Dexzole
Generic Name
Dexlansoprazole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dexzole 60 mg capsule | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Dexzole 60 mg Capsule contains Dexlansoprazole, a proton pump inhibitor (PPI) used to treat acid-related conditions of the stomach and esophagus.
Uses & Indications
Dosage
Adults
For Healing of EE: 60 mg once daily for up to 8 weeks. For Maintenance of Healed EE: 30 mg once daily. For Symptomatic Non-Erosive GERD: 30 mg once daily for up to 4 weeks.
Elderly
No dosage adjustment needed based on age alone. However, consider the overall health and comorbidities.
Renal_impairment
No dosage adjustment necessary for mild to moderate renal impairment. No data for severe renal impairment.
How to Take
Take Dexzole capsules orally, once daily. It can be taken with or without food. Swallow the capsule whole; do not chew or crush. If swallowing is difficult, the capsule may be opened, and the granules sprinkled onto a tablespoon of applesauce and swallowed immediately.
Mechanism of Action
Dexlansoprazole is a proton pump inhibitor that suppresses gastric acid secretion by irreversibly binding to and inhibiting the H+/K+-ATPase enzyme system (the proton pump) at the secretory surface of the gastric parietal cells. This blocks the final step of acid production.
Pharmacokinetics
Onset
Acid suppression begins within 1-2 hours, with full effect within 2-3 days of consistent dosing.
Excretion
Approximately 51% excreted in urine and 48% in feces as metabolites.
Half life
Plasma elimination half-life is approximately 1-2 hours, but duration of acid suppression is much longer due to irreversible binding.
Absorption
Rapidly absorbed. The dual delayed-release formulation provides two distinct peaks in plasma concentration, the first within 1-2 hours and the second within 4-5 hours post-dose, leading to prolonged exposure.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 (CYP) enzymes CYP2C19 and CYP3A4. CYP2C19 poor metabolizers may have higher plasma levels.
Side Effects
Contraindications
- Known hypersensitivity to dexlansoprazole or any component of the formulation.
- Hypersensitivity to other substituted benzimidazoles (e.g., other PPIs)
Drug Interactions
Warfarin
Monitor INR due to potential for increased bleeding risk.
Tacrolimus
Increased systemic exposure to tacrolimus.
Methotrexate
Increased and prolonged elevation of methotrexate and/or its metabolite serum levels, potentially leading to toxicity, especially with high-dose methotrexate.
Drugs dependent on gastric pH
Reduced absorption of drugs like ketoconazole, ampicillin esters, iron salts, and digoxin due to increased gastric pH.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Experience with dexlansoprazole overdose is limited. Reported symptoms include hypertension, peripheral edema, and abdominal pain. Management should be symptomatic and supportive. Dexlansoprazole is not dialyzable.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether dexlansoprazole is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Known hypersensitivity to dexlansoprazole or any component of the formulation.
- Hypersensitivity to other substituted benzimidazoles (e.g., other PPIs)
Drug Interactions
Warfarin
Monitor INR due to potential for increased bleeding risk.
Tacrolimus
Increased systemic exposure to tacrolimus.
Methotrexate
Increased and prolonged elevation of methotrexate and/or its metabolite serum levels, potentially leading to toxicity, especially with high-dose methotrexate.
Drugs dependent on gastric pH
Reduced absorption of drugs like ketoconazole, ampicillin esters, iron salts, and digoxin due to increased gastric pH.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Experience with dexlansoprazole overdose is limited. Reported symptoms include hypertension, peripheral edema, and abdominal pain. Management should be symptomatic and supportive. Dexlansoprazole is not dialyzable.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether dexlansoprazole is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture, refer to package for exact details.
Availability
Available in pharmacies nationwide
Approval Status
FDA Approved, DGDA Approved
Patent Status
Patent expired for original formulation, generic versions available
Clinical Trials
Dexlansoprazole has been extensively studied in numerous clinical trials for its efficacy and safety in treating erosive esophagitis and GERD.
Lab Monitoring
- No specific routine lab monitoring is required. However, for long-term use (over 1 year), consider monitoring Vitamin B12 levels and magnesium levels (if symptoms of hypomagnesemia develop).
Doctor Notes
- Prescribe the lowest effective dose for the shortest duration necessary to achieve treatment goals.
- Consider calcium and vitamin D supplementation for patients at risk of osteoporosis on long-term PPI therapy.
- Be aware of potential drug interactions, especially with warfarin and methotrexate.
Patient Guidelines
- Take the capsule whole with water; do not chew or crush it.
- Do not take more than the prescribed dose or for longer than recommended.
- Inform your doctor about all other medications you are taking.
- Seek medical attention if symptoms worsen or do not improve.
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 two doses at once to make up for a missed dose.
Driving Precautions
This medicine may cause dizziness in some individuals. If you experience dizziness or visual disturbances, avoid driving or operating machinery.
Lifestyle Advice
- Avoid foods and beverages that trigger heartburn (e.g., fatty foods, spicy foods, caffeine, alcohol).
- Elevate the head of your bed during sleep.
- Maintain a healthy weight.
- Avoid eating large meals close to bedtime.
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