Itranox
Generic Name
Itraconazole 100 mg Capsule
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itranox 100 mg capsule | ৳ 15.00 | ৳ 60.00 |
Description
Overview of the medicine
Itranox 100 mg Capsule contains Itraconazole, a broad-spectrum triazole antifungal agent used to treat various fungal infections.
Uses & Indications
Dosage
Adults
Typical dosage ranges from 100 mg once daily to 200 mg twice daily, depending on the infection. For Onychomycosis, pulsed dosing regimens are common (e.g., 200 mg twice daily for 7 days per month).
Elderly
No specific dosage adjustment based on age alone is generally required, but caution is advised, and dose adjustments may be needed for renal or hepatic impairment.
Renal_impairment
Use with caution in patients with renal impairment. Systemic exposure to Itraconazole may be reduced in severe renal impairment; however, an increase in exposure to some metabolites has been observed. Dosage adjustment may be considered.
How to Take
Itranox capsules should be taken immediately after a full meal for maximal absorption. Swallow the capsule whole with water.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylation of lanosterol, which is an essential step in fungal ergosterol biosynthesis. This inhibition leads to an accumulation of 14α-methyl sterols, which are toxic to the fungus, thereby impairing fungal cell membrane function and growth.
Pharmacokinetics
Onset
Therapeutic effects may take several days to weeks, depending on the type and severity of fungal infection.
Excretion
Excreted primarily in feces (3-18% unchanged drug, 34-54% as metabolites) and to a lesser extent in urine (0.03% unchanged drug, 65% as metabolites).
Half life
Terminal elimination half-life is approximately 20-30 hours after single dose, increasing to 30-40 hours with chronic dosing.
Absorption
Oral absorption is variable and significantly increased when taken with food or an acidic beverage. Peak plasma concentrations are reached within 3-5 hours.
Metabolism
Extensively metabolized in the liver mainly by cytochrome P450 3A4 (CYP3A4) to several metabolites, including the active metabolite hydroxyitraconazole, which has comparable antifungal activity.
Side Effects
Contraindications
- Hypersensitivity to Itraconazole or any component of the formulation
- Concomitant use with certain CYP3A4 substrates that can prolong QT interval (e.g., cisapride, dofetilide, quinidine, pimozide, levacetylmethadol, terfenadine, astemizole, triazolam, oral midazolam)
- Congestive Heart Failure (CHF) or history of CHF (unless benefits outweigh risks)
Drug Interactions
Proton Pump Inhibitors/H2 Blockers/Antacids
Reduced absorption of Itraconazole due to increased gastric pH. Administer Itraconazole with an acidic beverage or consider alternative antifungal therapy.
CYP3A4 Substrates (e.g., statins, benzodiazepines, CCBs)
Increased plasma levels of these drugs, leading to increased risk of toxicity. Dose adjustments or alternatives may be needed.
CYP3A4 Inducers (e.g., rifampicin, phenytoin, carbamazepine)
Decreased plasma levels of Itraconazole, leading to reduced efficacy. Avoid co-administration if possible.
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, symptomatic and supportive measures should be employed. 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 potential benefit outweighs the potential risk to the fetus. It is excreted in human milk, therefore, breastfeeding mothers should consider discontinuing nursing or the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Itraconazole or any component of the formulation
- Concomitant use with certain CYP3A4 substrates that can prolong QT interval (e.g., cisapride, dofetilide, quinidine, pimozide, levacetylmethadol, terfenadine, astemizole, triazolam, oral midazolam)
- Congestive Heart Failure (CHF) or history of CHF (unless benefits outweigh risks)
Drug Interactions
Proton Pump Inhibitors/H2 Blockers/Antacids
Reduced absorption of Itraconazole due to increased gastric pH. Administer Itraconazole with an acidic beverage or consider alternative antifungal therapy.
CYP3A4 Substrates (e.g., statins, benzodiazepines, CCBs)
Increased plasma levels of these drugs, leading to increased risk of toxicity. Dose adjustments or alternatives may be needed.
CYP3A4 Inducers (e.g., rifampicin, phenytoin, carbamazepine)
Decreased plasma levels of Itraconazole, leading to reduced efficacy. Avoid co-administration if possible.
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, symptomatic and supportive measures should be employed. 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 potential benefit outweighs the potential risk to the fetus. It is excreted in human milk, therefore, breastfeeding mothers should consider discontinuing nursing or the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture
Availability
Available in retail pharmacies and hospitals
Approval Status
Approved by DGDA and internationally recognized regulatory bodies (e.g., FDA)
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Itraconazole has undergone extensive clinical trials supporting its efficacy and safety in various fungal infections. Ongoing post-marketing surveillance continues to monitor its profile.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) at baseline and periodically during prolonged treatment
- Serum potassium levels, especially in patients at risk of hypokalemia
Doctor Notes
- Assess cardiac status and liver function before initiating therapy, especially in patients with pre-existing conditions.
- Review patient's concomitant medications for potential drug interactions, particularly with CYP3A4 substrates.
- Counsel patients on the importance of taking capsules with food and completing the full course of treatment.
Patient Guidelines
- Take Itranox capsules immediately after a full meal to maximize absorption.
- Complete the full course of treatment as prescribed by your doctor, even if symptoms improve.
- Report any signs of liver problems (e.g., unusual fatigue, yellowing of skin/eyes, dark urine, severe abdominal pain) or heart failure (e.g., shortness of breath, swelling of ankles/feet).
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 resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Itraconazole may cause dizziness or visual disturbances. Patients should be advised not to drive or operate machinery if they experience these symptoms.
Lifestyle Advice
- Avoid alcohol consumption while taking Itraconazole, as it may increase the risk of liver damage.
- Maintain good personal hygiene to prevent recurrence of fungal infections.
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