VPI-AMIKACIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMIKACIN (AMIKACIN SULFATE)

Available from:

VPI PHARMACEUTICALS INC

ATC code:

J01GB06

INN (International Name):

AMIKACIN

Dosage:

500MG

Pharmaceutical form:

SOLUTION

Composition:

AMIKACIN (AMIKACIN SULFATE) 500MG

Administration route:

INTRAMUSCULAR

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

AMINOGLYCOSIDES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-10-19

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VPI-AMIKACIN
AMIKACIN SULFATE INJECTION, USP
250 MG / ML
(500 MG / 2 ML)
AMIKACIN (AS AMIKACIN SULFATE)
ANTIBIOTIC
VPI Pharmaceuticals Inc.
16667 Hymus Blvd
Kirkland, QC, Canada H9H 4R9
Date of Preparation: October 13, 2020
Control No: 234447
- 2 -
PR
VPI-AMIKACIN
AMIKACIN SULFATE INJECTION, USP
250 MG / ML
(500 MG / 2 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
ototoxicity or
nephrotoxic