Drug Notebook

FDA Alerts

  • Patients should be under close clinical observation because of potential ototoxicity and nephrotoxicity. Safety of treatment for >14 days not established.
  • Neurotoxicity (manifested as vestibular and permanent bilateral auditory ototoxicity) can occur in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended. Risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage.
  • High-frequency deafness usually occurs first (detectable only by audiometric testing); vertigo may occur (may indicate vestibular injury). Other neurotoxicity manifestations include numbness, skin tingling, muscle twitching, and seizures.
  • Risk of hearing loss increases with degree of exposure to either high peak or high trough serum concentrations. Patients developing cochlear damage may not have symptoms during aminoglycoside treatment to warn them of developing eighth nerve toxicity and total or partial irreversible bilateral deafness may occur after drug discontinued. Aminoglycoside-induced ototoxicity usually is irreversible.
  • Potentially nephrotoxic. Risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged treatment.
  • Neuromuscular blockade and respiratory paralysis reported following parenteral, topical instillation (e.g., in orthopedic and abdominal irrigation, local treatment of empyema), or oral administration of aminoglycosides. Consider possibility of neuromuscular blockade when any route is used, especially in patients receiving anesthetics or neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in those receiving massive transfusions of citrate-anticoagulated blood. Calcium salts may reverse neuromuscular blockade, but mechanical respiratory assistance may be necessary.
  • Monitor renal and eighth-nerve function closely, especially in patients with known or suspected renal impairment at start of treatment and also in those whose renal function is initially normal but develop renal dysfunction during treatment. Monitor serum amikacin concentrations when feasible to assure adequate concentrations and avoid potentially toxic and prolonged peak concentrations (>35 mcg/mL). Evaluate urine for decreased specific gravity and periodically determine BUN, serum creatinine, or Clcr.
  • Obtain serial audiograms if feasible in patients old enough to be tested, particularly high-risk patients. Discontinue or adjust dosage if there is evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss) or nephrotoxicity.
  • Avoid concurrent and/or sequential use of other neurotoxic or nephrotoxic drugs (systemic, oral, or topical). Other factors that may increase risk of toxicity are advanced age and dehydration.
  • Avoid concurrent use of potent diuretics since diuretics themselves may cause ototoxicity and may enhance toxicity by altering serum and tissue aminoglycoside concentrations.

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amikacin
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(am E kay sin)

What is the most important information I should know about amikacin?

If you are injecting amikacin at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Amikacin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of nerve damage.

What is amikacin?

Amikacin is an antibiotic. It fights bacteria in the body.

Amikacin is used to treat severe or serious bacterial infections.

Amikacin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using amikacin?

Do not use amikacin without first talking to your doctor if you have

You may not be able to use amikacin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Do not use amikacin without first talking to your doctor if you are pregnant or could become pregnant during treatment. Do not use amikacin without first talking to your doctor if you are breast-feeding a baby.

How should I take amikacin?

If you are injecting amikacin at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Do not use any amikacin that is discolored, has particles in it, or looks different from your previous doses. Throw away any unused amikacin after the amount of time determined by your pharmacist or doctor.

Adequate hydration is important during treatment with amikacin. Fluids may be administered intravenously during treatment.

It is important that the medication be given on a regular schedule and for the entire amount of time prescribed by your doctor.

Amikacin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of nerve damage.

Dispose of used needles and syringes in a puncture resistant container out of the reach of children.

Your healthcare provider will store amikacin as directed by the manufacturer or give you detailed storage instructions if you are storing the medication at home.

What happens if I miss a dose?

Contact your doctor if a dose is missed.

What happens if I overdose?

Contact your doctor or seek emergency medical attention if an overdose is suspected. An overdose of the medication may result in damage to the kidneys or hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures (which may be signs of nerve damage).

What should I avoid while taking amikacin?

There are no restrictions on food, beverages, or activity while taking amikacin unless otherwise directed by your doctor.

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