Sporagin
Generic Name
Itraconazole
Manufacturer
MediCorp Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sporagin 50 mg oral solution | ৳ 400.00 | N/A |
Description
Overview of the medicine
Itraconazole is a broad-spectrum triazole antifungal agent indicated for the treatment of various fungal infections, including systemic and superficial mycoses. The oral solution form is particularly useful for certain infections like oropharyngeal and esophageal candidiasis.
Uses & Indications
Dosage
Adults
For oropharyngeal candidiasis: 100 mg (10 mL) once daily for 1 to 2 weeks. For esophageal candidiasis: 100 mg (10 mL) once daily for 2 weeks. For systemic mycoses, dosage varies significantly based on infection type and severity (e.g., 200 mg once or twice daily).
Elderly
Use with caution; dose adjustment may be necessary based on renal or hepatic function and potential for drug interactions. Close monitoring is recommended.
Renal_impairment
Use with caution. Itraconazole is primarily metabolized by the liver; however, metabolites are excreted renally. Dose adjustment may be needed for severe renal impairment. Monitor plasma concentrations if available.
How to Take
Take the oral solution on an empty stomach (at least 1 hour before a meal or 2 hours after). Swish the solution in the mouth for several seconds (for oropharyngeal candidiasis) before swallowing.
Mechanism of Action
Itraconazole inhibits cytochrome P450-dependent fungal 14-α-demethylase, an enzyme essential for the synthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to the accumulation of 14-α-methyl sterols and a corresponding decrease in ergosterol, disrupting fungal cell membrane function and growth.
Pharmacokinetics
Onset
Therapeutic effects may be observed within days to weeks, depending on the type and severity of infection.
Excretion
Approximately 35% of the dose is excreted in the urine as inactive metabolites and less than 0.03% as unchanged drug. About 54% of the dose is excreted in the feces as inactive metabolites.
Half life
The plasma elimination half-life of itraconazole is approximately 20-30 hours, while its active metabolite, hydroxyitraconazole, has a half-life of about 30-40 hours.
Absorption
Oral solution is better absorbed on an empty stomach, leading to higher and more consistent plasma concentrations compared to capsules taken with food. Peak plasma concentrations are reached within 2-5 hours.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 3A4 (CYP3A4) isoenzyme, to a large number of metabolites, including the active metabolite hydroxyitraconazole.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the solution.
- Concomitant administration with certain CYP3A4 substrates (e.g., lovastatin, simvastatin, oral midazolam, triazolam, cisapride, dofetilide, dronedarone, ranolazine, Lurasidone, Pimozide, Quinidine, Ergot alkaloids) due to increased risk of serious adverse effects.
- Patients with evidence of ventricular dysfunction or a history of congestive heart failure unless the potential benefits outweigh the risks (only for life-threatening or severe fungal infections).
Drug Interactions
Statins (e.g., Simvastatin, Lovastatin)
Itraconazole can increase plasma concentrations of HMG-CoA reductase inhibitors, increasing the risk of myopathy, including rhabdomyolysis. Concomitant use is contraindicated.
CYP3A4 Inhibitors (e.g., Clarithromycin, Ritonavir)
May increase itraconazole plasma concentrations, potentially enhancing adverse effects. Dose adjustment or monitoring may be necessary.
Calcium Channel Blockers (e.g., Amlodipine, Felodipine)
Itraconazole may increase plasma concentrations of calcium channel blockers, potentially leading to increased adverse effects (e.g., edema). Close monitoring and dose adjustment may be required.
CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine)
May significantly decrease itraconazole plasma concentrations, leading to reduced efficacy. Avoid co-administration.
Drugs that Prolong QT Interval (e.g., Quinidine, Cisapride, Dofetilide)
Itraconazole can increase plasma concentrations of these drugs, leading to life-threatening cardiac arrhythmias (e.g., Torsades de Pointes). Concomitant use is contraindicated.
Storage
Store below 30°C (86°F). Protect from light and moisture. Do not refrigerate or freeze. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. Gastric lavage may be performed within the first hour after ingestion. Itraconazole is not removed by hemodialysis. There is no specific antidote. Closely monitor vital signs and manage symptoms.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the potential risks, especially during the first trimester. Adequate contraception should be used by women of childbearing potential during and for two months after itraconazole therapy. Itraconazole is excreted in human milk; therefore, breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the solution.
- Concomitant administration with certain CYP3A4 substrates (e.g., lovastatin, simvastatin, oral midazolam, triazolam, cisapride, dofetilide, dronedarone, ranolazine, Lurasidone, Pimozide, Quinidine, Ergot alkaloids) due to increased risk of serious adverse effects.
- Patients with evidence of ventricular dysfunction or a history of congestive heart failure unless the potential benefits outweigh the risks (only for life-threatening or severe fungal infections).
Drug Interactions
Statins (e.g., Simvastatin, Lovastatin)
Itraconazole can increase plasma concentrations of HMG-CoA reductase inhibitors, increasing the risk of myopathy, including rhabdomyolysis. Concomitant use is contraindicated.
CYP3A4 Inhibitors (e.g., Clarithromycin, Ritonavir)
May increase itraconazole plasma concentrations, potentially enhancing adverse effects. Dose adjustment or monitoring may be necessary.
Calcium Channel Blockers (e.g., Amlodipine, Felodipine)
Itraconazole may increase plasma concentrations of calcium channel blockers, potentially leading to increased adverse effects (e.g., edema). Close monitoring and dose adjustment may be required.
CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine)
May significantly decrease itraconazole plasma concentrations, leading to reduced efficacy. Avoid co-administration.
Drugs that Prolong QT Interval (e.g., Quinidine, Cisapride, Dofetilide)
Itraconazole can increase plasma concentrations of these drugs, leading to life-threatening cardiac arrhythmias (e.g., Torsades de Pointes). Concomitant use is contraindicated.
Storage
Store below 30°C (86°F). Protect from light and moisture. Do not refrigerate or freeze. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. Gastric lavage may be performed within the first hour after ingestion. Itraconazole is not removed by hemodialysis. There is no specific antidote. Closely monitor vital signs and manage symptoms.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the potential risks, especially during the first trimester. Adequate contraception should be used by women of childbearing potential during and for two months after itraconazole therapy. Itraconazole is excreted in human milk; therefore, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture when stored under recommended conditions. Refer to the product packaging for specific expiration dates.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Itraconazole has undergone extensive clinical trials for the treatment of various fungal infections, demonstrating efficacy in both immunocompetent and immunocompromised patients. Studies have evaluated its use in superficial and systemic mycoses, with particular attention to its oral solution formulation for improved bioavailability in certain conditions.
Lab Monitoring
- Liver Function Tests (LFTs) should be monitored at baseline and periodically during long-term therapy, especially in patients with pre-existing hepatic impairment or those developing symptoms of hepatotoxicity.
- Serum potassium levels should be monitored, as hypokalemia has been reported.
- Renal function should be assessed, especially in elderly patients or those with pre-existing renal impairment.
- Therapeutic drug monitoring (TDM) may be considered in specific patient populations (e.g., immunocompromised patients, those with suspected malabsorption) to ensure adequate drug levels.
Doctor Notes
- Crucial to counsel patients on significant drug interactions, especially with CYP3A4 substrates, and contraindications related to heart failure.
- Monitor liver function tests (LFTs) at baseline and periodically, and advise patients to report symptoms of hepatotoxicity promptly.
- The oral solution offers improved bioavailability compared to capsules for certain indications; emphasize empty stomach administration.
- Consider therapeutic drug monitoring in high-risk patients (e.g., immunocompromised, suspected malabsorption).
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, especially regarding the empty stomach administration for the oral solution.
- Complete the full course of treatment, even if your symptoms improve, to prevent recurrence of the infection.
- Immediately report any signs of liver problems (e.g., unusual fatigue, yellowing of skin/eyes, dark urine) or heart failure (e.g., swelling of ankles/feet, shortness of breath) to your doctor.
- Be aware of potential drug interactions and inform your doctor about all other medications, supplements, and herbal products you are taking.
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 take a double dose to make up for a missed one.
Driving Precautions
Sporagin may cause dizziness, blurred vision, or hearing loss in some patients. If you experience these side effects, you should avoid driving or operating machinery.
Lifestyle Advice
- Avoid consuming alcohol during treatment with Sporagin, as it can potentially exacerbate liver-related side effects.
- Maintain good oral hygiene, especially if treating oral candidiasis, to aid in recovery and prevent further infection.
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