AMIKACIN SULFATE INJECTION SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

AMIKACIN (AMIKACIN SULFATE)

Verfügbar ab:

HIKMA CANADA LIMITED

ATC-Code:

J01GB06

INN (Internationale Bezeichnung):

AMIKACIN

Dosierung:

250MG

Darreichungsform:

SOLUTION

Zusammensetzung:

AMIKACIN (AMIKACIN SULFATE) 250MG

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2022-03-11

Fachinformation

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMIKACIN SULFATE INJECTION
250 MG / ML
AMIKACIN (AS AMIKACIN SULFATE)
INTRAMUSCULAR (IM) OR INTRAVENOUS (IV)
HOUSE STANDARD
ANTIBIOTIC
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Control No.: 262582
Date of preparation:
April
13, 2022
Amikacin Sulfate Injection
Page 2 of 22
PR
AMIKACIN SULFATE INJECTION
250 MG / ML
AMIKACIN (AS AMIKACIN SULFATE)
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