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Abelcet (Amphotericin B Lipid Complex)
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Pharmacology
The active component in amphotericin B lipid complex injection is amphotericin B which acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action.
Pharmacokinetics : The pharmacokinetics of amphotericin B after the administration of amphotericin B lipid complex injection are nonlinear. Volume of distribution and clearance from blood increase with increasing dose of amphotericin B lipid complex injection, resulting in less than proportional increases in blood concentrations of amphotericin B over a dose range of 0.6 to 5 mg/kg/day.
The large volume of distribution and high clearance value from the blood of amphotericin B after the administration of amphotericin B lipid complex injection probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of amphotericin B lipid complex injection 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of amphotericin B lipid complex injection has not been studied.
This pattern of distribution is consistent with that observed in preclinical studies in dogs in which greatest concentrations of amphotericin B after amphotericin B lipid complex injection administration were observed in the liver, spleen, and lung; however, the relationship of tissue concentrations of amphotericin B to its biological activity when administered as amphotericin B lipid complex injection is unknown.
The active component in amphotericin B lipid complex injection is amphotericin B which acts by binding to sterols in the cell membrane of susceptible fungi, with a resultant change in permeability of the membrane. Mammalian cell membranes also contain sterols, and damage to human cells is believed to occur through the same mechanism of action.
Pharmacokinetics : The pharmacokinetics of amphotericin B after the administration of amphotericin B lipid complex injection are nonlinear. Volume of distribution and clearance from blood increase with increasing dose of amphotericin B lipid complex injection, resulting in less than proportional increases in blood concentrations of amphotericin B over a dose range of 0.6 to 5 mg/kg/day.
The large volume of distribution and high clearance value from the blood of amphotericin B after the administration of amphotericin B lipid complex injection probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of amphotericin B lipid complex injection 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of amphotericin B lipid complex injection has not been studied.
This pattern of distribution is consistent with that observed in preclinical studies in dogs in which greatest concentrations of amphotericin B after amphotericin B lipid complex injection administration were observed in the liver, spleen, and lung; however, the relationship of tissue concentrations of amphotericin B to its biological activity when administered as amphotericin B lipid complex injection is unknown.
Indications
The Active Component In Amphotericin B Lipid Complex Injection Is Amphotericin B Which Acts By Binding To Sterols In The Cell Membrane Of Susceptible Fungi, With A Resultant Change In Permeability Of The Membrane. Mammalian Cell Membranes Also Contain Sterols, And Damage To Human Cells Is Believed To Occur Through The Same Mechanism Of Action.
Pharmacokinetics : The Pharmacokinetics Of Amphotericin B After The Administration Of Amphotericin B Lipid Complex Injection Are Nonlinear. Volume Of Distribution And Clearance From Blood Increase With Increasing Dose Of Amphotericin B Lipid Complex Injection, Resulting In Less Than Proportional Increases In Blood Concentrations Of Amphotericin B Over A Dose Range Of 0.6 To 5 Mg/kg/day.
The Large Volume Of Distribution And High Clearance Value From The Blood Of Amphotericin B After The Administration Of Amphotericin B Lipid Complex Injection Probably Reflect Uptake By Tissues. The Long Terminal Elimination Half-life Probably Reflects A Slow Redistribution From Tissues. Although Amphotericin B Is Excreted Slowly, There Is Little Accumulation In The Blood After Repeated Dosing. AUC Of Amphotericin B Increased Approximately 34% From Day 1 After The Administration Of Amphotericin B Lipid Complex Injection 5 Mg/kg/day For 7 Days. The Effect Of Gender Or Ethnicity On The Pharmacokinetics Of Amphotericin B Lipid Complex Injection Has Not Been Studied.
This Pattern Of Distribution Is Consistent With That Observed In Preclinical Studies In Dogs In Which Greatest Concentrations Of Amphotericin B After Amphotericin B Lipid Complex Injection Administration Were Observed In The Liver, Spleen, And Lung; However, The Relationship Of Tissue Concentrations Of Amphotericin B To Its Biological Activity When Administered As Amphotericin B Lipid Complex Injection Is Unknown.
The Active Component In Amphotericin B Lipid Complex Injection Is Amphotericin B Which Acts By Binding To Sterols In The Cell Membrane Of Susceptible Fungi, With A Resultant Change In Permeability Of The Membrane. Mammalian Cell Membranes Also Contain Sterols, And Damage To Human Cells Is Believed To Occur Through The Same Mechanism Of Action.
Pharmacokinetics : The Pharmacokinetics Of Amphotericin B After The Administration Of Amphotericin B Lipid Complex Injection Are Nonlinear. Volume Of Distribution And Clearance From Blood Increase With Increasing Dose Of Amphotericin B Lipid Complex Injection, Resulting In Less Than Proportional Increases In Blood Concentrations Of Amphotericin B Over A Dose Range Of 0.6 To 5 Mg/kg/day.
The Large Volume Of Distribution And High Clearance Value From The Blood Of Amphotericin B After The Administration Of Amphotericin B Lipid Complex Injection Probably Reflect Uptake By Tissues. The Long Terminal Elimination Half-life Probably Reflects A Slow Redistribution From Tissues. Although Amphotericin B Is Excreted Slowly, There Is Little Accumulation In The Blood After Repeated Dosing. AUC Of Amphotericin B Increased Approximately 34% From Day 1 After The Administration Of Amphotericin B Lipid Complex Injection 5 Mg/kg/day For 7 Days. The Effect Of Gender Or Ethnicity On The Pharmacokinetics Of Amphotericin B Lipid Complex Injection Has Not Been Studied.
This Pattern Of Distribution Is Consistent With That Observed In Preclinical Studies In Dogs In Which Greatest Concentrations Of Amphotericin B After Amphotericin B Lipid Complex Injection Administration Were Observed In The Liver, Spleen, And Lung; However, The Relationship Of Tissue Concentrations Of Amphotericin B To Its Biological Activity When Administered As Amphotericin B Lipid Complex Injection Is Unknown.
Contraindications
In patients who have shown hypersensitivity to amphotericinB or any other component in the formulation.
In patients who have shown hypersensitivity to amphotericinB or any other component in the formulation.
Safety Information / Warning
Anaphylaxis has been reported with amphotericinB desoxycholate and other amphotericinB-containing drugs. Anaphylaxis has been rarely reported with amphotericin B lipid complex injection with an incidence of <0.1%. Facilities for cardiopulmonary resuscitation should be available during administration due to the possibility of anaphylactoid reaction. If severe respiratory distress occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of amphotericin B lipid complex injection.
Anaphylaxis has been reported with amphotericinB desoxycholate and other amphotericinB-containing drugs. Anaphylaxis has been rarely reported with amphotericin B lipid complex injection with an incidence of <0.1%. Facilities for cardiopulmonary resuscitation should be available during administration due to the possibility of anaphylactoid reaction. If severe respiratory distress occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of amphotericin B lipid complex injection.
Precautions
General: As with any amphotericinB-containing product, during the initial dosing of amphotericin B lipid complex injection, the drug should be administered i.v. under close clinical observation by medically trained personnel.
Acute reactions including fever and chills may occur 1 to 2 hours after starting an i.v. infusion of amphotericin B lipid complex injection. These reactions are usually more common with the first few doses of amphotericin B lipid complex injection and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.
Renal toxicity of doses greater than 5 mg/kg/day of amphotericin B lipid complex injection has not been formally studied. Despite generally less nephrotoxicity of amphotericin B lipid complex injection observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6 to 1 mg/kg/day, dose-limiting renal toxicity may still be observed with amphotericin B lipid complex injection.
Geriatrics: Forty-nine elderly patients, age 65 years or over, have been treated with amphotericin B lipid complex injection at 5 mg/kg/day in 2 open-label studies and 1 small, prospective, single-arm study. No serious drug related adverse events have been reported that might not be expected from the general patient population.
Children: One hundred eleven children (2 were enrolled twice and counted as separate patients) age 16 years and under, of whom 11 were less than 1 year, have been treated with amphotericin B lipid complex injection at 5 mg/kg/day in 2 open-label studies and 1 small, prospective, single-arm study. No serious drug related adverse events have been reported that might not be expected from the general patient population.
Pregnancy : There are no reports of pregnant women having been treated with amphotericin B lipid complex injection. Reproductive studies in rats and rabbits at doses of amphotericin B lipid complex injection up to 0.64times the human dose revealed no harm to the fetus. Because animal reproductive studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, amphotericin B lipid complex injection should be used during pregnancy only after taking into account the importance of the drug to the mother.
Lactation : It is not known whether amphotericin B lipid complex injection is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from amphotericin B lipid complex injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Special Diseases or Conditions: Hepatic Impairment: The effect of hepatic impairment on the disposition of amphotericin B lipid complex injection is not known. The metabolic pathways of amphotericin B lipid complex injection are not known.
Renal Impairment: The effect of renal impairment on the disposition of amphotericin B lipid complex injection is not known. The effect of dialysis on the elimination of amphotericin B lipid complex injection has not been studied; however, amphotericin B is not removed by hemodialysis when administered as amphotericin B desoxycholate.
Laboratory Tests Interactions : Serum creatinine should be monitored frequently during amphotericin B lipid complex injection therapy. It is also advisable to regularly monitor liver function, serum electrolytes (particularly magnesium and potassium) and complete blood counts.
Dependence Liability: Amphotericin B lipid complex injection is not addictive.
Drug Interactions : No formal clinical studies of drug interactions have been conducted with amphotericin B lipid complex injection. However, when administered concomitantly, the following drugs are known to interact with amphotericin B; therefore, the following drugs may interact with amphotericin B lipid complex injection:
Antineoplastic Agents: Concurrent use of antineoplastic agents and amphotericin B may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with amphotericin B lipid complex injection with great caution.
Corticosteroids and Corticotropin (ACTH): Concurrent use of corticosteroids and corticotropin (ACTH) with amphotericin B may potentiate hypokalemia which could predispose the patient to cardiac dysfunction. If used concomitantly with amphotericin B lipid complex injection, serum electrolytes and cardiac function should be closely monitored.
Cyclosporin A: Data from a prospective study of prophylactic amphotericin B lipid complex injection in 22 patients undergoing bone marrow transplantation suggested that concurrent initiation of cyclosporin A and amphotericin B lipid complex injection within several days of bone marrow ablation may be associated with increased nephrotoxicity.
Digitalis Glycosides: Concurrent use of amphotericin B may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly with amphotericin B lipid complex injection, serum potassium levels should be closely monitored.
Flucytosine: Concurrent use of flucytosine with amphotericin B-containing preparations may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Flucytosine should be given concomitantly with amphotericin B lipid complex injection with caution.
Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): Antagonism between amphotericin B and imidazole derivatives such as miconazole and ketoconazole, which inhibit ergosterol synthesis, has been reported in both in vitro and in vivo animal studies. The clinical significance of these findings has not been determined.
Leukocyte Transfusions: Acute pulmonary toxicity has been reported in patients receiving i.v. amphotericin B and leukocyte transfusions. Leukocyte transfusions and amphotericin B lipid complex injection should not be given concurrently.
Other Nephrotoxic Medications: Concurrent use of amphotericin B and agents such as aminoglycosides and pentamidine may enhance the potential for drug-induced renal toxicity. Aminoglycosides and pentamidine should be used concomitantly with amphotericin B lipid complex injection only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.
Skeletal Muscle Relaxants: AmphotericinB-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine) due to hypokalemia. When administered concomitantly with amphotericin B lipid complex injection, serum potassium levels should be closely monitored.
Zidovudine: Increased myelotoxicity and nephrotoxicity were observed in dogs when either amphotericin B lipid complex injection (at doses 0.16 or 0.5 times the recommended human dose) or amphotericin B desoxycholate (at 0.5 times the recommended human dose) were administered concomitantly with zidovudine for 30 days. If zidovudine is used concomitantly with amphotericin B lipid complex injection, renal and hematologic function should be closely monitored.
General: As with any amphotericinB-containing product, during the initial dosing of amphotericin B lipid complex injection, the drug should be administered i.v. under close clinical observation by medically trained personnel.
Acute reactions including fever and chills may occur 1 to 2 hours after starting an i.v. infusion of amphotericin B lipid complex injection. These reactions are usually more common with the first few doses of amphotericin B lipid complex injection and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.
Renal toxicity of doses greater than 5 mg/kg/day of amphotericin B lipid complex injection has not been formally studied. Despite generally less nephrotoxicity of amphotericin B lipid complex injection observed at a dose of 5 mg/kg/day compared with conventional amphotericin B therapy at a dose range of 0.6 to 1 mg/kg/day, dose-limiting renal toxicity may still be observed with amphotericin B lipid complex injection.
Geriatrics: Forty-nine elderly patients, age 65 years or over, have been treated with amphotericin B lipid complex injection at 5 mg/kg/day in 2 open-label studies and 1 small, prospective, single-arm study. No serious drug related adverse events have been reported that might not be expected from the general patient population.
Children: One hundred eleven children (2 were enrolled twice and counted as separate patients) age 16 years and under, of whom 11 were less than 1 year, have been treated with amphotericin B lipid complex injection at 5 mg/kg/day in 2 open-label studies and 1 small, prospective, single-arm study. No serious drug related adverse events have been reported that might not be expected from the general patient population.
Pregnancy : There are no reports of pregnant women having been treated with amphotericin B lipid complex injection. Reproductive studies in rats and rabbits at doses of amphotericin B lipid complex injection up to 0.64times the human dose revealed no harm to the fetus. Because animal reproductive studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, amphotericin B lipid complex injection should be used during pregnancy only after taking into account the importance of the drug to the mother.
Lactation : It is not known whether amphotericin B lipid complex injection is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from amphotericin B lipid complex injection, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Special Diseases or Conditions: Hepatic Impairment: The effect of hepatic impairment on the disposition of amphotericin B lipid complex injection is not known. The metabolic pathways of amphotericin B lipid complex injection are not known.
Renal Impairment: The effect of renal impairment on the disposition of amphotericin B lipid complex injection is not known. The effect of dialysis on the elimination of amphotericin B lipid complex injection has not been studied; however, amphotericin B is not removed by hemodialysis when administered as amphotericin B desoxycholate.
Laboratory Tests Interactions : Serum creatinine should be monitored frequently during amphotericin B lipid complex injection therapy. It is also advisable to regularly monitor liver function, serum electrolytes (particularly magnesium and potassium) and complete blood counts.
Dependence Liability: Amphotericin B lipid complex injection is not addictive.
Drug Interactions : No formal clinical studies of drug interactions have been conducted with amphotericin B lipid complex injection. However, when administered concomitantly, the following drugs are known to interact with amphotericin B; therefore, the following drugs may interact with amphotericin B lipid complex injection:
Antineoplastic Agents: Concurrent use of antineoplastic agents and amphotericin B may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with amphotericin B lipid complex injection with great caution.
Corticosteroids and Corticotropin (ACTH): Concurrent use of corticosteroids and corticotropin (ACTH) with amphotericin B may potentiate hypokalemia which could predispose the patient to cardiac dysfunction. If used concomitantly with amphotericin B lipid complex injection, serum electrolytes and cardiac function should be closely monitored.
Cyclosporin A: Data from a prospective study of prophylactic amphotericin B lipid complex injection in 22 patients undergoing bone marrow transplantation suggested that concurrent initiation of cyclosporin A and amphotericin B lipid complex injection within several days of bone marrow ablation may be associated with increased nephrotoxicity.
Digitalis Glycosides: Concurrent use of amphotericin B may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly with amphotericin B lipid complex injection, serum potassium levels should be closely monitored.
Flucytosine: Concurrent use of flucytosine with amphotericin B-containing preparations may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Flucytosine should be given concomitantly with amphotericin B lipid complex injection with caution.
Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): Antagonism between amphotericin B and imidazole derivatives such as miconazole and ketoconazole, which inhibit ergosterol synthesis, has been reported in both in vitro and in vivo animal studies. The clinical significance of these findings has not been determined.
Leukocyte Transfusions: Acute pulmonary toxicity has been reported in patients receiving i.v. amphotericin B and leukocyte transfusions. Leukocyte transfusions and amphotericin B lipid complex injection should not be given concurrently.
Other Nephrotoxic Medications: Concurrent use of amphotericin B and agents such as aminoglycosides and pentamidine may enhance the potential for drug-induced renal toxicity. Aminoglycosides and pentamidine should be used concomitantly with amphotericin B lipid complex injection only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.
Skeletal Muscle Relaxants: AmphotericinB-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine) due to hypokalemia. When administered concomitantly with amphotericin B lipid complex injection, serum potassium levels should be closely monitored.
Zidovudine: Increased myelotoxicity and nephrotoxicity were observed in dogs when either amphotericin B lipid complex injection (at doses 0.16 or 0.5 times the recommended human dose) or amphotericin B desoxycholate (at 0.5 times the recommended human dose) were administered concomitantly with zidovudine for 30 days. If zidovudine is used concomitantly with amphotericin B lipid complex injection, renal and hematologic function should be closely monitored.
Side Effects / Adverse Effects
The total safety data base is composed of 921patients treated with amphotericin B lipid complex injection, (5patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in 4 comparative studies, 25 were treated in open-label, noncomparative studies, and 556 patients were treated in an open-label, emergency-use program. These 556 patients were treated for their invasive fungal infections, and were refractory to or intolerant of conventional amphotericin B therapy. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with amphotericin B lipid complex injection, 9% of amphotericin B lipid complex injection patients discontinued treatment due to adverse events, regardless of presumed relationship to drug.
In general, the adverse events most commonly reported with amphotericin B lipid complex injection were transient chills and fever during infusion of the drug. TableIII lists the most frequently reported adverse events.
Body as a Whole: anorexia, malaise, weight loss, deafness, injection site reaction including inflammation.
Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions.
Cardiopulmonary: cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.
Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme.
Gastrointestinal: acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis.
Hematologic: coagulation defects, leukocytosis, blood dyscrasias including eosinophilia.
Musculoskeletal: myasthenia, including bone, muscle, and joint pains.
Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, tremors, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms.
Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria.
Altered Laboratory Findings: Serum Electrolyte Abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia.
Liver Function Test Abnormalities: increased AST, ALT, alkaline phosphatase, LDH.
Renal Function Test Abnormalities: increased BUN.
Other Test Abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia.
The total safety data base is composed of 921patients treated with amphotericin B lipid complex injection, (5patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in 4 comparative studies, 25 were treated in open-label, noncomparative studies, and 556 patients were treated in an open-label, emergency-use program. These 556 patients were treated for their invasive fungal infections, and were refractory to or intolerant of conventional amphotericin B therapy. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with amphotericin B lipid complex injection, 9% of amphotericin B lipid complex injection patients discontinued treatment due to adverse events, regardless of presumed relationship to drug.
In general, the adverse events most commonly reported with amphotericin B lipid complex injection were transient chills and fever during infusion of the drug. TableIII lists the most frequently reported adverse events.
Body as a Whole: anorexia, malaise, weight loss, deafness, injection site reaction including inflammation.
Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions.
Cardiopulmonary: cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.
Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme.
Gastrointestinal: acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis.
Hematologic: coagulation defects, leukocytosis, blood dyscrasias including eosinophilia.
Musculoskeletal: myasthenia, including bone, muscle, and joint pains.
Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, tremors, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms.
Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria.
Altered Laboratory Findings: Serum Electrolyte Abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia.
Liver Function Test Abnormalities: increased AST, ALT, alkaline phosphatase, LDH.
Renal Function Test Abnormalities: increased BUN.
Other Test Abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia.
Overdose
Symptoms and Treatment: AmphotericinB desoxycholate overdose has been reported to result in cardiorespiratory arrest. Twelve patients have been reported to have received 2 or more doses of amphotericin B lipid complex injections between 7 and 13mg/kg. None of these patients had a serious acute reaction to amphotericin B lipid complex injection. If an overdose is suspected, discontinue therapy, monitor the patient's clinical status, and administer supportive therapy as required. Amphotericin B lipid complex injection is not hemodialyzable .
Symptoms and Treatment: AmphotericinB desoxycholate overdose has been reported to result in cardiorespiratory arrest. Twelve patients have been reported to have received 2 or more doses of amphotericin B lipid complex injections between 7 and 13mg/kg. None of these patients had a serious acute reaction to amphotericin B lipid complex injection. If an overdose is suspected, discontinue therapy, monitor the patient's clinical status, and administer supportive therapy as required. Amphotericin B lipid complex injection is not hemodialyzable .
Recommended Dosage
The recommended daily dosage for adults and children (see Precautions) is 5 mg/kg given as a single infusion. Amphotericin B lipid complex injection should be administered by i.v. infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, resuspend the contents by shaking the infusion bag every 2 hours. Facilities for cardiopulmonary resuscitation should be available during administration due to the possibility of anaphylactoid reaction.
The median and mean duration of amphotericin B lipid complex injection treatment was 22 days and 33 days, respectively. Amphotericin B lipid complex injection has been administered for as long as 17 months, and cumulative doses have been as high as 56.6g.
Renal Impairment: Renal toxicity of amphotericin B lipid complex injection, as measured by serum creatinine levels, has been shown to be dose dependent. There are no firm guidelines for dose adjustment based on laboratory test results and decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient (see Precautions and Overdose: Symptoms and Treatment). Some patients with elevated serum creatinine levels have improved renal function while on amphotericin B lipid complex injection treatment.
Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.
Preparation of Admixture for Infusion: Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose from the required number of vials into 1 or more sterile 20mL syringes using an 18-gauge needle. Remove the needle from each syringe filled with amphotericin B lipid complex injection and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100mg vials or eight 50mg vials. Insert the filter needle of the syringe into an i.v. bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 to 2 mg/mL. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of Abelcet since no bacteriostatic agent or preservative is present.
Do not dilute with saline solutions or mix with other drugs or electrolytes as the compatibility of amphotericin B lipid complex injection with these materials has not been established. An existing i.v. line should be flushed with 5% Dextrose Injection before infusion, or a separate infusion line should be used. Do not use an in-line filter.
The diluted ready-for-use admixture is stable for up to 48 hours at 2 to 8°C and an additional 6 hours at room temperature.
Stability and Storage: Prior to admixture, store at 2 to 8°C and protect from exposure to light. Do not freeze. Retain in the carton until time of use.
The admixture and 5% Dextrose Injection may be stored for up to 48 hours at 2 to 8°C and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.
The recommended daily dosage for adults and children (see Precautions) is 5 mg/kg given as a single infusion. Amphotericin B lipid complex injection should be administered by i.v. infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, resuspend the contents by shaking the infusion bag every 2 hours. Facilities for cardiopulmonary resuscitation should be available during administration due to the possibility of anaphylactoid reaction.
The median and mean duration of amphotericin B lipid complex injection treatment was 22 days and 33 days, respectively. Amphotericin B lipid complex injection has been administered for as long as 17 months, and cumulative doses have been as high as 56.6g.
Renal Impairment: Renal toxicity of amphotericin B lipid complex injection, as measured by serum creatinine levels, has been shown to be dose dependent. There are no firm guidelines for dose adjustment based on laboratory test results and decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient (see Precautions and Overdose: Symptoms and Treatment). Some patients with elevated serum creatinine levels have improved renal function while on amphotericin B lipid complex injection treatment.
Hepatic Impairment: No dose adjustment is required for patients with hepatic impairment.
Preparation of Admixture for Infusion: Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose from the required number of vials into 1 or more sterile 20mL syringes using an 18-gauge needle. Remove the needle from each syringe filled with amphotericin B lipid complex injection and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100mg vials or eight 50mg vials. Insert the filter needle of the syringe into an i.v. bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 to 2 mg/mL. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of Abelcet since no bacteriostatic agent or preservative is present.
Do not dilute with saline solutions or mix with other drugs or electrolytes as the compatibility of amphotericin B lipid complex injection with these materials has not been established. An existing i.v. line should be flushed with 5% Dextrose Injection before infusion, or a separate infusion line should be used. Do not use an in-line filter.
The diluted ready-for-use admixture is stable for up to 48 hours at 2 to 8°C and an additional 6 hours at room temperature.
Stability and Storage: Prior to admixture, store at 2 to 8°C and protect from exposure to light. Do not freeze. Retain in the carton until time of use.
The admixture and 5% Dextrose Injection may be stored for up to 48 hours at 2 to 8°C and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.
Supplied / Packaging
Each mL of yellow, opaque, sterile, pyrogen-free suspension contains: amphotericin B 5 mg, combined with 2 phospholipids in roughly a 1:1 drug-to-lipid weight ratio. Nonmedicinal ingredients: 1-a-dimyristoylphosphatidylcholine (DMPC), 1-a-dimyristoylphosphatidylglycerol (DMPG), sodium chloride and water for injection. pH of 5 to 7. Single use, glass vials of 10mL (50 mg) and 20 mL (100 mg), along with filter needles individually packaged. Store at 2 to 8°C and protect from exposure to light. Do not freeze. Retain in the carton until time of use.
Each mL of yellow, opaque, sterile, pyrogen-free suspension contains: amphotericin B 5 mg, combined with 2 phospholipids in roughly a 1:1 drug-to-lipid weight ratio. Nonmedicinal ingredients: 1-a-dimyristoylphosphatidylcholine (DMPC), 1-a-dimyristoylphosphatidylglycerol (DMPG), sodium chloride and water for injection. pH of 5 to 7. Single use, glass vials of 10mL (50 mg) and 20 mL (100 mg), along with filter needles individually packaged. Store at 2 to 8°C and protect from exposure to light. Do not freeze. Retain in the carton until time of use.
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Brand Name
Abelcet
Abelcet
Generic Name
Amphotericin B Lipid Complex
Amphotericin B Lipid Complex
General Indications
Antifungal
Antifungal
