction of gastric acid production and modulation of upper gastrointestinal motility/nausea, where clinically appropriate.

---

3. Mechanism of Action

Pantoprazole – Proton Pump Inhibitor

Pantoprazole suppresses the final step of gastric acid secretion.

It inhibits the H⁺/K⁺-ATPase enzyme system in gastric parietal cells. This reduces both basal and stimulated gastric acid secretion.

Reduced acid production can help in conditions associated with excessive gastric acid and acid-related mucosal injury, including GERD and erosive esophagitis. Pantoprazole 40 mg is an established strength for treatment of erosive esophagitis associated with GERD.

---

Domperidone – Dopamine D₂ Antagonist

Domperidone blocks peripheral dopamine D₂ receptors.

Its pharmacological effects include:

• Enhancement of upper gastrointestinal motility
• Promotion of gastric emptying
• Increased lower oesophageal sphincter tone
• Antiemetic activity through peripheral dopamine receptor blockade

However, domperidone requires particular attention to cardiac safety, including QT prolongation and potentially serious ventricular arrhythmias.

---

4. Combined Action of GASTRIC PD

The two components work through different mechanisms:

Pantoprazole 40 mg
↓
Reduces gastric acid secretion

Domperidone 10 mg
↓
Supports upper-GI motility and provides antiemetic activity

Combined pharmacological approach
↓
Acid suppression + management of selected associated upper-GI symptoms

The exact rationale for prescribing the combination should be determined by the treating physician rather than assuming that every patient with acidity or reflux requires domperidone.

---

5. Therapeutic Uses

Depending on the approved indication for the specific product and the physician’s assessment, the combination may be used in selected patients with gastrointestinal symptoms associated with acid-related disorders.

Potential clinical contexts include:

• Gastroesophageal reflux disease (GERD)
• Acid-related dyspeptic symptoms
• Acid-related upper gastrointestinal symptoms associated with nausea
• Conditions requiring gastric acid suppression where an antiemetic/prokinetic component is specifically considered appropriate

Pantoprazole itself has established indications including short-term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions such as Zollinger-Ellison syndrome.

Important: Do not automatically describe GASTRIC PD as indicated for every type of “gas,” bloating or acidity. The indication for the combination product should correspond to its current Indian prescribing information.

---

6. Role of Pantoprazole 40 mg

Pantoprazole provides the primary acid-suppressive component.

It can help:

• Reduce excessive gastric acid exposure
• Promote healing of acid-related esophageal injury
• Control acid-related reflux symptoms
• Reduce acid-related irritation of the upper GI tract
• Maintain healing in appropriately diagnosed acid-related conditions

Pantoprazole delayed-release tablets are swallowed whole and should not be crushed or chewed.

---

7. Role of Domperidone 10 mg

Domperidone contributes:

• Antiemetic action
• Peripheral dopamine D₂ receptor blockade
• Upper gastrointestinal prokinetic activity
• Support for gastric emptying

However, modern safety recommendations emphasize that domperidone should be used at the lowest effective dose for the shortest appropriate duration, because of its association with QT prolongation and serious cardiac adverse reactions.

---

8. Dosage and Administration

Product strength shown on the artwork

Pantoprazole 40 mg + Domperidone 10 mg per tablet.

The artwork does not specify a dosage schedule, so the website should not prescribe a universal dose for GASTRIC PD.

Suggested website wording:

Dosage: Take GASTRIC PD exactly as prescribed by the treating physician. Dose and duration depend on the patient’s diagnosis, symptoms, response to treatment and other medicines being taken.

For pantoprazole alone, approved prescribing information contains different regimens depending on the indication; therefore, the 40 mg strength should not be interpreted as automatically requiring the same schedule for every patient.

---

9. How to Take GASTRIC PD

• Take the tablet orally with water.
• Swallow the enteric-coated tablet whole.
• Do not crush, chew or split the enteric-coated tablet.
• Follow the timing prescribed by the physician.
• Do not increase the dose because symptoms have not improved.
• Do not continue long-term treatment without medical review.

Pantoprazole delayed-release tablets are designed to be swallowed whole.

---

10. Missed Dose

If a dose is missed:

• Take it when remembered unless it is nearly time for the next dose.
• If the next dose is due soon, skip the missed dose.
• Do not take two doses together to compensate.

Follow the physician’s specific instructions where applicable.

---

11. Common Side Effects

Possible adverse effects may include:

Pantoprazole-related

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

Domperidone-related

• Dry mouth
• Abdominal cramps
• Headache
• Diarrhoea
• Breast tenderness or other prolactin-related effects in some patients

Not every patient experiences side effects.

---

12. Important Cardiac Safety – Domperidone

This is an important section to retain on the product page.

Domperidone has been associated with:

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

The risk is higher in certain populations, including people over 60 years of age, those receiving higher daily doses, and people taking QT-prolonging medicines or potent CYP3A4 inhibitors.

Domperidone is contraindicated in certain patients with:

• Existing QT prolongation
• Significant electrolyte disturbances
• Bradycardia
• Certain underlying cardiac diseases, including congestive heart failure
• Moderate/severe hepatic impairment
• Concomitant use of certain QT-prolonging medicines or potent CYP3A4 inhibitors

Seek urgent medical attention for:

• Fainting
• Fast or irregular heartbeat
• Severe dizziness
• Palpitations
• Chest discomfort associated with an abnormal heartbeat

---

13. Liver Precautions

Patients with liver disease should inform their doctor before using GASTRIC PD.

Domperidone should not be used in patients with moderate or severe hepatic impairment under the referenced safety recommendations.

Pantoprazole is also metabolized in the liver, so patients with significant hepatic disease should be evaluated appropriately.

---

14. Kidney Precautions

Patients with significant renal impairment should inform their physician.

Repeated administration of domperidone may require adjustment of dosing frequency in severe renal impairment because elimination is prolonged.

---

15. Drug Interactions

Tell your doctor about all medicines you take.

Particular attention should be given to medicines that may interact with domperidone, especially:

• QT-prolonging medicines
• Certain antiarrhythmic medicines
• Potent CYP3A4 inhibitors
• Certain macrolide antibiotics
• Certain azole antifungal medicines

These combinations can increase the risk of cardiac adverse effects.

Pantoprazole can also interact with selected medicines. The full medication history should therefore be reviewed before prescribing.

---

16. Long-Term Pantoprazole Considerations

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

Prolonged acid suppression may be associated with issues such as:

• Hypomagnesemia
• Vitamin B12 deficiency with prolonged use
• Increased fracture risk in certain circumstances
• Acute interstitial nephritis
• Certain gastrointestinal infections

The clinical need for long-term treatment should be periodically reassessed.

---

17. Pregnancy

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

The combination should not be self-medicated during pregnancy.

---

18. Breastfeeding

Consult a physician before using GASTRIC PD while breastfeeding.

The healthcare professional can assess the individual benefit-risk profile and determine whether an alternative treatment is more appropriate.

---

19. Use in Elderly Patients

Extra caution may be appropriate in older adults because the cardiac risk associated with domperidone is higher in people above 60 years in the referenced safety review.

The lowest appropriate exposure should be used when domperidone is prescribed.

---

20. Pediatric Use

GASTRIC PD should not be routinely promoted for children unless the specific formulation, indication and dose are approved for the relevant pediatric population.

Domperidone dosing and eligibility are particularly dependent on age/weight and regulatory authorization.

---

21. Driving and Operating Machinery

Some patients may experience:

• Dizziness
• Headache
• Weakness or discomfort

Patients should understand how the medicine affects them before driving or operating machinery.

---

22. Contraindications / Important Precautions

GASTRIC PD should be avoided or carefully assessed in patients with:

• Known hypersensitivity to pantoprazole, domperidone or formulation components
• Significant cardiac rhythm abnormalities
• QT prolongation
• Significant electrolyte disturbances
• Certain cardiac diseases
• Moderate/severe hepatic impairment
• Certain interacting medicines
• History of serious reaction to PPIs or related medicines

Domperidone-specific contraindications are particularly important because of its cardiac safety profile.

---

23. When to Contact a Doctor

Patients should seek medical assessment for:

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

Urgent medical attention is appropriate for fainting, severe palpitations or suspected serious allergic reactions.

---

24. Key Features of GASTRIC PD

Dual-action gastrointestinal formulation

Pantoprazole 40 mg + Domperidone 10 mg

Acid suppression

Pantoprazole inhibits the gastric proton pump and suppresses acid secretion.

Prokinetic/antiemetic component

Domperidone provides peripheral dopamine D₂ receptor blockade and associated prokinetic/antiemetic effects.

Enteric-coated tablet

Designed to deliver pantoprazole appropriately through the upper GI tract.

Prescription product

Use should be based on physician assessment.

---

25. Why GASTRIC PD?

GASTRIC PD provides two pharmacologically distinct components in one tablet:

Pantoprazole 40 mg
→ Acid suppression

Domperidone 10 mg
→ Peripheral prokinetic/antiemetic activity

This combination may be considered by physicians when both therapeutic actions are clinically appropriate.

However, the presence of domperidone means that cardiac risk assessment and appropriate duration of therapy are important.