Amikacin

Amikacin is an antibiotic that fights bacteria.

Amikacin is used to treat severe or serious bacterial infections.

Amikacin may also be used for purposes not listed in this medication guide.

Amikacin can harm your kidneys, and may also cause nerve damage or hearing loss, especially if you have kidney disease or use certain other medicines.

Tell your doctor about all your medical conditions and all the medicines you are using. If you need surgery, tell the surgeon ahead of time that you are using amikacin.

You should not use this medicine if you are allergic to amikacin or similar antibiotics such as gentamicin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin.

To make sure amikacin is safe for you, tell your doctor if you have:

• kidney disease;
• asthma or sulfite allergy;
• myasthenia gravis;
• a nerve-muscle disorder; or
• a nervous system disorder such as Parkinson's disease.

Do not use amikacin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

It is not known whether amikacin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Dosage Forms & Strengths

injectable solution

• 50mg/mL
• 250mg/mL

General Dosing

15 mg/kg/day divided IV/IM q8-12hr 

Urinary Tract Infection

250 mg IV/IM q12hr

Extended Interval Dosing (q24 Hours)

First dose: 15 mg/kg IV based on lean body weight 

Subsequent doses: consult pharmacist

Hospital Acquired Pneumonia

20 mg/kg/day IV; may administer with antipseudomonal beta-lactam or carbapenem 

Dosage Modifications

Renal impairment

• CrCl >90 mL/min and aged <60 yr: q8hr
• CrCl 60-90 mL/min OR aged ≥60 yr: q12hr
• CrCl 25-60 mL/min: q24hr
• CrCl 10-25 mL/min: q48hr
• CrCl <10 mL/min: q72hr
• Administer after dialysis in ESRD

Dosing Considerations

Monitor: peak, trough, renal & auditory function

Peak 15-40 mg/L, trough 5-10 mg/L

Mycobacterium Infections (Orphan)

Inhaled liposomal amikacin (Arikayce)

Orphan designation for treatment infections caused by nontuberculous mycobacteria

Sponsor

• Insmed Incorporated; Princeton Corporate Plaza IV, Suite C; Monmouth Junction, NJ 08852-1919

Pseudomonas aeruginosa Lung Infections (Orphan)

Orphan designation for management of P aeruginosa lung infections in patients with cystic fibrosis

Sponsor

• PlumeStars s.r.l.; Via Lago Scuro 11; 43124 Parma; Italy

Bronchopulmonary Pseudomonas aeruginosa (Orphan)

Inhaled liposomal amikacin (Arikayce)

Orphan designation for treatment of broncophulmonary P aeurginosa infections in cystic fibrosis

Administration: Inhalation NOTE: FDA imposed clinical hold on trials on August 1, 2011

Sponsor

• Insemed Inc; 11 Deer Park Drive, Suite 117; Monmouth Junction, NJ 08852

Bronchiectasis (Orphan)

Inhaled liposomal amikacin (Arikayce)

Orphan designation for treatment of bronchiectasis in patients with P aeurginosa infections or other susceptible microbial pathogens (eg, NTM)

Administration: Inhalation NOTE: FDA imposed clinical hold on trials on August 1, 2011

Sponsor

• Insemed Inc; 11 Deer Park Drive, Suite 117; Monmouth Junction, NJ 08852

Non-tuberculous Mycobacteria Infections (Orphan)

Encochleated amikacin product

Orphan designation for non-tuberculous mycobacteria (NTM) infections

Sponsor

• Aquarius Biotechnologies, Inc; 1545 U.S. 206; Bedminster Township, New Jersey 07921

Dosage Forms & Strengths

injectable solution

• 50mg/mL
• 250mg/mL

General Dosing

15-22.5 mg/kg/day IV/IM divided q8hr 

Neonates

Aged ≤7 days

• ≤29 weeks gestational age: 18 mg/kg IV/IM q48hr 
• 30-33 weeks gestational age: 18 mg/kg IV/IM q36hr
• ≥34 weeks gestational age: 15 mg/kg IV/IM q24hr

Aged >7 days

• 30-33 weeks gestational age: 15 mg/kg IV/IM q24hr 
• ≥34 weeks gestational age: 15 mg/kg IV/IM q12-18hr

Aged 8-28 days old & <29 weeks gestational age

• 15 mg/kg IV/IM q36hr 
• Also use this dose for the following: significant asphyxia, indomethacin for PDA, poor cardiac output, or renal impairment

Neonates Aged >28 days old & <29 weeks gestational age

• 15 mg/kg IV/IM q24hr 
• Also use this dose for the following: significant asphyxia, indomethacin for PDA, poor cardiac output, or renal impairmen

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.

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.

If you take too much amikacin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If amikacin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

You should not use this medicine if you are allergic to amikacin or similar antibiotics such as gentamicin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin.

To make sure amikacin is safe for you, tell your doctor if you have:

• kidney disease;

• asthma or sulfite allergy;

• myasthenia gravis;

• a nerve-muscle disorder; or

• a nervous system disorder such as Parkinson's disease.

Do not use amikacin if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy during treatment.

It is not known whether amikacin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Amikacin is usually given for 7 to 10 days.

Amikacin is injected into a muscle, or into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not use amikacin if it has changed colors or has particles in it. Call your pharmacist for new medication.

Do not mix amikacin with other medicines in a syringe or IV bag.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Drink plenty of liquids while you are taking amikacin. This will help keep your kidneys working properly.

While using amikacin, you may need frequent blood or urine tests. Your hearing, kidney function, and nerve function may also need to be checked.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Amikacin will not treat a viral infection such as the flu or a common cold.

If you need surgery, tell the surgeon ahead of time that you are using amikacin.

Store this medicine at room temperature away from moisture and heat.

Call your doctor for instructions if you miss a dose of amikacin.

• It is used to treat bacterial infections.

The 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 should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate.  The blood urea nitrogen (BUN) is much less reliable for this purpose.  Reassessment of renal function should be made periodically during therapy.

Whenever possible, Amikacin concentrations in serum should be measured to assure adequate but not excessive levels.  It is desirable to measure both peak and trough serum concentrations intermittently during therapy.  Peak concentrations (30 to 90 minutes after injection) above 35 micrograms per mL and trough concentrations (just prior to the next dose) above 10 micrograms per mL should be avoided. Dosage should be adjusted as indicated.

Intramuscular Administration for Patients with Normal Renal Function

The recommended dosage for adults, children and older infants (see BOXED WARNINGS) with normal renal function is 15 mg/kg/day divided into 2 or 3 equal doses administered at equally-divided intervals, i.e., 7.5 mg/kg q12h or 5 mg/kg q8h. Treatment of patients in the heavier weight classes should not exceed 1.5 gram/day.

When Amikacin is indicated in newborns (see BOXED WARNINGS), it is recommended that a loading dose of 10 mg/kg be administered initially to be followed with 7.5 mg/kg every 12 hours.

The usual duration of treatment is 7 to 10 days.  It is desirable to limit the duration of treatment to short term whenever feasible.  The total daily dose by all routes of administration should not exceed 15 mg/kg/day.  In difficult and complicated infections where treatment beyond 10 days is considered, the use of Amikacin should be re-evaluated.  If continued, Amikacin serum levels, and renal, auditory, and vestibular functions should be monitored.  At the recommended dosage level, uncomplicated infections due to Amikacin-sensitive organisms should respond in 24 to 48 hours.  If definite clinical response does not occur within 3 to 5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked. Failure of the infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage.

When Amikacin is indicated in uncomplicated urinary tract infections, a dose of 250 mg twice daily may be used.

Intramuscular Administration for Patients with Impaired Renal Function

Whenever possible, serum Amikacin concentrations should be monitored by appropriate assay procedures.  Doses may be adjusted in patients with impaired renal function either by administering normal doses at prolonged intervals or by administrating reduced doses at a fixed interval.

Both methods are based on the patient’s creatinine clearance or serum creatinine values since these have been found to correlate with aminoglycoside half-lives in patients with diminished renal function.  These dosage schedules must be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary.  Neither method should be used when dialysis is being performed.

Normal Dosage at Prolonged Intervals

If the creatinine clearance rate is not available and the patient’s condition is stable, a dosage interval in hours for the normal dose can be calculated by multiplying the patient’s serum creatinine by 9, e.g., if the serum creatinine concentration is 2 mg/100 mL, the recommended single dose (7.5 mg/kg) should be administered every 18 hours.

Reduced Dosage at Fixed Time Intervals

When renal function is impaired and it is desirable to administer Amikacin at a fixed time interval, dosage must be reduced.  In these patients, serum Amikacin concentrations should be measured to assure accurate administration of Amikacin and to avoid concentrations above 35 mcg/mL.  If serum assay determinations are not available and the patient’s condition is stable, serum creatinine and creatinine clearance values are the most readily available indicators of the degree of renal impairment to use as a guide for dosage.

First, initiate therapy by administering a normal dose, 7.5 mg/kg, as a loading dose.  This loading dose is the same as the normally recommended dose which would be calculated for a patient with a normal renal function as described above.

To determine the size of maintenance doses administered every 12 hours, the loading dose should be reduced in proportion to the reduction in the patient’s creatinine clearance rate:

An alternate rough guide for determining reduced dosage at 12-hour intervals (for patients whose steady state serum creatinine values are known) is to divide the normally recommended dose by the patient’s serum creatinine.

The above dosage schedules are not intended to be rigid recommendations but are provided as guides to dosage when the measurement of Amikacin serum levels is not feasible.

Intravenous Administration

The individual dose, the total daily dose, and the total cumulative dose of Amikacin sulfate are identical to the dose recommended for intramuscular administration.  The solution for intravenous use is prepared by adding the contents of a 500 mg vial to 100 or 200 mL of sterile diluent such as 0.9% sodium chloride injection or 5% dextrose injection or any of the compatible solutions listed below.

The solution is administered to adults over a 30 to 60 minute period.  The total daily dose should not exceed 15 mg/kg/day and may be divided into either 2 or 3 equally-divided doses at equally-divided intervals.

In pediatric patients the amount of fluid used will depend on the amount of Amikacin ordered for the patient.  It should be a sufficient amount to infuse the Amikacin sulfate injection over a 30 to 60 minute period.  Infants should receive a 1 to 2 hour infusion.

Amikacin should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.

Stability in IV Fluids

Amikacin sulfate is stable for 24 hours at room temperature at concentrations of 0.25 and 5 mg/mL in the following solutions:

     5% Dextrose Injection

     5% Dextrose and 0.2% Sodium Chloride Injection

     5% Dextrose and 0.45% Sodium Chloride Injection

     0.9% Sodium Chloride Injection

     Lactated Ringer’s Injection

     Normosol® M in 5% Dextrose Injection (or Plasma-Lyte 56 Injection in 5% Dextrose in Water)

     Normosol® R in 5% Dextrose Injection (or Plasma-Lyte 148 Injection in 5% Dextrose in Water)

In the above solutions with Amikacin sulfate injection concentrations of 0.25 and 5 mg/mL, solutions aged for 60 days at 4°C and then stored at 25°C had utility times of 24 hours.

At the same concentrations, solutions frozen and aged for 30 days at -15°C, thawed, and stored at 25°C had utility times of 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

Aminoglycosides administered by any of the above routes should not be physically premixed with other drugs but should be administered separately.

Because of the potential toxicity of aminoglycosides, “fixed dosage” recommendations which are not based upon body weight are not advised. Rather, it is essential to calculate the dosage to fit the needs of each patient.

1. Clinical and Laboratory Standards Institute (CLSI).  Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Ninth Edition.  CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
2. Clinical and Laboratory Standards Institute (CLSI).  Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition.  CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
3. Clinical and Laboratory Standards Institute (CLSI).  Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.

The brand names mentioned in this document are the trademarks of their respective owners.

Manufactured for:

 

Lake Zurich, IL 60047

www.fresenius-kabi.us

Made in Austria

451298
Issued: November 2015

PACKAGE LABEL - PRINCIPAL DISPLAY - Amikacin 500 mg Single Dose Vial Label
Amikacin Sulfate Injection, USP
500 mg per 2 mL (250 mg per mL)*
For intramuscular or intravenous use.
2 mL Single Dose Vial
Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY - Amikacin 500 mg Single Dose Vial Carton Panel
NDC 63323-815-02
Amikacin Sulfate Injection, USP
500 mg per 2 mL (250 mg per mL)*
For intramuscular or intravenous use.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection, as sulfate:

Generic: 500 mg/2 mL (2 mL); 1 g/4 mL (4 mL)

Solution, Injection, as sulfate [preservative free]:

Generic: 500 mg/2 mL (2 mL); 1 g/4 mL (4 mL)

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

Absorption

IM: Rapid

Oral: Poorly absorbed

Distribution

Vd: 0.25 L/kg (Vozeh 1988); primarily into extracellular fluid (highly hydrophilic); poor penetration into the blood-brain barrier even when meninges are inflamed; Vd is increased in neonates and patients with edema, ascites, fluid overload; Vd is decreased in patients with dehydration

Relative diffusion of antimicrobial agents from blood into CSF: Good only with inflammation (exceeds usual MICs)

CSF:blood level ratio: Infants: Normal meninges: 10% to 20%; Inflamed meninges: up to 50%

Excretion

Urine (94% to 98% unchanged)

Time to Peak

Serum: IM: 60 minutes; IV: Within 30 minutes following a 30-minute infusion

Half-Life Elimination

Renal function and age dependent:

Infants: Low birth weight (1 to 3 days): 7 to 9 hours; Full-term >7 days: 4 to 5 hours (Howard 1975)

Children: 1.6 to 2.5 hours

Adolescents: 1.5 ± 1 hour

Adults: Normal renal function: ~2 hours; Anuria/end-stage renal disease: 17 to 150 hours (Aronoff 2007)

Protein Binding

0% to 11%

In moderate obesity (TBW/IBW ≥1.25) or greater (eg, morbid obesity [TBW/IBW >2]), initial dosage requirement may be estimated using a dosing weight of IBW + 0.4 (TBW - IBW) (Traynor 1995).

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.

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 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. Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.

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. Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established.

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 mcg/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 because diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.

All aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade (see DESCRIPTION: WARNINGS box). They occur more frequently in patients with present or past history of renal impairment, of treatment with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended.

Neurotoxicity-Ototoxicity: Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected.

Neurotoxicity-Neuromuscular Blockage: Acute muscular paralysis and apnea can occur following treatment with aminoglycoside drugs.

Nephrotoxicity: Elevation of serum creatinine, albuminuria, presence of red and white cells, casts, azotemia, and oliguria have been reported. Renal function changes are usually reversible when the drug is discontinued.

Other: In addition to those described above, other adverse reactions which have been reported o nrare occasions are skin rash, drug fever, headache, paresthesia, tremor, nausea and vomiting, eosinophilia, arthralgia, anemia, and hypotension.

Read the entire FDA prescribing information for Amikin (Amikacin)

Amikacin has been assigned to pregnancy category D by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancies. Aminoglycosides cross the placenta and there is a potential risk of fetal nephrotoxicity and ototoxicity. There are reports of fetal eighth cranial nerve toxicity with permanent bilateral deafness after exposure to other aminoglycosides during pregnancy. Amikacin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.