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Amikacin

    Brands

    DEA Class; Rx

    Common Brand Names; Amikin (DSC)

    • Aminoglycosides

    amikacin liposome inhalation (Rx)

    Brand and Other Names: Arikayce
    • Classes: Aminoglycosides
     

    Inhalation and parenteral aminoglycoside antibiotic
    Used for a variety of gram-negative bacterial infections and Mycobacterium avium complex (MAC) lung disease
    Major toxicities include nephrotoxicity, ototoxicity, neurotoxicity; careful patient monitoring recommended

    Indicated for

    • Urinary Tract Infection
    • Hospital Acquired Pneumonia

    Indicated for Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in adults who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

    Documented hypersensitivity

    • Dysphonia (47%)
    • Cough (39%)
    • Bronchospasm (29%)
    • Hemoptysis (18%)
    • Ototoxicity (17%)
    • Upper airway irritation (17%)
    • Musculoskeletal pain (17%)
    • Fatigue and asthenia (16%)
    • Exacerbation of underlying pulmonary disease (15%)
    • Diarrhea (13%)
    • Nausea (12%)
    • Neurotoxicity
    • Nephrotoxicity (if trough >10 mg/L)
    • Ototoxicity
    • Hypotension
    • Headache
    • Drug fever
    • Rash
    • Nausea
    • Vomiting
    • Eosinophilia
    • Paresthesia
    • Tremor
    • Arthralgia
    • Weakness
    • Allergic reaction

    Limitation of use

    Immune system disorders: Hypersensitivity, anaphylaxis

    Caution in patients with renal impairment

    Not intended for long-term therapy; caution in patients with renal failure (not on dialysis), hypocalcemia, myasthenia gravis, and conditions that depress neuromuscular transmission

    Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, reported; before therapy instituted, evaluate for previous hypersensitivity reactions to aminoglycosides; if anaphylaxis or a hypersensitivity reaction occurs, discontinue therapy and institute appropriate supportive measures

    Hypersensitivity pneumonitis reported; if hypersensitivity pneumonitis occurs, discontinue therapy and manage patients as medically appropriate

    Higher frequency of hemoptysis and bronchospasm, reported with treatment; if these occur, manage patients as medically appropriate

    Aminoglycosides can cause nephrotoxicity; close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing drug

    Higher frequency of ototoxicity reported with treatment; closely monitor patients with known or suspected auditory or vestibular dysfunction; if patients develop tinnitus this may be an early symptom of ototoxicity

    Aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function; if neuromuscular blockade occurs, it may be reversed by the administration of calcium salts, but mechanical assistance may be necessary

    Higher frequency of exacerbations of underlying pulmonary disease reported with treatment; treat patients as medically appropriate if this occurs

    Aminoglycosides can cause total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero

    Pregnancy Category: D

    Lactation: excretion in milk unknown/not recommended

    Adults

    Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum dose is 15 mg/kg/day IV/IM (Max: 1.5 g/day); however, doses up to 20 mg/kg/day IV/IM are used off-label, and up to 35 mg/kg/day is used off-label for cystic fibrosis patients. Liposome inhalation suspension maximum dose is 590 mg/day.

    Geriatric

    Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum dose is 15 mg/kg/day IV/IM (Max: 1.5 g/day); however, doses up to 20 mg/kg/day IV/IM are used off-label, and up to 35 mg/kg/day is used off-label for cystic fibrosis patients. Liposome inhalation suspension maximum dose is 590 mg/day.

    Adolescents

    Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum dose is 15 mg/kg/day IV/IM (Max: 1.5 g/day); however, doses up to 22.5 mg/kg/day IV/IM are used off-label, and up to 35 mg/kg/day is used off-label for cystic fibrosis patients. Safety and efficacy of liposome inhalation suspension have not been established.

    Children

    Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum dose is 15 mg/kg/day IV/IM (Max: 1.5 g/day); however, doses up to 22.5 mg/kg/day IV/IM are used off-label, and up to 35 mg/kg/day is used off-label for cystic fibrosis patients. Safety and efficacy of liposome inhalation suspension have not been established.

    Infants

    Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA-approved maximum dose is 15 mg/kg/day IV/IM; however, doses up to 22.5 mg/kg/day are used off-label, and up to 35 mg/kg/day is used off-label for cystic fibrosis patients. Safety and efficacy of liposome inhalation suspension have not been established.

    Neonates

    Injectable aminoglycoside dosing is highly variable and dependent on several factors. The FDA maximum dose is 15 mg/kg/day IV/IM; however, this dosing does not account for gestational age or birthweight and may be excessive in some patients. Usual maximum doses in neonates are as follows:
    35 weeks gestation and older: 15 to 18 mg/kg/dose IV/IM every 24 hours, depending on postnatal age.
    30 to 34 weeks gestation: 15 mg/kg/dose IV/IM every 24 to 36 hours, depending on postnatal age.
    Younger than 30 weeks gestation: 15 mg/kg/dose IV/IM every 24 to 48 hours, depending on postnatal age.
     
    Safety and efficacy of liposome inhalation suspension have not been established.

    Amikacin Sulphate

    injectable solution

    • 50mg/mL
    • 250mg/mL

     

    amikacin liposome

    liposome suspension for oral inhalation

    • 590mg/8.4mL; single-use vial (623mg/8.4mL amikacin sulfate equivalent)