Itra
Generic Name
Itraconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itra 200 mg tablet | ৳ 28.00 | ৳ 168.00 |
Description
Overview of the medicine
Itraconazole is an antifungal medication used to treat a wide variety of fungal infections, including blastomycosis, histoplasmosis, aspergillosis, and candidiasis.
Uses & Indications
Dosage
Adults
Blastomycosis/Histoplasmosis: 200 mg once daily, increased to 200 mg twice daily if no improvement or for severe disease. Aspergillosis: 200 mg once daily, increased to 200 mg twice daily for invasive or disseminated disease. Onychomycosis: 200 mg once daily for 3 months (continuous therapy) or pulse therapy (200 mg twice daily for 1 week, followed by 3 weeks off, repeated for 2-3 cycles).
Elderly
No specific dosage adjustment guidance for elderly patients; dose selection should be cautious, starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.
Renal_impairment
Use with caution in patients with renal impairment. Consider dose reduction.
How to Take
Itraconazole tablets should be taken immediately after a full meal to maximize absorption. Capsules should be swallowed whole. Liquid formulations (oral solution) should be taken on an empty stomach.
Mechanism of Action
Itraconazole works by inhibiting cytochrome P450-dependent 14α-demethylation of ergosterol, an essential component of the fungal cell membrane. This leads to an accumulation of 14α-methyl sterols and a decrease in ergosterol, disrupting cell membrane integrity and inhibiting fungal growth.
Pharmacokinetics
Onset
Variable, depending on the infection type and site, typically within days to weeks for therapeutic effects.
Excretion
Mainly excreted in feces (3-18% as unchanged drug) and urine (less than 0.03% as unchanged drug, 35% as metabolites).
Half life
Initial phase: 15-30 hours; Steady state: 30-40 hours.
Absorption
Well absorbed orally, especially when taken with a full meal. Bioavailability is increased by food and decreased by antacids.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, to active and inactive metabolites. The major active metabolite is hydroxyitraconazole.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Congestive heart failure or history of congestive heart failure (unless the benefit clearly outweighs the risk).
- Co-administration with certain CYP3A4 substrates that can prolong the QT interval (e.g., cisapride, dofetilide, quinidine, pimozide, levacetylmethadol, terfenadine, astemizole).
- Co-administration with certain HMG-CoA reductase inhibitors (e.g., simvastatin, lovastatin, atorvastatin).
- Pregnancy (except for life-threatening fungal infections where the benefits outweigh the risks).
Drug Interactions
Digoxin
Increased digoxin levels, requiring monitoring.
CYP3A4 Inducers
Decreased itraconazole levels (e.g., rifampin, phenytoin, carbamazepine, phenobarbital).
CYP3A4 Inhibitors
Increased itraconazole levels (e.g., ritonavir, indinavir, clarithromycin, erythromycin).
Midazolam/Triazolam
Potentiated sedative effects, increased risk of respiratory depression.
Oral Anticoagulants
Enhanced anticoagulant effect (e.g., warfarin).
Calcium Channel Blockers
Increased levels of both itraconazole and CCBs, leading to increased risk of toxicity (e.g., verapamil, diltiazem).
HMG-CoA Reductase Inhibitors
Increased risk of myopathy/rhabdomyolysis (e.g., simvastatin, lovastatin, atorvastatin - contraindicated).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should be avoided during pregnancy unless it's a life-threatening fungal infection and the benefits outweigh the risks. Women of childbearing potential should use adequate contraception during treatment and for two months after. Itraconazole is excreted in breast milk; therefore, breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation.
- Congestive heart failure or history of congestive heart failure (unless the benefit clearly outweighs the risk).
- Co-administration with certain CYP3A4 substrates that can prolong the QT interval (e.g., cisapride, dofetilide, quinidine, pimozide, levacetylmethadol, terfenadine, astemizole).
- Co-administration with certain HMG-CoA reductase inhibitors (e.g., simvastatin, lovastatin, atorvastatin).
- Pregnancy (except for life-threatening fungal infections where the benefits outweigh the risks).
Drug Interactions
Digoxin
Increased digoxin levels, requiring monitoring.
CYP3A4 Inducers
Decreased itraconazole levels (e.g., rifampin, phenytoin, carbamazepine, phenobarbital).
CYP3A4 Inhibitors
Increased itraconazole levels (e.g., ritonavir, indinavir, clarithromycin, erythromycin).
Midazolam/Triazolam
Potentiated sedative effects, increased risk of respiratory depression.
Oral Anticoagulants
Enhanced anticoagulant effect (e.g., warfarin).
Calcium Channel Blockers
Increased levels of both itraconazole and CCBs, leading to increased risk of toxicity (e.g., verapamil, diltiazem).
HMG-CoA Reductase Inhibitors
Increased risk of myopathy/rhabdomyolysis (e.g., simvastatin, lovastatin, atorvastatin - contraindicated).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be implemented. Itraconazole is not removed by hemodialysis. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should be avoided during pregnancy unless it's a life-threatening fungal infection and the benefits outweigh the risks. Women of childbearing potential should use adequate contraception during treatment and for two months after. Itraconazole is excreted in breast milk; therefore, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date
Availability
Pharmacies nationwide
Approval Status
Approved by FDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of Itraconazole for its approved indications. Ongoing research explores its use in emerging fungal infections and combination therapies.
Lab Monitoring
- Liver function tests (baseline and periodically during prolonged therapy, or if symptoms of hepatic dysfunction occur)
- Serum potassium levels (periodically, especially with diuretics or renal impairment)
- Therapeutic drug monitoring (TDM) may be considered in certain situations (e.g., severe infections, drug interactions, poor absorption, immunosuppressed patients).
Doctor Notes
- Counsel patients on the importance of adherence, especially for onychomycosis, to achieve optimal outcomes.
- Be vigilant for signs of hepatic toxicity and heart failure; discontinue if suspected.
- Review patient's concomitant medications carefully for potential drug-drug interactions, particularly CYP3A4 substrates and inducers.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Take tablets/capsules with food for best absorption.
- Do not stop taking the medicine early, even if you feel better.
- Report any signs of liver problems (e.g., unusual tiredness, dark urine, yellowing of skin/eyes) or heart failure (e.g., shortness of breath, swelling of ankles/feet) to your doctor immediately.
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 can cause dizziness, blurred vision, or hearing loss in some patients. If you experience these side effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol while taking Itraconazole due to potential liver effects.
- Maintain good hygiene to prevent recurrence of fungal infections.
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