Esoral
Generic Name
Esomeprazole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
esoral 40 mg capsule | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Esoral 40 mg Capsule is a proton pump inhibitor used to treat conditions where there is too much acid in the stomach, such as gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison syndrome. It works by reducing the amount of acid produced in the stomach.
Uses & Indications
Dosage
Adults
GERD: 20-40 mg once daily for 4-8 weeks. Erosive Esophagitis: 20-40 mg once daily for 4-8 weeks. Zollinger-Ellison Syndrome: Initial dose 40 mg twice daily, adjusted as needed.
Elderly
No dosage adjustment generally required, but caution is advised.
Renal_impairment
No dosage adjustment required for mild to moderate renal impairment. For severe impairment, caution is advised.
How to Take
Take Esoral 40 mg Capsule whole, with water, at least one hour before a meal, preferably in the morning. Do not chew or crush the capsule.
Mechanism of Action
Esomeprazole is a proton pump inhibitor that specifically inhibits the H+/K+-ATPase (proton pump) in the gastric parietal cells. This irreversible inhibition reduces gastric acid secretion by blocking the final step in acid production.
Pharmacokinetics
Onset
Within 1 hour
Excretion
Eliminated mainly in the urine (about 80%) and feces (about 20%) as metabolites. Less than 1% is excreted unchanged.
Half life
Approximately 1-1.5 hours
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations occur in 1-2 hours. Bioavailability is about 64% after a single 40 mg dose, increasing to 89% after repeated once-daily administration.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system, primarily by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole or any components of the formulation or to other substituted benzimidazoles.
- Concomitant use with nelfinavir.
Drug Interactions
Digoxin
Increased absorption of digoxin, especially in patients taking high doses. Monitor digoxin levels.
Warfarin
Increased INR and prothrombin time, monitor carefully.
Clopidogrel
Esomeprazole can reduce the antiplatelet effect of clopidogrel, potentially increasing the risk of thrombotic events. Avoid concomitant use or consider alternative antiplatelet therapy.
Methotrexate
Increased plasma levels of methotrexate, particularly with high doses. Monitor for toxicity.
Nelfinavir/Atazanavir
Reduced plasma concentrations of nelfinavir and atazanavir, leading to loss of therapeutic effect and potential resistance. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, tachycardia, nausea, abdominal pain, and diarrhea. Treatment is symptomatic and supportive. Esomeprazole is highly protein-bound and not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. It is unknown if esomeprazole is excreted in human milk. Caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole or any components of the formulation or to other substituted benzimidazoles.
- Concomitant use with nelfinavir.
Drug Interactions
Digoxin
Increased absorption of digoxin, especially in patients taking high doses. Monitor digoxin levels.
Warfarin
Increased INR and prothrombin time, monitor carefully.
Clopidogrel
Esomeprazole can reduce the antiplatelet effect of clopidogrel, potentially increasing the risk of thrombotic events. Avoid concomitant use or consider alternative antiplatelet therapy.
Methotrexate
Increased plasma levels of methotrexate, particularly with high doses. Monitor for toxicity.
Nelfinavir/Atazanavir
Reduced plasma concentrations of nelfinavir and atazanavir, leading to loss of therapeutic effect and potential resistance. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include drowsiness, tachycardia, nausea, abdominal pain, and diarrhea. Treatment is symptomatic and supportive. Esomeprazole is highly protein-bound and not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. It is unknown if esomeprazole is excreted in human milk. Caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA (US) and DGDA (Bangladesh)
Patent Status
Off-patent (generic versions available)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated esomeprazole's efficacy and safety in acid-related disorders. Ongoing research focuses on long-term safety and specific patient populations.
Lab Monitoring
- No routine lab monitoring is generally required. However, for long-term use (over a year), monitoring of serum magnesium levels is recommended, especially in patients taking other drugs that can cause hypomagnesemia.
Doctor Notes
- Consider lowest effective dose for shortest duration possible.
- Monitor magnesium levels in patients on long-term therapy or concomitant diuretics.
- Counsel patients on potential long-term risks, especially bone fractures and *C. difficile* infection.
Patient Guidelines
- Take the capsule whole; do not chew or crush it.
- Take it at least one hour before a meal.
- Inform your doctor about all other medications you are taking.
- Report any new or worsening symptoms to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your 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
Esomeprazole generally has no or negligible influence on the ability to drive or use machines. However, some side effects like dizziness or visual disturbances may occur; if affected, patients should avoid driving or operating machinery.
Lifestyle Advice
- Avoid spicy and fatty foods.
- Limit alcohol and caffeine intake.
- Maintain a healthy weight.
- Avoid lying down immediately after meals.
- Elevate the head of your bed.
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