Protopa
Generic Name
Esomeprazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| protopa 20 mg tablet | ৳ 4.00 | N/A |
Description
Overview of the medicine
Protopa 20 mg Tablet contains Esomeprazole, a proton pump inhibitor used to reduce stomach acid production. It is prescribed for conditions like gastroesophageal reflux disease (GERD), ulcers, and Zollinger-Ellison syndrome.
Uses & Indications
Dosage
Adults
For erosive esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. For symptomatic GERD: 20 mg once daily for 4 weeks. For H. pylori eradication: 20 mg twice daily for 7-10 days (with antibiotics). For Zollinger-Ellison syndrome: Initial dose 40 mg twice daily.
Elderly
No specific dose adjustment is required for the elderly based on age alone, but caution is advised due to potential comorbidities.
Renal_impairment
No dose adjustment is necessary for patients with impaired renal function.
How to Take
Take orally, at least one hour before a meal. Swallow the tablet whole with water. Do not chew or crush.
Mechanism of Action
Esomeprazole is a proton pump inhibitor that specifically and irreversibly blocks the H+/K+-ATPase enzyme system (the proton pump) in the gastric parietal cells. This action inhibits the final step of acid production, thereby reducing both basal and stimulated gastric acid secretion.
Pharmacokinetics
Onset
Within 1 hour
Excretion
Metabolites are primarily excreted in the urine (about 80%) and feces (about 20%).
Half life
Approximately 1-1.5 hours
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations occurring within 1-2 hours. Bioavailability is about 64% after a single 40 mg dose and increases to 89% after repeated once-daily dosing.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 system, mainly by CYP2C19 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole or any components of the formulation
- Hypersensitivity to other substituted benzimidazoles
Drug Interactions
Digoxin
Increased digoxin levels; monitor digoxin concentration.
Diazepam
Decreased clearance of diazepam; monitor for increased sedation.
Warfarin
Increased INR/prothrombin time; monitor closely.
Clopidogrel
Decreased antiplatelet effect of clopidogrel; consider alternative anti-ulcer therapy.
Methotrexate
Increased methotrexate levels, particularly with high doses; monitor for toxicity.
Atazanavir, Nelfinavir
Reduced absorption of antiretroviral drugs; concomitant use is not recommended.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and self-limiting (e.g., drowsiness, tachycardia, nausea, abdominal pain, diarrhea). Treatment is symptomatic and supportive. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. It is unknown if esomeprazole is excreted in human milk; use with caution during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole or any components of the formulation
- Hypersensitivity to other substituted benzimidazoles
Drug Interactions
Digoxin
Increased digoxin levels; monitor digoxin concentration.
Diazepam
Decreased clearance of diazepam; monitor for increased sedation.
Warfarin
Increased INR/prothrombin time; monitor closely.
Clopidogrel
Decreased antiplatelet effect of clopidogrel; consider alternative anti-ulcer therapy.
Methotrexate
Increased methotrexate levels, particularly with high doses; monitor for toxicity.
Atazanavir, Nelfinavir
Reduced absorption of antiretroviral drugs; concomitant use is not recommended.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose are generally mild and self-limiting (e.g., drowsiness, tachycardia, nausea, abdominal pain, diarrhea). Treatment is symptomatic and supportive. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies the potential risk to the fetus. It is unknown if esomeprazole is excreted in human milk; use with caution during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of esomeprazole in treating acid-related disorders, including GERD, erosive esophagitis, and H. pylori eradication.
Lab Monitoring
- Magnesium levels (for long-term use)
- Chromogranin A (CgA) levels (can be increased by PPIs, affecting neuroendocrine tumor diagnosis)
- Liver function tests (in patients with severe hepatic impairment)
Doctor Notes
- Always assess the patient for underlying causes of dyspepsia or reflux symptoms before initiating PPI therapy.
- Consider the lowest effective dose for the shortest possible duration to manage symptoms.
- Review concomitant medications for potential drug interactions, especially with warfarin, clopidogrel, and methotrexate.
- Educate patients on potential long-term risks and the importance of adherence to lifestyle modifications.
Patient Guidelines
- Take as directed by your doctor, usually once daily.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Inform your doctor about all other medications you are taking.
- Report any severe or persistent side effects to your doctor.
Missed Dose Advice
If you miss a dose, 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 take a double dose to make up for a missed one.
Driving Precautions
Esomeprazole is generally not expected to affect the ability to drive or operate machinery. However, if you experience side effects like dizziness or visual disturbances, you should avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid foods and drinks that trigger heartburn (e.g., fatty foods, spicy foods, caffeine, alcohol).
- Eat smaller, more frequent meals.
- Avoid lying down immediately after eating.
- Raise the head of your bed if you experience nighttime reflux.
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