Somazole-MUPS
Generic Name
Esomeprazole (as magnesium trihydrate) MUPS Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
somazole mups 20 mg tablet | ৳ 11.00 | ৳ 110.00 |
Description
Overview of the medicine
Somazole-MUPS 20 mg tablet is a proton pump inhibitor containing Esomeprazole, used to reduce stomach acid production. It is formulated as a Multiple Unit Pellet System (MUPS) for improved absorption and stability.
Uses & Indications
Dosage
Adults
GERD: 20 mg or 40 mg once daily for 4-8 weeks. Erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. Zollinger-Ellison Syndrome: Initial dose 40 mg twice daily, adjusted as needed.
Elderly
No specific dose adjustment required based on age alone.
Renal_impairment
No dose adjustment required for mild to moderate renal impairment. For severe renal impairment, caution is advised.
How to Take
Take one tablet orally at least one hour before a meal, preferably in the morning. Swallow whole, do not chew or crush. If swallowing is difficult, the tablet can be dispersed in half a glass of non-carbonated water, stirred, and drunk immediately or within 30 minutes. The pellets should not be chewed or crushed.
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 reduces both basal and stimulated acid secretion.
Pharmacokinetics
Onset
Within 1 hour
Excretion
Approximately 80% excreted as metabolites in urine and 20% in feces.
Half life
Approximately 1-1.5 hours
Absorption
Rapidly absorbed after oral administration, peak plasma levels reached within 1-2 hours. Bioavailability is about 64% after a single 40 mg dose and increases to 89% with repeated once-daily administration.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system, mainly 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 digoxin absorption may occur, especially in patients with low gastric pH. Monitor digoxin levels.
Warfarin
Increased INR and prothrombin time may occur, requiring monitoring.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19. Consider alternative antiplatelet therapy or PPI.
Methotrexate
Increased methotrexate levels may occur, especially with high doses. Monitor methotrexate levels and adjust dose if needed.
HIV Antivirals (e.g., Atazanavir, Nelfinavir)
Reduced absorption, significantly reducing efficacy. Concomitant use with nelfinavir is contraindicated. Use with atazanavir is not recommended.
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 gastrointestinal disturbances, fatigue, headache. Treatment is largely symptomatic and supportive. Esomeprazole is extensively protein bound and not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, use during pregnancy only if clearly needed. Excretion into breast milk is unknown; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to Esomeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Digoxin
Increased digoxin absorption may occur, especially in patients with low gastric pH. Monitor digoxin levels.
Warfarin
Increased INR and prothrombin time may occur, requiring monitoring.
Clopidogrel
Esomeprazole may reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19. Consider alternative antiplatelet therapy or PPI.
Methotrexate
Increased methotrexate levels may occur, especially with high doses. Monitor methotrexate levels and adjust dose if needed.
HIV Antivirals (e.g., Atazanavir, Nelfinavir)
Reduced absorption, significantly reducing efficacy. Concomitant use with nelfinavir is contraindicated. Use with atazanavir is not recommended.
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 gastrointestinal disturbances, fatigue, headache. Treatment is largely symptomatic and supportive. Esomeprazole is extensively protein bound and not readily dialyzable.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, use during pregnancy only if clearly needed. Excretion into breast milk is unknown; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date, depending on manufacturer.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available (original patent expired)
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Esomeprazole in various acid-related disorders. Ongoing post-marketing surveillance and studies continue to monitor its long-term effects and new indications.
Lab Monitoring
- Magnesium levels (for long-term use)
- Chromogranin A (CgA) levels (can be falsely elevated, affecting neuroendocrine tumor diagnosis)
- Liver function tests (if liver impairment suspected)
Doctor Notes
- Counsel patients on potential long-term risks, especially bone health and magnesium levels, for extended PPI therapy.
- Consider step-down therapy or 'on-demand' use for chronic GERD management.
- Assess for H. pylori infection in appropriate cases before long-term PPI initiation.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Do not stop taking the medication abruptly, even if you feel better, unless advised by your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any severe or persistent 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 the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Esomeprazole generally does not impair the ability to drive or operate machinery. However, if side effects like dizziness or visual disturbances occur, caution should be exercised.
Lifestyle Advice
- Avoid foods and beverages that trigger heartburn (e.g., spicy foods, caffeine, alcohol, fatty foods).
- Eat smaller, more frequent meals.
- Avoid eating close to bedtime (within 2-3 hours).
- Elevate the head of your bed.
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