Prolert
Generic Name
Esomeprazole
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
prolert 20 mg capsule | ৳ 3.01 | ৳ 30.10 |
Description
Overview of the medicine
Esomeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach. It is used to treat acid-related conditions like GERD, ulcers, and Zollinger-Ellison syndrome.
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. H. pylori eradication: 20 mg twice daily for 7-14 days (with antibiotics). Zollinger-Ellison Syndrome: Initial 40 mg twice daily, adjusted as needed.
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is required for patients with renal impairment.
How to Take
Take orally, generally 30-60 minutes before a meal. Swallow the capsule whole with water; do not chew or crush it. For patients who have difficulty swallowing, the capsule can be opened and the pellets mixed with water or a semi-solid food.
Mechanism of Action
Esomeprazole works by irreversibly blocking the H+/K+-ATPase enzyme (the proton pump) in the gastric parietal cells, thereby inhibiting the final step in acid production.
Pharmacokinetics
Onset
Onset of acid suppression typically occurs within 1 hour.
Excretion
Approximately 80% of metabolites are excreted in the urine and 20% in the feces.
Half life
Plasma elimination half-life is approximately 1-1.5 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically within 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 (CYP) system, primarily by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Digoxin
Increased absorption and plasma levels of digoxin.
Warfarin
Increased INR and prothrombin time; monitor closely.
Nelfinavir
Significant decrease in nelfinavir plasma levels; concomitant use is contraindicated.
Clopidogrel
Reduced antiplatelet effect of clopidogrel.
Methotrexate
Increased plasma levels of methotrexate, particularly with high doses.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and transient, including drowsiness, confusion, blurred vision, tachycardia, nausea, vomiting, and diarrhea. Treatment is symptomatic and supportive, as there is no specific antidote.
Pregnancy & Lactation
Pregnancy Category B (older classification). Use with caution during pregnancy if clearly needed, after consulting a doctor. Esomeprazole is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing mother. Consult your doctor.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Digoxin
Increased absorption and plasma levels of digoxin.
Warfarin
Increased INR and prothrombin time; monitor closely.
Nelfinavir
Significant decrease in nelfinavir plasma levels; concomitant use is contraindicated.
Clopidogrel
Reduced antiplatelet effect of clopidogrel.
Methotrexate
Increased plasma levels of methotrexate, particularly with high doses.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and transient, including drowsiness, confusion, blurred vision, tachycardia, nausea, vomiting, and diarrhea. Treatment is symptomatic and supportive, as there is no specific antidote.
Pregnancy & Lactation
Pregnancy Category B (older classification). Use with caution during pregnancy if clearly needed, after consulting a doctor. Esomeprazole is excreted in human breast milk; therefore, caution should be exercised when administered to a nursing mother. Consult your doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies like FDA, DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of esomeprazole in treating various acid-related disorders including GERD, peptic ulcers, and Zollinger-Ellison syndrome, establishing it as a standard treatment option.
Lab Monitoring
- No specific routine laboratory monitoring is typically required for short-term use.
- Magnesium levels may be monitored periodically with prolonged use (e.g., >3 months) to detect hypomagnesemia.
Doctor Notes
- Consider the lowest effective dose for the shortest duration necessary, especially for long-term maintenance.
- Periodically reassess the need for continued PPI therapy.
- Be aware of potential drug interactions, especially with clopidogrel and methotrexate.
- Monitor for symptoms of hypomagnesemia or B12 deficiency in patients on prolonged therapy.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Swallow capsules whole; do not chew, crush, or break them.
- Take it at least 30-60 minutes before a meal for best results.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any unusual symptoms or severe side effects 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 resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Esomeprazole may cause dizziness or visual disturbances in some individuals. If you experience these symptoms, avoid driving or operating machinery until you know how the medicine affects you.
Lifestyle Advice
- Avoid trigger foods like spicy, fatty, acidic foods, caffeine, and chocolate.
- Limit alcohol consumption and stop smoking, as these can worsen acid reflux.
- Elevate the head of your bed if you suffer from nighttime acid reflux.
- Eat smaller, more frequent meals and avoid eating right before bedtime.
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