Adult Dosing

Bacterial infections

• 15 mg/kg/day IM/IV divided q8-12 hrs
• Max: 1.5 g/day

Uncomplicated urinary tract infections

• 250 mg IM/IV bid
• Note: Usual duration of treatment is 7-10 days

Pediatric Dosing

Serious infections caused by susceptible organisms

• Neonates: Initially, 10 mg/kg IM/IV, then 7.5 mg/kg q12 hrs
• Infants/Children: 5 mg/kg IM/IV q8 hrs; Max: 1.5 g/day

• Short term treatment of serious gram-negative bacterial infections caused by susceptible gram negative bacteria
• Initial therapy of known/suspected staphylococcal infections, where the causative organism may be either gram-negative bacteria or staphylococcus
• Treatment of infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and in mixed staphylococcal/gram-negative infections
• Management of gentamicin-and/or tobramycin-resistant strains of Gram-negative organisms
• Concomitant therapy with a penicillin-type drug in the management of neonatal sepsis caused by organisms such as streptococci or pneumococci

• Hypersensitivity to aminoglycosides

• Closely monitor due to potential for ototoxicity and nephrotoxicity. Safety for treatment periods > 14 days is not established
• 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 for periods longer than those recommended. Ototoxicity is usually irreversible. Neurotoxic symptoms may include vertigo, numbness, tingling, muscle twitching and convulsions. Discontinue therapy or decrease dose if ototoxicity. Avoid concurrent and/or sequential neurotoxic and/or nephrotoxic agents; avoid concurrent potent diuretics. Other risk factors include advanced age or dehydration
• Patients who have cochlear damage may not have symptoms during therapy. Partial or complete irreversible deafness may continue to develop after discontinuation. Monitor eight nerve function closely in known or suspected renal impairment and in patients who develop signs of renal dysfunction during therapy
• Monitor renal function, peak/trough levels in high risk patients. Prolonged serum concentrations >35 mcg/mL should be avoided. Rising trough levels may indicate tissue accumulation
• Monitor BUN, creatinine, creatinine clearance, urine examinations periodically
• Aminoglycosides can cause fetal harm when administered to a pregnant woman. Use with caution in premature infants and neonates because of renal immaturity and resulting prolongation of half-life
• Neuromuscular blockade and respiratory paralysis reported after administration 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

Renal Dose Adjustment (Based on CrCl)

Normal dosage at prolonged intervals

• Loading dose: 7.5 mg/kg IM/IV
• Maintenance dose: 7.5 mg/kg per calculated interval, SrCr (mg/100 mL) × 9 = interval (hours)

Reduced dosage at fixed intervals

• Measure serum amikacin concentrations to assure accurate administration of amikacin and to avoid concentrations above 35 mcg/mL
• Loading dose: 7.5 mg/kg IM/IV
• Maintenance dose: [Observed CrCl in mL/min/Normal CrCl in mL/min] x calculated loading dose in mg (administer maintenance dose q 12 hrs)

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Amikacin causes nephrotoxicity and neurotoxicity, risk factors include concomitant neurotoxic and/or nephrotoxic agents, diuretics, advancing age, and dehydration [U.S Black Box Warning]
• Neuromuscular blockade leading to irreversible deafness, renal failure, and death due to respiratory paralysis reported after administration by topical application
• Obtain culture and susceptibility tests before starting therapy; use only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
• Significant potential for nephrotoxicity. Patients should be well-hydrated to minimize chemical irritation of the renal tubules
• Aminoglycosides can cause fetal harm when administered to a pregnant woman
• Risk of sensitivity to sulfites, may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible individuals
• Peak concentrations (30-90 minutes after injection) > 35 mcg/mL and trough concentrations (just prior to the next dose) > 35 mcg/mL should be avoided
• Superinfection may occur, initiate appropriate therapy
• Cross-sensitivity among aminoglycosides may occur
• Monitor BUN/Cr at baseline, then periodically
• Monitor serum drug levels; urinalysis
• Perform audiometry for high risk pts, planned prolonged therapy, if high serum levels or signs of hearing impairment

Cautions: Use cautiously in

• Renal impairment (refer dose adjustment section)
• Auditory impairment
• Impaired vestibular function
• High dose therapy
• Prolonged treatment
• Electrolytes abnormalities
• Concurrent ototoxic agents
• Concurrent nephrotoxic agents
• Concurrent neurotoxic agents
• Neuromuscular disease
• Electrolyte abnormalities
• Dehydration
• Neonates/infants
• Geriatric population

Pregnancy Category:D

Breastfeeding: Amikacin is poorly excreted in breastmilk. Monitor the infant for possible effects on the GI flora, such as diarrhea, candidiasis or rarely, blood in the stool indicating possible antibiotic-associated colitis. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 July 2010)

• EENT: Auditory toxicity, vestibular toxicity, hearing loss, cochlear damage, deafness, tinnitus
• GU: Renal toxicity, elevated serum creatinine, elevated BUN, albuminuria, azotemia, oliguria, presence of red and white cells, nephrotoxicity
• RESP: Apnea
• NEURO: Acute muscular paralysis, paresthesia, neurotoxicity, neuromuscular blockade
• CNS: Headache, tremor, dizziness, vertigo
• CV: Hypotension
• DERM: Rash
• GI: Nausea, vomiting
• HEMA: Eosinophilia, anemia
• MUSC: Arthralgia
• METABOLIC: Hypomagnesemia
• LOCAL: Injection site reaction
• MISC: Drug fever, superinfection, hypersensitivity

• Aminoglycoside; bactericidal, binds to bacterial 30S ribosomal subunit and inhibits protein synthesis
• Not metabolized
• Renally excreted: 100% unchanged
• Half-life: 2 hrs; 30-86 hrs (Severe renal impairment)

US Trade Name(s)

• Only generic available

US Availability

amikacin (generic)

• INJ: 50 mg/mL (2 mL vial)
• INJ: 250 mg/mL (2, 4 mL vial)
• INJ: 500 mg/100 mL

Canadian Trade Name(s)

• Only generic available

Canadian Availability

amikacin (generic)

• INJ: 250 mg/mL (2 mL vial)

UK Trade Name(s)

• Amikin

UK Availability

amikacin (generic)

• INJ: 250 mg/mL (2 mL vial)

Amikin

• INJ: 50 mg/mL (2 mL vial)

Australian Trade Name(s)

• Amikin

Australian Availability

amikacin (generic)

• INJ: 500 mg/2 mL (2 mL vials)

Amikin

• INJ: 500 mg/2 mL (2 mL vials)

Antimicrobials

Antibiotics

Aminoglycosides

Infectious Disease

Antibiotics

Aminoglycosides