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Drug overview for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
Generic name: amikacin sulfate liposomal with nebulizer accessories (AM-i-KAY-sin)
Drug class: Inhaled Aminoglycosides
Therapeutic class: Anti-Infective Agents
Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin A.
No enhanced Uses information available for this drug.
Generic name: amikacin sulfate liposomal with nebulizer accessories (AM-i-KAY-sin)
Drug class: Inhaled Aminoglycosides
Therapeutic class: Anti-Infective Agents
Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin A.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories) have been approved by the FDA:
Indications:
Refractory Mycobacterium avium complex pulmonary disease
Professional Synonyms:
None.
Indications:
Refractory Mycobacterium avium complex pulmonary disease
Professional Synonyms:
None.
The following dosing information is available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
Dosage of amikacin sulfate is expressed in terms of amikacin. IM and IV dosage is identical.
Like other aminoglycosides, dosage of amikacin should be individualized taking into consideration the patient's pretreatment body weight, renal status, severity of the infection, and susceptibility of the causative organism. Many clinicians recommend that amikacin dosage be determined using appropriate pharmacokinetic methods for calculating dosage requirements and patient-specific pharmacokinetic parameters (e.g., elimination rate constant, volume of distribution) derived from serum concentration-time data.
Whenever possible, especially in patients with life-threatening infections, suspected toxicity or nonresponse to treatment, decreased or varying renal function, and/or when increased aminoglycoside clearance (e.g., patients with cystic fibrosis, burns) or prolonged therapy is likely, peak and trough serum concentrations of amikacin should be determined periodically and dosage should be adjusted to maintain desired serum concentrations. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.) A causal relationship between maintenance of certain peak or trough serum concentrations or other pharmacodynamic endpoints and clinical response or toxicity has not been established to date for amikacin dosing regimens. However, for amikacin administered in conventional dosage regimens (i.e., multiple daily doses), peak serum concentrations of 15-30 and trough concentrations less than 5-10 mcg/mL have been suggested.
Amikacin serum concentrations greater than 30-35 mcg/mL may be associated with toxicity. The manufacturers recommend that peak serum concentrations (30-90 minutes after injection) greater than 35 mcg/mL and trough serum concentrations (just prior to the next dose) greater than 10 mcg/mL should be avoided.
Parenteral aminoglycosides historically have been administered in dosage regimens that include multiple daily doses, and current prescribing information for IM or IV amikacin only includes dosage regimens that involve multiple daily doses (usually 2 or 3 doses daily). However, there is evidence that once-daily+ (single-daily) aminoglycoside dosage regimens are at least as effective as, may provide superior pharmacokinetics, and may be less toxic than conventional dosage regimens employing multiple daily doses. Once-daily parenteral aminoglycoside regimens should not be used in all patients.
Additional controlled studies in children, patients with renal dysfunction, and other appropriate patient groups are needed to fully define the optimal use of once-daily aminoglycoside dosing regimens. In addition, the most appropriate methods for optimizing dosage selection for once-daily regimens and monitoring serum aminoglycoside concentrations in patients receiving such regimens have not been clearly established. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.)
The usual duration of amikacin treatment is 7-10 days. The manufacturers state that safety of amikacin treatment for longer than 14 days has not been established. If a clinical response does not occur within 3-5 days, amikacin should be discontinued and in vitro susceptibility to the drug should be reassessed.
In difficult and complicated infections, use of amikacin should be re-evaluated if treatment longer than 10 days is being considered. If the drug is continued, serum amikacin concentrations and renal, auditory, and vestibular functions should be monitored closely.
The maximum dosage of amikacin recommended by the manufacturers is 15 mg/kg (up to 1.5 g) daily.
If IM or IV amikacin is used for the treatment of serious infections caused by susceptible bacteria in adults with normal renal function, the usual adult dosage recommended by the manufacturers is 15 mg/kg daily given in 2 or 3 equally divided doses (i.e., 5 mg/kg every 8 hours or 7.5 mg/kg every 12 hours).
Adults have received amikacin in a once-daily+ regimen of 15 mg/kg once daily.
The manufacturers state that amikacin should be used with caution in premature and full-term neonates because renal immaturity in these patients may result in a prolonged serum half-life of the drug.
When IM or IV amikacin is used in neonates, the manufacturers recommend an initial loading dose of 10 mg/kg followed by 7.5 mg/kg every 12 hours.
The American Academy of Pediatrics (AAP) recommends that neonates younger than 1 week of age receive IM or IV amikacin in a dosage of 7.5 mg/kg every 18-24 hours if they weigh less than 1.2 kg, 7.5
mg/kg every 12 hours if they weigh 1.2-2 kg, or 7.5-10 mg/kg every 12 hours if they weigh more than 2 kg.
For neonates 1-4 weeks of age, the AAP recommends a dosage of 7.5 mg/kg every 18-24 hours for those weighing less than 1.2 kg, 7.5-10
mg/kg every 8 or 12 hours for those weighing 1.2-2 kg, and 10 mg/kg every 8 hours for those weighing more than 2 kg. The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Full-term neonates have received amikacin in a once-daily+ regimen of 15 mg/kg once daily.
The usual dosage of IM or IV amikacin recommended by the manufacturers for children and older infants with normal renal function is 15 mg/kg daily given in 2 or 3 equally divided doses (i.e., 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours).
The AAP recommends that pediatric patients beyond the neonatal period receive IM or IV amikacin in a dosage of 15-22.5 mg/kg daily given in 3 equally divided doses for the treatment of severe infections. Some clinicians suggest a dosage of 30 mg/kg daily given in 3 equally divided doses in this age group.
The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Children have received amikacin in a once-daily+ regimen of 15-20 mg/kg once daily.
In patients with impaired renal function, doses and/or frequency of administration of amikacin must be modified in response to serum concentrations of the drug and the degree of renal impairment. There are various methods to determine dosage and a wide variation in dosage recommendations for these patients. However, even when one of these methods is used, peak and trough serum concentrations of the drug should be monitored, especially in patients with changing renal function.
The manufacturers recommend an initial amikacin loading dose of 7.5 mg/kg. For subsequent therapy, the manufacturers state that 7.5-mg/kg
doses can be given at intervals (in hours) calculated by multiplying the patient's steady-state serum creatinine (in mg/dL) by 9. Alternatively, many clinicians recommend the dosing method of Sarubbi and Hull, which is based on corrected creatinine clearance. (See Dosage and Administration: Dosage in Renal Impairment, in the Aminoglycosides General Statement 8:12.02.)
In adults with renal failure undergoing hemodialysis, some clinicians recommend supplemental doses of 50-75% of the initial loading dose at the end of each dialysis period. Others suggest that supplemental amikacin doses may not be necessary in patients undergoing short-term hemodialysis. Serum amikacin concentrations should be monitored in dialysis patients and dosage adjusted as needed to maintain desired serum concentrations.
For the treatment of active tuberculosis+ in adults with renal impairment, the ATS, CDC, and IDSA recommend that usual doses be given at less frequent intervals since use of lower doses may reduce efficacy of the drug. These experts recommend that adults with renal impairment receive amikacin in a dosage of 12-15 mg/kg daily given 2 or 3 times weekly. In addition, if the patient is receiving hemodialysis, the dose should be given after the procedure is finished and serum concentrations of the drug monitored to avoid toxicity.
Like other aminoglycosides, dosage of amikacin should be individualized taking into consideration the patient's pretreatment body weight, renal status, severity of the infection, and susceptibility of the causative organism. Many clinicians recommend that amikacin dosage be determined using appropriate pharmacokinetic methods for calculating dosage requirements and patient-specific pharmacokinetic parameters (e.g., elimination rate constant, volume of distribution) derived from serum concentration-time data.
Whenever possible, especially in patients with life-threatening infections, suspected toxicity or nonresponse to treatment, decreased or varying renal function, and/or when increased aminoglycoside clearance (e.g., patients with cystic fibrosis, burns) or prolonged therapy is likely, peak and trough serum concentrations of amikacin should be determined periodically and dosage should be adjusted to maintain desired serum concentrations. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.) A causal relationship between maintenance of certain peak or trough serum concentrations or other pharmacodynamic endpoints and clinical response or toxicity has not been established to date for amikacin dosing regimens. However, for amikacin administered in conventional dosage regimens (i.e., multiple daily doses), peak serum concentrations of 15-30 and trough concentrations less than 5-10 mcg/mL have been suggested.
Amikacin serum concentrations greater than 30-35 mcg/mL may be associated with toxicity. The manufacturers recommend that peak serum concentrations (30-90 minutes after injection) greater than 35 mcg/mL and trough serum concentrations (just prior to the next dose) greater than 10 mcg/mL should be avoided.
Parenteral aminoglycosides historically have been administered in dosage regimens that include multiple daily doses, and current prescribing information for IM or IV amikacin only includes dosage regimens that involve multiple daily doses (usually 2 or 3 doses daily). However, there is evidence that once-daily+ (single-daily) aminoglycoside dosage regimens are at least as effective as, may provide superior pharmacokinetics, and may be less toxic than conventional dosage regimens employing multiple daily doses. Once-daily parenteral aminoglycoside regimens should not be used in all patients.
Additional controlled studies in children, patients with renal dysfunction, and other appropriate patient groups are needed to fully define the optimal use of once-daily aminoglycoside dosing regimens. In addition, the most appropriate methods for optimizing dosage selection for once-daily regimens and monitoring serum aminoglycoside concentrations in patients receiving such regimens have not been clearly established. (See Dosage and Administration: Dosage, in the Aminoglycosides General Statement 8:12.02.)
The usual duration of amikacin treatment is 7-10 days. The manufacturers state that safety of amikacin treatment for longer than 14 days has not been established. If a clinical response does not occur within 3-5 days, amikacin should be discontinued and in vitro susceptibility to the drug should be reassessed.
In difficult and complicated infections, use of amikacin should be re-evaluated if treatment longer than 10 days is being considered. If the drug is continued, serum amikacin concentrations and renal, auditory, and vestibular functions should be monitored closely.
The maximum dosage of amikacin recommended by the manufacturers is 15 mg/kg (up to 1.5 g) daily.
If IM or IV amikacin is used for the treatment of serious infections caused by susceptible bacteria in adults with normal renal function, the usual adult dosage recommended by the manufacturers is 15 mg/kg daily given in 2 or 3 equally divided doses (i.e., 5 mg/kg every 8 hours or 7.5 mg/kg every 12 hours).
Adults have received amikacin in a once-daily+ regimen of 15 mg/kg once daily.
The manufacturers state that amikacin should be used with caution in premature and full-term neonates because renal immaturity in these patients may result in a prolonged serum half-life of the drug.
When IM or IV amikacin is used in neonates, the manufacturers recommend an initial loading dose of 10 mg/kg followed by 7.5 mg/kg every 12 hours.
The American Academy of Pediatrics (AAP) recommends that neonates younger than 1 week of age receive IM or IV amikacin in a dosage of 7.5 mg/kg every 18-24 hours if they weigh less than 1.2 kg, 7.5
mg/kg every 12 hours if they weigh 1.2-2 kg, or 7.5-10 mg/kg every 12 hours if they weigh more than 2 kg.
For neonates 1-4 weeks of age, the AAP recommends a dosage of 7.5 mg/kg every 18-24 hours for those weighing less than 1.2 kg, 7.5-10
mg/kg every 8 or 12 hours for those weighing 1.2-2 kg, and 10 mg/kg every 8 hours for those weighing more than 2 kg. The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Full-term neonates have received amikacin in a once-daily+ regimen of 15 mg/kg once daily.
The usual dosage of IM or IV amikacin recommended by the manufacturers for children and older infants with normal renal function is 15 mg/kg daily given in 2 or 3 equally divided doses (i.e., 7.5 mg/kg every 12 hours or 5 mg/kg every 8 hours).
The AAP recommends that pediatric patients beyond the neonatal period receive IM or IV amikacin in a dosage of 15-22.5 mg/kg daily given in 3 equally divided doses for the treatment of severe infections. Some clinicians suggest a dosage of 30 mg/kg daily given in 3 equally divided doses in this age group.
The AAP states that the drug is inappropriate for the treatment of mild to moderate infections.
Children have received amikacin in a once-daily+ regimen of 15-20 mg/kg once daily.
In patients with impaired renal function, doses and/or frequency of administration of amikacin must be modified in response to serum concentrations of the drug and the degree of renal impairment. There are various methods to determine dosage and a wide variation in dosage recommendations for these patients. However, even when one of these methods is used, peak and trough serum concentrations of the drug should be monitored, especially in patients with changing renal function.
The manufacturers recommend an initial amikacin loading dose of 7.5 mg/kg. For subsequent therapy, the manufacturers state that 7.5-mg/kg
doses can be given at intervals (in hours) calculated by multiplying the patient's steady-state serum creatinine (in mg/dL) by 9. Alternatively, many clinicians recommend the dosing method of Sarubbi and Hull, which is based on corrected creatinine clearance. (See Dosage and Administration: Dosage in Renal Impairment, in the Aminoglycosides General Statement 8:12.02.)
In adults with renal failure undergoing hemodialysis, some clinicians recommend supplemental doses of 50-75% of the initial loading dose at the end of each dialysis period. Others suggest that supplemental amikacin doses may not be necessary in patients undergoing short-term hemodialysis. Serum amikacin concentrations should be monitored in dialysis patients and dosage adjusted as needed to maintain desired serum concentrations.
For the treatment of active tuberculosis+ in adults with renal impairment, the ATS, CDC, and IDSA recommend that usual doses be given at less frequent intervals since use of lower doses may reduce efficacy of the drug. These experts recommend that adults with renal impairment receive amikacin in a dosage of 12-15 mg/kg daily given 2 or 3 times weekly. In addition, if the patient is receiving hemodialysis, the dose should be given after the procedure is finished and serum concentrations of the drug monitored to avoid toxicity.
Amikacin sulfate is administered by IM injection or IV infusion. Amikacin sulfate has been given intrathecally+ or intraventricularly+ as an adjunct to IM or IV administration of the drug for the treatment of meningitis and other CNS infections. Although amikacin has been given intraperitoneally+, the risk of toxicity associated with this route should be considered.
(See Cautions in the Aminoglycosides General Statement 8:12.02.) Patients should be well hydrated prior to and during amikacin therapy to minimize chemical irritation of renal tubules which may occur as the result of high urine amikacin concentrations. Renal function should be assessed prior to and daily during amikacin therapy. Patients should be under close clinical observation because of the risk of ototoxicity and nephrotoxicity.
(See Cautions in the Aminoglycosides General Statement 8:12.02.) Prior to administration, amikacin solutions should be inspected visually for particulate matter or discoloration.
(See Cautions in the Aminoglycosides General Statement 8:12.02.) Patients should be well hydrated prior to and during amikacin therapy to minimize chemical irritation of renal tubules which may occur as the result of high urine amikacin concentrations. Renal function should be assessed prior to and daily during amikacin therapy. Patients should be under close clinical observation because of the risk of ototoxicity and nephrotoxicity.
(See Cautions in the Aminoglycosides General Statement 8:12.02.) Prior to administration, amikacin solutions should be inspected visually for particulate matter or discoloration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ARIKAYCE 590 MG/8.4 ML VIAL | Maintenance | Adults inhale 8.4 milliliters (590 mg) via nebulizer by inhalation route once daily |
No generic dosing information available.
The following drug interaction information is available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
| Selected Nephrotoxic Agents/Bacitracin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3) CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3) PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1) PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3) DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3) |
BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC |
There are 4 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Live BCG/Selected Antimycobacterials SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Bacillus Calmette-Guerin (BCG) is a live, attenuated strain of Mycobacterium bovis (M.bovis) used to induce a granulomatous response in the treatment of localized bladder cancer and as a vaccine to prevent tuberculosis.(1-2) Co-treatment with antibacterial agents active against M.bovis may lead to an attenuation of the immune response associated with BCG administration.(1-2) CLINICAL EFFECTS: The effectiveness of chemotherapy may be impaired, or the vaccine may be ineffective. Agents linked to this monograph may have activity against M.bovis: amikacin, capreomycin, ciprofloxacin, clofazimine, cycloserine, ethambutol, ethionamide, gatifloxacin, isoniazid, kanamycin, levofloxacin, moxifloxacin, ofloxacin, rifabutin, rifampin, rifapentine, and streptomycin. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Intravesical instillation of BCG should be postponed during treatment with antibacterials which may decrease effectiveness.(2) Administration of BCG vaccine to patients receiving antibiotic therapy should only be done under close medical supervision.(1) If a patient develops a systemic BCG infection due to intravesicular or vaccine administration, treatment with multiple antimycobacterial agents may be required. DISCUSSION: Because antibiotic therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of BCG vaccine states that administration of BCG vaccine to patients receiving antibiotic therapy should only be done under close medical supervision.(1) Pyrazinamide is not included in this interaction as BCG is not sensitive to pyrazinamide.(2) |
BCG (TICE STRAIN), BCG VACCINE (TICE STRAIN) |
| Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
| Cyclosporine/Aminoglycosides SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Cyclosporine and aminoglycosides can both cause nephrotoxicity. Concurrent administration may result in an additive or synergistic risk of nephrotoxicity.(1-3) CLINICAL EFFECTS: Concurrent use of cyclosporine with aminoglycosides may result in a higher risk of renal dysfunction, including structural kidney damage.(1-3) PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include pre-existing renal impairment, older age, higher doses or longer treatment duration of either drug, and dehydration.(1-3) PATIENT MANAGEMENT: Avoid the concurrent use of cyclosporine and aminoglycosides whenever possible.(2,3) If concurrent use cannot be avoided, it should be undertaken with great caution. Minimize the cyclosporine dose and monitor renal function carefully. Frequent dose adjustment may be indicated. If renal function deteriorates, the aminoglycoside may need to be decreased or discontinued.(1-4) DISCUSSION: Coadministration of cyclosporine with other drugs that may impair renal function, like aminoglycosides, may cause additive or synergistic impairment of renal function. A meta-analysis of 30 studies that evaluated the correlation and risk factors between cyclosporine and kidney injury in allogeneic hematopoietic stem cell transplant (allo-HSCT) patients included 7 studies that examined the role of the combination with other drugs in the development of nephrotoxicity. Coadministration of aminoglycosides and amphotericin B were independent risk factors for acute or chronic kidney diseases related to cyclosporine in allo-HSCT patients.(5) |
CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE |
| Selected Nephrotoxic Agents/Polymyxin B SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Polymyxin B can cause nephrotoxicity with a slight degree of tubular damage. Concurrent administration of other nephrotoxic agents may result in an increased risk of nephrotoxicity.(1) CLINICAL EFFECTS: Concurrent use of polymyxin B with other nephrotoxic agents may result in additive nephrotoxic effects. Polymyxin B nephrotoxicity is characterized by albuminuria, cellular casts, azotemia, diminished urine output, elevated BUN and rising blood levels usually after about 4 days of therapy.(1,2) PREDISPOSING FACTORS: Factors predisposing to nephrotoxicity include higher cumulative doses and longer duration of therapy of polymyxin B and exposure to multiple nephrotoxins.(2) PATIENT MANAGEMENT: Concurrent or sequential use of potentially nephrotoxic agents with polymyxin B should be avoided. If concurrent use is necessary, it should be undertaken with great caution. Check renal function at baseline and monitor renal function and polymyxin B blood levels frequently during therapy.(1) DISCUSSION: Polymyxin B is associated with high rates of nephrotoxicity. Concurrent use with other nephrotoxins may increase the risk of nephrotoxicity. |
POLYMYXIN B SULFATE |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Gentamicin, Amikacin, Tobramycin/Amphotericin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive with those of amphotericin. CLINICAL EFFECTS: The concurrent administration of gentamicin, amikacin, or tobramycin with amphotericin may result in additive ototoxic or nephrotoxic effects.(1) PREDISPOSING FACTORS: Preexisting renal impairment, sepsis, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, or concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin appear to increase the risk for nephrotoxicity and ototoxicity.(1-6). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides.(7) PATIENT MANAGEMENT: The Australian manufacturer of gentamicin, amikacin, and tobramycin state that the concurrent use of gentamicin, amikacin, or tobramycin and amphotericin should be avoided.(1,4,5) DISCUSSION: The Australian and U.K. manufacturers of gentamicin, amikacin, and tobramycin state that since the ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including amphotericin.(1,3,4,5) |
ABELCET, AMBISOME, AMPHOTERICIN B, AMPHOTERICIN B LIPOSOME |
| Selected Nephrotoxic Agents/Cisplatin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The nephrotoxic effects of aminoglycosides or non-steroidal anti-inflammatory drugs (NSAIDs) may be additive to those of cisplatin. CLINICAL EFFECTS: The concurrent administration of amikacin, gentamicin, tobramycin, or NSAIDs with cisplatin may result in additive nephrotoxic effects.(1,2,5,6) PREDISPOSING FACTORS: Pre-existing renal insufficiency, advanced age, dehydration may increase the risk of nephrotoxicity.(1,5,6) PATIENT MANAGEMENT: The US labeling for aminoglycosides and cisplatin states that the concurrent use of aminoglycosides and cisplatin should be avoided.(1,3,4,6) Inform patients that concurrent cisplatin and aminoglycosides or NSAIDs can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary.(2) DISCUSSION: The US manufacturers of amikacin, gentamicin and tobramycin state that since the nephrotoxic effects of these medications may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including cisplatin.(1,3,6) |
CISPLATIN, KEMOPLAT |
| Gentamicin, Amikacin, Tobramycin/Vancomycin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive with those of vancomycin. CLINICAL EFFECTS: The concurrent administration of gentamicin, amikacin, or tobramycin with vancomycin may result in additive ototoxic or nephrotoxic effects.(1) PREDISPOSING FACTORS: Preexisting renal impairment, sepsis, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, or concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin appear to increase the risk for nephrotoxicity and ototoxicity.(1-5). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides. PATIENT MANAGEMENT: The Australian manufacturer of gentamicin, amikacin, and tobramycin state that the concurrent use of gentamicin, amikacin, or tobramycin and vancomycin should be avoided.(1,4,5) DISCUSSION: The Australian and U.K. manufacturers of gentamicin, amikacin, and tobramycin state that since the ototoxic or nephrotoxic effects of gentamicin, amikacin, or tobramycin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including vancomycin.(1,3,4,5) |
FIRVANQ, VANCOCIN HCL, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W |
The following contraindication information is available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Mt-RNr1 increased risk of aminoglycoside-induced hearing loss |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic obstructive pulmonary disease |
| Myasthenia gravis |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Asthma |
| Disorder of the vestibulocochlear nerve |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Parkinsonism |
| Tinnitus |
| Vertigo |
The following adverse reaction information is available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 13 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bronchospastic pulmonary disease Hemoptysis Ototoxicity |
Exacerbation of chronic obstructive pulmonary disease Hypersensitivity pneumonitis Pneumonia Pneumothorax |
| Rare/Very Rare |
|---|
|
Anaphylaxis Lip swelling Nephrotoxicity Neuromuscular blockade Tongue swelling Urticaria |
There are 29 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Cough Diarrhea Fatigue General weakness Musculoskeletal pain Nausea Voice change |
Ataxia Chest discomfort Dysgeusia Epistaxis Fever Headache disorder Increased sputum Laryngitis Oral candidiasis Pain in oropharynx Pharyngeal edema Pharyngitis Skin rash Symptoms of anxiety Vomiting Weight loss Xerostomia |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Dyspnea Oral pruritus Syncope Tachycardia |
The following precautions are available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories):
WARNING: Amikacin liposomal may increase the risk of serious breathing or lung problems. Tell your doctor right away if you have symptoms such as new or worsening shortness of breath/trouble breathing, fever, cough, wheezing, or coughing up blood or blood-tinged sputum.
WARNING: Amikacin liposomal may increase the risk of serious breathing or lung problems. Tell your doctor right away if you have symptoms such as new or worsening shortness of breath/trouble breathing, fever, cough, wheezing, or coughing up blood or blood-tinged sputum.
The following icd codes are available for ARIKAYCE (amikacin sulfate liposomal with nebulizer accessories)'s list of indications:
| Refractory mycobacterium avium complex pulmonary disease | |
| A31 | Infection due to other mycobacteria |
| A31.0 | Pulmonary mycobacterial infection |
| A31.9 | Mycobacterial infection, unspecified |
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