vancomycin hydrochloride, USP 5 G and 10 G, PHARMACY BULK PACKAGE Other

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PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

PREPARATION AND STABILITY

For Administration by Intravenous Drip

Refer to Directions for Proper Use of a Pharmacy Bulk Package Bottle.

CAUTION: NOT TO BE DISPENSED AS A UNIT.

Directions for Proper Use of Pharmacy Bulk Package

The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents.
Use of this product is restricted to a suitable work area, such as a laminar flow hood.
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 for Injection, USP.

Preparation and Stability

5 g Pharmacy Bulk Package Bottle

At the time of use, reconstitute by adding 100 mL of Sterile Water for Injection to the 5 g Pharmacy Bulk Package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/10 mL (1 g/20 mL). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED. Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. Doses of 1 g/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 IV infusion over a period of at least 60 minutes.

10 g Pharmacy Bulk Package Bottle

At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection to the 10 g Pharmacy Bulk Package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED. Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 g/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 or container permits.

For Oral Administration

Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g 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 g. The appropriate dose may be diluted in 1 oz. of water and given to the patient 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.

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PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

PREPARATION AND STABILITY

For Administration by Intravenous Drip

Refer to Directions for Proper Use of a Pharmacy Bulk Package Bottle.

CAUTION: NOT TO BE DISPENSED AS A UNIT.

Directions for Proper Use of Pharmacy Bulk Package

The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents.
Use of this product is restricted to a suitable work area, such as a laminar flow hood.
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 for Injection, USP.

Preparation and Stability

5 g Pharmacy Bulk Package Bottle

At the time of use, reconstitute by adding 100 mL of Sterile Water for Injection to the 5 g Pharmacy Bulk Package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/10 mL (1 g/20 mL). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED. Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. Doses of 1 g/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 IV infusion over a period of at least 60 minutes.

10 g Pharmacy Bulk Package Bottle

At the time of use, reconstitute by adding 95 mL of Sterile Water for Injection to the 10 g Pharmacy Bulk Package bottle of dry, sterile vancomycin powder. The resultant solution will contain vancomycin equivalent to 500 mg/5 mL (1 g/10 mL). AFTER RECONSTITUTION, FURTHER DILUTION IS REQUIRED. Reconstituted solutions of vancomycin (500 mg/5 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 g/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 or container permits.

For Oral Administration

Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g 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 g. The appropriate dose may be diluted in 1 oz. of water and given to the patient 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.

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