AMIKACIN SULFATE INJECTION USP LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMIKACIN (AMIKACIN SULFATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01GB06

INN (International Name):

AMIKACIN

Dosage:

250MG

Pharmaceutical form:

LIQUID

Composition:

AMIKACIN (AMIKACIN SULFATE) 250MG

Administration route:

INTRAMUSCULAR

Units in package:

2 ML

Prescription type:

Prescription

Therapeutic area:

AMINOGLYCOSIDES

Product summary:

Active ingredient group (AIG) number: 0111922001; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-08-08

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMIKACIN SULFATE INJECTION USP
AMIKACIN (AS AMIKACIN SULFATE)
250 MG/ML
ANTIBIOTIC
SANDOZ CANADA INC.
Date of Preparation: July 20, 2017
145, Jules-Léger Street
Boucherville, QC, Canada
J4B 7K8
Control No: # 203905
- 1 -
AMIKACIN SULFATE INJECTION USP
AMIKACIN (AS AMIKACIN SULFATE)
250 MG/ML AMIKACIN
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Amikacin is a semi-synthetic aminoglycoside antibiotic which exhibits
activity primarily against
gram-negative
organisms,
including
_Pseudomonas_.
It
is
a
bactericidal
antibiotic
affecting
bacterial growth by specific inhibition of protein synthesis in
susceptible bacteria.
PHARMACOKINETICS
Amikacin is readily available and rapidly absorbed via the IV and IM
routes of administration.
The mean serum half-life is 2.2 hours with a mean renal clearance rate
of 1.24 mL/kg/min. No
accumulation is associated with dosing at 12 hour intervals in
individuals with a normal renal
function.
In 36 neonates, after IM or IV administration of 7.5 mg/kg every 12
hours, the mean serum half-
life is 5.4 ± 2.0 hours and the mean peak serum level is 17.7 ± 5.4
mcg/mL. No accumulation has
been observed for a dosing period of 10 to 14 days. After an IM dose
of 7.5 mg/kg to 8 neonates,
the mean peak serum level was reached at 32 minutes.
Amikacin is not metabolized; small amounts (1 to 2% of the dose) are
excreted in the bile, while
the remainder 98 to 99% is excreted in the urine via glomerular
filtration. The mean human
serum protein binding is 11% over a concentration range of 5 to 50
mcg/mL of serum. The
volume of distribution of amikacin is 25 to 30% of body weight.
Amikacin pharmacokinetics
remain linear over the entire dosage range studies (0.5 mcg/kg to 9
mg/kg).
Tolerance studies in normal volunteers revealed amikacin to be well
tolerated locally following
repeated
IM
dosing.
When
given
at
maximally
recommended
doses,
no
ototoxicity
or
nephrotoxicity was reported. There is no evidence of drug accumu