Vancomycin Hydrochloride (Page 4 of 4)
Compatibility with Other Drugs and IV Fluids
The following diluents are physically and chemically compatible (with 4 g/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
Normosol® -M and 5% Dextrose
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 solution has a low pH and may cause physical instability of other compounds.
Preparation and Stability
At the time of use, reconstitute the vials of Vancomycin Hydrochloride for Injection, USP with Sterile Water for Injection to a concentration of 50 mg of vancomycin/mL (see following table for volume of diluent).
| Concentration/Vial | Volume of Diluent |
| 500 mg | 10 mL |
| 1 gram | 20 mL |
After reconstitution, the vials may be stored in a refrigerator for 14 days without significant loss of potency.
Reconstituted solutions of vancomycin (500 mg/10 mL) must be further diluted in at least 100 mL of a suitable infusion solution. For doses of 1 gram (20 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.
Compatibility with Intravenous Fluids
Solutions that are diluted with 5% Dextrose Injection or 0.9% Sodium Chloride Injection may be stored in a refrigerator for 14 days without significant loss of potency. Solutions that are diluted with the following infusion fluids may be stored in a refrigerator for 96 hours:
5% Dextrose Injection and 0.9% Sodium Chloride Injection USP
Lactated Ringer’s Injection USP
Lactated Ringer’s and 5% Dextrose Injection USP
Normosol® -M and 5% Dextrose
Isolyte® E
Acetated Ringer’s Injection
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 lines between 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.
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 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 Factor |
| 70860-104-10 | 500 mg Vial (equivalent to 500 mg vancomycin) | 10 vials per carton |
| 70860-105-20 | 1 gram Vial (equivalent to 1 gram vancomycin) | 10 vials per carton |
Storage Conditions
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/mL and an infusion rate of 13.3 mL/min.
REFERENCES
- 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.
Athenex
Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India
©2018 Athenex.
Revised: February 2018
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 70860-104-41
Vancomycin Hydrochloride for Injection, USP
500 mg per vial
Rx only
For Intravenous Use
MUST BE FURTHER DILUTED BEFORE USE, SEE INSERT
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
NDC 70860-105-41
Vancomycin Hydrochloride for Injection, USP
1 gram per vial
Rx only
For Intravenous Use
MUST BE FURTHER DILUTED BEFORE USE, SEE INSERT
| VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution | |||||||||||||||||
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| VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride injection, powder, lyophilized, for solution | |||||||||||||||||
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| Labeler — Athenex Pharmaceutical Division, LLC. (080318964) |
Revised: 12/2018 Athenex Pharmaceutical Division, LLC.
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