Sporagin
Generic Name
Itraconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sporagin 100 mg capsule | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Sporagin 100 mg Capsule contains Itraconazole, an azole antifungal agent used to treat various fungal infections including candidiasis, aspergillosis, blastomycosis, histoplasmosis, and onychomycosis.
Uses & Indications
Dosage
Adults
Vaginal candidiasis: 200 mg twice daily for 1 day or 200 mg once daily for 3 days. Onychomycosis: Pulse therapy (200 mg twice daily for 1 week, followed by 3 weeks off, repeated for 2-3 cycles) or continuous therapy (200 mg once daily for 3 months). Systemic fungal infections: 100-400 mg daily, depending on the infection type and severity, often for prolonged periods.
Elderly
Use with caution due to potential decreased hepatic or renal function and concurrent diseases/medications. Dose adjustment may be necessary.
Renal_impairment
Use with caution. Dosage adjustment may be required, particularly for severe impairment. Consider monitoring plasma concentrations.
How to Take
Take Sporagin 100 mg Capsule immediately after a full meal to ensure maximum absorption. Swallow the capsule whole with water. Do not chew or open the capsule.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent enzyme lanosterol 14α-demethylase, which is essential for ergosterol biosynthesis. Ergosterol is a vital component of fungal cell membranes. Inhibition of its synthesis leads to increased cellular permeability and leakage of essential intracellular components, ultimately resulting in fungal cell death.
Pharmacokinetics
Onset
Clinical improvement usually observed within days to weeks, depending on the infection type.
Excretion
Approximately 35% of a dose is excreted in urine (mainly as inactive metabolites) and 3-18% in feces (as unchanged drug and metabolites).
Half life
Plasma elimination half-life is approximately 15-42 hours, with steady-state concentrations achieved within 1-2 weeks of daily dosing.
Absorption
Oral absorption is variable and increases when taken with a full meal. Bioavailability is approximately 55%. Peak plasma concentrations are reached within 2-5 hours.
Metabolism
Extensively metabolized in the liver 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.
- Congestive heart failure or a history of congestive heart failure (unless the benefit clearly outweighs the risk).
- Co-administration with certain drugs metabolized by CYP3A4, which can lead to increased plasma concentrations of these drugs and potentially serious or life-threatening adverse events (e.g., cisapride, dofetilide, dronedarone, levacetylmethadol (levomethadyl), quinidine, ranolazine, simvastatin, lovastatin, lurasidone, pimozide, ergot alkaloids like ergotamine, dihydroergotamine, methylergometrine).
Drug Interactions
Statins
Increased risk of myopathy/rhabdomyolysis with HMG-CoA reductase inhibitors (e.g., simvastatin, lovastatin) due to inhibited metabolism by itraconazole.
QT-prolonging drugs
Itraconazole can inhibit the metabolism of certain drugs that prolong the QT interval (e.g., quinidine, dofetilide), leading to increased risk of ventricular arrhythmias.
Calcium channel blockers
Itraconazole can inhibit the metabolism of dihydropyridine calcium channel blockers (e.g., felodipine, verapamil), increasing their plasma concentrations and potentially adverse effects.
CYP3A4 inhibitors/inducers
Itraconazole is metabolized by CYP3A4. Strong inhibitors (e.g., ritonavir, indinavir, clarithromycin, erythromycin) can increase itraconazole levels. Strong inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital) can decrease itraconazole levels, reducing efficacy.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, provide supportive measures. Itraconazole is not removed by hemodialysis. There is no specific antidote. Gastric lavage may be considered within the first hour after ingestion.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the potential risks to the fetus. Itraconazole is excreted in human milk; therefore, nursing mothers should avoid using it or discontinue breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Congestive heart failure or a history of congestive heart failure (unless the benefit clearly outweighs the risk).
- Co-administration with certain drugs metabolized by CYP3A4, which can lead to increased plasma concentrations of these drugs and potentially serious or life-threatening adverse events (e.g., cisapride, dofetilide, dronedarone, levacetylmethadol (levomethadyl), quinidine, ranolazine, simvastatin, lovastatin, lurasidone, pimozide, ergot alkaloids like ergotamine, dihydroergotamine, methylergometrine).
Drug Interactions
Statins
Increased risk of myopathy/rhabdomyolysis with HMG-CoA reductase inhibitors (e.g., simvastatin, lovastatin) due to inhibited metabolism by itraconazole.
QT-prolonging drugs
Itraconazole can inhibit the metabolism of certain drugs that prolong the QT interval (e.g., quinidine, dofetilide), leading to increased risk of ventricular arrhythmias.
Calcium channel blockers
Itraconazole can inhibit the metabolism of dihydropyridine calcium channel blockers (e.g., felodipine, verapamil), increasing their plasma concentrations and potentially adverse effects.
CYP3A4 inhibitors/inducers
Itraconazole is metabolized by CYP3A4. Strong inhibitors (e.g., ritonavir, indinavir, clarithromycin, erythromycin) can increase itraconazole levels. Strong inducers (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital) can decrease itraconazole levels, reducing efficacy.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, provide supportive measures. Itraconazole is not removed by hemodialysis. There is no specific antidote. Gastric lavage may be considered within the first hour after ingestion.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the potential risks to the fetus. Itraconazole is excreted in human milk; therefore, nursing mothers should avoid using it or discontinue breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Itraconazole has undergone extensive clinical trials demonstrating its efficacy and safety in various fungal infections. Ongoing research explores its use in emerging fungal pathogens and resistance.
Lab Monitoring
- Liver function tests (LFTs) should be performed at baseline and periodically, especially during prolonged treatment or in patients with pre-existing hepatic impairment.
- Electrolyte levels (especially potassium) should be monitored in patients at risk of hypokalemia.
- Plasma itraconazole levels may be monitored in certain situations (e.g., severe infections, suspected malabsorption, drug interactions, renal impairment).
Doctor Notes
- Carefully assess patient's cardiac history, especially for congestive heart failure. Itraconazole is contraindicated in patients with known CHF.
- Review concomitant medications for potential drug interactions, especially those metabolized by CYP3A4 or with QT-prolonging effects.
- Monitor liver function tests, particularly during extended therapy and in patients with pre-existing hepatic impairment.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor, even if your symptoms improve.
- Always take capsules immediately after a full meal to maximize absorption.
- Be aware of the symptoms of liver problems (e.g., unusual tiredness, dark urine, pale stools, yellowing of skin/eyes) and heart failure (e.g., shortness of breath, swelling of ankles), and report them to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Sporagin 100 mg Capsule may cause dizziness or visual disturbances in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption during treatment, as it may increase the risk of liver damage.
- Maintain good hygiene to prevent reinfection, especially for skin and nail conditions.
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