AMBISOME PACKAGE INSERT PDF

While case reports have suggested there may be a role for long-term therapy to prevent relapses in HIV coinfected patients Lopez-Dupla, et al. J Antimicrob Chemother ; , there are no data to date documenting the efficacy or safety of repeat courses of AmBisome or of maintenance therapy with this drug among immunocompromised patients. Contraindications AmBisome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk. Warnings Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including AmBisome. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome.

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While case reports have suggested there may be a role for long-term therapy to prevent relapses in HIV coinfected patients Lopez-Dupla, et al. J Antimicrob Chemother ; , there are no data to date documenting the efficacy or safety of repeat courses of AmBisome or of maintenance therapy with this drug among immunocompromised patients.

Contraindications AmBisome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk. Warnings Anaphylaxis has been reported with amphotericin B deoxycholate and other amphotericin B-containing drugs, including AmBisome. If a severe anaphylactic reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome.

Precautions General 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.

AmBisome has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur. Laboratory Tests Patient management should include laboratory evaluation of renal, hepatic and hematopoietic function, and serum electrolytes particularly magnesium and potassium. Drug-Laboratory Interactions: Serum phosphate false elevation False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay e.

This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples. Antineoplastic agents should be given concomitantly with caution. If used concomitantly, serum electrolytes and cardiac function should be closely monitored. Digitalis Glycosides Concurrent use may induce hypokalemia and may potentiate digitalis toxicity.

When administered concomitantly, serum potassium levels should be closely monitored. Azoles e. Combination therapy should be administered with caution, especially in immunocompromised patients. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.

Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to evaluate carcinogenic potential of AmBisome. AmBisome has not been tested to determine its mutagenic potential. AmBisome did not affect fertility or days to copulation. There were no effects on male reproductive function. Pregnancy There have been no adequate and well-controlled studies of AmBisome in pregnant women.

Systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small. Segment II studies in both rats and rabbits have concluded that AmBisome had no teratogenic potential in these species.

Rabbits receiving the higher doses, equivalent to 0. AmBisome should only be used during pregnancy if the possible benefits to be derived outweigh the potential risks involved.

Nursing Mothers Many drugs are excreted in human milk; however, it is not known whether AmBisome is excreted in human milk.

Due to the potential for serious adverse reactions in breastfed 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. Pediatric Use Pediatric patients, age 1 month to 16 years, with presumed fungal infection empirical therapy , confirmed systemic fungal infections or with visceral leishmaniasis have been successfully treated with AmBisome. In studies which included pediatric patients administered AmBisome, there was no evidence of any differences in efficacy or safety of AmBisome compared to adults.

Since pediatric patients have received AmBisome at doses comparable to those used in adults on a per kilogram body weight basis, no dosage adjustment is required in this population. Elderly Patients Experience with AmBisome in the elderly 65 years or older comprised 72 patients.

It has not been necessary to alter the dose of AmBisome for this population. As with most other drugs, elderly patients receiving AmBisome should be carefully monitored. Adverse Reactions The following adverse events are based on the experience of adult patients treated with AmBisome and treated with amphotericin B deoxycholate and 95 pediatric patients 48 treated with AmBisome and 47 treated with amphotericin B deoxycholate in Study , a randomized double-blind, multi-center study in febrile, neutropenic patients.

AmBisome and amphotericin B were infused over two hours.

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AMBISOME PACKAGE INSERT PDF

The primary endpoint was safety and the study was not designed to draw statistically meaningful conclusions related to efficacy. Abelcet is not labeled for this indication. Important Safety Information and Indications Contraindications AmBisome is contraindicated in those patients who have demonstrated or have a known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product, unless benefit of therapy outweighs the risk. Warnings and Precautions Anaphylaxis has been reported with amphotericin B—containing drugs, including AmBisome. If a severe reaction occurs, the AmBisome infusion should be immediately discontinued and the patient should not receive further infusions of AmBisome. General: During the initial dosing period, patients should be under close observation.

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Amphotericin B for Injection, USP

Muramar False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay e. Back to top Gilead Sciences Ltd contact details. Withdraw the calculated volume of reconstituted AmBisome into a sterile syringe. The effect of renal impairment on the pharmacokinetics of L-AmB has not been formally akbisome. During the initial dosing period, patients should be under close observation.

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