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Amikacin information from DrugsUpdate  

See Available Brands of Amikacin in India

P - Contraindicated in pregnancy
L - Caution when used during lactation

Amikacin is an aminoglycoside antibiotic used to treat different types of bacterial infections. Amikacin works by binding to the bacterial 30S  subunit, causing misreading of mRNA and leaving the bacterium unable to synthesize proteins vital to its growth.

Pharmacodynamics

Pharmacokinetics

Amikacin binds to 30S ribosomal subunits of susceptible bacteria, thus inhibiting its protein synthesis.

Distribution
Detected in body tissues and fluids after inj; crosses the placenta but does not readily penetrate the CSF. Significant amounts penetrate the blood-brain barrier in children with meningitis.

Excretion
Via the urine by glomerular filtration (within 24 hours); 2-3 hours (elimination half-life).

Amikacin Indications / Amikacin Uses

Information Not Available

Amikacin Adverse Reactions / Amikacin Side Effects

All 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 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 Blockade
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 on rare occasions are skin rash, drug fever, headache, paresthesia, tremor, nausea and vomiting, eosinophilia, arthralgia, anemia, and hypotension.

Precautions

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 risk of the development of drug-resistant bacteria.


Aminoglycosides are quickly and almost totally absorbed when they are applied topically, except to the urinary bladder, in association with surgical procedures. Irreversible deafness, renal failure, and death due to neuromuscular blockade have been reported following irrigation of both small and large surgical fields with an aminoglycoside preparation.


Amikacin Sulfate Injection is potentially nephrotoxic, ototoxic and neurotoxic. The concurrent or serial use of other ototoxic or nephrotoxic agents should be avoided either systemically or topically because of the potential for additive effects. Increased nephrotoxicity has been reported following concomitant parenteral administration of aminoglycoside antibiotics and cephalosporin. Concomitant cephalosporins may spuriously elevate creatinine determinations.

Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. Kidney function should be assessed by the usual methods prior to starting therapy and daily during the course of treatment.

If signs of renal irritation appear (casts, white or red cells, or albumin), hydration should be increased. A reduction in dosage may be desirable if other evidence of renal dysfunction occurs such as decreased creatinine clearance; decreased urine specific gravity; increased BUN, creatinine, or oliguria. If azotemia increases or if a progressive decrease in urinary output occurs, treatment should be stopped.


Note: When patients are well-hydrated and kidney function is normal the risk of nephrotoxic reactions with Amikacin is low if the dosage recommendations are not exceeded.


Elderly patients may have reduced renal function which may not be evident in routine screening tests such as BUN or serum creatinine. A creatinine clearance determination may be more useful. Monitoring of renal function during treatment with aminoglycosides is particularly important.


Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
In vitro mixing of aminoglycosides with beta-lactam antibiotics (penicillin or cephalosporin) may result in a significant mutual
inactivation. A reduction in serum half-life or serum level may occur when an aminoglycoside or penicillin-type drug is administered by separate routes. Inactivation of the aminoglycoside is clinically significant only in patients with severely impaired renal function.

Inactivation may continue in specimens of body fluids collected for assay, resulting in inaccurate aminoglycoside readings. Such specimens should be properly handled (assayed promptly, frozen, or treated with beta-lactamase).
Cross-allergenicity among aminoglycosides has been demonstrated. As with other antibiotics, the use of Amikacin may result in overgrowth of nonsusceptible organisms. If this occurs, appropriate therapy should be instituted.
Aminoglycosides should not be given concurrently with potent diuretics.

Special Precautions

Renal impairment; vertigo, tinnitus. Discontinue if signs of ototoxicity, neurotoxicity or hypersensitivity occurs; lactation. Safety has not been established for treatment period >14 days. Monitor renal function before and during treatment.

Other Drug Interactions

Other drugs, especially those that affect the kidneys, can interact with amikacin resulting in dangerous side effects and/or decreased effectiveness.


Amphotericin B may lead to increased nephrotoxicity and reduced clearance of amikacin when used together.

Potentially Fatal: Increased ototoxic or nephrotoxic effects with other nephrotoxic or ototoxic drugs. Enhanced neuromuscular blockade with neuromuscular blocking drugs. Increased risk of ototoxicity with potent diuretics.

Other Interactions

Information Not Available

Dosage

Usual Adult Dose for Bacteremia
15 to 22.5 mg/kg/day IV or IM in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Adult Dose for Intraabdominal Infection
15 to 22.5 mg/kg/day IV or IM in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Adult Dose for Joint Infection
15 to 22.5 mg/kg/day IV or IM in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Adult Dose for Osteomyelitis
15 to 22.5 mg/kg/day IV or IM in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Adult Dose for Pneumonia
15 to 22.5 mg/kg/day IV or IM in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Adult Dose for Skin or Soft Tissue Infection
15 to 22.5 mg/kg/day IV or IM in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Adult Dose for Cystic Fibrosis
Higher doses may be required for the treatment of Pseudomonas aeruginosa pulmonary infections in cystic fibrosis patients. Dosing should be individualized and based on serum concentrations. Doses of up to 35 mg/kg/day once daily by IV infusion or in divided doses every 6 to 8 hours have been reported.


Usual Adult Dose for Febrile Neutropenia
Higher doses may be required. Dosing should be individualized and based on serum concentrations. Doses of up to 15 to 30 mg/kg/day IV in 1 to 3 divided doses have been reported in conjunction with a beta-lactam antibiotic (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels).


Usual Adult Dose for Meningitis
IV or IM: 15 to 22.5 mg/kg/day in 1 to 3 divided doses, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Intrathecal: 0.1 mg per mL of CSF or approximately 2 mg/kg body weight per day has been used to treat gram-negative bacillary meningitis in conjunction with parenteral antibiotics.


Usual Adult Dose for Nosocomial Pneumonia
20 mg/kg /day IV in 1 to 3 divided doses.

Initial empiric treatment with broad-spectrum coverage according to the hospital's and/or ICU's.

antibiogram is recommended if multidrug-resistant organisms are suspected.

Duration: If the causative organism is not Pseudomonas aeruginosa, the duration of treatment should be as short as clinically possible (e.g., as little as 7 days) to reduce the risk of superinfections with resistant organisms.


Usual Adult Dose for Peritonitis
Peritoneal dialysis-related peritonitis: CAPD intermittent dosing: 2 mg/kg in 1 exchange/day (based on ideal body weight) intraperitoneally for anuric patients and 2.5 mg/kg/bag for nonanuric patients (investigational). CAPD continuous dosing: 24 mg/L exchange intraperitoneally for anuric patients and 30 mg/L for nonanuric patients. Maximum dose: 1.5 g/day by all routes.


Usual Adult Dose for Tuberculosis -- Active
15 mg/kg (maximum 1 g) IM or IV every 24 hours.

May be given in combination with at least 3 other active drugs for treatment of multi-drug resistant TB, or when the patient is intolerant of first-line agents. AFB smear and culture should be monitored monthly.

Duration: Treatment for TB should generally continue for 18 to 24 months, or for 12 to 18 months after culture results are negative.


Usual Adult Dose for Urinary Tract Infection
Uncomplicated: 250 mg IV or IM every 12 hours
Amikacin is not recommended for mild to moderate infections.


Usual Pediatric Dose for not applicable
0 to 4 weeks, birthweight 1199 g or less: 7.5 mg/kg every 18 to 24 hours
0 to 7 days, birthweight 1200 to 2000 g: 7.5 mg/kg every 12 hours
0 to 7 days, birthweight 2001 g or more: 7.5 to 10 mg/kg every 12 hours


7 days to 4 weeks, birthweight 1200 to 2000 g: 7.5 to 10 mg/kg every 8 to 12 hours
7 days to 4 weeks, birthweight 2001 g or more: 10 mg/kg every 8 hours
1 month to 5 years: 15 to 22.5 mg/kg/day in divided doses every 8 hours, depending on severity of infection
6 to 17 years: 15 to 22.5 mg/kg/day in divided doses every 8 to 12 hours, depending on severity of infection (initial maximum of 1.5 g/day, then adjust dose based on desired serum levels)


Usual Pediatric Dose for Febrile Neutropenia
1 to 18 years: Higher doses may be required. Dosing should be individualized and based on serum concentrations. Doses ranging from 15 to 30 mg/kg/day in 1 to 3 divided doses have been reported in conjunction with a beta-lactam antibiotic.
Usual Pediatric Dose for Cystic Fibrosis:
1 to 18 years: Higher doses and/or more frequent intervals may be required. Dosing should be individualized and based on serum concentrations. Doses of up to 35 mg/kg/day IV in 1 to 3 divided doses have been reported.


Usual Pediatric Dose for Peritonitis
Peritoneal dialysis-related peritonitis: 17 years or less:Initial dose: 25 mg/L dialysate intraperitoneally
Maintenance dose: 12 mg/L dialysate. Maximum dose: 1.5 g/day by all routes.


Usual Pediatric Dose for Tuberculosis


Active:15 to 30 mg/kg (maximum 1 g) IM or IV every 24 hours.May be given in combination with at least 3 other active drugs for treatment of multi-drug resistant TB, or when the patient is intolerant of first-line agents. AFB smear and culture should be monitored monthly.

Duration: Treatment for TB should generally continue for 18 to 24 months, or for 12 to 18 months after culture results are negative.

Food(before/after)

Information Not Available

List of Contraindications

Amikacin and Pregnancy

Contraindicated in pregnancy


Teratogenic Effects;Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk(e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Amikacin and Lactation

Caution when used during lactation.

It is not known whether Amikacin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Amikacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Amikacin and Children

Aminoglycosides should be used with caution in premature and neonatal infants because of the renal immaturity of these patients and the resulting prolongation of serum half-life of these drugs.

Amikacin and Geriatic

Elderly patients may have reduced renal function which may not be evident in routine screening tests such as BUN or serum creatinine. A creatinine clearance determination may be more useful. Monitoring of renal function during treatment with aminoglycosides is particularly important.

Amikacin and Other Contraindications

Pregnancy, peforated ear drums, myasthenia gravis, hypersensitivity.

Storage

Parenteral
Store at 15-30°C.

Lab interference

Parenteral
Store at 15-30°C.

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