AMIKACIN SULFATE INJECTION SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

AMIKACIN (AMIKACIN SULFATE)

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

J01GB06

INN (Alþjóðlegt nafn):

AMIKACIN

Skammtar:

250MG

Lyfjaform:

SOLUTION

Samsetning:

AMIKACIN (AMIKACIN SULFATE) 250MG

Stjórnsýsluleið:

INTRAMUSCULAR

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-07-26

Vara einkenni

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMIKACIN SULFATE INJECTION
250 MG / ML
AMIKACIN (AS AMIKACIN SULFATE)
INTRAMUSCULAR (IM) OR INTRAVENOUS (IV)
MANUFACTURER’S STANDARD
ANTIBIOTIC
JAMP Pharma Corporation
Date of Preparation: July 25, 2022
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Control No: 246233
- 2 -
PR
AMIKACIN SULFATE INJECTION
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
nep