Label: AMIKACIN SULFATE injection
- NDC Code(s): 83301-0022-1, 83301-0022-2, 83301-0023-1, 83301-0023-2
- Packager: Mullan Pharmaceutical Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 14, 2025
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SPL UNCLASSIFIED SECTIONRx only - To reduce the development of drug-resistant bacteria and maintain the effectiveness of the amikacin and other antibacterial drugs, amikacin should be used only to treat or prevent ...
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BOXED WARNING
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WARNINGS
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.
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DESCRIPTIONAmikacin Sulfate Injection, USP is semi-synthetic aminoglycoside antibiotic derived from kanamycin. It is ...
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CLINICAL PHARMACOLOGYIntramuscular Administration - Amikacin is rapidly absorbed after intramuscular administration. In normal adult volunteers, average peak serum concentrations of about 12, 16, and 21 mcg/mL are ...
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INDICATIONS AND USAGEAmikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli ...
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CONTRAINDICATIONSA history of hypersensitivity to amikacin is a contraindication for its use. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any other ...
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WARNINGSSee WARNINGS box above. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and there have been several reports of total irreversible ...
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PRECAUTIONSGeneral - Prescribing amikacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the ...
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ADVERSE REACTIONSAll aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade (see WARNINGS box). They occur more frequently in patients with present or past ...
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OVERDOSAGEIn the event of overdosage or toxic reaction, peritoneal dialysis or hemodialysis will aid in the removal of amikacin from the blood. In the newborn infant, exchange transfusion may also be ...
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DOSAGE AND ADMINISTRATIONThe patient's pretreatment body weight should be obtained for calculation of correct dosage. Amikacin Sulfate Injection may be given intramuscularly or intravenously. The status of renal function ...
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HOW SUPPLIEDAmikacin Sulfate Injection USP, 250 mg/mL is supplied as a clear colorless to light straw colored solution which requires no refrigeration. At times the solution may become a very pale yellow ...
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SPL UNCLASSIFIED SECTIONManufactured for: Mullan Pharmaceutical Inc. Pasadena, CA 91101, USA - Manufactured by: Qilu Pharmaceutical Co., Ltd., Jinan, 250104, China - Revised: 04/2025 - 34040139911B
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PRINCIPAL DISPLAY PANEL - 2 mL Vial CartonNDC 83301-0022-2 - Rx only - Amikacin Sulfate Injection, USP - Equivalent to Amikacin - 500 mg/2 mL - (250 mg/mL) For Intramuscular or Intravenous use - 10 X 2 mL Single-Dose Vials - MULLAN - More choices for ...
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PRINCIPAL DISPLAY PANEL - 4 mL Vial CartonNDC 83301-0023-2 - Rx only - Amikacin Sulfate Injection, USP - Equivalent to Amikacin - 1 gram/4 mL - (250 mg/mL) For Intramuscular or Intravenous use - 10 X 4 mL Single-Dose Vials - MULLAN - More choices for ...
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INGREDIENTS AND APPEARANCEProduct Information