Vancomycin Hydrochloride: Package Insert and Label Information (Page 3 of 3)

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.

ANIMAL PHARMACOLOGY

In animal studies, hypotension and bradycardia occurred in dogs receiving an intravenous infusion of vancomycin hydrochloride 25 mg/kg, at a concentration of 25 mg per mL and an infusion rate of 13.3 mL/min.

REFERENCES

1. Moellering RC, Krogstad DJ, Greenblatt DJ: Vancomycin therapy in patients with impaired renal function: A nomogram for dosage. Ann Inter Med 1981; 94:343.

Brands listed are the trademarks of their respective owners.

meitheal_®

Mfd. for Meitheal Pharmaceuticals
Chicago, IL 60631 (USA)
©2022 Meitheal Pharmaceuticals Inc.

Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Nanjing, China 210061

May 2022

810152-00

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 5 gram Container Label

NDC 71288-025 -75

Rx Only

Vancomycin Hydrochloride for Injection, USP

5 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED BEFORE USE

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 5 gram Carton

NDC 71288-025 -75

1 Pharmacy Bulk Package Bottle

Rx Only

Vancomycin Hydrochloride for Injection, USP

5 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED AFTER RECONSTITUTION AND BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT.

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 10 gram Container Label

NDC 71288-026 -75

Rx Only

Vancomycin Hydrochloride for Injection, USP

10 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED BEFORE USE

PRINCIPAL DISPLAY PANEL – Vancomycin Hydrochloride for Injection, USP 10 gram Carton

NDC 71288-026 -75

1 Pharmacy Bulk Package Bottle

Rx Only

Vancomycin Hydrochloride for Injection, USP

10 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION

For Intravenous Infusion

MUST BE FURTHER DILUTED AFTER RECONSTITUTION AND BEFORE INFUSION. NOT TO BE DISPENSED AS A UNIT.

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-025 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 5 g in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71288-025-75 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON contains a VIAL, PHARMACY BULK PACKAGE 1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the CARTON (71288-025-75)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215196 07/27/2022

VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-026 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 10 g in 95 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71288-026-75 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON contains a VIAL, PHARMACY BULK PACKAGE 1 95 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the CARTON (71288-026-75)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215196 07/27/2022

Labeler — Meitheal Pharmaceuticals Inc. (080548348)

Revised: 08/2022 Meitheal Pharmaceuticals Inc.