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Amikacin
Pronunciation
U.S. Brand Names
Generic Available
Canadian Brand Names
Synonyms
Pharmacological Index
Use
Pregnancy Risk Factor
Contraindications
Warnings/Precautions
Adverse Reactions
Overdosage/Toxicology
Drug Interactions
Stability
Mechanism of Action
Pharmacodynamics/Kinetics
Usual Dosage
Monitoring Parameters
Reference Range
Test Interactions
Mental Health: Effects on Mental Status
Mental Health: Effects on Psychiatric Treatment
Dental Health: Local Anesthetic/Vasoconstrictor Precautions
Dental Health: Effects on Dental Treatment
Patient Information
Nursing Implications
Dosage Forms
References

Pronunciation
(am i KAY sin)

U.S. Brand Names
Amikin® Injection

Generic Available

No


Canadian Brand Names
Amikin®

Synonyms
Amikacin Sulfate

Pharmacological Index

Antibiotic, Aminoglycoside


Use

Treatment of serious infections due to organisms resistant to gentamicin and tobramycin including Pseudomonas, Proteus, Serratia, and other gram-positive bacilli (bone infections, respiratory tract infections, endocarditis, and septicemia); documented infection of mycobacterial organisms susceptible to amikacin


Pregnancy Risk Factor

C


Contraindications

Hypersensitivity to amikacin sulfate or any component; cross-sensitivity may exist with other aminoglycosides


Warnings/Precautions

Dose and/or frequency of administration must be monitored and modified in patients with renal impairment; drug should be discontinued if signs of ototoxicity, nephrotoxicity, or hypersensitivity occur; 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; renal damage is usually reversible


Adverse Reactions

1% to 10%:

Central nervous system: Neurotoxicity

Otic: Ototoxicity (auditory), ototoxicity (vestibular)

Renal: Nephrotoxicity

<1%: Hypotension, headache, drowsiness, drug fever, rash, nausea, vomiting, eosinophilia, paresthesia, tremor, arthralgia, weakness, dyspnea


Overdosage/Toxicology

Symptoms of overdose include ototoxicity, nephrotoxicity, and neuromuscular toxicity

Treatment of choice following a single acute overdose appears to be the maintenance of good urine output of at least 3 mL/kg/hour. Dialysis is of questionable value in the enhancement of aminoglycoside elimination. If required, hemodialysis is preferred over peritoneal dialysis in patients with normal renal function.


Drug Interactions

Decreased effect of aminoglycoside: High concentrations of penicillins and/or cephalosporins ( in vitro data)

Increased toxicity of aminoglycoside: Indomethacin I.V., amphotericin, loop diuretics, vancomycin, enflurane, methoxyflurane; increased toxicity of depolarizing and nondepolarizing neuromuscular blocking agents and polypeptide antibiotics with administration of aminoglycosides


Stability

Stable for 24 hours at room temperature and 2 days at refrigeration when mixed in D5W, D51/4 NS, D51/2 NS, NS, LR


Mechanism of Action

Inhibits protein synthesis in susceptible bacteria by binding to 30S ribosomal subunits


Pharmacodynamics/Kinetics

Absorption: I.M.: May be delayed in the bedridden patient

Distribution: Crosses the placenta; primarily distributes into extracellular fluid (highly hydrophilic); penetrates the blood-brain barrier when meninges are inflamed

Relative diffusion of antimicrobial agents from blood into cerebrospinal fluid (CSF): Good only with inflammation (exceeds usual MICs); ratio of CSF to blood level (%):

Normal meninges: 10-20

Inflamed meninges: 15-24

Half-life (dependent on renal function):

Infants: Low birthweight (1-3 days): 7-9 hours; Full term >7 days: 4-5 hours

Children: 1.6-2.5 hours

Adults: Normal renal function: 1.4-2.3 hours; Anuria: End-stage renal disease: 28-86 hours

Time to peak serum concentration: I.M.: Within 45-120 minutes

Elimination: 94% to 98% excreted unchanged in urine via glomerular filtration within 24 hours; clearance dependent on renal function and patient age


Usual Dosage

Individualization is critical because of the low therapeutic index

In morbid obesity, dosage requirement may best be estimated using a dosing weight of IBW + 0.4 (TBW - IBW)

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)

Infants, Children, and Adults: I.M., I.V.: 5-7.5 mg/kg/dose every 8 hours

Some clinicians suggest a daily dose of 15-20 mg/kg for all patients with normal renal function. This dose is at least as efficacious with similar, if not less, toxicity than conventional dosing.

Dosing interval in renal impairment: Some patients may require larger or more frequent doses if serum levels document the need (ie, cystic fibrosis or febrile granulocytopenic patients)

Clcr greater than or equal to 60 mL/minute: Administer every 8 hours

Clcr 40-60 mL/minute: Administer every 12 hours

Clcr 20-40 mL/minute: Administer every 24 hours

Clcr <20 mL/minute: Loading dose, then monitor levels

Hemodialysis: Dialyzable (50% to 100%); administer dose postdialysis or administer 2/3 normal dose as a supplemental dose postdialysis and follow levels

Peritoneal dialysis: Dose as Clcr <20 mL/minute: Follow levels

Continuous arteriovenous or venovenous hemodiafiltration (CAVH) effects: Dose as for Clcr 10-40 mL/minute and follow levels


Monitoring Parameters

Urinalysis, BUN, serum creatinine, appropriately timed peak and trough concentrations, vital signs, temperature, weight, I & O, hearing parameters


Reference Range

Sample size: 0.5-2 mL blood (red top tube) or 0.1-1 mL serum (separated)

Therapeutic levels:

Peak:

Life-threatening infections: 25-30 mg/mL

Serious infections: 20-25 mg/mL

Urinary tract infections: 15-20 mg/mL

Trough:

Serious infections: 1-4 mg/mL

Life-threatening infections: 4-8 mg/mL

Toxic concentration: Peak: >35 mg/mL; Trough: >10 mg/mL

Timing of serum samples: Draw peak 30 minutes after completion of 30-minute infusion or at 1 hour following initiation of infusion or I.M. injection; draw trough within 30 minutes prior to next dose


Test Interactions

Penicillin may decrease aminoglycoside serum concentrations in vitro


Mental Health: Effects on Mental Status

May cause drowsiness; case reports of delirium and psychosis


Mental Health: Effects on Psychiatric Treatment

None reported


Dental Health: Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions


Dental Health: Effects on Dental Treatment

No effects or complications reported


Patient Information

This drug can only be administered I.V. or I.M. It is important to maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). Report change in hearing acuity, ringing or roaring in ears, alteration in balance, vertigo, feeling of fullness in head; pain, tingling, or numbness of any body part; change in urinary pattern or decrease in urine; signs of opportunistic infection (eg, white plaques in mouth, vaginal discharge, unhealed sores, sore throat, unusual fever, chills); pain, redness, or swelling at injection site; or other adverse reactions. Pregnancy precautions: Inform prescriber if you are or intend to be pregnant.


Nursing Implications

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)


Dosage Forms

Injection, as sulfate: 50 mg/mL (2 mL, 4 mL); 250 mg/mL (2 mL, 4 mL)


References

Bauer LA and Blouin RA, "Influence of Age on Amikacin Pharmacokinetics in Patients Without Renal Disease. Comparison With Gentamicin and Tobramycin," Eur J Clin Pharmacol, 1983, 24(5):639-42.

Begg EJ and Barclay ML, "Aminoglycosides - 50 Years On," Br J Clin Pharmacol, 1995, 39(6):597-603.

Cunha BA, "Aminoglycosides: Current Role in Antimicrobial Therapy," Pharmacotherapy, 1988, 8(6):334-50.

Edson RS and Terrell CL, "The Aminoglycosides," Mayo Clin Proc, 1999, 74(5):519-28.

Gilbert DN, "Once-Daily Aminoglycoside Therapy," Antimicrob Agents Chemother, 1991, 35(3):399-405.

Iseman MD, "Treatment of Multidrug-Resistant Tuberculosis," N Engl J Med, 1993, 329(11):784-91.

Kenyon CF, Knoppert DC, Lee SK, et al, "Amikacin Pharmacokinetics and Suggested Dosage Modifications for the Preterm Infant," Antimicrob Agents Chemother, 1990, 34(2):265-8.

Lortholary O, Tod M, Cohen Y, et al, "Aminoglycosides," Med Clin North Am, 1995, 79(4):761-87.

McCormack JP and Jewesson PJ, "A Critical Re-evaluation of the "Therapeutic Range" of Aminoglycosides," Clin Infect Dis, 1992, 14(1):320-39

Nicolau DP, Freeman CD, Belliveau PP, et al, "Experience With a Once-Daily Aminoglycoside Program Administered to 2184 Adult Patients," Antimicrob Agents Chemother, 1995, 39(3):650-5.

Preston SL and Briceland LL, "Single Daily Dosing of Aminoglycosides," Pharmacotherapy, 1995, 15(3):297-316.

Public Health Service Task Force on Prophylaxis and Therapy for Mycobacterium avium Complex, "Recommendations on Prophylaxis and Therapy for Disseminated Mycobacterium avium Complex Disease in Patients Infected With the Human Immunodeficiency Virus," N Engl J Med, 1993, 329(12):898-904.

Starke JR and Correa AG, "Management of Mycobacterial Infection and Disease in Children," Pediatr Infect Dis J, 1995, 14(6):455-69.

Van der Auwera P, "Pharmacokinetic Evaluation of Single Daily Dose Amikacin," J Antimicrob Chemother, 1991, 27(Suppl C):63-71.

Vanhaeverbeek M, Siska G, Douchamps J, et al, "Comparison of the Efficacy and Safety of Amikacin Once or Twice-a-Day in the Treatment of Severe Gram-Negative Infections in the Elderly," Int J Clin Pharmacol Ther Toxicol, 1993, 31(3):153-6.

Vogelstein B, Kowarski A, and Lietman PS, "The Pharmacokinetics of Amikacin in Children," J Pediatr, 1977, 91(2):333-9.

Yasuhara H, Kobayashi S, Sakamoto K, et al, "Pharmacokinetics of Amikacin and Cephalothin in Bedridden Elderly Patients," J Clin Pharmacol, 1982, 22(8-9):403-9.


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