Alneed-Plus
Generic Name
Esomeprazole + Domperidone
Manufacturer
Popular Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| alneed plus capsule | ৳ 3.50 | ৳ 35.00 |
Description
Overview of the medicine
Alneed-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 disorders accompanied by nausea or vomiting, by reducing stomach acid production and improving gut motility.
Uses & Indications
Dosage
Adults
One capsule once or twice daily, preferably before meals, or as directed by the physician.
Elderly
No special dosage adjustment is required for elderly patients, but caution is advised in those with severe renal or hepatic impairment.
Renal_impairment
Caution is advised. For severe renal impairment (creatinine clearance < 30 mL/min), the dosage interval for Domperidone should be extended. No dose adjustment for Esomeprazole in renal impairment.
How to Take
Take the capsule orally with water, preferably 30-60 minutes before a meal. Do not crush or chew the capsule; swallow it whole.
Mechanism of Action
Esomeprazole, a proton pump inhibitor, irreversibly blocks the H+/K+-ATPase enzyme system (proton pump) in gastric parietal cells, thereby suppressing gastric acid secretion. Domperidone, a dopamine D2-receptor antagonist, acts as a prokinetic agent by blocking dopamine receptors in the chemoreceptor trigger zone and in the gastrointestinal tract, increasing gastric and intestinal motility and preventing reflux.
Pharmacokinetics
Onset
Esomeprazole: Acid suppression begins within 1 hour. Domperidone: Prokinetic effects typically within 30-60 minutes.
Excretion
Esomeprazole: Excreted primarily via urine (80%) as metabolites and feces (20%). Domperidone: Excreted via feces (66%) and urine (33%) primarily as metabolites.
Half life
Esomeprazole: Approximately 1.5 hours. Domperidone: Approximately 7-9 hours.
Absorption
Esomeprazole is rapidly absorbed after oral administration, with peak plasma levels occurring at 1-2 hours. Bioavailability is approximately 64% after a single 40 mg dose. Domperidone is rapidly absorbed after oral administration; however, extensive first-pass metabolism results in a low oral bioavailability of approximately 15%.
Metabolism
Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system, mainly by CYP2C19 and CYP3A4. Domperidone is extensively metabolized in the liver via CYP3A4 hydroxylation and N-dealkylation.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, Domperidone, or any component of the formulation.
- Patients with known prolongation of QT intervals, significant electrolyte disturbances, or underlying cardiac diseases (due to Domperidone).
- Patients with prolactin-releasing pituitary tumor (prolactinoma).
- Patients with moderate to severe hepatic impairment (due to Domperidone).
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir).
Drug Interactions
Digoxin
Esomeprazole may increase serum digoxin levels.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel.
Ketoconazole, Itraconazole, Erlotinib
Esomeprazole may reduce the absorption of these drugs by increasing gastric pH.
QT-prolonging drugs (e.g., Amiodarone, Haloperidol)
Increased risk of QT prolongation with Domperidone.
Potent CYP3A4 inhibitors (e.g., Erythromycin, Clarithromycin, Fluconazole, Ritonavir)
Concomitant use with Domperidone is contraindicated due to increased risk of QT 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 Esomeprazole overdose may include confusion, drowsiness, blurred vision, tachycardia, nausea, sweating, flushing, headache, dry mouth, and other gastrointestinal disturbances. Domperidone overdose symptoms may include agitation, altered consciousness, convulsions, disorientation, somnolence, and extrapyramidal reactions. Management is supportive and symptomatic; there is no specific antidote. Gastric lavage and activated charcoal may be considered. ECG monitoring is recommended due to the risk of QT prolongation with Domperidone.
Pregnancy & Lactation
Pregnancy: Category C for Esomeprazole (animal studies show adverse effects, but human data are insufficient; use only if potential benefit justifies potential risk). Domperidone is generally not recommended during pregnancy unless clearly necessary. Consult your doctor. Lactation: Both Esomeprazole and Domperidone are excreted in breast milk. Domperidone is generally contraindicated in breastfeeding mothers due to potential cardiac risks to the infant. Use with caution or avoid.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, Domperidone, or any component of the formulation.
- Patients with known prolongation of QT intervals, significant electrolyte disturbances, or underlying cardiac diseases (due to Domperidone).
- Patients with prolactin-releasing pituitary tumor (prolactinoma).
- Patients with moderate to severe hepatic impairment (due to Domperidone).
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir).
Drug Interactions
Digoxin
Esomeprazole may increase serum digoxin levels.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel.
Ketoconazole, Itraconazole, Erlotinib
Esomeprazole may reduce the absorption of these drugs by increasing gastric pH.
QT-prolonging drugs (e.g., Amiodarone, Haloperidol)
Increased risk of QT prolongation with Domperidone.
Potent CYP3A4 inhibitors (e.g., Erythromycin, Clarithromycin, Fluconazole, Ritonavir)
Concomitant use with Domperidone is contraindicated due to increased risk of QT 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 Esomeprazole overdose may include confusion, drowsiness, blurred vision, tachycardia, nausea, sweating, flushing, headache, dry mouth, and other gastrointestinal disturbances. Domperidone overdose symptoms may include agitation, altered consciousness, convulsions, disorientation, somnolence, and extrapyramidal reactions. Management is supportive and symptomatic; there is no specific antidote. Gastric lavage and activated charcoal may be considered. ECG monitoring is recommended due to the risk of QT prolongation with Domperidone.
Pregnancy & Lactation
Pregnancy: Category C for Esomeprazole (animal studies show adverse effects, but human data are insufficient; use only if potential benefit justifies potential risk). Domperidone is generally not recommended during pregnancy unless clearly necessary. Consult your doctor. Lactation: Both Esomeprazole and Domperidone are excreted in breast milk. Domperidone is generally contraindicated in breastfeeding mothers due to potential cardiac risks to the infant. Use with caution or avoid.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from the date of manufacture, specific to manufacturer.
Availability
Pharmacies, hospitals, and drug stores
Approval Status
Approved by regulatory bodies (e.g., DGDA)
Patent Status
Generic available (Esomeprazole original patent expired)
Clinical Trials
Various clinical trials have demonstrated the efficacy and safety of Esomeprazole-Domperidone combination in managing GERD and dyspepsia. Studies typically show superior symptom relief compared to monotherapy with either agent.
Lab Monitoring
- Liver function tests (periodically in prolonged use or in patients with hepatic impairment)
- Electrolyte levels (especially potassium and magnesium, if concern for QT prolongation with Domperidone)
- ECG monitoring (in patients with cardiac risk factors or concomitant QT-prolonging drugs, for Domperidone)
Doctor Notes
- Emphasize the importance of patient counseling regarding Domperidone's cardiac risks, especially in patients with pre-existing conditions or on interacting medications.
- Advise patients on lifestyle modifications to complement drug therapy.
- Review the necessity of continued PPI therapy periodically to minimize long-term risks.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Swallow the capsule whole; do not chew, crush, or open it.
- Take it preferably 30-60 minutes before a meal.
- Inform your doctor about all other medications you are taking, especially any heart medications.
- Report any unusual heartbeats, dizziness, or fainting immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with 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 heavy machinery.
Lifestyle Advice
- Avoid fatty, spicy, and acidic foods that can worsen reflux.
- Elevate the head of your bed to reduce nighttime reflux.
- Avoid eating large meals close to bedtime.
- Maintain a healthy weight and quit smoking.
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