Itrazen
Generic Name
Itraconazole
Manufacturer
Popular Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| itrazen 100 mg capsule | ৳ 17.00 | ৳ 102.00 |
Description
Overview of the medicine
Itraconazole is a broad-spectrum triazole antifungal agent used to treat various systemic and superficial fungal infections.
Uses & Indications
Dosage
Adults
Onychomycosis (toenails): 200 mg once daily for 12 weeks. Oropharyngeal candidiasis: 100 mg once daily for 15 days. Vulvovaginal candidiasis: 200 mg twice daily for 1 day or 200 mg once daily for 3 days. Systemic infections (e.g., aspergillosis, blastomycosis, histoplasmosis): 200 mg once or twice daily, up to 400 mg/day in divided doses.
Elderly
Use with caution, considering potential decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Dosage adjustments may be necessary.
Renal_impairment
Use with caution. Dosage adjustments may be needed; specific recommendations vary. Close monitoring of drug levels and renal function is advised.
How to Take
Take Itraconazole capsules immediately after a full meal to ensure maximum absorption. Swallow the capsule whole with water. Do not chew or crush.
Mechanism of Action
Itraconazole inhibits fungal cytochrome P450-dependent 14α-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. This inhibition leads to the accumulation of 14α-methyl sterols and a decrease in ergosterol, resulting in altered fungal cell membrane permeability and cell growth inhibition.
Pharmacokinetics
Onset
Clinical effects usually seen within days to weeks depending on the infection type and severity.
Excretion
Mainly excreted in feces (35-65%) and urine (3-18%) as inactive metabolites. Less than 0.2% of the dose is excreted unchanged in urine.
Half life
Approximately 15-24 hours after a single dose; 30-40 hours at steady-state.
Absorption
Well absorbed orally, especially when taken with a full meal. Bioavailability is increased with food and decreased with elevated gastric pH.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 3A4 (CYP3A4) enzyme system, into numerous metabolites, including the active metabolite hydroxyitraconazole.
Side Effects
Contraindications
- Hypersensitivity to Itraconazole or any component of the formulation
- Co-administration with certain CYP3A4 substrates (e.g., astemizole, cisapride, dofetilide, lovastatin, midazolam (oral), pimozide, quinidine, simvastatin, terfenadine, triazolam)
- Congestive heart failure or history of congestive heart failure (unless the potential benefits clearly outweigh the risks)
- Pregnancy (except for life-threatening fungal infections)
Drug Interactions
Digoxin
Increased digoxin levels and toxicity.
Warfarin
Increased anticoagulant effect, leading to bleeding risk.
Oral Midazolam, Triazolam
Potentiated and prolonged sedative-hypnotic effects.
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy and rhabdomyolysis.
Proton Pump Inhibitors/H2 Blockers/Antacids
Reduce gastric acidity, which can impair itraconazole absorption.
CYP3A4 Inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital)
May decrease itraconazole plasma concentrations, reducing efficacy.
CYP3A4 Inhibitors (e.g., ritonavir, indinavir, clarithromycin, erythromycin)
May increase itraconazole plasma concentrations, increasing risk of adverse effects.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
In the event of an overdose, supportive measures should be instituted. 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, especially for life-threatening fungal infections. Small amounts of Itraconazole are excreted into breast milk; therefore, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies
Approval Status
Approved by DGDA
Patent Status
Off-patent (Generic available)
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of Itraconazole for various fungal infections. Post-marketing surveillance continues to monitor for rare adverse effects.
Lab Monitoring
- Liver function tests (LFTs) should be monitored at baseline and periodically during prolonged therapy, especially in patients with pre-existing hepatic impairment or those developing symptoms of liver dysfunction.
- Potassium levels (in patients at risk of hypokalemia).
Doctor Notes
- Carefully assess cardiac history before prescribing, especially for patients with or at risk of CHF.
- Monitor LFTs regularly during extended treatment.
- Counsel patients on potential drug interactions and to take with food.
Patient Guidelines
- Take the medication exactly as prescribed by your doctor.
- Complete the full course of treatment, even if your symptoms improve.
- Report any signs of liver problems (e.g., unusual fatigue, dark urine, yellowing of skin/eyes, nausea, abdominal pain) or heart failure (e.g., shortness of breath, swelling, rapid weight gain) to your doctor immediately.
- Do not stop taking the medication without consulting your doctor.
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. If you experience these side effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid alcohol consumption while on Itraconazole, as it may increase the risk of liver damage.
- Maintain good personal hygiene to prevent recurrence of fungal infections.
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Global Brand Names
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