( 1/1,000 to < 1/100)

(<1/10,000), not known (cannot be estimated from the available data)

BLOOD AND LYMPHATIC SYSTEM DISORDERS

Uncommon: thrombocytopenia

Not known: anemia

IMMUNE SYSTEM DISORDERS

Uncommon: anaphylactoid reaction

Not known: anaphylactic reactions, hypersensitivity

METABOLISM AND NUTRITION DISORDERS

Very common: hypokalemia

Common: hyponatremia, hypocalcemia, hypomagnesaemia hyperglycemia,

NERVOUS SYSTEM DISORDERS

Common: headache

Uncommon: convulsion

CARDIAC DISORDERS

Common: tachycardia

Not known: cardiac arrest, arrhythmia

VASCULAR DISORDERS

Common: hypotension, vasodilatation, flushing,

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

Common: dyspnoea

Uncommon: bronchospasm

GASTROINTESTINAL DISORDERS

Very common: nausea, vomiting

Common: diarrhoea, abdominal pain

HEPATOBILIARY DISORDERS

Common: liver function tests abnormal, hyperbilirubinaemia, alkaline phosphatase increased

SKIN AND SUBCUTANEOUS DISORDERS

Common: rash

Not known: angioneurotic oedema

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Common: back pain

Not Known: rhabdomyolysis (associated with hypokalemia), musculoskeletal pain (described as arthralgia or bone pain)

RENAL AND URINARY DISORDERS

Common: increased creatinine, blood urea increased

Not known: renal failure, renal insufficiency

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

Very Common: rigors, pyrexia,

Common: chest pain

Interference with Phosphorus Chemistry Assay:

False elevations of serum phosphate may occur when samples from patients receiving AmBisome are analyzed using the PHOSm assay (e.g. used in Beckman Coulter analyzers including the Synchron LX20). This assay is intended for the quantitative determination of inorganic phosphorus in human serum, plasma or urine samples.

Go to top of the page4.9 Overdose
 The toxicity of AmBisome due to acute overdose has not been defined. If overdose should occur, cease administration immediately. Carefully monitor clinical status including renal and hepatic function, serum electrolytes and haematological status. Haemodialysis or peritoneal dialysis does not appear to affect the elimination of AmBisome.

Go to top of the page5. PHARMACOLOGICAL PROPERTIES

Go to top of the page5.1 Pharmacodynamic properties
 ATC classification

Pharmacotherapeutic group: Antimycotics for systemic use, antibiotics; ATC code: J02AA01.

Mode of action

Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. Amphotericin B is fungistatic or fungicidal depending on the concentration attained in body fluids and the susceptibility of the fungus. The drug is thought to act by binding to sterols in the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules.

Mammalian cell membranes also contain sterols, and it has been suggested that the damage to human cells and fungal cells caused by amphotericin B may share common mechanisms. The lipophilic moiety of amphotericin allows the drug to be integrated into the lipid bilayer of the liposomes. Liposomes are closed, spherical vesicles formed from a variety of amphip