Itrapex
Generic Name
Itraconazole
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itrapex 100 mg capsule | ৳ 15.00 | ৳ 60.00 |
Description
Overview of the medicine
Itrapex (Itraconazole) is a broad-spectrum antifungal agent used to treat various fungal infections including candidiasis, aspergillosis, and cryptococcosis.
Uses & Indications
Dosage
Adults
Typical dosage varies by indication. For onychomycosis: 200 mg once daily for 3 months, or pulse therapy 200 mg twice daily for 1 week/month for 2-3 months. For vulvovaginal candidiasis: 200 mg twice daily for 1 day, or 200 mg once daily for 3 days.
Elderly
Use with caution, consider age-related decrease in hepatic/renal function. Generally, no specific dosage adjustment needed unless severe impairment.
Renal_impairment
Use with caution. Dosage adjustment may be required in severe renal impairment (CrCl < 30 mL/min). Consider starting with lower doses.
How to Take
Take capsules immediately after a full meal to ensure maximum absorption. Oral solution should be taken without food.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14-alpha-demethylation of lanosterol, which is an essential step in fungal ergosterol biosynthesis. Ergosterol is a vital component of the fungal cell membrane, and its inhibition leads to increased fungal cell membrane permeability, leakage of cellular contents, and eventual fungal cell death.
Pharmacokinetics
Onset
Therapeutic concentrations reached within hours, full effect over days/weeks depending on infection.
Excretion
Mainly excreted in feces (3-18% as unchanged drug) and urine (<0.03% as unchanged drug, 35% as metabolites).
Half life
Approximately 20-30 hours for itraconazole; 30-40 hours for active metabolite, hydroxyitraconazole.
Absorption
Well absorbed orally, bioavailability is increased with food and acidic pH.
Metabolism
Extensively metabolized in the liver via CYP3A4 to several metabolites, including hydroxyitraconazole (active).
Side Effects
Contraindications
- Hypersensitivity to itraconazole or any component of the formulation
- Concomitant administration with certain CYP3A4 substrates (e.g., simvastatin, lovastatin, midazolam, triazolam, cisapride, dofetilide, quinidine, pimozide)
- Patients with evidence of ventricular dysfunction or history of congestive heart failure (CHF) unless the potential benefit outweighs the risk
- Pregnancy (unless life-threatening systemic fungal infection)
Drug Interactions
Statins (e.g., simvastatin, atorvastatin)
Increased risk of myopathy/rhabdomyolysis due to increased statin levels.
H2-blockers/PPIs (e.g., omeprazole, ranitidine)
Decrease gastric acidity, reducing itraconazole absorption. Take with acidic beverage or avoid if possible.
CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine)
Decrease itraconazole plasma levels, reducing efficacy.
Calcium channel blockers (e.g., dihydropyridines, verapamil)
Increased risk of edema and/or cardiac effects.
CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, ritonavir)
Increase itraconazole plasma levels, potentially increasing side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Limited information available. Symptoms may include exaggerated side effects like nausea, vomiting, abdominal pain, and liver dysfunction. Treatment is supportive; gastric lavage may be considered soon after ingestion. Itraconazole is not dialyzable.
Pregnancy & Lactation
Pregnancy Category C. Itraconazole should not be used during pregnancy unless the benefits outweigh the risks (e.g., life-threatening systemic fungal infections). Women of childbearing potential should use adequate contraception during treatment and for two months after stopping. Itraconazole is excreted in breast milk; breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA/FDA
Patent Status
Off-patent
Clinical Trials
Extensively studied in numerous clinical trials for its efficacy and safety in various fungal infections. Ongoing research explores new indications and formulations.
Lab Monitoring
- Liver function tests (ALT, AST, ALP, bilirubin) at baseline and periodically during prolonged therapy.
- Potassium levels (in patients at risk for hypokalemia).
- Monitor for signs and symptoms of congestive heart failure.
Doctor Notes
- Counsel patients on potential drug interactions, especially with concomitant use of statins, benzodiazepines, and certain cardiac medications.
- Emphasize the importance of taking capsules with food for optimal absorption.
- Be vigilant for signs of hepatotoxicity and heart failure, particularly in vulnerable populations.
Patient Guidelines
- Complete the full course of treatment even if symptoms improve.
- Report any signs of liver problems (e.g., unusual fatigue, dark urine, yellowing of skin/eyes) or heart problems (e.g., shortness of breath, swelling) immediately.
- Avoid antacids for at least 2 hours before and after taking itraconazole capsules.
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 take a double dose.
Driving Precautions
May cause dizziness or visual disturbances. Patients should be cautious when driving or operating machinery until they know how itraconazole affects them.
Lifestyle Advice
- Maintain good hygiene to prevent reinfection.
- Avoid excessive alcohol consumption during treatment, as it can exacerbate liver side effects.
- Follow doctor's advice regarding diet and hydration.
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