Azisan Plus
Generic Name
Esomeprazole 40 mg + Domperidone 10 mg
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| azisan plus 40 mg tablet | ৳ 22.00 | ৳ 220.00 |
Description
Overview of the medicine
Azisan Plus 40 mg Tablet is a combination medicine containing Esomeprazole, a proton pump inhibitor, and Domperidone, a prokinetic agent. It is used to treat gastroesophageal reflux disease (GERD), peptic ulcers, and other conditions involving excess stomach acid and impaired gastric motility.
Uses & Indications
Dosage
Adults
Usually one Azisan Plus 40 mg Tablet once daily, preferably before breakfast. The duration of treatment depends on the condition being treated, typically 4-8 weeks for GERD.
Elderly
No specific dose adjustment is generally required for elderly patients unless severe hepatic or renal impairment is present. Use with caution.
Renal_impairment
No dose adjustment is needed for Esomeprazole in renal impairment. For Domperidone, caution is advised in severe renal impairment, and dose frequency may need to be reduced.
How to Take
Azisan Plus 40 mg Tablet should be taken orally with water, preferably at least 30 minutes before a meal. Do not crush, chew, or break the tablet; swallow it whole.
Mechanism of Action
Esomeprazole works by irreversibly blocking the H+/K+-ATPase (proton pump) in the gastric parietal cells, thereby reducing gastric acid secretion. Domperidone acts as a dopamine D2 receptor antagonist, increasing esophageal and gastric motility and acting as an antiemetic by blocking receptors in the chemoreceptor trigger zone.
Pharmacokinetics
Onset
Esomeprazole: Symptom relief typically begins within 1 hour. Domperidone: Antiemetic effect usually starts within 30-60 minutes.
Excretion
Esomeprazole metabolites are primarily excreted via the kidney (approx. 80%) and the remainder in feces. Domperidone is excreted about 31% via the kidney and 66% in feces.
Half life
Esomeprazole: Plasma elimination half-life is approximately 1-1.5 hours. Domperidone: Plasma elimination half-life is approximately 7-9 hours.
Absorption
Esomeprazole is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1-2 hours. Bioavailability is approximately 89% after repeated dosing. Domperidone is rapidly absorbed but undergoes extensive first-pass metabolism, resulting in low absolute bioavailability (approx. 15%). Peak plasma concentrations are reached within 1 hour.
Metabolism
Esomeprazole is extensively metabolized in the liver by the cytochrome P450 system (CYP2C19 and CYP3A4). Domperidone is primarily metabolized by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, Domperidone, or any components of the tablet.
- Patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Patients with prolactin-releasing pituitary tumor (prolactinoma).
- Patients with moderate to severe hepatic impairment (for Domperidone component).
- Concomitant use with QT-prolonging drugs or potent CYP3A4 inhibitors.
Drug Interactions
Diazepam
Delayed elimination of diazepam due to Esomeprazole.
Warfarin
Increased INR/prothrombin time; monitor closely.
Clopidogrel
Reduced antiplatelet effect of clopidogrel due to CYP2C19 inhibition by Esomeprazole.
Erythromycin, Amiodarone
Increased risk of QT prolongation with Domperidone when co-administered with other QT-prolonging drugs or CYP3A4 inhibitors.
Ketoconazole, Itraconazole
Reduced absorption of these drugs due to increased gastric pH by Esomeprazole. Also, potent CYP3A4 inhibitors like ketoconazole can increase Domperidone plasma levels and cardiac risk.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Esomeprazole overdose are generally mild and non-specific. Domperidone overdose symptoms may include drowsiness, disorientation, extrapyramidal reactions, and potential cardiac events. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. ECG monitoring is recommended in case of Domperidone overdose.
Pregnancy & Lactation
Pregnancy: Esomeprazole is Pregnancy Category C. Domperidone is Pregnancy Category B. Use only if clearly needed and the potential benefits outweigh the potential risks. Lactation: Both Esomeprazole and Domperidone are excreted in breast milk. Domperidone's excretion in breast milk is low but potential risk to infants. Consultation with a doctor is essential.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, Domperidone, or any components of the tablet.
- Patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Patients with prolactin-releasing pituitary tumor (prolactinoma).
- Patients with moderate to severe hepatic impairment (for Domperidone component).
- Concomitant use with QT-prolonging drugs or potent CYP3A4 inhibitors.
Drug Interactions
Diazepam
Delayed elimination of diazepam due to Esomeprazole.
Warfarin
Increased INR/prothrombin time; monitor closely.
Clopidogrel
Reduced antiplatelet effect of clopidogrel due to CYP2C19 inhibition by Esomeprazole.
Erythromycin, Amiodarone
Increased risk of QT prolongation with Domperidone when co-administered with other QT-prolonging drugs or CYP3A4 inhibitors.
Ketoconazole, Itraconazole
Reduced absorption of these drugs due to increased gastric pH by Esomeprazole. Also, potent CYP3A4 inhibitors like ketoconazole can increase Domperidone plasma levels and cardiac risk.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of Esomeprazole overdose are generally mild and non-specific. Domperidone overdose symptoms may include drowsiness, disorientation, extrapyramidal reactions, and potential cardiac events. Treatment is symptomatic and supportive. Gastric lavage and activated charcoal may be considered. ECG monitoring is recommended in case of Domperidone overdose.
Pregnancy & Lactation
Pregnancy: Esomeprazole is Pregnancy Category C. Domperidone is Pregnancy Category B. Use only if clearly needed and the potential benefits outweigh the potential risks. Lactation: Both Esomeprazole and Domperidone are excreted in breast milk. Domperidone's excretion in breast milk is low but potential risk to infants. Consultation with a doctor is essential.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic available
Clinical Trials
Clinical trials have demonstrated the efficacy and safety of Esomeprazole in acid suppression and Domperidone in improving gastric motility. Combination therapy trials support the use in managing conditions where both acid suppression and prokinetic effects are beneficial.
Lab Monitoring
- Periodic monitoring of liver function tests may be considered, especially in patients with pre-existing hepatic impairment.
- Electrolyte monitoring (e.g., magnesium levels) with long-term PPI use.
- ECG monitoring, especially in patients with cardiac risk factors, due to Domperidone.
Doctor Notes
- Evaluate patient's cardiovascular risk factors before prescribing Domperidone, especially in elderly patients or those with pre-existing heart conditions.
- Assess the need for long-term PPI therapy; consider stepping down or discontinuing if possible.
- Advise patients on lifestyle modifications to manage GERD symptoms.
Patient Guidelines
- Take the tablet exactly as prescribed by your doctor.
- Do not crush, chew, or break the tablet; swallow it whole.
- Take the tablet before meals, preferably in the morning.
- Inform your doctor about all other medications you are taking, especially any heart medications.
- Report any severe or persistent side effects to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
This medicine may cause dizziness or somnolence in some individuals. If you experience such effects, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid foods and drinks that trigger acid reflux (e.g., fatty foods, spicy foods, caffeine, alcohol).
- Eat smaller, more frequent meals.
- Avoid lying down immediately after eating.
- Elevate the head of your bed while sleeping.
- Quit smoking.
- Manage stress.
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