Itranox
Generic Name
Itraconazole
Manufacturer
Eskayef Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itranox 200 mg tablet | ৳ 28.00 | ৳ 280.00 |
Description
Overview of the medicine
Itraconazole is a broad-spectrum triazole antifungal agent indicated for the treatment of various fungal infections including candidiasis, aspergillosis, histoplasmosis, blastomycosis, and onychomycosis.
Uses & Indications
Dosage
Adults
Dosage varies by indication. For Onychomycosis (pulse therapy): 200 mg twice daily for 1 week, followed by 3 weeks off. Repeat for 2 or 3 cycles. For Vaginal Candidiasis: 200 mg twice daily for 1 day. For Systemic Mycoses: 100-200 mg once or twice daily, depending on severity and type of infection. Consult a physician for specific dosing.
Elderly
Use with caution. Dosage adjustments may be necessary based on renal or hepatic function and potential for drug interactions. Close monitoring is recommended.
Renal_impairment
Use with caution. Itraconazole should be used with caution in patients with renal impairment. Systemic exposure may be reduced. Dose adjustment may be necessary in some cases, often starting with a lower dose.
How to Take
Take the tablet orally with a full meal to maximize absorption. Swallow whole with water. Do not chew or crush.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylase, which is an essential enzyme in the biosynthesis of ergosterol, a vital component of the fungal cell membrane. This inhibition leads to the accumulation of 14α-methylsterols and a decrease in ergosterol, thereby disrupting the fungal cell membrane and inhibiting fungal growth.
Pharmacokinetics
Onset
Onset of action varies depending on the infection type and site. Clinical improvement may take several weeks for superficial infections like onychomycosis.
Excretion
Approximately 35% of a dose is excreted in the urine as inactive metabolites and less than 0.03% as unchanged drug. About 3-18% is excreted in feces, partly as unchanged drug and partly as metabolites.
Half life
The elimination half-life of Itraconazole is approximately 20-30 hours, and its active metabolite, hydroxyitraconazole, has a half-life of about 30-40 hours. Steady-state concentrations are typically reached within 7-10 days of dosing.
Absorption
Oral absorption of Itraconazole is variable and increased when taken with a full meal. Absorption is also improved in an acidic environment. Peak plasma concentrations are reached 2-5 hours post-dose.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 3A4 (CYP3A4) enzyme system, to a large number of metabolites, including the major active metabolite, hydroxyitraconazole.
Side Effects
Contraindications
- Hypersensitivity to Itraconazole or any component of the formulation.
- Co-administration with certain CYP3A4 substrates that can prolong the QT interval (e.g., cisapride, dofetilide, dronedarone, levacetylmethadol, pimozide, quinidine, ranolazine, terfenadine).
- Co-administration with HMG-CoA reductase inhibitors (e.g., lovastatin, simvastatin) due to increased risk of rhabdomyolysis.
- Congestive Heart Failure (CHF) or a history of CHF, unless the benefits clearly outweigh the risks.
Drug Interactions
CYP3A4 Inducers
Decreased Itraconazole levels (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort).
CYP3A4 Inhibitors
Increased Itraconazole levels (e.g., ritonavir, indinavir, clarithromycin).
QT-prolonging drugs
Increased risk of arrhythmias (e.g., cisapride, quinidine, dofetilide).
Calcium Channel Blockers
Increased levels of both drugs (e.g., dihydropyridines, verapamil).
HMG-CoA Reductase Inhibitors
Increased risk of rhabdomyolysis (e.g., simvastatin, lovastatin).
Drugs affecting gastric acidity
Reduced absorption of Itraconazole (e.g., antacids, H2-receptor blockers, proton pump inhibitors).
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, symptomatic and supportive measures should be initiated. Gastric lavage may be considered within the first hour. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the potential risks to the fetus. It is excreted in breast milk; therefore, breastfeeding mothers should avoid using Itraconazole or discontinue breastfeeding during treatment.
Side Effects
Contraindications
- Hypersensitivity to Itraconazole or any component of the formulation.
- Co-administration with certain CYP3A4 substrates that can prolong the QT interval (e.g., cisapride, dofetilide, dronedarone, levacetylmethadol, pimozide, quinidine, ranolazine, terfenadine).
- Co-administration with HMG-CoA reductase inhibitors (e.g., lovastatin, simvastatin) due to increased risk of rhabdomyolysis.
- Congestive Heart Failure (CHF) or a history of CHF, unless the benefits clearly outweigh the risks.
Drug Interactions
CYP3A4 Inducers
Decreased Itraconazole levels (e.g., rifampin, phenytoin, carbamazepine, St. John's Wort).
CYP3A4 Inhibitors
Increased Itraconazole levels (e.g., ritonavir, indinavir, clarithromycin).
QT-prolonging drugs
Increased risk of arrhythmias (e.g., cisapride, quinidine, dofetilide).
Calcium Channel Blockers
Increased levels of both drugs (e.g., dihydropyridines, verapamil).
HMG-CoA Reductase Inhibitors
Increased risk of rhabdomyolysis (e.g., simvastatin, lovastatin).
Drugs affecting gastric acidity
Reduced absorption of Itraconazole (e.g., antacids, H2-receptor blockers, proton pump inhibitors).
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, symptomatic and supportive measures should be initiated. Gastric lavage may be considered within the first hour. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the potential risks to the fetus. It is excreted in breast milk; therefore, breastfeeding mothers should avoid using Itraconazole or discontinue breastfeeding during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from the manufacturing date, consult packaging for exact date.
Availability
Pharmacies, Hospitals
Approval Status
Approved (DGDA, FDA for active ingredient)
Patent Status
Off-patent (for active ingredient)
WHO Essential Medicine
YesClinical Trials
Itraconazole has undergone extensive clinical trials demonstrating its efficacy and safety for various fungal infections. Ongoing research explores new indications and formulations.
Lab Monitoring
- Liver function tests (LFTs) should be monitored before starting treatment and periodically during prolonged therapy, especially in patients with pre-existing hepatic impairment.
- Serum potassium levels should be monitored, especially in patients at risk of hypokalemia.
- Therapeutic Drug Monitoring (TDM) may be considered in severe or life-threatening infections, or in patients with impaired absorption or suspected drug interactions.
Doctor Notes
- Assess patient's cardiac history for CHF risk before initiating Itraconazole.
- Monitor liver function tests (LFTs) at baseline and periodically during treatment.
- Thoroughly review patient's concomitant medications to identify and manage potential drug-drug interactions, especially with CYP3A4 substrates/inhibitors/inducers.
- Advise patients to take Itraconazole with food and report any new or worsening symptoms, particularly those related to liver or heart function.
Patient Guidelines
- Take Itranox with a full meal to improve absorption.
- Complete the entire course of medication as prescribed by your doctor, even if your symptoms improve.
- Report any signs of liver problems (e.g., unusual fatigue, dark urine, pale stools, yellowing of skin/eyes) or symptoms of heart failure (e.g., shortness of breath, swelling of ankles/feet) to your doctor immediately.
- Inform your doctor about all other medications, herbal products, and supplements you are taking to avoid potential drug interactions.
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 double the dose to catch up.
Driving Precautions
Itraconazole may cause dizziness or visual disturbances in some patients. Patients should be cautious when driving or operating machinery until they know how this medication affects them.
Lifestyle Advice
- Avoid consuming grapefruit or grapefruit juice while taking this medication.
- Limit or avoid alcohol consumption, as it may exacerbate liver side effects.
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