📋 Indications & Clinical Dosage
*Invasive aspergillosis, Mucormycosis in patients for whom amphotericin B is inappropriate:*
ORAL, OR BY IV INF: Adult: Loading dose 200 mg every 8 hours for 48 hours
(6 administrations in total), then maintenance 200 mg once daily, maintenance dose to be started at least
12 hours after the last loading dose; long-term treatment should be reviewed after 6-months.*
💊 Mode of Administration
For IV Infusion reconstitute each 200 mg with 5 ml Water for Injection; dilute dose to concentration of 0.8 mg/ml with Glucose 5% or Sodium Chloride 0.9% and give via a 0.2–1.2 micron filter over at least 1 hr.
⛔ Contraindications
Acute porphyrias, short QT syndrome
⚠️ Precautions & Warnings
Elderly, caution in severe hepatic impairment; toxicity with related drugs. Monitor liver function
🔄 Drug Interactions
Antifungals, azoles, CYP3A4/5 inducers (eg, rifamycins, carbamazepine, phenytoin, St Johns wort), inhibitors (eg, ketoconazole, protease inhibitors) or substrates (eg, immunosuppressants). Substrates of BCRP, CYP34, CYP2B6, P-gp,
UGT or OCT2. Drugs that shorten QT interval.
⚠️ Adverse Reactions / Side Effects
Asthenia, arrhythmias, confusion, depression, delirium, diarrhoea, dizziness, dyspnoea, electrolyte imbalance, GI discomfort, hepatic disorders, hyperbilirubinaemia, nausea, respiratory disorders, skin reactions, thrombophlebitis, vomiting, taste altered, appetite decreased, encephalopathy, hypersensitivity, hypoalbuminaemia, leucopenia, malaise, palpitations, pancytopenia, paraesthesia. Rare: Alopecia anaemia, circulatory collapse, peripheral neuropathy, peripheral oedema, seizures, syncope, thrombocytopenia, vertigo, severe cutaneous adverse reactions (SCARs), renal failure, haemorrhage, neutropenia.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Avoid unless severe or life-threatening infection
Lactation / Breastfeeding:
Avoid
🧪 Compatibility & Storage Stability
Stability & Storage: Store in refrigerator (2–8 C) consult product literature for storage after reconstitution or dilution.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.