Itracon
Generic Name
Itraconazole Oral Solution
Manufacturer
Generic Pharmaceutical Co.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
itracon 50 mg oral solution | ৳ 580.00 | N/A |
Description
Overview of the medicine
Itraconazole is an antifungal medication used to treat a variety of fungal infections, including those affecting the lungs, mouth, throat, fingernails, and toenails. The oral solution is particularly effective for infections of the mouth and throat.
Uses & Indications
Dosage
Adults
Oropharyngeal candidiasis: 200 mg (20 ml) once daily for 1-2 weeks. Esophageal candidiasis: 100-200 mg (10-20 ml) once daily for 2-4 weeks. Systemic infections: Dosage varies significantly (e.g., 200 mg 1-2 times daily). Consult prescribing information for specific infection dosages.
Elderly
No specific dosage adjustment required, but caution is advised due to potential age-related decrease in renal/hepatic function. Monitor for adverse effects.
Renal_impairment
Use with caution. Dosage adjustments may be necessary for patients with severe renal impairment. Monitor plasma concentrations where possible.
How to Take
Administer the oral solution without food for better absorption. Swish the solution in the mouth for several seconds before swallowing, especially for oropharyngeal candidiasis. Use the provided measuring device to ensure accurate dosing.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. Ergosterol is a vital component of fungal cell membranes, and its inhibition leads to increased fungal cell membrane permeability, leakage of cellular contents, and ultimately, fungal cell death.
Pharmacokinetics
Onset
Therapeutic effects may take several days to weeks to become apparent, depending on the type and severity of infection.
Excretion
Approximately 35% of a dose is excreted in the urine as inactive metabolites within one week, and approximately 54% is excreted in the feces.
Half life
The elimination half-life of itraconazole is approximately 20-30 hours, increasing with prolonged dosing. The active metabolite, hydroxyitraconazole, has a half-life of about 30-40 hours.
Absorption
Oral solution is generally well-absorbed, particularly when taken without food. Peak plasma concentrations are reached within 2-5 hours.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 3A4 (CYP3A4) enzyme system to several metabolites, including the active metabolite hydroxyitraconazole.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation
- Congestive heart failure (CHF) or a history of CHF, unless the benefits outweigh the risks
- Co-administration with certain CYP3A4 substrates that can prolong the QT interval (e.g., cisapride, dofetilide, quinidine, pimozide, levacetylmethadol, terfenadine, astemizole)
- Co-administration with HMG-CoA reductase inhibitors metabolized by CYP3A4 (e.g., lovastatin, simvastatin)
Drug Interactions
CYP3A4 Inducers
Decreased itraconazole levels (e.g., rifampin, phenytoin, carbamazepine, phenobarbital).
CYP3A4 Inhibitors
Increased itraconazole levels (e.g., ritonavir, indinavir, clarithromycin, erythromycin).
CYP3A4 Substrates
Itraconazole inhibits CYP3A4, leading to increased levels of co-administered drugs like warfarin, digoxin, calcium channel blockers (e.g., nifedipine, verapamil), protease inhibitors, some benzodiazepines, HMG-CoA reductase inhibitors (statins), and many others. Dose adjustments and careful monitoring are required.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Do not freeze. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. There is no specific antidote for itraconazole. It is not removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk; therefore, breastfeeding is not recommended during treatment with itraconazole.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date when stored unopened. Once opened, refer to product specific instructions (usually 30 days).
Availability
Available in pharmacies and hospitals
Approval Status
FDA and DGDA approved
Patent Status
Patent expired, generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of itraconazole in various fungal infections. Ongoing research explores new indications and formulations.
Lab Monitoring
- Liver function tests (baseline and periodically during prolonged therapy)
- Serum potassium levels
- Renal function tests (for patients with renal impairment)
- Therapeutic drug monitoring (TDM) may be considered in certain situations.
Doctor Notes
- Carefully assess patient's cardiac history before initiating itraconazole due to CHF risk.
- Review all concomitant medications to identify potential CYP3A4 interactions; dose adjustments or alternative therapies may be necessary.
- Monitor LFTs and patient symptoms for signs of hepatotoxicity, especially during prolonged treatment.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Complete the full course of treatment, even if you feel better.
- Report any new or worsening symptoms, especially signs of liver problems or heart failure, to your doctor immediately.
Missed Dose Advice
If a dose is missed, 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 to make up for a missed one.
Driving Precautions
Itraconazole may cause dizziness or visual disturbances. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption during treatment.
- Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking.
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