Nispore
Generic Name
Itraconazole
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nispore 200 mg capsule | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Itraconazole is a broad-spectrum triazole antifungal agent used to treat a variety of fungal infections, including systemic and superficial mycoses.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on the infection. For Onychomycosis (toenails): 200 mg once daily for 3 months. For Onychomycosis (fingernails, pulse dosing): 200 mg twice daily for 1 week, followed by 3 weeks off, for 2 cycles. Systemic infections: 200-400 mg daily, usually in divided doses.
Elderly
Use with caution in elderly patients due to potential decrease in hepatic or renal function and concurrent medication use. Dose adjustment may be considered based on overall health and LFTs.
Renal_impairment
Use with caution. Dose adjustments may be necessary for severe renal impairment (CrCl < 30 mL/min). Monitoring of plasma levels is recommended if available.
How to Take
Take orally, immediately after a full meal to ensure maximal absorption. Swallow capsules whole.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylation of lanosterol, an essential step in ergosterol synthesis. This disruption leads to impaired fungal cell membrane integrity, growth inhibition, and ultimately cell death.
Pharmacokinetics
Onset
Steady-state plasma concentrations are typically reached within 7-15 days. Clinical onset of action depends on the type and severity of infection.
Excretion
Approximately 35-54% of the dose is excreted in the feces as inactive metabolites within one week. About 3-18% is excreted renally, predominantly as metabolites.
Half life
The elimination half-life of itraconazole is approximately 20-30 hours, and for its active metabolite, hydroxyitraconazole, it is about 30-40 hours.
Absorption
Oral absorption is variable and enhanced by food (especially fatty meals) and an acidic gastric environment. Bioavailability can be significantly increased when taken immediately after a full meal.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 3A4 (CYP3A4) isoenzyme, into several metabolites, including the active metabolite hydroxyitraconazole.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Concurrent use with certain CYP3A4 substrates (e.g., lovastatin, simvastatin, midazolam, triazolam, cisapride, dofetilide, dronedarone, quinidine, ranolazine, pimozide, ergot alkaloids).
- Congestive heart failure or a history of heart failure (unless the benefit outweighs the risk).
- Pregnancy (unless life-threatening or other effective antifungal therapies are unavailable).
Drug Interactions
Calcium Channel Blockers
Increased plasma concentrations of CCBs (e.g., dihydropyridines, verapamil) leading to enhanced hypotensive effects and peripheral edema.
CYP3A4 Inhibitors/Inducers
Co-administration with strong CYP3A4 inhibitors (e.g., ritonavir, indinavir, clarithromycin, erythromycin) can increase itraconazole levels. Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital) can decrease itraconazole levels, reducing efficacy.
Drugs causing QT prolongation
Increased risk of ventricular arrhythmias, including torsades de pointes, when co-administered with drugs that prolong the QT interval (e.g., dofetilide, quinidine, pimozide).
Oral Anticoagulants (e.g., Warfarin)
Itraconazole can increase the anticoagulant effect, requiring INR monitoring and dose adjustment.
HMG-CoA Reductase Inhibitors (Statins)
Increased risk of myopathy/rhabdomyolysis with statins like simvastatin, lovastatin, atorvastatin. Co-administration with simvastatin and lovastatin is contraindicated.
Proton Pump Inhibitors (PPIs) / H2-receptor antagonists / Antacids
These agents reduce gastric acidity, impairing itraconazole absorption. Administer itraconazole with an acidic beverage (e.g., cola) or consider alternative antifungals.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C/D (depending on indication and duration). Itraconazole should not be used during pregnancy unless the benefits outweigh the risks (e.g., in life-threatening infections where other treatments are not suitable). It is excreted in breast milk; therefore, breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Concurrent use with certain CYP3A4 substrates (e.g., lovastatin, simvastatin, midazolam, triazolam, cisapride, dofetilide, dronedarone, quinidine, ranolazine, pimozide, ergot alkaloids).
- Congestive heart failure or a history of heart failure (unless the benefit outweighs the risk).
- Pregnancy (unless life-threatening or other effective antifungal therapies are unavailable).
Drug Interactions
Calcium Channel Blockers
Increased plasma concentrations of CCBs (e.g., dihydropyridines, verapamil) leading to enhanced hypotensive effects and peripheral edema.
CYP3A4 Inhibitors/Inducers
Co-administration with strong CYP3A4 inhibitors (e.g., ritonavir, indinavir, clarithromycin, erythromycin) can increase itraconazole levels. Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital) can decrease itraconazole levels, reducing efficacy.
Drugs causing QT prolongation
Increased risk of ventricular arrhythmias, including torsades de pointes, when co-administered with drugs that prolong the QT interval (e.g., dofetilide, quinidine, pimozide).
Oral Anticoagulants (e.g., Warfarin)
Itraconazole can increase the anticoagulant effect, requiring INR monitoring and dose adjustment.
HMG-CoA Reductase Inhibitors (Statins)
Increased risk of myopathy/rhabdomyolysis with statins like simvastatin, lovastatin, atorvastatin. Co-administration with simvastatin and lovastatin is contraindicated.
Proton Pump Inhibitors (PPIs) / H2-receptor antagonists / Antacids
These agents reduce gastric acidity, impairing itraconazole absorption. Administer itraconazole with an acidic beverage (e.g., cola) or consider alternative antifungals.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C/D (depending on indication and duration). Itraconazole should not be used during pregnancy unless the benefits outweigh the risks (e.g., in life-threatening infections where other treatments are not suitable). It is excreted in breast milk; therefore, breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, refer to product packaging for exact date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies, including DGDA
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Itraconazole has undergone extensive clinical trials to establish its efficacy and safety for various fungal infections. Ongoing research explores new formulations and indications.
Lab Monitoring
- Liver function tests (LFTs) should be performed at baseline and periodically (e.g., monthly) during long-term treatment, especially in patients with pre-existing hepatic impairment or those developing symptoms of liver dysfunction.
- Serum potassium levels should be monitored, particularly in patients at risk of hypokalemia or those on concomitant medications that can affect potassium levels.
Doctor Notes
- Emphasize patient counseling regarding the importance of taking itraconazole capsules with a full meal for optimal absorption.
- Alert patients about potential severe adverse effects, including signs of liver toxicity (e.g., fatigue, dark urine, jaundice) and heart failure (e.g., dyspnea, edema), and instruct them to seek immediate medical attention if these occur.
- Review concomitant medications for potential drug interactions, especially those metabolized by CYP3A4, and adjust doses or recommend alternatives as necessary.
- Monitor liver function tests at baseline and periodically during prolonged treatment.
Patient Guidelines
- Always take Nispore 200 mg Capsule immediately after a full meal to maximize absorption.
- Report any signs or symptoms of liver problems (e.g., unusual fatigue, dark urine, pale stools, jaundice) to your doctor immediately.
- Report any symptoms of heart failure (e.g., shortness of breath, sudden weight gain, swelling of ankles or feet) to your doctor immediately.
- Do not take antacids, H2-blockers, or proton pump inhibitors within 2 hours of taking Nispore, or consult your doctor for advice.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
Driving Precautions
Nispore 200 mg Capsule may cause dizziness, blurred vision, or hearing loss in some patients. If you experience these symptoms, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption during treatment with itraconazole, as it can increase the risk of liver side effects.
- Maintain good personal hygiene to help prevent reinfection, especially for superficial fungal infections.
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