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Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.
Neurotoxicity, manifested as vestibular and permanent bilateral auditory ototoxicity, can occur in patients with preexisting renal damage and in patients with normal renal function treated at higher doses and/or for periods longer than those recommended. The risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage. High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of hearing loss due to aminoglycosides increases with the degree of exposure to either high peak or high trough serum concentrations. Patients developing cochlear damage may not have symptoms during therapy to warn them of developing eighth-nerve toxicity, and total or partial irreversible bilateral deafness may occur after the drug has been discontinued. Aminoglycoside-induced ototoxicity is usually irreversible.
Aminoglycosides are potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high doses or prolonged therapy.
Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides. The possibility of these phenomena should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate-anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena, but mechanical respiratory assistance may be necessary.
Renal and eighth-nerve function should be closely monitored especially in patients with known or suspected renal impairment at the onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels and prolonged peak concentrations above 35 micrograms per mL. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained where feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment.
Concurrent and/or sequential systemic oral, or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. Other factors that may increase risk of toxicity are advanced age and dehydration.
The concurrent use of amikacin with potent diuretics (ethacrynic acid , or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Amikacin sulfate is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. D-Streptamine, O-3-amino-3-deoxy-a-b-glucopyranosyl)1>6)-O-[6-amino-6-deoxy-a-D-glucopyranosyl(1>4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-(S)-,sulfate (1:2)(salt).
It has the following molecular formula C22H43N5O13 •2H2SO4 with a molecular weight of 781.75.
The dosage form is supplied as asterile, colorless to lightstraw colored solution for IM or IV use. The 100 mg per 2 mL vial, each mL contains: 50 mg Amikacin(as the sulfate), 0.13% Sodium Metabisulfite, 0.5% Sodium Citrate Dihydrate, Water for Injections, Air replaced with Nitrogen. pH is adjusted with Sulfuric Acid and/or if necessary Sodium Hydroxide. pH 3.5-5.5. The 500 mg per 2 mL vial and the 1 gram per 4 mL vial, each mL contains: 250 mg Amikacin(as the sulfate), 0.66% Sodium Metabisulfite, 2.5% Sodium Citrate Dihydrate, Water for Injection qs, Air replaced with Nitrogen. pH is adjusted with Sulfuric Acid and/or if necessary Sodium Hydroxide. pH 3.5-5.5.
What are the possible side effects of amikacin (Amikin, Amikin Pediatric)?
If you experience any of the following serious side effects, stop taking amikacin and seek emergency medical attention:
- an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
- little or no urine;
- decreased hearing or ringing in the ears;
- dizziness, clumsiness, or unsteadiness;
- numbness, skin tingling, muscle twitching, or seizures; or
- severe watery diarrhea and abdominal cramps.
Other, less serious side effects may be more likely to occur....
What are the precautions when taking amikacin (Amikin)?
Before using amikacin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as gentamicin, tobramycin); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: cystic fibrosis, hearing problems (including deafness, decreased hearing), kidney problems, low blood minerals (including potassium, magnesium, calcium), myasthenia gravis, Parkinson's disease.
Amikacin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any...
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Amikin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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