AMIKACIN SULFATE INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

AMIKACIN (AMIKACIN SULFATE)

Disponibil de la:

OMEGA LABORATORIES LIMITED

Codul ATC:

J01GB06

INN (nume internaţional):

AMIKACIN

Dozare:

250MG

Forma farmaceutică:

SOLUTION

Compoziție:

AMIKACIN (AMIKACIN SULFATE) 250MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

AMINOGLYCOSIDES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2019-03-15

Caracteristicilor produsului

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_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMIKACIN SULFATE INJECTION
AMIKACIN (AS AMIKACIN SULFATE)
250 MG / ML
(500 MG / 2ML)
INTRAVENOUS (IV) OR INTRAMUSCULAR (IM)
HOUSE STANDARD
ANTIBIOTIC
Omega Laboratories Limited Date of Preparation: March 15, 2019
11 177 rue Hamon
Montreal, Quebec
Canada, H3M 3E4
Control No: # 209397
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_Page 2 of 23_
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