Amphoject 50 mg/vial

INDICATIONS

Amphotericin B is indicated for the following:

Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
Treatment of Cryptococcal Meningitis in HIV infected patients 
Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. ... Read moreAmphotericin B is indicated for the following:

Empirical therapy for presumed fungal infection in febrile, neutropenic patients.
Treatment of Cryptococcal Meningitis in HIV infected patients 
Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.
Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with Amphotericin B, relapse rates were high following initial clearance of parasites

PHARMACOLOGY

Amphotericin B is fungistatic or fungicidal depending on the concentration obtained in body fluids and the susceptibility of the fungus. The drug acts by binding to sterols (ergosterol) in the cell membrane of susceptible fungi. This creates a transmembrane channel, and the resultant change in membrane permeability allowing leakage of intracellular components. Ergosterol, the principal sterol in the fungal cytoplasmic membrane, is the target site of action of amphotericin B and the azoles. Amphotericin B, a polyene, binds irreversibly to ergosterol, resulting in disruption of membrane integrity and ultimately cell death.

DOSAGE & ADMINISTRATION

Systemic Fungal Infections-

Test dose: 1 mg IV infused over 20-30 min
Load: 0.25-0.5 mg/kg IV infused over 2-6 hour
Maintenance: 0.25-1 mg/kg IV qDay OR up to 1.5 mg/kg IV every other day (may increase gradually by 0.25 mg-increments/day)

INTERACTION

Increased toxicity with flucytosine. Drug induced renal toxicity enhanced in presence of other nephrotoxic medications. Antagonises effects of azole antifungals.

SIDE EFFECTS

Common side effects are Fever, chills, convulsions, malaise; nausea, vomiting, diarrhoea, anorexia; tinnitus, vertigo, hearing loss; hypotension, hypertension, cardiac arrhythmias; peripheral neuropathy; phloebitis, pain at Inj site, disturbances in renal function and renal toxicity.

PREGNANCY & LACTATION

Pregnancy Category B. There have been no adequate and well-controlled studies of Amphotericin B in pregnant women. It is not known whether Amphotericin B is excreted in human milk.

PRECAUTIONS & WARNINGS

As with any amphotericin B-containing product the drug should be administered by medically trained personnel. During the initial dosing period, patients should be under close clinical observation. amphotericin B has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur.

THERAPEUTIC CLASS

Other Antifungal preparations

STORAGE CONDITIONS

Unopened vials of lyophilized material are to be stored at temperatures up to 25°C. The reconstituted product concentrate may be stored for up to 24 hours at 2-8° C.