Itra
Generic Name
Itraconazole Oral Solution
Manufacturer
PharmaCorp
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itra 50 mg oral solution | ৳ 580.00 | N/A |
Description
Overview of the medicine
Itraconazole is a broad-spectrum triazole antifungal agent used to treat various fungal infections.
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 weeks.
Elderly
Use with caution; dose adjustment may be necessary based on renal and hepatic function, and potential for drug interactions.
Renal_impairment
Use with caution. Dosage adjustments may be needed as the drug is partially excreted via kidneys. Monitor closely.
How to Take
Take without food. Swish the solution in the mouth for approximately 10 seconds before swallowing. Do not rinse the mouth after swallowing.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylase, which impairs ergosterol synthesis, a vital component of the fungal cell membrane.
Pharmacokinetics
Onset
Clinical improvement typically observed within days to weeks, depending on the type and severity of infection.
Excretion
Primarily excreted in feces (3-18% as unchanged drug) and to a lesser extent in urine (0.03% as unchanged drug).
Half life
Variable, approximately 15-30 hours after a single dose, extending to 40 hours with chronic dosing for parent drug, and up to 60 hours for its active metabolite hydroxyitraconazole.
Absorption
Well absorbed when taken without food for oral solution (opposite of capsules). Bioavailability is increased by food and acidic pH for capsules, but for oral solution, it's better on an empty stomach.
Metabolism
Extensively metabolized in the liver by CYP3A4 to several metabolites, primarily hydroxyitraconazole, which is also active.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Concomitant use with certain CYP3A4 substrates (e.g., simvastatin, midazolam, lovastatin).
- Patients with evidence of ventricular dysfunction (e.g., congestive heart failure) unless benefits outweigh risks.
Drug Interactions
CYP3A4 Substrates
Itraconazole is a strong CYP3A4 inhibitor, increasing plasma concentrations of co-administered drugs metabolized by CYP3A4 (e.g., statins, benzodiazepines, calcium channel blockers, digoxin, warfarin).
Antacids/H2 Blockers/PPIs
Reduced gastric acidity may impair absorption of itraconazole (especially capsules). Take antacids at least 2 hours apart from itraconazole oral solution.
CYP3A4 Inhibitors/Inducers
Co-administration with potent CYP3A4 inhibitors (e.g., ritonavir, clarithromycin) may increase itraconazole levels. Potent CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease itraconazole levels.
Storage
Store at room temperature (15-30°C or 59-86°F). Protect from light and moisture. Do not freeze.
Overdose
In the event of an overdose, supportive measures should be employed. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Itraconazole is excreted in breast milk; therefore, nursing mothers should discontinue either nursing or the drug.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Concomitant use with certain CYP3A4 substrates (e.g., simvastatin, midazolam, lovastatin).
- Patients with evidence of ventricular dysfunction (e.g., congestive heart failure) unless benefits outweigh risks.
Drug Interactions
CYP3A4 Substrates
Itraconazole is a strong CYP3A4 inhibitor, increasing plasma concentrations of co-administered drugs metabolized by CYP3A4 (e.g., statins, benzodiazepines, calcium channel blockers, digoxin, warfarin).
Antacids/H2 Blockers/PPIs
Reduced gastric acidity may impair absorption of itraconazole (especially capsules). Take antacids at least 2 hours apart from itraconazole oral solution.
CYP3A4 Inhibitors/Inducers
Co-administration with potent CYP3A4 inhibitors (e.g., ritonavir, clarithromycin) may increase itraconazole levels. Potent CYP3A4 inducers (e.g., rifampicin, phenytoin) may decrease itraconazole levels.
Storage
Store at room temperature (15-30°C or 59-86°F). Protect from light and moisture. Do not freeze.
Overdose
In the event of an overdose, supportive measures should be employed. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Itraconazole is excreted in breast milk; therefore, nursing mothers should discontinue either nursing or the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years when unopened. Refer to the product label for specific expiry dates.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of itraconazole in various superficial and systemic fungal infections. Ongoing research continues to explore its use and optimize treatment regimens.
Lab Monitoring
- Liver function tests (LFTs) at baseline and periodically during prolonged treatment.
- Serum potassium levels (especially in patients at risk of hypokalemia).
- Therapeutic drug monitoring (TDM) may be considered in specific patient populations or for resistant infections.
Doctor Notes
- Counsel patients thoroughly on the potential for congestive heart failure and hepatotoxicity, emphasizing symptoms to monitor.
- Conduct a comprehensive review of all concomitant medications to identify and manage potential drug-drug interactions, particularly those involving CYP3A4.
- Monitor liver function tests at baseline and periodically, especially during extended treatment courses or in patients with pre-existing hepatic impairment.
- Advise patients on the correct administration technique for the oral solution (empty stomach, swish and swallow) to maximize absorption.
Patient Guidelines
- Complete the full course of treatment as prescribed, even if symptoms improve.
- Report any new or worsening symptoms of heart failure (e.g., shortness of breath, swelling of ankles/feet).
- Report any signs of liver problems (e.g., unusual tiredness, dark urine, yellowing of skin/eyes, persistent nausea/vomiting).
- Shake the bottle well before each use.
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
Itraconazole may cause dizziness or blurred vision. If you experience these side effects, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good oral hygiene, especially for oropharyngeal candidiasis. Avoid alcohol consumption, particularly if you have liver problems or are on prolonged treatment.
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