AMIKACIN SULFATE INJECTION USP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AMIKACIN (AMIKACIN SULFATE)

Disponible depuis:

MARCAN PHARMACEUTICALS INC

Code ATC:

J01GB06

DCI (Dénomination commune internationale):

AMIKACIN

Dosage:

500MG

forme pharmaceutique:

SOLUTION

Composition:

AMIKACIN (AMIKACIN SULFATE) 500MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

10X2ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

AMINOGLYCOSIDES

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-09-20

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION IN
FORM
ATION
PR
AMIKACIN SULFATE INJECTION USP
Amikacin (as Amikacin Sulfate)
250 MG / ML
ANTIBIOTIC
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112
Ottawa, ON - K2E 1A2
Control # 198586
Date of Preparation
September 20, 2018
PR
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 acc