VANCOMYCIN HYDROCHLORIDE (Page 5 of 5)

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 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 supplied as follows:

NDC	Vancomycin Hydrochloride for Injection USP	Package Size
70436-020-82	500 mg Vial (equivalent to 500 mg vancomycin)	10 vials per carton
70436-021-82	1 g Vial (equivalent to 1 gram vancomycin)	10 vials per carton

Prior to reconstitution, store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature].

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/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.

NORMOSOL®-M is a registered trademark of Abbott Hospital Products (Division of Abbott Laboratories).
ISOLYTE® E is a registered trademark of McGaw, Inc.

Manufactured by:
Hainan Poly Pharm. Co., Ltd., China
Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127

Distributed by:
Slate Run Pharmaceuticals, LLC
Columbus, Ohio 43215

10000053/02

Revised: 05/2021

PRINCIPAL DISPLAY PANEL — 500 mg Vial Label

NDC 70436-020-82

PRINCIPAL DISPLAY PANEL – 1 g Vial Label

NDC 70436-021-82

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-021 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 1 g

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70436-021-82 10 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (70436-021-82)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212332 06/03/2019

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-020 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN) VANCOMYCIN 500 mg

Inactive Ingredients Ingredient Name Strength HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70436-020-82 10 VIAL in 1 CARTON contains a VIAL 1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (70436-020-82)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212332 06/03/2019

Labeler — Slate Run Pharmaceuticals, LLC (039452765)

Registrant — Hainan Poly Pharm. Co., Ltd. (654561638)

Establishment
Name	Address	ID/FEI	Operations
Hainan Poly Pharm. Co., Ltd.		654561638	manufacture (70436-021), manufacture (70436-020), analysis (70436-021), analysis (70436-020)

Revised: 05/2021 Slate Run Pharmaceuticals, LLC