Prescription Drug Information: Vancomycin Hydrochloride (Page 3 of 4)

Patients With Normal Renal Function

Adults


The usual daily intravenous dose is 2 grams divided either as 500 mg every 6 hours or 1 gram every 12 hours. Each dose should be administered at no more than 10 mg/min or over a period of at least 60 minutes, whichever is longer. Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose.


Pediatric Patients


The usual intravenous dosage of vancomycin hydrochloride for injection is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.


Neonates

In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

Patients With Impaired Renal Function and Elderly Patients

Dosage adjustment must be made in patients with impaired renal function. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography. 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 hydrochloride for injection per day in mg is about 15 times the glomerular filtration rate in mL/min (see following table).

DOSAGE TABLE FOR VANCOMYCIN HYDROCHLORIDE FOR INJECTION IN PATIENTS WITH IMPAIRED RENAL FUNCTION

(Adapted from Moellering et al.1)

Creatinine Clearance mL/min Vancomycin Hydrochloride for Injection Dose mg/24 h
100 1,545
90 1,390
80 1,235
70 1,080
60 925
50 770
40 620
30 465
20 310
10 155

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 to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1,000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1,000 mg every 7 to 10 days has been recommended.

When only serum creatinine 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.

Men: [Weight (kg) x (140 – age in years)]
72 x serum creatinine concentration (mg/dL)
Women: 0.85 x above value

The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance is not 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 hydrochloride for injection administration by the intrathecal (intralumbar or intraventricular) routes have not been established. Intermittent infusion is the recommended method of administration.

Compatibility with Other Drugs and Intravenous Fluids

The following diluents are physically and chemically compatible (with 4 grams per L vancomycin hydrochloride):


5% Dextrose Injection, USP

5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP

Lactated Ringer’s Injection, USP

5% Dextrose and Lactated Ringer’s Injection, USP

Normosol® -M and 5% Dextrose Injection, USP

0.9% Sodium Chloride Injection, USP

Isolyte® E

Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.


Vancomycin hydrochloride for injection solution has a low pH and may cause physical instability of other compounds.

Mixtures of solutions of vancomycin hydrochloride and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin hydrochloride. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin hydrochloride to 5 mg per mL or less.

Although intravitreal injection is not an approved route of administration for vancomycin hydrochloride for injection, precipitation has been reported after intravitreal injection of vancomycin hydrochloride 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.

Preparation and Stability

For Administration by Intravenous Drip

Refer to Directions for Proper Use of Pharmacy Bulk Package .

CAUTION: NOT TO BE DISPENSED AS A UNIT.

Directions for Proper Use of Pharmacy Bulk Package

a. The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents.
b. Use of this product is restricted to a suitable work area, such as a laminar flow hood. c. Once this container closure has been punctured, withdrawal of the contents should be completed without delay. If prompt fluid transfer cannot be accomplished, discard the contents no later than 4 HOURS after initial closure puncture. This time limit should begin with the introduction of solvent for diluent into the Pharmacy Bulk Package.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not add supplementary medication to vancomycin hydrochloride for injection.

Preparation and Stability

5 gram Pharmacy Bulk Package Bottle

At the time of use, reconstitute by adding 100 mL of Sterile Water for Injection to the 5 gram Pharmacy Bulk Package bottle of dry, sterile vancomycin hydrochloride for injection powder. The resultant solution will contain vancomycin equivalent to 500 mg per 10 mL. FURTHER DILUTION IS REQUIRED.

Reconstituted solutions of vancomycin (500 mg per 10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. Doses of 1 gram per 20 mL must be further diluted in at least 200 mL of a suitable infusion solution. The desired dose diluted in this manner should be administered by intermittent intravenous infusion over a period of at least 60 minutes.

10 gram Pharmacy Bulk Package Bottle

At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection, USP to the 10 gram bottle of dry, sterile vancomycin hydrochloride for injection powder. The resultant solution will contain vancomycin equivalent to 500 mg per 5 mL (1 gram per 10 mL). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED.

Reconstituted solutions of vancomycin (500 mg per 5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (10 mL), at least 200 mL of solution must be used. The desired dose diluted in this manner should be administered by intermittent IV infusion over a period of at least 60 minutes.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.

For Oral Administration

Oral vancomycin hydrochloride is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin hydrochloride is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 grams given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 grams. The appropriate dose may be diluted in 1 oz of water and given to the patients to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

HOW SUPPLIED/STORAGE AND HANDLING

Vancomycin Hydrochloride for Injection, USP is a white or off-white to light tan-colored powder or cake, and is available in a Pharmacy Bulk Package. It is supplied as follows:

NDC Vancomycin Hydrochloride for Injection, USP Package Factor
71288-025 -75 5 grams equivalent of vancomycin in a Pharmacy Bulk Package Bottle 1 bottle per carton
71288-026 -75 10 grams equivalent of vancomycin in a Pharmacy Bulk Package Bottle 1 bottle per carton

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Sterile, Nonpyrogenic, Preservative-free.

Lyophilized.

The container closure is not made with natural rubber latex.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.