Amikacin

AMIKIN

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Pronunciation: am-i-KAY-sin

Amikacin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Amikacin ballicule

What it isAminoglycoside inhibiting the 30S ribosomal subunit; resistant Gram-negative and mycobacterial infection.

Why this oneResistance to many modifying enzymes preserves activity when other aminoglycosides fail; a liposomal inhaled form targets refractory MAC.

What limits itMonitor levels and kidney function: nephrotoxicity and often-irreversible ototoxicity are boxed risks; neuromuscular blockade can occur.

Amikacin molecular structure (skeletal formula) — Molecular structure: Amikacin

FDA-approved for

gram-negative infections (~1976)

FDA label

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BOXED WARNING Ototoxicity (often irreversible), nephrotoxicity, and neuromuscular blockade/respiratory paralysis; monitor renal and eighth-nerve function and serum levels; avoid other neuro/nephrotoxic drugs and potent diuretics.

FDA dosing	Population	Start	Target	Max
Serious infections due to susceptible Gram-negative bacteria (septicemia, respiratory, bone/joint, CNS incl. meningitis, skin/soft tissue, intra-abdominal, burns/post-op, complicated/recurrent UTI); also staphylococcal infections	Adult	7.5 mg/kg IM/IV q12h or 5 mg/kg q8h	15 mg/kg/day divided q8–12h × 7–10 days	15 mg/kg/day (heavier patients ≤1.5 g/day)
Uncomplicated UTI (only if organisms not susceptible to less-toxic agents)	Adult	250 mg BID	250 mg BID	15 mg/kg/day
Serious Gram-negative/staphylococcal infections	Children and older infants	7.5 mg/kg IM/IV q12h or 5 mg/kg q8h	15 mg/kg/day divided q8–12h	15 mg/kg/day
Serious infections incl. neonatal sepsis	Newborns	10 mg/kg loading dose once	7.5 mg/kg q12h	15 mg/kg/day

Renal Load 7.5 mg/kg, then either normal dose at interval (h) = SCr × 9, or reduced dose q12h = load × (observed CrCl / normal CrCl); monitor levels. Neither method applies during dialysis.

Hepatic Undefined

Reevaluate if treatment beyond 10 days is considered; safety >14 days not established.

Instructions

Dose by pretreatment body weight; IM or IV.
IV: add 500 mg to 100–200 mL NS or D5W; infuse over 30–60 min (infants 1–2 h).
Avoid peak >35 mcg/mL and trough >10 mcg/mL; monitor levels when feasible.
Do not premix with other drugs; administer separately.

Available strengths

inj 50, 250 mg/mL
susp 590 mg/8.4 mL

Contraindications

History of hypersensitivity or serious toxic reaction to any aminoglycoside (class cross-sensitivity)

Cautions

Ototoxicity, nephrotoxicity, neuromuscular blockade (boxed)
Fetal harm (congenital deafness)
Sulfite sensitivity (contains sodium metabisulfite)
C. difficile–associated diarrhea
Ototoxicity with MT-RNR1 mitochondrial DNA variants

Adverse reactions

Ototoxicity (hearing loss, vestibular)
Neuromuscular blockade/apnea
Nephrotoxicity
Skin rash
Drug fever
Headache
Paresthesia
Tremor
Nausea/vomiting
Eosinophilia
Arthralgia
Anemia

Pregnancy Aminoglycosides can cause fetal harm (total irreversible bilateral congenital deafness reported with streptomycin); no well-controlled human studies.

Lactation Unknown whether excreted in human milk; decide whether to discontinue nursing or the drug.

Cost

Amikacin (AMIKIN)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $/unit	CostPlus
50 mg/mL	inj	per unit		not offered
250 mg/mL	inj	per unit	$2.33/mL	not offered

Generic entry1984

⚠ BOXED WARNINGS

Nephrotoxicity and ototoxicity
Neuromuscular blockade

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryD

Defining liabilityNephrotoxicity and often irreversible ototoxicity require level and renal monitoring.

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