VANCOMYCIN (Vancomycin Hydrochloride)

 VANCOMYCIN (Vancomycin Hydrochloride)

VANCOMYCIN (Vancomycin Hydrochloride)

VANCOMYCIN (Vancomycin Hydrochloride)

DESCRIPTION

Vancomycin is ABBOTTs brand name for Vancomycin HCI Injection for I.V. use.

Vancomycin Hydrochloride has the chemical formula C H Cl N O . HCL. The 66 75 2 8 24 

formula weightis1.486:500 mg ofthe base is equivalentto0.34mmol and 1 g ofthe base

isequivalentto0.67mmol.

COMPOSITION

EachvialofVancomycininjection contains:

(1) VancomycinHCI equivalantto, 

Vancomycin................. 500 mg

(2) VancomycinHCI equivalentto, 

Vancomycin......... 1000mg

CLINICAL PHARMACOLOGY: Vancomycin Hydrochloride is poorly absorbed after 

oral administration: It is given intravenously for therapy of systemic injections. 

Intramuscular injection ispainful.

In subjects with normal kidney function, multiple intravenous dosing of1g ofVancomycin

(15 mg/kg) infused over 60 minutes produces mean plasma concentrations of

approximately 63 mg/L immediately at the completion of infusion, mean plasma

concentrations of approximately 23mg/L 2 hours after infusion, and mean plasma

concentrations of approximately 8 mg/L 11 hours after the end of the infusion. Multiple 

dosingof500 mginfused over30minutes producesmeanplasmaconcentrationsofabout 49 mg/L at the completion of infusion, mean plasma concentrations of about 19 mg/L 2hours after infusion, and mean plasma concentrations of about 10 mg/L 6 hours after infusion. The plasma concentrations during multiple dosing are similar to those after a singledose.

The mean elimination half-life ofVancomycin fromplasma is4 to 6 hours in subjects with normal renal functions. In the first 24 hours, about 75% of an administered dose of Vancomycin is excreted in urine by glomerularfiltration. Mean plasma clearance is about 

0.058 L/kg/hr and mean renal clearance is about 0.048 L/kg/hr.Renal dysfunction slows excretion of Vancomycin. In anephric patients, the average half-life of elimination is 7.5days. The distributioncoefficient isfrom0.3 - 0.43L/kg. There isnoapparentmetabolism

of a drug. About 60 percent of an intraperitoneal dose of vancomycin Hydrochloride administered during peritoneal dialysis is absorbed systematically in 6 hours, Serum 

concentrations of about 10mg/L are achieved by intraperitoneal injection of 30mg/kg of Vancomycin. Vancomycin is not effectively removed by either hemodialysis or peritoneal dialysis, there havebeennoreports ofVancomycinclearance withhemoperfusion.

Total systematicand renal clearance ofVancomycinmay bereduced inthe elderly.

Vancomycin is approximately 55% serum protein bound as measured by ultrafiltration at

Vancomycinserum concentrationsof10-100mg/L. After IVpericardial administrationof

Vancomycin Hcl, inhibitory concentrations are present in pleural, pericardial, ascitic, and synovial fluids; in urine: in peritoneal dialysis fluid; and in atrial appendage tissue. 

VancomycinHCI dosenot readily diffuse acrossnormalmeningesintothe spinalfluid,but.

whenthe meningesare inflamed, penetration intothe spinalfluid occurs.