Preparation and Stability
At the time of use, reconstitute by adding 10 mL of Sterile Water for Injection to the 500 mg vial of dry, sterile vancomycin poweder. Vials reconstituted in this manner will give a solution of 50 mg/mL. FURTHER DILUTIO IS REQUIRED. After reconstitution, the vials my be stored in a refrigerator (2-8 C) for 14 days without significant loss of potency. Reconstituted solutions containing 500 mg of vancomycin must be diluted with at lest 100 mL of diluent. The desired dose, diluted in this manner, should be administered by intermittent intravenous 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 may be stored in a refrigerator for 96 hours:
5% Dextrose Injection and 0.9% Sodium Chloride Injection, USp
Lactated Ringer’s Injection, USP
Normosol A-M and 5% Dextrose
Isolyte
Aceetated Ringer’s Injection
For Oral Administration
Oral vancomycin hydrochloride is used in treating antibiotic-associated pseudomembraneous colitis caused by C. dfifficiile and for staphylococcal enterocolitis. Vancomycin hydrochloride is not effective by 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 dosage 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.
Prior to reconstitution, the vials may be stored at temperature not exceeding 30 C.
Major Incompatibility
Vanconmycin solution has a low pH that may cause chemical or physical instability when it is mixed with other compounds. Mixing with alkaline solutions should be avoided. 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 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.
Prior to administration, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution or container permit.
Storage
Prior to reconstitution, vials should be stored at temperature not exceeding 30 C. Reconstituted solution solution be stored between 2 C to 8 C.
Availability
500 mg vials of 1’s
Caution
Foods, drugs, devices and Cosmetics Act prohibits dispensing without prescription.