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.
This medicine is infused into a vein or injected into a muscle. It is usually given by a health care professional in a hospital or clinic setting.
If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor if your symptoms do not improve. You may need to have your blood checked while you are taking this medicine. Report any side effects to your doctor or healthcare professional. Be aware that side effects may occur in the weeks after you finish taking this medicine.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label. Do not use if the solution is cloudy or contains any solids.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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