Zepiron Plus
Generic Name
Esomeprazole + Domperidone
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zepiron plus capsule | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Zepiron Plus Capsule is a combination medicine containing Esomeprazole (a proton pump inhibitor) and Domperidone (a prokinetic agent). It is used to treat conditions like gastroesophageal reflux disease (GERD), dyspepsia, and other acid-related stomach problems by reducing stomach acid and improving gut motility.
Uses & Indications
Dosage
Adults
One capsule once daily, 15-30 minutes before a meal, preferably in the morning, or as directed by the physician.
Elderly
Generally, no special dosage adjustment is required for elderly patients, but caution is advised in patients with renal or hepatic impairment.
Renal_impairment
No dosage adjustment is generally required for mild to moderate renal impairment. Use with caution in severe renal impairment.
How to Take
Take the capsule orally with a glass of water, 15-30 minutes before a meal. Do not chew, crush, or open the capsule.
Mechanism of Action
Esomeprazole selectively blocks the H+/K+-ATPase proton pump in gastric parietal cells, leading to a reduction in gastric acid secretion. Domperidone is a dopamine D2 receptor antagonist that acts as a prokinetic agent, increasing lower esophageal sphincter tone and improving gastric emptying, thereby reducing reflux and associated symptoms.
Pharmacokinetics
Onset
Esomeprazole: Acid suppression within 1 hour, maximal effect in 3-4 days. Domperidone: Onset of prokinetic action within 15-30 minutes.
Excretion
Esomeprazole: Approximately 80% excreted as metabolites in urine, 20% in feces. Domperidone: Approximately 66% excreted in feces, 33% in urine as metabolites.
Half life
Esomeprazole: Approximately 1-1.5 hours. Domperidone: Approximately 7-9 hours.
Absorption
Esomeprazole is rapidly absorbed, with peak plasma levels occurring within 1-2 hours. Domperidone is rapidly absorbed orally, but undergoes extensive first-pass metabolism, resulting in low absolute bioavailability (~15%).
Metabolism
Esomeprazole is extensively metabolized in the liver by the cytochrome P450 enzyme system, mainly CYP2C19 and CYP3A4. Domperidone is extensively metabolized in the liver by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, domperidone, or any other components of the formulation
- Gastrointestinal hemorrhage, obstruction, or perforation
- Prolactin-releasing pituitary tumor (Prolactinoma)
- Moderate to severe hepatic impairment for domperidone
- Patients with significant electrolyte disturbances (e.g., hypokalemia, hypomagnesemia)
- Patients with pre-existing cardiac conditions such as prolonged QTc interval, congestive heart failure, or bradycardia
- Concomitant use with potent CYP3A4 inhibitors that prolong the QT interval (e.g., ketoconazole, erythromycin)
Drug Interactions
Warfarin
Increased INR and bleeding risk with concomitant esomeprazole.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19.
Methotrexate
Increased and prolonged methotrexate plasma levels when used with PPIs.
Atazanavir/Nelfinavir
Reduced absorption of these antiretrovirals due to increased gastric pH by esomeprazole.
Ketoconazole/Erythromycin/Strong CYP3A4 inhibitors
May increase plasma levels of domperidone, increasing the risk of QTc prolongation and cardiac adverse effects.
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, tachycardia, and extrapyramidal reactions (due to domperidone). Management is symptomatic and supportive. There is no specific antidote. Gastric lavage may be considered if appropriate, and cardiac monitoring is recommended due to the potential for QTc prolongation with domperidone.
Pregnancy & Lactation
Pregnancy Category C. Use Zepiron Plus during pregnancy only if the potential benefit justifies the potential risk to the fetus. Both esomeprazole and domperidone are excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. A decision should be made whether to discontinue nursing or to discontinue the drug.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, domperidone, or any other components of the formulation
- Gastrointestinal hemorrhage, obstruction, or perforation
- Prolactin-releasing pituitary tumor (Prolactinoma)
- Moderate to severe hepatic impairment for domperidone
- Patients with significant electrolyte disturbances (e.g., hypokalemia, hypomagnesemia)
- Patients with pre-existing cardiac conditions such as prolonged QTc interval, congestive heart failure, or bradycardia
- Concomitant use with potent CYP3A4 inhibitors that prolong the QT interval (e.g., ketoconazole, erythromycin)
Drug Interactions
Warfarin
Increased INR and bleeding risk with concomitant esomeprazole.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19.
Methotrexate
Increased and prolonged methotrexate plasma levels when used with PPIs.
Atazanavir/Nelfinavir
Reduced absorption of these antiretrovirals due to increased gastric pH by esomeprazole.
Ketoconazole/Erythromycin/Strong CYP3A4 inhibitors
May increase plasma levels of domperidone, increasing the risk of QTc prolongation and cardiac adverse effects.
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, tachycardia, and extrapyramidal reactions (due to domperidone). Management is symptomatic and supportive. There is no specific antidote. Gastric lavage may be considered if appropriate, and cardiac monitoring is recommended due to the potential for QTc prolongation with domperidone.
Pregnancy & Lactation
Pregnancy Category C. Use Zepiron Plus during pregnancy only if the potential benefit justifies the potential risk to the fetus. Both esomeprazole and domperidone are excreted in breast milk; therefore, caution should be exercised when administering to a nursing mother. A decision should be made whether to discontinue nursing or to discontinue the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
DGDA Approved
Patent Status
Generic
Clinical Trials
Extensive clinical trials have established the efficacy and safety of both esomeprazole and domperidone individually. Combination formulations like Zepiron Plus have undergone trials to demonstrate synergistic effects and improved symptom control in patients with GERD and dyspepsia compared to monotherapy.
Lab Monitoring
- Electrolytes (especially magnesium and potassium during long-term use of PPIs)
- Liver function tests (in patients with hepatic impairment or during prolonged use)
- Vitamin B12 levels (in patients on prolonged PPI therapy, >3 years)
Doctor Notes
- Counsel patients on proper administration (before food, swallowed whole) and lifestyle modifications.
- Monitor for cardiac risk factors, especially in elderly patients or those on higher doses of domperidone.
- Re-evaluate the need for continued therapy periodically, especially for long-term use, to minimize potential risks.
- Be aware of potential drug interactions, particularly with CYP3A4 inhibitors and drugs that prolong the QT interval.
Patient Guidelines
- Take the medicine as prescribed by your doctor, usually once daily before a meal.
- Do not stop taking the medicine abruptly without consulting your doctor.
- Inform your doctor about all your medical conditions and other medications you are taking.
- Report any unusual symptoms, especially severe abdominal pain, persistent vomiting, or heart palpitations.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness or drowsiness in some individuals. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Avoid trigger foods such as spicy, fatty, acidic foods, caffeine, and chocolate.
- Eat smaller, more frequent meals instead of large ones.
- Avoid lying down immediately after eating; wait at least 2-3 hours.
- Elevate the head of your bed to help reduce nighttime reflux symptoms.
- Maintain a healthy weight, as obesity can worsen reflux.
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