Deflux
Generic Name
Esomeprazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| deflux 5 mg pediatric drop | ৳ 20.00 | N/A |
Description
Overview of the medicine
Deflux 5 mg Pediatric Drop is a proton pump inhibitor used to reduce the amount of acid produced in the stomach. It is primarily prescribed for infants and children to treat gastroesophageal reflux disease (GERD) and its associated symptoms, such as heartburn, acid regurgitation, and difficulty swallowing.
Uses & Indications
Dosage
Adults
This formulation is specifically for pediatric use. Adult dosage differs and requires different formulations.
Elderly
This formulation is specifically for pediatric use. Elderly dosage differs and requires different formulations.
Renal_impairment
No dosage adjustment needed for patients with renal impairment in children or adults for Esomeprazole. However, caution is advised in severe impairment.
How to Take
Administer orally, preferably 30-60 minutes before a meal. Measure the exact dose using the provided dropper. For children aged 1-11 years, weighing <20 kg, the usual dose is 5 mg once daily. For children aged 1-11 years, weighing ≥20 kg, the usual dose is 10 mg once daily. Can be mixed with a small amount of water or fruit juice (apple, orange, pineapple) or soft food (apple sauce, yogurt) for easier administration. Do not chew or crush.
Mechanism of Action
Esomeprazole, an S-isomer of Omeprazole, is a proton pump inhibitor that specifically inhibits the H+/K+-ATPase (proton pump) in the gastric parietal cells. This inhibition prevents the final step of acid production, leading to a profound and long-lasting reduction in gastric acid secretion.
Pharmacokinetics
Onset
Within 1 hour
Excretion
Approximately 80% excreted as metabolites in urine and the remainder in feces
Half life
Approximately 1-1.5 hours
Absorption
Rapidly absorbed after oral administration, peak plasma levels reached in 1-2 hours. Bioavailability is approximately 64% after a single 40 mg dose and increases to 89% after repeated once-daily administration.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 system (CYP2C19 and CYP3A4)
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, substituted benzimidazoles, or any component of the formulation
- Concomitant use with nelfinavir (an antiretroviral drug)
Drug Interactions
Warfarin
Increased INR and prothrombin time, monitor carefully.
Nelfinavir
Significant decrease in nelfinavir plasma levels, concomitant use is contraindicated.
Clopidogrel
Potential reduction in clopidogrel's antiplatelet effect; caution advised, consider alternative antiplatelet therapy or PPI.
Methotrexate
Increased plasma levels of methotrexate, especially at high doses, leading to potential toxicity.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children. After reconstitution, store refrigerated (2-8°C) and use within 28 days. Do not freeze.
Overdose
Symptoms of overdose are generally mild and self-limiting (e.g., drowsiness, tachycardia, nausea, abdominal pain). No specific antidote is known. Treatment should be symptomatic and supportive. Esomeprazole is extensively protein-bound and not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. Limited human data suggest no increased risk. Use during pregnancy only if clearly needed. Esomeprazole is likely excreted in human milk; caution should be exercised when administered to a nursing mother, weighing benefits vs. risks.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, substituted benzimidazoles, or any component of the formulation
- Concomitant use with nelfinavir (an antiretroviral drug)
Drug Interactions
Warfarin
Increased INR and prothrombin time, monitor carefully.
Nelfinavir
Significant decrease in nelfinavir plasma levels, concomitant use is contraindicated.
Clopidogrel
Potential reduction in clopidogrel's antiplatelet effect; caution advised, consider alternative antiplatelet therapy or PPI.
Methotrexate
Increased plasma levels of methotrexate, especially at high doses, leading to potential toxicity.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children. After reconstitution, store refrigerated (2-8°C) and use within 28 days. Do not freeze.
Overdose
Symptoms of overdose are generally mild and self-limiting (e.g., drowsiness, tachycardia, nausea, abdominal pain). No specific antidote is known. Treatment should be symptomatic and supportive. Esomeprazole is extensively protein-bound and not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. Limited human data suggest no increased risk. Use during pregnancy only if clearly needed. Esomeprazole is likely excreted in human milk; caution should be exercised when administered to a nursing mother, weighing benefits vs. risks.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months (unreconstituted powder). 28 days after reconstitution when stored at specified conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies (e.g., DGDA, FDA for pediatric use)
Patent Status
Generic available, patent expired for active ingredient
WHO Essential Medicine
YesClinical Trials
Clinical trials have demonstrated the efficacy and safety of Esomeprazole in pediatric patients for GERD, showing significant symptom improvement and healing of esophagitis compared to placebo.
Lab Monitoring
- Magnesium levels (for long-term use)
- Liver function tests (in patients with hepatic impairment)
Doctor Notes
- Counsel parents/caregivers on proper administration and adherence.
- Consider the potential for drug interactions, especially with CYP2C19 substrates.
- Monitor for long-term adverse effects, particularly hypomagnesemia and bone health, in chronic users.
- Evaluate children for underlying causes of GERD if symptoms persist or worsen.
Patient Guidelines
- Follow the doctor's instructions regarding dose and duration.
- Do not stop the medication suddenly without consulting your doctor.
- Ensure proper administration using the provided dropper, especially for infants.
- Report any persistent or severe side effects to your doctor.
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 double the dose to catch up.
Driving Precautions
Esomeprazole is unlikely to affect the ability to drive or operate machinery. However, if side effects like dizziness or visual disturbances occur, caution should be exercised.
Lifestyle Advice
- Elevate the head of the bed for infants with GERD.
- Avoid overfeeding and ensure appropriate feeding techniques.
- Identify and avoid trigger foods if applicable (e.g., spicy foods, caffeine for older children).
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Global Brand Names
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