Pregnancy Cat

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

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.

Overdose Effects

n/a

Drug Classes

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.

Composition

n/a

Mode Of Action

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.

Reconstitution

Aseptically add 12 mL of Sterile Water for Injection, to each Amphotericin B vial to yield a preparation containing 4 mg amphotericin B/mL. Immediately after the addition of water, shake the vial vigorously for 30 seconds to completely disperse the Amphotericin B. This forms a yellow, translucent suspension. Visually inspect the vial for particulate matter and continue shaking until completely dispersed.