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- Amikacin Sulfate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection, as sulfate:
Generic: 500 mg/2 mL (2 mL); 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 MICs)
CSF:blood level ratio: Infants: Normal meninges: 10% to 20%; Inflamed meninges: up to 50%
Urine (94% to 98% unchanged)
Time to Peak
Serum: IM: 60 minutes; IV: Within 30 minutes following a 30-minute infusion
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.
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
Bacterial endophthalmitis; Mycobacterium avium complex (MAC; fibrocavitary or severe nodular/bronchiectatic disease)
Hypersensitivity to amikacin, other aminoglycosides, or any component of the formulation
Individualization is critical because of the low therapeutic index
In underweight and nonobese patients, use of total body weight (TBW) instead of ideal body weight for determining the initial mg/kg/dose is widely accepted (Nicolau, 1995). Ideal body weight (IBW) also may be used to determine doses for patients who are neither underweight nor obese (Gilbert 2009).
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). 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.
Intrathecal/intraventricular (off-label route): Meningitis (susceptible gram-negative organisms): 5 to 50 mg/day (Gilbert, 1986; Guardado 2008; IDSA 2004; Kasiakou 2005)
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)
Endophthalmitis, bacterial (off-label use): Intravitreal: 0.4 mg/0.1 mL NS in combination with vancomycin
Meningitis (susceptible gram-negative organisms):
IV: 5 mg/kg every 8 hours (administered with another bactericidal drug) (IDSA 2004)
Intrathecal/intraventricular (off-label route): Usual dose: 30 mg/day (IDSA 2004); Range: 5 to 50 mg/day (with concurrent systemic antimicrobial therapy) (Gilbert, 1986; Guardado 2008; IDSA 2004; Kasiakou 2005)
Mycobacterium avium complex (MAC) (off-label use): IV: Adjunct therapy (with macrolide, rifamycin, and ethambutol): 8 to 25 mg/kg 2 to 3 times weekly for first 2 to 3 months for severe disease (maximum single dose for age >50 years: 500 mg) (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) (off-label dose): 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).
Refer to adult dosing.
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])
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).
CNS infections (off-label dose):
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 (systemic use) (off-label use): 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.
Cystic fibrosis, pulmonary infection (inhalational use; off-label use/route): Inhalation for nebulization:
Adolescents ≥14 years: Monotherapy: Refer to adult dosing
Children ≥3 years and Adolescents: Adjunctive therapy: Refer to adult dosing
Endocarditis, treatment (off-label dose): 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 (off-label dose): 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) (off-label use): 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 [pediatric] 2013)
Adolescents: IV: 10 to 15 mg/kg/day every 24 hours as part of a multiple drug regimen (HHS [adult] 2015; HHS [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)
Tuberculosis, drug-resistant (off-label use):
Infants, Children, and Adolescents ≤14 years: IM, IV: 15 to 30 mg/kg/dose once daily as part of a multiple drug regimen; maximum daily dose: 1,000 mg/day (ATS/CDC/IDSA 2003; HHS [pediatric] 2013)
Adolescents ≥15 years, HIV-exposed/-positive: IM, IV: 15 mg/kg/dose once daily as part of a multiple drug regimen for the first 2 to 3 months; maximum daily dose: 1,000 mg/day (ATS/CDC/IDSA 2003;)
Dosing: Renal Impairment
Some patients may require larger or more frequent doses if serum levels document the need (ie, cystic fibrosis or febrile granulocytopenic patients).
Adults: The following adjustments have been recommended: Note: Renally adjusted dose recommendations are based on a dose of 7.5 mg/kg every 12 hours (Aronoff 2007).
GFR >50 mL/minute: No dosage adjustment necessary.
GFR 10 to 50 mL/minute: Administer every 24 to 72 hours based on serum concentrations
GFR <10 mL/minute: Administer every 48 to 72 hours based on serum concentrations
Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Dialyzable (20%; variable; dependent on filter, duration, and type of HD): 5 to 7.5 mg/kg every 48 to 72 hours. Follow levels. Redose when pre-HD concentration <10 mg/L; redose when post-HD concentration <6 to 8 mg/L (Heintz 2009). Note: Dosing dependent on the assumption of 3 times/week, complete IHD sessions.
Peritoneal dialysis (PD) (Li 2010):
Intermittent dosing: 2 mg/kg per exchange once daily; allow to dwell ≥6 hours
Continuous dosing (all exchanges): Loading dose: 25 mg/L; maintenance dose: 12 mg/L
Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:
CVVH/CVVHD/CVVHDF: Loading dose of 10 mg/kg followed by maintenance dose of 7.5 mg/kg every 24 to 48 hours
Note: For severe gram-negative rod infections, target peak concentration of 15 to 30 mg/L; redose when concentration <10 mg/L (Heintz 2009).
Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following adjustments have been recommended (Aronoff 2007):
Renally adjusted dose recommendations are based on doses of 5 to 7.5 mg/kg/dose every 8 hours.
GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary
GFR 30 to 50 mL/minute/1.73 m2: Administer every 12 to 18 hours
GFR 10 to 29 mL/minute/1.73 m2: Administer every 18 to 24 hours
GFR <10 mL/minute/1.73 m2: Administer every 48 to 72 hours
Intermittent hemodialysis: 5 mg/kg/dose; redose as indicated by serum concentrations
Peritoneal dialysis (PD): 5 mg/kg/dose; redose as indicated by serum concentrations
Continuous renal replacement therapy (CRRT): 7.5 mg/kg/dose every 12 hours, monitor serum concentrations
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
In moderate obesity (TBW/IBW ≥1.25) or greater, (eg, morbid obesity [TBW/IBW >2]), initial dosage requirement may be estimated using a dosing weight of IBW + 0.4 (TBW - IBW) (Traynor 1995).
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 (children, adolescents, and adults) or over 1 to 2 hours (infants).
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): Reserved solely for meningitis due to susceptible gram-negative organisms.
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.
See Trissel’s IV Compatibility Database
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).
AbobotulinumtoxinA: Aminoglycosides may enhance the neuromuscular-blocking effect of AbobotulinumtoxinA. Monitor therapy
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
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
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
Cefazedone: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalosporins (2nd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalosporins (3rd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalosporins (4th Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephalothin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cephradine: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. 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. 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 respiratory depressant effect of Neuromuscular-Blocking Agents. Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Monitor therapy
OnabotulinumtoxinA: Aminoglycosides may enhance the neuromuscular-blocking effect of OnabotulinumtoxinA. 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. Exceptions: Amoxicillin; Ampicillin; Cloxacillin; Dicloxacillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Potassium. Consider therapy modification
RimabotulinumtoxinB: Aminoglycosides may enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. 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
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: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. 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.
1% to 10%:
Central nervous system: Neurotoxicity
Otic: Auditory ototoxicity, vestibular ototoxicity
<1% (Limited to important or life-threatening): Dyspnea, eosinophilia, hypersensitivity reaction
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:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• 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.
Pregnancy Risk Factor
Adverse events were not observed in the initial animal reproduction studies. Amikacin crosses the placenta and produces detectable concentrations in the fetus. Aminoglycosides may cause fetal harm if administered to a pregnant woman. There are several reports of total irreversible bilateral congenital deafness in children whose mothers received another 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 amikacin may be altered (Bernard 1977).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience diarrhea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), hearing impairment, hearing loss, change in balance, confusion, dizziness, passing out, tinnitus, burning or tingling feeling, twitching, seizures, shortness of breath, signs of Clostridium difficile (C. diff)–associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or loss of strength and energy (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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Other brands: Amikin