Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
AMIKACIN (AMIKACIN SULFATE)
MARCAN PHARMACEUTICALS INC
J01GB06
AMIKACIN
500MG
SOLUTION
AMIKACIN (AMIKACIN SULFATE) 500MG
INTRAMUSCULAR
10X2ML
Prescription
AMINOGLYCOSIDES
Active ingredient group (AIG) number: 0111922001; AHFS:
APPROVED
2018-09-20
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 Baca dokumen lengkap