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Amphotec

Amphotericin B (Fungilin®, Fungizone®, Abelcet®, AmBisome®, Fungisome®, Amphocil®, Amphotec®) is a polyene antimycotic drug, used intravenously in systemic fungal infections. It was originally extracted from Streptomyces nodosus fungi. Currently the drug is available as plain Amphotericin B, as cholesteryl sulfate complex, as lipid complex, and as liposomal formulation. The latter formulations have been developed to improve tolerability for the patient but may show considerable pharmacokinetic characteristics compared to plain Amphotericin B. more...

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Uses

Oral preparations of amphotericin B are used to treat oral thrush; these are virtually nontoxic. The main i.v. use is in systemic fungal infections (e.g. in immunocompromised patients), and in visceral leishmaniasis. Aspergillosis, cryptococcus infections (e.g. meningitis) and candidiasis are treated with amphotericin B. It is also used empirically in febrile immunocompromised patients who do not respond to broad-spectrum antibiotics.

Method of action

As with other polyene antifungals, amphotericin B associates with ergosterol, a membrane chemical of fungi, forming a pore that leads to K⁺ leakage and fungal cell death. Recently, however, researchers found evidence that pore formation is not necessarily linked to cell death (i.e. Angewandte Chemie Int. Ed. Engl. 2004). The actual mechanism of action may be more complex and multi-faceted.

Side effects

Very often a most serious acute reaction after the infusion (1 to 3 hours later) is noted consisting of fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, dyspnea, and tachypnea. This reaction sometimes subsides with later applications of the drug and may in part be due to histamine liberation. An increase in prostaglandin-synthesis may also play a role. Often the most difficult decision has to be made, whether the fever is disease- or drug-related. In order to decrease the likelihood and severity of the symptoms, initial doses should be low and increased slowly. The liposomal preperation obviously has a lower incidence of the syndrome. Acetaminophen, pethidine, diphenhydramine and/or hydrocortisone have all be used to treat or prevent the syndrome, but the prophylactic use of these drugs should be limited.

Nephrotoxicity (kidney damage) is a major issue and can be severe and/or irreversible. It is much milder when amphotericin B is delivered in liposomes (AmBisome). Electrolyte imbalances (e.g. hypokalema and hypocalcemia) may also occur.

Increased liver enzymes and hepatotoxicity up to acute liver failure, several forms of anemia and other blood dyscrasias (leukopenia, thrombopenia), serious cardiac arrhythmias (including ventricular fibrillation), and cardiac failure have also been reported frequently. Skin reactions, including serious forms, are also possible.

Interactions

Flucytosine : Toxicity of Flucytosine increased and vice versa
Diuretics or Cisplatin : Increased renal toxicity and incrised risk of hypokalema
Corticosterioids : Increased risk of hypokalema
Cytostatic drugs : Increased risk of kidney damage, hypotension and bronchospasms.
Other nephrotoxic drugs : Increased risk of serious renal damage. Monitor patients closely.
Foscarnet, Ganciclovir, Tenofovir, Adefovir : Risk of hematological and renal side-effects of Amphotericin B increased.
Transfusion of Leukocytes : Risk of pulmonal (lung) damage. Space intervalls between the application of Amphotericin B and the transfusion and monitor pulmonal function.

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Intermune/Boehringer To Commercialize Interferon/Gamma-1b
From Worldwide Biotech, 5/1/01

InterMune (Nasdaq: ITMN), Burlingame, Calif. and Boehringer Ingelheim International GmbH, Germany, have formed an international strategic partnership to develop and commercialize interferon gamma-1b under Boehringer Ingelheim's trade name, Imukin(R), in all countries outside of the United States, Canada and Japan. Indications to be developed include idiopathic pulmonary fibrosis (IPF), tuberculosis, systemic fungal infections, chronic granulomatous disease (CGD) and osteopetrosis, as well as additional indications to be agreed upon later. This strategic alliance adds worldwide scope to InterMune's existing rights to develop and commercialize interferon gamma-1b under the trade name ACTIMMUNE(R) in the United States, Canada, and Japan.

Under the agreement, InterMune will fund and manage clinical and regulatory development of interferon gamma-1b for all indications. Boehringer Ingelheim has an option to exclusively promote Imukin(R) and InterMune may opt to promote the product where Boehringer Ingelheim does not do so. Furthermore, the two companies will share in the profits from commercializing interferon gamma-1b through a specified royalty schedule.

"This partnership allows InterMune to participate in up to approximately $2.5 billion in additional revenue opportunities, bringing our worldwide market opportunity in these indications for interferon gamma-1b to approximately $6.0 billion," said W. Scott Harkonen, M.D., president and CEO of InterMune. "This partnership also provides us with the opportunity to leverage our existing clinical programs, many of which are being conducted internationally, to access these very significant markets outside of the United States. We have a strong relationship with Boehringer Ingelheim through our existing manufacturing arrangement, and look forward to building upon that relationship with this very exciting partnership. It is really a win-win for both companies."

"The cooperation with InterMune will enable us to determine the efficacy of Imukin in patients suffering from serious diseases such as tuberculosis and idiopathic pulmonary fibrosis and to make the product widely available for the treatment of these patients if the results are positive," said Dr. Andreas Barner, member of the board of managing directors of Boehringer Ingelheim responsible for Research, Development and Medicine.

Prior to receiving regulatory approvals for IPF, tuberculosis, or systemic fungal infections, the agreement provides InterMune with royalties on Imukin(R) net sales above current levels. Imukin(R) is currently approved and marketed for CGD in 36 countries. Boehringer Ingelheim and InterMune plan to immediately seek expedited EU approvals for Imukin(R) for the treatment of severe, malignant osteopetrosis, an indication for which ACTIMMUNE(R) is already approved in the United States. InterMune also plans to expand its Phase III clinical development programs to target approvals in the expanded international markets.

InterMune is a biotechnology company dedicated to the development and commercialization of innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune currently markets ACTIMMUNE(R) (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis and is in Phase III clinical trials for the treatment of idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis (MDR TB). The company also markets Amphotec(R), an FDA-approved lipid-complexed form of amphotericin B for the treatment of invasive aspergillosis, a life-threatening fungal infection.

For more information about InterMune and ACTIMMUNE(R), please visit InterMune's web sites at www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.

The Boehringer Ingelheim group of companies, with headquarters in Ingelheim, Germany, is one of the 20 leading pharmaceutical companies in the world. In 1999, it posted revenues of almost DM 10 billion. Boehringer Ingelheim has some 140 affiliated companies worldwide. The focus is on the human pharmaceutical and animal health businesses. The human pharmaceutical business, which accounts for 92% of sales, mainly includes prescription medicines and products for consumer health care but also products for industrial customers (chemicals and biopharmaceuticals). Substantial research and development, production, and distribution facilities are located around the globe. In 1999, Boehringer Ingelheim spent DM 1.6 billion on R&D, equivalent to 16% of net sales.

For more information on Boehringer Ingelheim, please see the Internet website http://www.boehringer-ingelheim.com.

For more information, call 650-409-2028 or 415-433-5381.

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