Medically reviewed by Drugs.com. Last updated on Jul 1, 2020.
(am i KAY sin)
- Amikacin Sulfate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Injection, as sulfate:
Generic: 500 mg/2 mL (2 mL [DSC]); 1 g/4 mL (4 mL)
Solution, Injection, as sulfate [preservative free]:
Generic: 500 mg/2 mL (2 mL); 1 g/4 mL (4 mL)
- Antibiotic, Aminoglycoside
Inhibits protein synthesis in susceptible bacteria by binding to 30S ribosomal subunits
Oral: Poorly absorbed
Vd: 0.25 L/kg (Vozeh 1988); primarily into extracellular fluid (highly hydrophilic); poor penetration into the blood-brain barrier even when meninges are inflamed; Vd is increased in neonates and patients with edema, ascites, fluid overload; Vd is decreased in patients with dehydration.
Relative diffusion of antimicrobial agents from blood into CSF: Good only with inflammation (exceeds usual minimum inhibitory concentrations).
CSF:blood level ratio:
Adults: Normal meninges: <10%; Inflamed meninges: ≤25% (MacDougall 2011).
Infants: Normal meninges: 10% to 20%; Inflamed meninges: up to 50%.
Bronchial secretions Cmax (peak):serum Cmax (peak) ratio: ~30% to 40%, varies with time (Santré 1995).
Epithelial lining fluid Cmax (peak):Cmax (peak) ratio: ~10% to 18%, likely varies with time (Heffernan 2019; Najmeddin 2020).
Urine (94% to 98% unchanged)
Time to Peak
Serum: IM: 60 minutes; IV: Within 30 minutes following a 30-minute infusion; Note: Distribution is prolonged after larger doses (≥60 minutes after 30 minute-infusion of 20 mg/kg [Tod 1998]; ≥90 minutes after 60-minute infusion of a high-dose aminoglycoside [gentamicin 7 mg/kg] [Demczar 1997]).
Renal function and age dependent:
Infants: Low birth weight (1 to 3 days): 7 to 9 hours; Full-term >7 days: 4 to 5 hours (Howard 1975)
Children: 1.6 to 2.5 hours
Adolescents: 1.5 ± 1 hour
Adults: Normal renal function: ~2 hours; Anuria/end-stage renal disease: 17 to 150 hours (Aronoff 2007)
0% to 11%
Special Populations: Renal Function Impairment
Clearance is decreased in renal impairment.
Special Populations Note
Parameters associated with efficacy: Gram-negative bacilli: Concentration-dependent, associated with Cmax/minimum inhibitory concentration (MIC), goal: ≥8 to 10 (Kato 2017; Moore 1987; Ruiz 2018; White 2015) or AUC24/MIC, goal: 30 to 50 (mild/moderate infection) or 80 to 100 (severe infection) (Bland 2018; Craig 2011; Drusano 2007; Noel 2019; White 2015).
Expected drug exposure in patients with normal renal function:
Cmax (peak), postdistributional:
Infants and Children:
15 mg/kg: ~24 mg/L (Yu 2015).
7.5 mg/kg: ~15 to 20 mg/L (Alqahtani 2018; Kafetzis 1979).
Adults: 15 mg/kg: ~43 mg/L (Maller 1993).
AUC24: 15 mg/kg: 110 to 145 mg•hour/L (Craig 2011).
Parameters associated with toxicity: Nephrotoxicity is associated with more frequent administration and elevated Cmin (trough) concentrations leading to renal accumulation (Rybak 1999); AUC >300 mg/L has also been found to be predictive (Ruiz 2018).
Postantibiotic effect: Bacterial killing continues after amikacin concentration drops below the MIC of targeted pathogen; generally 0.5 to 7.5 hours, though the actual time of postantibiotic effect varies based on multiple factors including organism, amikacin Cmax (peak), and concomitant antimicrobial therapy (Craig 2011; Lacy 1998; Renneberg 1989).
Use: Labeled Indications
Serious infections: Treatment of serious infections (eg, bone infections, respiratory tract infections, endocarditis, septicemia) due to gram-negative organisms, including Pseudomonas, Escherichia coli, Proteus, Providencia, Klebsiella, Enterobacter, Serratia, and Acinetobacter
Off Label Uses
Cystic fibrosis exacerbation (aerosolized amikacin)
The use of aerosolized amikacin for cystic fibrosis exacerbations has not been well studied. There is evidence to support the use of aerosolized amikacin to eradicate P. aeruginosa, Mycobacterium abscessus, and Mycobacterium avium complex (MAC) in patients with cystic fibrosis when used as adjunctive therapy with amikacin IV and ceftazidime. A Society of Infectious Diseases Pharmacists consensus summary does not recommend routine use of aerosolized antibiotics to treat acute cystic fibrosis exacerbations. [Le 2010], [Schaad 1987]
Mycobacterium avium complex
Based on an official statement on the diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases from the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA), amikacin (or streptomycin) for the first 2 to 3 months of therapy in combination with a macrolide, rifamycin, and ethambutol is effective and recommended for the treatment of extensive MAC disease, especially fibrocavitary or severe nodular/bronchiectatic disease, or patients who have failed prior drug therapy [ATS/IDSA [Griffith 2007]].
Based on the HHS guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV, amikacin is a recommended additional agent, as part of an appropriate combination regimen, for the treatment of disseminated MAC disease in patients with HIV [HHS [OI adult 2020]].
According to the ATS, CDC, European Respiratory Society, and IDSA guidelines for the treatment of drug-resistant tuberculosis, IV or IM amikacin can be used as second-line therapy for patients with drug-resistant TB whose isolate has demonstrated presumed susceptibility to amikacin [ATS/CDC/ERS/IDSA [Nahid 2019]], [ATS/CDC/IDSA [Nahid 2016]].
Hypersensitivity to amikacin, other aminoglycosides, or any component of the formulation
Note: Aminoglycoside dosing weight: For underweight (ie, total body weight [TBW] < ideal body weight [IBW]), calculate dose based on TBW. For nonobese patients (ie, TBW 1 to 1.25 × IBW), calculate the dose based on TBW or IBW. TBW may be preferred in nonobese patients who may have increased volume of distribution (eg, critically ill). For obese patients (ie, TBW >1.25 × IBW), use 40% adjusted body weight ([0.4 × (TBW - IBW)] + IBW) for initial weight-based dosing and for estimating kidney function with Cockcroft-Gault (CrCl) (Bailey 1997; Blackburn 2015; Nicolau 1995; Pai 2014; Traynor 1995).
Therapeutic drug monitoring: Initial and periodic peak and trough plasma drug levels should be determined, particularly in critically ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, major surgery). Manufacturer recommends a maximum daily dose of 15 mg/kg/day (or 1.5 g/day in heavier patients). Higher doses may be warranted based on therapeutic drug monitoring or susceptibility information.
Usual dosage range:
IM, IV: 5 to 7.5 mg/kg/dose every 8 hours; Note: Some clinicians suggest a daily dose of 15 to 20 mg/kg/day for all patients with normal renal function. This dose is at least as efficacious with similar, if not less, toxicity than conventional dosing.
Cerebrospinal fluid (CSF) shunt infection (susceptible gram-negative organisms):
IV: 5 mg/kg every 8 hours in combination with other appropriate agents (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).
Intraventricular/intrathecal (adjunct to systemic therapy; use a preservative-free preparation): 5 to 50 mg/day; usual dose: 30 mg/day (Guardado 2008; IDSA [Tunkel 2004]; IDSA [Tunkel 2017]; Khan 2017; Shofty 2016; Wang 2014). Some experts recommend adjusting dosage and administration interval based on CSF amikacin concentrations (goal: 10 to 20 times MIC of causative organism (IDSA [Tunkel 2017]); data are limited (Smetana 2018). When intraventricular amikacin is administered via a ventricular drain, clamp drain for 15 to 60 minutes after administration (allows solution to equilibrate in CSF) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]). Note: Intraventricular/intrathecal administration is generally reserved for use in patients who fail parenteral therapy despite removal of CSF shunt or when CSF shunt cannot be removed (Baddour 2018).
Cystic fibrosis exacerbation (off-label use/route): Inhalation for nebulization:
Monotherapy: 500 mg twice daily (Le 2010).
Adjunctive therapy: 100 mg twice daily with concomitant IV amikacin and ceftazidime (Schaad 1987).
Meningitis, bacterial (susceptible gram-negative organisms): IV: 5 mg/kg every 8 hours in combination with other appropriate agents (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).
Mycobacterium avium complex (MAC) (off-label use):
Disseminated disease in patients with HIV, adjunct therapy: IV: 10 to 15 mg/kg daily as part of an appropriate combination regimen. Note: Some experts recommend addition of amikacin in patients with high mycobacterial loads (ie, >2 log CFU/mL of blood) or in the absence of effective antiretroviral therapy (HHS [OI adult 2020]).
Pulmonary disease (severe nodular/bronchiectatic or cavitary disease), adjunct therapy: IV: 8 to 25 mg/kg (maximum single dose for age >50 years: 500 mg) 2 to 3 times weekly for first 2 to 3 months as part of an appropriate combination regimen (Griffith 2007).
Mycobacterium fortuitum, M. chelonae, or M. abscessus: IV: 10 to 15 mg/kg daily for at least 2 weeks with high dose cefoxitin.
Pneumonia, hospital-acquired (HAP) or ventilator-associated (VAP) (alternative therapy): IV: 15 to 20 mg/kg/dose once every 24 hours for 7 days; may consider shorter or longer durations depending on rate of clinical improvement. When used as empiric therapy, use in combination with an agent active against S. aureus and an additional antipseudomonal agent. Note: Aminoglycosides are not recommended as monotherapy in patients with HAP or VAP due to P. aeruginosa (Kalil 2016).
Tuberculosis, drug resistant (alternative agent) (off-label use):
Note: Expert consultation for optimal regimen and duration of treatment is advised.
IM, IV: 15 mg/kg once daily or 25 mg/kg 3 times weekly in combination with additional appropriate antituberculosis agents (ATS/CDC/ERS/IDSA [Nahid 2019]; ATS/CDC/IDSA [Nahid 2016]; Peloquin 2004).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Refer to adult dosing.
Note: Individualization is critical because of the low therapeutic index. Dosage should be based on an estimate of ideal body weight. In morbidly obese children and adolescents, dosage requirement may best be estimated using a dosing weight of IBW + 0.4 (TBW - IBW). Initial dosing recommendation presented; dosage should be individualized based upon serum concentration monitoring. Initial and periodic plasma drug concentrations (eg, peak and trough with conventional dosing, post dose level at a prespecified time with extended-interval dosing) should be determined, particularly in critically ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery).
General dosing, severe, susceptible infections: Infants, Children, and Adolescents:
IM, IV: 15 to 22.5 mg/kg/day divided every 8 hours or 15 to 20 mg/kg/dose every 24 hours (Red Book [AAP 2015]);
Meningitis (Tunkel 2004):
Infants and Children: IV: 20 to 30 mg/kg/day divided every 8 hours
Adolescents: IV: 15 mg/kg/day divided every 8 hours
VP-shunt infection, ventriculitis: Limited data available: Intraventricular/intrathecal (use a preservative-free preparation): Infants, Children, and Adolescents: 5 to 50 mg/day; usual dose: 30 mg/day
Cystic fibrosis, pulmonary infection: Infants, Children, and Adolescents:
Traditional dosing: IV, IM: 10 mg/kg/dose every 8 hours (Wallace 1993)
Extended-interval dosing: IV: 30 mg/kg/dose every 24 hours (Flume 2009); Note: The CF Foundation recommends extended-interval dosing as preferred over traditional dosing.
Endocarditis, treatment: Children and Adolescents: IV: 15 mg/kg/day divided every 8 to 12 hours; use in combination with other antibiotics dependent upon organism and source of infection (ie, valve-type) (AHA [Baltimore 2015])
Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 15 to 22.5 mg/kg/day divided every 8 to 24 hours (Solomkin 2010)
Mycobacterium, avium complex infection (MAC), treatment: HIV-exposed/-positive:
Infants and Children: IV: 15 to 30 mg/kg/day divided every 12 to 24 hours as part of a multiple drug regimen; maximum daily dose: 1,500 mg/day (HHS [OI pediatric 2013])
Adolescents: IV: 10 to 15 mg/kg/dose every 24 hours as part of a multiple drug regimen; maximum daily dose: 1,500 mg/day (HHS [OI adult 2016]; HHS [OI pediatric 2013])
Infants, Children, and Adolescents ≤14 years:
Once-daily regimen: IM, IV: 15 to 20 mg/kg/dose once daily as part of a multiple drug regimen (ATS/CDC/IDSA [Nahid 2016]); current guidelines do not provide a maximum daily dose; for HIV-exposed/-positive pediatric patients, a maximum daily dose of 1,000 mg/day has been suggested for similar mg/kg doses (HHS [OI pediatric 2013])
Twice-weekly regimen: IM, IV: 25 to 30 mg/kg/dose administered twice weekly as part of a multiple drug regimen; dosing based on experience in adult patients and pediatric pharmacokinetic considerations (ATS/CDC/IDSA [Nahid 2016]); current guidelines do not provide a maximum daily dose; for HIV-exposed/-positive pediatric patients, a maximum daily dose of 1,000 mg/day has been suggested for similar mg/kg doses (HHS [OI pediatric 2013])
HIV-exposed/-positive: IM, IV: 15 to 30 mg/kg/dose once daily as part of a multiple drug regimen; maximum daily dose: 1,000 mg/day (HHS [OI pediatric 2013])
Adolescents ≥15 years: Independent of HIV status:
Once-daily regimen: IM, IV: 15 mg/kg/dose once daily as part of a multiple drug regimen (ATS/CDC/IDSA [Nahid 2016]; HHS [OI adult 2016]); current guidelines do not provide a maximum daily dose; for HIV-exposed/-positive pediatric patients, a maximum daily dose of 1,000 mg/day has been suggested for similar mg/kg doses (HHS [OI pediatric 2013])
Three-times-weekly regimen: IM, IV: 25 mg/kg/dose 3 times weekly (ATS/CDC/IDSA [Nahid 2016]; HHS [OI adult 2016]). Current guidelines do not provide a maximum dose; for HIV-exposed/-positive pediatric patients, a maximum daily dose of 1,000 mg/day has been suggested for similar mg/kg doses (HHS [OI pediatric 2013]).
Peritonitis (CAPD): Infants, Children, and Adolescents: Intraperitoneal: Continuous: Loading dose: 25 mg per liter of dialysate; maintenance dose: 12 mg per liter (Warady 2012)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The recommendations for dosing in obese patients are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.
Principles of body weight dosing:
Note: Aminoglycosides are hydrophilic medications with a low Vd and clearance that is proportional to glomerular filtration rate. Pharmacokinetic studies have revealed adjusted body weight (AdjBW), using a correction factor of 0.4, is the most appropriate weight metric to correct Vd in the setting of obesity. However, there is wide variation in the correction factors reported which could lead to under- or over-dosing in clinical practice (MacDougall 2011; Pai 2007). Early use of therapeutic drug monitoring is recommended (Pai 2014).
Obese patients (total body weight >125% of ideal body weight):
IV: Use 40% AdjBW for initial weight-based dosing when targeting Cmax/minimum inhibitory concentration (MIC) goals with either loading dose equation or mg/kg approach and when estimating kidney function with Cockcroft-Gault (CrCl) (Bland 2018; Pai 2014; Traynor 1995). Alternatively, use 40% AdjBW to estimate CrCl and aminoglycoside clearance with the Bayesian approach when targeting AUC/MIC goals (Bland 2018; Pai 2014). Note: If aminoglycoside therapy is continued, use Cmax/MIC or AUC/MIC goals to optimize therapy, especially in the critically ill where weight and kidney function may be poor surrogates of Vd and clearance (Hassan 1987; Rughoo 2014).
AdjBW = [0.4 × (total body weight - ideal body weight) + ideal body weight].
For intravenous administration, dilute in a compatible solution (eg, NS, D5W) to a final concentration of 0.25 to 5 mg/mL.
IM: Administer IM injection in large muscle mass.
IV: Infuse over 30 to 60 minutes.
Some penicillins (eg, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate in vitro. This has been observed to a greater extent with tobramycin and gentamicin, while amikacin has shown greater stability against inactivation. Concurrent use of these agents may pose a risk of reduced antibacterial efficacy in vivo, particularly in the setting of profound renal impairment. However, definitive clinical evidence is lacking. If combination penicillin/aminoglycoside therapy is desired in a patient with renal dysfunction, separation of doses (if feasible), and routine monitoring of aminoglycoside levels, CBC, and clinical response should be considered.
Intrathecal/Intraventricular (off-label route): Reconstitute with preservative-free diluent (NS) only to a final volume of 3 mL (Corpus 2004; Preston 1993). When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow amikacin solution to equilibrate in the CSF (IDSA [Tunkel 2017).
Inhalation (off-label route): Nebulization: Use with standard jet nebulizer connected to an air compressor or ultrasonic nebulizer; administer with mouthpiece or face mask (Le 2010)
Some products may contain sodium.
Store intact vials at 20°C to 25°C (68°F to 77°F). Following admixture at concentrations of 0.25 to 5 mg/mL in D5W, NS, D51/4NS, D51/2NS, LR, Normosol M in D5W, Normosol R in D5, Plasma-Lyte 56 in D5 or Plasma-Lyte 148 in D5W, amikacin is stable for 24 hours at room temperature, 60 days at 4°C (39°F), or 30 days at -15°C (5°F). Previously refrigerated or thawed frozen solutions are stable for 24 hours when stored at 25°C (77°F).
Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Arbekacin: May enhance the nephrotoxic effect of Aminoglycosides. Arbekacin may enhance the ototoxic effect of Aminoglycosides. Monitor therapy
Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Avoid combination
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Monitor therapy
Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Monitor therapy
CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Monitor therapy
Cephalosporins: May enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination
CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Management: Avoid coadministration of colistimethate and aminoglycosides whenever possible due to the risk of nephrotoxicity and neuromuscular blockade. If coadministration cannot be avoided, monitor renal and neuromuscular function. Consider therapy modification
CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Monitor therapy
Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Monitor therapy
Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Monitor therapy
Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination
Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination
Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination
Neuromuscular-Blocking Agents: Aminoglycosides may enhance the therapeutic effect of Neuromuscular-Blocking Agents. Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Monitor therapy
Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Monitor therapy
Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Tacrolimus (Systemic): Aminoglycosides may enhance the nephrotoxic effect of Tacrolimus (Systemic). Monitor therapy
Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Consider therapy modification
Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Neurotoxicity
Otic: Auditory ototoxicity, vestibular ototoxicity
<1%, postmarketing, and/or case reports: Arthralgia, drowsiness, drug fever, dyspnea, eosinophilia, headache, hypersensitivity reaction, hypotension, nausea, paresthesia, skin rash, tremor, vomiting, weakness
ALERT: U.S. Boxed WarningOtotoxicity:
Neurotoxicity, manifested as vestibular and permanent bilateral auditory ototoxicity, can occur in patients with preexisting renal damage and in patients with normal renal function treated at higher doses and/or periods longer than those recommended. The risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage. High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of hearing loss due to aminoglycosides increases with the degree of exposure to either high peak or high trough serum concentrations. Patients developing cochlear damage may not have symptoms during therapy to warn them of developing eighth-nerve toxicity, and total or partial irreversible bilateral deafness may occur after the drug has been discontinued. Aminoglycoside-induced ototoxicity is usually irreversible. Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.Nephrotoxicity:
Aminoglycosides are potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high doses or prolonged therapy. Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.Neuromuscular blockade:
Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides. The possibility of these phenomena should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate-anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena, but mechanical respiratory assistance may be necessary.Monitoring:
Renal and eighth-nerve function should be closely monitored especially in patients with known or suspected renal impairment at the onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels and prolonged peak concentrations above 35 mcg/mL. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained where feasible in patients old enough to be tested, particularly high-risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment.Concurrent therapy:
Concurrent and/or sequential systemic, oral, or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. Other factors that may increase risk of toxicity are advanced age and dehydration.
The concurrent use of amikacin with potent diuretics (ethacrynic acid, or furosemide) should be avoided because diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Concerns related to adverse effects:
• Hypersensitivity: Cross-sensitivity to other aminoglycosides may occur.
• Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include preexisting renal impairment, concomitant nephrotoxic medications, advanced age and dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible.
• Neuromuscular blockade and respiratory paralysis: [US Boxed Warning]: May cause neuromuscular blockade and respiratory paralysis; especially when given soon after anesthesia or muscle relaxants.
• Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity; usual risk factors include preexisting renal impairment, concomitant neuro-/nephrotoxic medications, advanced age and dehydration. Ototoxicity is proportional to the amount of drug given and the duration of treatment. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible damage. Discontinue treatment if signs of ototoxicity occur.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Hearing impairment: Use with caution in patients with preexisting vertigo, tinnitus, or hearing loss.
• Hypocalcemia: Use with caution in patients with hypocalcemia.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis or parkinsonism.
• Renal impairment: Use with caution in patients with preexisting renal insufficiency; dosage modification required.
Concurrent drug therapy issues:
• Neurotoxic and/or nephrotoxic drugs: [US Boxed Warning]: Avoid concomitant or sequential use of other neurotoxic and/or nephrotoxic drugs (eg, bacitracin, cisplatin, amphotericin B, paromomycin, polymyxin B, colistin, vancomycin, other aminoglycosides).
• Potent diuretics: [US Boxed Warning]: Avoid concomitant use with potent diuretics (eg, ethacrynic acid, furosemide) since diuretics themselves may cause ototoxicity and may enhance aminoglycoside toxicity.
Dosage form specific issues:
• Sulfites: May contain sulfites which may cause allergic-type reactions (including anaphylaxis) as well as life-threatening or less severe asthmatic episodes in certain individuals.
• Surgical irrigation: Irreversible deafness, renal failure, and death due to neuromuscular blockade have been reported following use of aminoglycosides as surgical irrigation; rapid systemic absorption occurs with topical application (except to the urinary bladder).
Urinalysis, BUN, serum creatinine, appropriately timed peak and trough concentrations, vital signs, temperature, weight, I & O, hearing parameters
Initial and periodic peak and trough plasma drug levels should be determined, particularly in critically-ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery). Aminoglycoside levels measured from blood taken from Silastic® central catheters can sometimes give falsely high readings (draw levels from alternate lumen or peripheral stick, if possible).
Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro. This may be clinically-significant for certain penicillin (ticarcillin, piperacillin, carbenicillin) and aminoglycoside (gentamicin, tobramycin) combination therapy in patients with significant renal impairment. Close monitoring of aminoglycoside levels is warranted.
Evaluate pregnancy status prior to treatment of multidrug-resistant tuberculosis in females of reproductive potential. Females of reproductive potential should use effective contraception during treatment for multidrug-resistant tuberculosis (Esmail 2018).
Pregnancy Risk Factor D Pregnancy Considerations
Amikacin crosses the placenta.
Aminoglycosides may cause fetal harm if administered during pregnancy. There are several reports of total irreversible bilateral congenital deafness in children whose mothers received a different aminoglycoside (streptomycin) during pregnancy. Although serious side effects to the fetus/infant have not been reported following maternal use of all aminoglycosides, a potential for harm exists.
Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of intravenous amikacin may be altered. Thirty patients between 6 to 20 weeks' gestation were given a single IM dose of amikacin 7.5 mg/kg within 24 hours prior to elective hysterectomy and therapeutic abortion. Mean peak concentrations and half-life of amikacin were slightly lower than in nonpregnant adults but still within the normal therapeutic range (Bernard 1977).
Amikacin is recommended off label as part of a multiantibiotic treatment regimen of nontuberculosis Mycobacterium avium complex (MAC) in patients with cystic fibrosis in certain situations; route of administration (IV or nebulized) may be dependent upon severity and location of infection (CFF/ECFS [Floto 2016]). Use of the IV route should be reserved for life-threatening infections in pregnant patients due to the potential risk of fetal toxicity (Panchaud 2016).
Amikacin is used off label for the treatment of multidrug-resistant tuberculosis. Active tuberculosis infection is associated with adverse fetal outcomes, including intrauterine growth restriction, low birth weight, preterm birth, and perinatal death (Esmail 2018; Miele 2020), as well as adverse maternal outcomes, including increased risks for anemia and cesarean delivery. Placental transmission may rarely occur with active maternal disease (Miele 2020). The treatment of multidrug-resistant tuberculosis in pregnant patients should be individualized; evidence to support a specific regimen is not available (ATS/CDC/ERS/IDSA [Nahid 2019]; WHO 2020). When second-line agents are needed for the treatment of multidrug-resistant tuberculosis during pregnancy, aminoglycosides should be avoided when alternative agents are effective (ATS/CDC/ERS/IDSA [Nahid 2019]). Amikacin may be considered when an aminoglycoside is needed (HHS [OI adult 2020]).
What is this drug used for?
• It is used to treat bacterial infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain
• Noise or ringing in the ears
• Trouble hearing
• Hearing loss
• Change in balance
• Muscle weakness
• Burning or tingling feeling
• Trouble breathing
• Slow breathing
• Shallow breathing
• Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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