Unicus
Generic Name
Esomeprazole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| unicus 20 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Unicus 20 mg Tablet contains Esomeprazole, a proton pump inhibitor used to treat conditions where the stomach produces too much acid. It is effective in treating gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome.
Uses & Indications
Dosage
Adults
For GERD (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 appropriate antibiotics).
Elderly
No specific dose adjustment is needed for elderly patients with normal renal and hepatic function. However, caution is advised.
Renal_impairment
No dose adjustment is needed for patients with renal impairment. However, caution is advised for severe renal impairment.
How to Take
Take the tablet whole with water, at least one hour before a meal, preferably in the morning. Do not chew or crush the tablet.
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 inhibition prevents the final step of acid secretion, thereby reducing gastric acidity.
Pharmacokinetics
Onset
Onset of acid suppression within 1 hour.
Excretion
Approximately 80% excreted as metabolites in urine and 20% in feces.
Half life
Plasma elimination half-life is approximately 1.5 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 1-2 hours. Bioavailability is about 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 system (primarily CYP2C19 and CYP3A4).
Side Effects
Contraindications
- Hypersensitivity to esomeprazole, substituted benzimidazoles, or any component of the formulation.
- Concomitant use with nelfinavir.
Drug Interactions
Diazepam
May increase plasma levels of diazepam.
Warfarin
Increased INR and prothrombin time. Monitor closely.
Clopidogrel
Esomeprazole can reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19. Consider alternative antiplatelet therapy.
Methotrexate
Increased methotrexate levels, especially in high-dose therapy. Monitor methotrexate levels.
Nelfinavir/Atazanavir
Reduced plasma levels of these antiretroviral drugs, significantly reducing their efficacy. Concomitant use is contraindicated for nelfinavir and not recommended for atazanavir.
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 minimal and transient, including drowsiness, confusion, blurred vision, tachycardia, nausea, sweating, flushing, headache, dry mouth, and other mild gastrointestinal disturbances. Treatment should be symptomatic and supportive. There is no specific antidote.
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 whether esomeprazole is excreted in human milk, so 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
Diazepam
May increase plasma levels of diazepam.
Warfarin
Increased INR and prothrombin time. Monitor closely.
Clopidogrel
Esomeprazole can reduce the antiplatelet effect of clopidogrel by inhibiting CYP2C19. Consider alternative antiplatelet therapy.
Methotrexate
Increased methotrexate levels, especially in high-dose therapy. Monitor methotrexate levels.
Nelfinavir/Atazanavir
Reduced plasma levels of these antiretroviral drugs, significantly reducing their efficacy. Concomitant use is contraindicated for nelfinavir and not recommended for atazanavir.
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 minimal and transient, including drowsiness, confusion, blurred vision, tachycardia, nausea, sweating, flushing, headache, dry mouth, and other mild gastrointestinal disturbances. Treatment should be symptomatic and supportive. There is no specific antidote.
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 whether esomeprazole is excreted in human milk, so caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies and hospitals.
Approval Status
Approved by regulatory authorities worldwide, including FDA and DGDA.
Patent Status
Generic versions available, patent expired for original formulation.
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of esomeprazole in various acid-related disorders, showing superior or comparable outcomes to other PPIs.
Lab Monitoring
- No routine lab monitoring required for most patients.
- Consider Vitamin B12 levels for long-term use (more than 3 years) due to potential malabsorption.
- Monitor magnesium levels periodically in patients on long-term treatment or with concomitant drugs that can cause hypomagnesemia.
Doctor Notes
- Advise patients to take before meals for optimal effect.
- Counsel on potential long-term risks with chronic use.
- Evaluate for underlying causes of symptoms before initiating therapy.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not stop taking the medicine suddenly without consulting your doctor.
- Inform your doctor about all other medicines you are taking, including herbal supplements.
- Seek immediate medical attention if you experience severe allergic reactions or any unusual symptoms.
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 continue with your regular dosing schedule. Do not double the dose.
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 blurred vision, avoid these activities.
Lifestyle Advice
- Avoid foods and drinks that trigger acid reflux (e.g., spicy foods, fatty foods, caffeine, alcohol).
- Maintain a healthy weight.
- Eat smaller, more frequent meals.
- Do not lie down immediately after eating.
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