AMPHOTERICIN B DUMEX Infusion
Amphotericin B
50mg
A/S DUMEX (DUMEX LTD.)
| Pack size | 1 Vial (Dry) |
|---|---|
| Dispensing mode | POM |
| Source | DENMARK |
| Agent | GULF DRUG EST. |
| Retail Price | 31.00 AED |
Indications
AMPHOTERICIN B DUMEX Infusion is used for:
Endocarditis, Systemic fungal infections, Visceral leishmaniasis, Primary amoebic meningoencephalitis, Thrush, Cryptococcal meningitis, Candidiasis, Aspergillosis, Candidal cystitis
Adult Dose
Adult: Dosing regimens are applicable to amphotericin B (conventional). PO Oral candidiasis Per loz contains amphotericin B 10 mg: Suck 1 loz 4 times/day, up to 8 loz/day if needed.
IV Systemic Fungal Infections
Test dose: 1 mg IV x1 infused over 20-30 min
Load: 0.25-0.5 mg/kg IV infused over 2-6 hr
Maintenance: 0.25-1 mg/kg IV qDay OR up to 1.5 mg/kg IV qOD (may increase gradually by 0.25 mg-increments/day)
Child Dose
Systemic Fungal Infections
Test dose: 0.1 mg/kg IV, not to exceed 1 mg; administer over 20-60 min
Initial dose: 0.25 mg/kg/dose IV qDay/qOD
Maintenance: Increase by 0.25 mg/day increments as tolerated to 1-1.5 mg/kg/day
Renal Dose
Renal Impairment
CrCl <10 mL/min: 0.5-0.7 mg/kg IV q24-48hr
Consider other antifungal agents that may be less nephrotoxic
Intermittent hemodialysis: 0.5-1 mg/kg IV q24hr after dialysis session
Continuous renal replacement therapy: 0.5-1 mg/kg IV q24hr
Administration
IV Administration
Use promptly after dilution. Infuse over 2-6 hr
Reconstitution: For conventional amphotericin B: Reconstitute with sterile water for inj (without preservatives), then further dilute with glucose inj 5% (with a pH>4.2) to a final concentration not exceeding 0.1 mg/ml for peripheral infusion or 0.25 mg/ml for central infusion.
Contra Indications
Hypersensitivity; lactation; do not give to patients receiving antineoplastics.
Precautions
Renal and hepatic impairment; pregnancy; monitor renal and liver function changes.
Lactation: Excretion in milk is unknown; due to the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy-Lactation
Pregnancy Category: B
Lactation: Excretion in milk is unknown; due to the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account the importance of the drug to the mother
Interactions
Increased toxicity with flucytosine. Drug induced renal toxicity enhanced in presence of other nephrotoxic medications. Antagonises effects of azole antifungals.
Potentially Fatal: Potentiates K loss by corticosteroids. Avoid diuretics. Enhances digitalis toxicity and neuromuscular blocker effects.
Adverse Effects
Side effects of Amphotericin B :
>10%
Anorexia, Chills, Diarrhea, Fever, Headache, Hypokalemia, Hypomagnesemia, Hypotension, Malaise, Nausea, Pain (generalized), Pain at injection site, Renal function abnormalities, Tachypnea, Vomiting
1-10%
Arachnoiditis, Delerium, Flushing, Hypertension, Leukocytosis, Lumbar nerve pain, Paresthesia, Urinary retention
<1%
Agranulocytosis, Anuria, Bone marrow suppression, Cardiac arrest, Coagulation defects, Convulsions, Dyspnea, Hearing loss, Leukopenia, Maculopapular rash, Renal failure, Thrombocytopenia, Vision changes
Potentially Fatal: Anaphylactic reaction; leucoencephalopathy. Overdosage can result in cardio-respiratory arrest.
Mechanism of Action
Amphotericin B is a polyene antifungal antibiotic which alters cell membrane permeability by binding to ergosterol, thus causing leakage of cell components and subsequent cell death. It is active against Absidia spp, Aspergillus spp, Basidiobolus spp, B. dermatitidis, Candida spp, C. immitis, Conidobolus spp, C. neoformans, H. capsulatum, Mucor spp, P. brasiliensis, Rhizopus spp, Rodotorula spp. and S. schenckii.
Note
AMPHOTERICIN B DUMEX 50mg Infusion manufactured by A/S DUMEX (DUMEX LTD.). Its generic name is Amphotericin B. AMPHOTERICIN B DUMEX is availble in United Arab Emirates.
Farmaco UAE drug index information on AMPHOTERICIN B DUMEX Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.