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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
|Minimizing risk of thrombophlebitis:
* See important points listed further down the page....
Concentration less than or equal to 5 mg/ml
[0 to 500 mg] [100 ml] [ 30 minutes ]
[501-1250 mg] [250 ml] [ 60 minutes ]
[1251-1750mg] [500ml] [ ≥ 90 minutes ]
[1751-2250mg] [500 ml] [ ≥120 minutes ]
(Concentration less than or equal to 2.5 mg/ml )
Minimum Dilutions - Monitor for infusion related reactions
Premixed bags: Vancomycin Injection, USP is supplied as a frozen, iso-osmotic, premixed solution in a 100 mL or 200 mL single dose GALAXY plastic container in the following vancomycin-equivalent dose:
Additional support / Important points:
Infusion-related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/min are recommended in adults. In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.
|EXP: 24 hrs (RT) / 7 DAYS(REF)
Vd=0.65 l/kg (range: 0.5 to 0.9)
Stability (Source: Lexi-drugs):
INDICATIONS AND USAGE
Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Vancomycin hydrochloride has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin hydrochloride has been reported to be effective only in combination with an aminoglycoside.
Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin.
The parenteral form of Sterile Vancomycin Hydrochloride may be administered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and for staphylococcal enterocolitis. Parenteral administration of vancomycin hydrochloride alone is of unproven benefit for these indications. Vancomycin is not effective by the oral route for other types of infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
Patients with Normal Renal Function
Pediatric Patients: The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every six hours. Each dose should be administered over a period of at least 60 minutes.
Infants and Neonates: In neonates and young infants, the total daily intravenous dosage may be lower. In both neonates and infants, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the first week of life and every eight hours thereafter up to the age of one month. Each dose should be administered over 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.
Patients with Impaired Renal Function and Elderly Patients
If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min:
The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.
The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given in order to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 h. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.
When only serum creatinine concentration is known, the following formula (based on sex, weight, and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.
The serum creatinine must represent a steady state of renal function or the estimated value for creatinine clearance will not be valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions: (1) characterized by decreasing renal function, such as shock, severe heart failure, or oliguria; (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema, or ascites; and (3) accompanied by debilitation, malnutrition, or inactivity.
The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.
Intermittent infusion is the recommended method of administration.
PREPARATION AND STABILITY
After reconstitution with Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, the vials may be stored in a refrigerator for 14 days without significant loss of potency.
Reconstituted solutions containing 500 mg of vancomycin must be diluted with at least 100 mL of diluent. Reconstituted solutions containing 1 g must be diluted with at least 200 mL of diluent. The desired dose, diluted in this manner, should be administered by intermittent intravenous infusion over a period of at least 60 minutes.
Compatibility with Other Drugs and Intravenous Fluids
5% Dextrose Injection, USP
Vancomycin solution has a low pH and may cause chemical or physical instability when it is mixed with other compounds.
Mixtures of solutions of vancomycin and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous linesbetween the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less.
Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles. The precipitates dissolved gradually, with complete clearing of the vitreous cavity over two months and with improvement of visual acuity.
Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permits.
For Oral Administration
Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP.]
Source: [package insert]