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Pharmacologic class: Aminoglycoside
Therapeutic class: Anti-infective
Pregnancy risk category D
FDA Box Warning
• Observe patient closely because of potential ototoxicity and nephrotoxicity. Safety isn't established for treatment exceeding 14 days.
• Neuromuscular blockade and respiratory paralysis have occurred after parenteral injection, topical use (as in orthopedic and abdominal irrigation), and oral use.
• Monitor renal function and eighth-nerve function closely, especially in patients with known or suspected renal impairment at onset of therapy, as well as those with initially normal renal function who develop signs of renal dysfunction during therapy.
• Avoid concurrent use with potent diuretics (such as furosemide and ethacrynic acid) because diuretics may cause ototoxicity. Also, I.V. diuretics may increase aminoglycoside toxicity by altering antibiotic serum and tissue levels.
• Avoid concurrent and sequential systemic, oral, or topical use of other neurotoxic or nephrotoxic products and other aminoglycosides. Advanced age and dehydration also may increase toxicity risk.
Interferes with protein synthesis in bacterial cells by binding to 30S ribosomal subunit, leading to bacterial cell death
Injection: 50 mg/ml, 250 mg/ml
Indications and dosages
➣ Severe systemic infections caused by sensitive strains of Pseudomonas aeruginosa, Escherichia coli, or Proteus, Klebsiella, Serratia, Enterobacter, Actinobacter, Providencia, Citrobacter, or Staphylococcus species
Adults, children, and older infants: 15 mg/kg/day I.V. or I.M. in two to three divided doses q 8 to 12 hours in 100 to 200 ml of dextrose 5% in water (D5W) over 30 to 60 minutes. Maximum dosage is 1.5 g/day.
Neonates: Initially, 10 mg/kg I.M., then 7.5 mg/kg I.M. q 12 hours
➣ Uncomplicated urinary tract infections caused by susceptible organisms
Adults, children, and older infants: 250 mg I.M. or I.V. twice daily
• Renal impairment (adults)
• Patients undergoing hemodialysis
• Mycobacterium avium-intracellulare infection
• Hypersensitivity to aminoglycosides
Use cautiously in:
• decreased renal function, neuromuscular disorders
• parkinsonism, myasthenia gravis
• concurrent or serial use of other nephrotoxic and ototoxic drugs
• elderly patients
• pregnant patients.
• Don't physically mix amikacin with other drugs. Administer separately.
• For I.V. use, dilute in 100 to 200 ml of normal saline solution or D5W and give over 30 to 60 minutes.
• Ensure adequate fluid intake to avoid dehydration.
• Draw peak blood level 1 hour after I.M. infusion or 30 to 60 minutes after I.V. infusion.
• Draw trough blood level just before next dose.
CNS: dizziness, vertigo, tremor, numbness, depression, confusion, lethargy, headache, paresthesia, ataxia, neuromuscular blockade, seizures, neurotoxicity
CV: hypotension, hypertension, palpitations
EENT: nystagmus and other visual disturbances, ototoxicity, hearing loss, tinnitus
GI: nausea, vomiting, splenomegaly, stomatitis, increased salivation, anorexia
GU: azotemia, increased urinary excretion of casts, polyuria, painful urination, impotence, nephrotoxicity Hematologic: purpura, eosinophilia, leukemoid reaction, aplastic anemia, neutropenia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, hemolytic anemia
Hepatic: hepatomegaly, hepatic necrosis, hepatotoxicity
Musculoskeletal: joint pain, muscle twitching
Skin: rash, alopecia, urticaria, itching, exfoliative dermatitis
Other: weight loss, superinfection, pain and irritation at I.M. site
Drug-drug. Acyclovir, amphotericin B, cephalosporin, cisplatin, diuretics, vancomycin: increased risk of ototoxicity and nephrotoxicity
Depolarizing and nondepolarizing neuromuscular junction blockers, general anesthetics: increased amikacin effect, possibly leading to respiratory depression
Dimenhydrinate: masking of ototoxicity signs and symptoms
Indomethacin: increased trough and peak amikacin levels
Parenteral penicillin: amikacin inactivation
Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, blood urea nitrogen, creatinine, lactate dehydrogenase, nonprotein nitrogen, nitrogen compounds (such as urea): increased levels
Calcium, potassium, magnesium, sodium: decreased levels
Reticulocytes: increased or decreased count
• Monitor kidney function test results and urine cultures, output, protein, and specific gravity.
• Monitor results of peak and trough drug blood levels.
• Evaluate for signs and symptoms of ototoxicity (hearing loss, tinnitus, ataxia, and vertigo).
• Assess for secondary superinfections, particularly upper respiratory tract infections.
☞ Inform patient that drug may cause hearing loss, seizures, and other neurologic problems. Tell him to report these symptoms immediately.
• Instruct patient to immediately report fever, cough, breathing problems, sore throat, and other signs and symptoms of infection.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Instruct patient to notify prescriber if he's urinating much more or much less than normal.
• Advise patient to minimize GI upset by eating small, frequent servings of food, and drinking plenty of fluids.
• Inform patient that he'll undergo regular blood and urine testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.