Amphotec


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Amphotec®

Amphocil Infectious disease A proprietary antifungal formulation in which toxic amphotericin B is wrapped inside a liposome envelope. See Amphotericin B, Liposome.
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AMPHOTEC was approved for market clearance by the FDA on November 22, 1996 and is indicated for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B therapy in effective doses, and in patients where prior amphotericin B therapy has failed.
Since we believe we are the lowest cost producer and have the best product, we have embarked on a bold pricing policy that will enable physicians and pharmacists to move toward greater use of AMPHOTEC where they believe it will provide clinical benefit and value to their patients.
Although the findings seem to favor AMPHOTEC over amphotericin B in treating invasive aspergillosis, the safety and efficacy of AMPHOTEC as first- line therapy for treating this condition needs to be confirmed in randomized, prospective comparative trials.
AMPHOTEC was somewhat more effective than AmBisome (difference not statistically significant) and significantly better than Abelcet and amphotericin B in clearing fungus from affected tissues.
In November 1996, the FDA cleared AMPHOTEC for the treatment of invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate in effective doses and in patients with invasive aspergillosis where prior amphotericin B deoxycholate therapy has failed.
AMPHOTEC is a novel lipid formation of amphotericin B, which is currently the standard treatment for patients with severe fungal infections that do not respond to other drugs.
Under the terms of the agreement, Bayer will have exclusive rights to AMPHOTEC for a period of five years, after which SEQUUS has an option to co-market the drug with Bayer.
AMPHOTEC is a lipid-based formulation of amphotericin B, a broad-spectrum antifungal antibiotic which is widely considered to be the "gold standard" for treating progressive and potentially fatal systemic fungal infections.
Mary White of the Memorial Sloan-Kettering Cancer Center in New York City also showed that AMPHOTEC had a renal safety advantage over amphotericin B when used in conjunction with common anti-rejection therapy (cyclosporine or tacrolimus) in both adults and children.
SEQUUS is marketing AMPHOTEC directly through its 45-person sales force.
AMPHOTEC is indicated for the treatment invasive aspergillosis in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B deoxycholate ("amphotericin B") therapy in effective doses and in patients where prior amphotericin B deoxycholate therapy has failed.
NASDAQ:SEQU) today announced that AMPHOTEC has been approved in Argentina (under the tradename AMPHOCIL(TM)), bringing to 17 the number of countries in which AMPHOTEC has been authorized for sale.