Somazole-MUPS
Generic Name
Esomeprazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| somazole mups 40 mg tablet | ৳ 16.00 | ৳ 160.00 |
Description
Overview of the medicine
Somazole-MUPS 40 mg Tablet contains Esomeprazole, a proton pump inhibitor, used to reduce stomach acid production. It is formulated as a Multiple Unit Pellet System (MUPS) for improved absorption and bioavailability.
Uses & Indications
Dosage
Adults
GERD: 20 mg or 40 mg once daily for 4-8 weeks. Erosive esophagitis: 40 mg once daily for 4-8 weeks. Zollinger-Ellison syndrome: 40 mg twice daily. H. pylori eradication: 40 mg once daily with antibiotics for 10 days.
Elderly
No dosage adjustment is generally needed.
Renal_impairment
No dosage adjustment is generally needed for mild to moderate renal impairment. Use with caution in severe renal impairment.
How to Take
Should be taken at least one hour before a meal, preferably in the morning. Swallow the tablet whole with water; do not chew or crush. For patients who cannot swallow, the tablet can be dispersed in non-carbonated water and taken orally or via an NG tube.
Mechanism of Action
Esomeprazole is a proton pump inhibitor that specifically inhibits the H+/K+-ATPase enzyme system (the proton pump) in the gastric parietal cells. This irreversible inhibition blocks the final step of acid secretion, reducing both basal and stimulated acid production.
Pharmacokinetics
Onset
Acid-suppressive effects begin within 1 hour, full effect within 2-3 days of daily dosing.
Excretion
Excreted mainly via urine (approximately 80%) and feces (approximately 20%) as inactive metabolites.
Half life
Approximately 1-1.5 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations occur within 1-2 hours. Bioavailability is about 64% after a single 40 mg dose, increasing to 89% with repeated dosing. Food intake delays and decreases absorption but does not significantly affect efficacy.
Metabolism
Primarily metabolized in the liver by the cytochrome P450 enzyme system, mainly CYP2C19 and CYP3A4, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Warfarin
Increased INR and prothrombin time have been reported with concomitant use. Monitor INR closely and adjust warfarin dose as needed.
Clopidogrel
May reduce the antiplatelet effect of clopidogrel by inhibiting its conversion to the active metabolite via CYP2C19. Avoid concomitant use or consider alternative antiplatelet therapy.
Methotrexate
Concomitant use may increase and prolong serum levels of methotrexate and/or its metabolite, possibly leading to toxicity. Consider temporary withdrawal of esomeprazole or closely monitor methotrexate levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include drowsiness, tachycardia, nausea, and abdominal pain. Treatment is symptomatic and supportive. Esomeprazole is not dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but human studies are limited. Use during pregnancy only if clearly needed. Excreted in breast milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Warfarin
Increased INR and prothrombin time have been reported with concomitant use. Monitor INR closely and adjust warfarin dose as needed.
Clopidogrel
May reduce the antiplatelet effect of clopidogrel by inhibiting its conversion to the active metabolite via CYP2C19. Avoid concomitant use or consider alternative antiplatelet therapy.
Methotrexate
Concomitant use may increase and prolong serum levels of methotrexate and/or its metabolite, possibly leading to toxicity. Consider temporary withdrawal of esomeprazole or closely monitor methotrexate levels.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Symptoms may include drowsiness, tachycardia, nausea, and abdominal pain. Treatment is symptomatic and supportive. Esomeprazole is not dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but human studies are limited. Use during pregnancy only if clearly needed. Excreted in breast 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 the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved, DGDA Approved
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Esomeprazole has undergone extensive clinical trials demonstrating its efficacy and safety in various acid-related disorders. Ongoing research continues to explore its role and optimize treatment protocols.
Lab Monitoring
- Magnesium levels (for long-term use, especially with diuretics)
- INR/prothrombin time (with concomitant warfarin)
- Chromogranin A (CgA) levels (can be elevated, may interfere with neuroendocrine tumor diagnosis)
- Bone mineral density (for prolonged use, due to increased fracture risk)
Doctor Notes
- Consider dose reduction for elderly patients with severe hepatic impairment.
- Advise patients to report any new or worsening symptoms, especially concerning diarrhea, abdominal pain, or unexplained weight loss.
- Be aware of potential drug interactions, especially with clopidogrel and warfarin.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not chew or crush the tablet; swallow it whole.
- Take it at least one hour before a meal, usually in the morning.
- Inform your doctor about all other medicines you are taking, including over-the-counter drugs and herbal supplements.
- Do not stop taking this medicine suddenly without consulting 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 resume your regular dosing schedule. Do not double the dose.
Driving Precautions
This medicine may cause dizziness or visual disturbances in some individuals. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Avoid trigger foods like fatty, spicy, and acidic foods.
- Elevate the head of your bed to reduce nighttime reflux.
- Avoid lying down immediately after meals.
- Maintain a healthy weight.
- Quit smoking and reduce alcohol consumption.
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