Protace-H
Generic Name
Pantoprazole + Domperidone
Manufacturer
ACI Limited
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| protace h 25 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Protace-H is a combination medication containing Pantoprazole, a proton pump inhibitor, and Domperidone, a prokinetic agent. It is used to treat gastroesophageal reflux disease (GERD), dyspepsia, and other conditions involving excess stomach acid and impaired gastric motility.
Uses & Indications
Dosage
Adults
Usually one capsule once daily before breakfast, or as directed by physician.
Elderly
Similar to adult dosage, but caution with renal/hepatic impairment.
Renal_impairment
Caution, dosage adjustment may be necessary for Domperidone in severe impairment. Pantoprazole generally not requiring adjustment for mild-moderate.
How to Take
Take orally, preferably 30 minutes before breakfast. Swallow whole, do not chew or crush.
Mechanism of Action
Pantoprazole irreversibly binds to the H+/K+-ATPase pump in gastric parietal cells, inhibiting acid secretion. Domperidone acts as a peripheral dopamine D2 receptor antagonist, increasing gastric and intestinal motility and preventing nausea and vomiting.
Pharmacokinetics
Onset
Pantoprazole: Acid suppression typically within 2-3 hours. Domperidone: Prokinetic effects within 30-60 minutes.
Excretion
Pantoprazole: Primarily renal (approx 80%), remainder via feces. Domperidone: Primarily via feces (approx 66%), remainder via urine (approx 33%).
Half life
Pantoprazole: Approx 1 hour. Domperidone: Approx 7-9 hours.
Absorption
Pantoprazole: Rapidly absorbed, bioavailability approx 77%. Domperidone: Rapidly absorbed, low oral bioavailability (approx 15%) due to extensive first-pass metabolism.
Metabolism
Pantoprazole: Extensively metabolized in the liver via CYP2C19 and CYP3A4. Domperidone: Extensively metabolized in the liver via CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Pantoprazole, Domperidone, or any component
- Known or suspected gastric malignancy
- Moderate to severe hepatic impairment (Domperidone)
- Patients with prolongation of cardiac conduction intervals (e.g., QTc)
- Significant electrolyte disturbances
- Concomitant use with potent CYP3A4 inhibitors (Domperidone)
Drug Interactions
Warfarin
Increased INR/prothrombin time with PPIs, monitor carefully.
Methotrexate
Increased and prolonged methotrexate levels with PPIs.
Ketoconazole, Itraconazole, Posaconazole
PPIs may reduce absorption of pH-dependent drugs.
Drugs that prolong QTc interval (e.g., Amiodarone, Haloperidol, Quinidine)
Increased risk of cardiac arrhythmias with Domperidone.
Strong CYP3A4 inhibitors (e.g., Erythromycin, Clarithromycin, Fluconazole, Ritonavir)
Increased Domperidone plasma levels, increasing risk of QTc prolongation.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, extrapyramidal reactions (Domperidone), tachycardia. Management is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Hemodialysis is not effective.
Pregnancy & Lactation
Pregnancy: Use only if clearly needed and potential benefits outweigh risks. Lactation: Domperidone is excreted in breast milk and may pose a risk to the infant. Use with caution or avoid.
Side Effects
Contraindications
- Hypersensitivity to Pantoprazole, Domperidone, or any component
- Known or suspected gastric malignancy
- Moderate to severe hepatic impairment (Domperidone)
- Patients with prolongation of cardiac conduction intervals (e.g., QTc)
- Significant electrolyte disturbances
- Concomitant use with potent CYP3A4 inhibitors (Domperidone)
Drug Interactions
Warfarin
Increased INR/prothrombin time with PPIs, monitor carefully.
Methotrexate
Increased and prolonged methotrexate levels with PPIs.
Ketoconazole, Itraconazole, Posaconazole
PPIs may reduce absorption of pH-dependent drugs.
Drugs that prolong QTc interval (e.g., Amiodarone, Haloperidol, Quinidine)
Increased risk of cardiac arrhythmias with Domperidone.
Strong CYP3A4 inhibitors (e.g., Erythromycin, Clarithromycin, Fluconazole, Ritonavir)
Increased Domperidone plasma levels, increasing risk of QTc prolongation.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, disorientation, extrapyramidal reactions (Domperidone), tachycardia. Management is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. Hemodialysis is not effective.
Pregnancy & Lactation
Pregnancy: Use only if clearly needed and potential benefits outweigh risks. Lactation: Domperidone is excreted in breast milk and may pose a risk to the infant. Use with caution or avoid.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies nationwide in Bangladesh
Approval Status
Approved by DGDA
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have established the efficacy and safety of Pantoprazole and Domperidone individually and in combination for GI conditions.
Lab Monitoring
- Magnesium levels (for long-term PPI use)
- Liver function tests (especially with hepatic impairment)
- ECG monitoring (for patients at risk of QTc prolongation with Domperidone)
Doctor Notes
- Evaluate for underlying gastric malignancy before starting treatment.
- Advise patients about potential cardiac risks associated with Domperidone.
- Consider dose adjustment in renal/hepatic impairment.
Patient Guidelines
- Take as directed by your doctor.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Inform your doctor if you experience any unusual symptoms or side effects.
- Avoid self-medication for prolonged periods.
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not double the dose.
Driving Precautions
This medicine may cause dizziness or drowsiness in some individuals. If affected, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid trigger foods like fatty, spicy, and acidic foods.
- Eat smaller, more frequent meals.
- Elevate the head of your bed to reduce reflux.
- Avoid lying down immediately after meals.
- Quit smoking and reduce alcohol intake.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Protace-H Brand
Other medicines available under the same brand name
