|
Stability Information for Vancomycin with Dianeal/Delflex Peritoneal Dialysis Solutions
|
| Reference |
Concentration |
Study Period |
Storage Conditions |
Chemical Stability |
Notes |
|
Strong et al., 1989
|
14.3 mg/mL
|
24 hours
|
Room temperature of 25 °C exposed to fluorescent room light.
|
No information available
|
Tested in two peritoneal dialysis solutions: (1) Dianeal with dextrose 2.5% and (2) Dianeal with dextrose 4.25%, both with heparin sodium 0.5 to 14.3 units/mL. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Strong et al., 1989
|
6.9 mg/mL |
24 hours |
Room temperature of 25 °C exposed to fluorescent room light. |
No information available |
Tested in two peritoneal dialysis solutions: (1) Dianeal with dextrose 2.5% and (2) Dianeal with dextrose 4.25%, both with heparin sodium 0.5 to 14.3 units/mL. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
| Tobudic et al., 2012 |
1 to 8 mcg/mL
|
24 hours |
Simulated intraperitoneal administration at 37 °C. |
Variable activity depending on the specific peritoneal dialysis solution used. No antibiotic activity was found when vancomycin hydrochloride was added to the dextrose-containing peritoneal dialysis solutions Dianeal PD4 and Physioneal 40. The best activity was found in Nutrineal PD4 and to a lesser extent Extraneal, although the activity was still lower than in the activity in a growth-promoting medium used as a control.
|
Antibiotic concentrations tested were 1 to 8 times the minimum inhibitory concentration (MIC) of the antibiotic. Four Baxter peritoneal dialysis solutions used in this testing: 1. Dianeal PD4 (lactate buffered with dextrose 1.36%) 2. Physioneal 40 (lactate and bicarbonate buffered with dextrose 1.36%) 3. Nutrineal PD4 (lactate buffered with amino acids) 4. Extraneal (lactate buffered containing icodextrin) Human serum albumin was added to a concentration of 2 mg/mL and pH was adjusted to 7.4 with sodium hydroxide to simulate and 4- to 6-hour dwell. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
| Glew et al., 1981 |
10 mcg/mL
|
24 hours |
Room temperature.
|
Unstable. About 7% or less antibiotic activity loss occurred in 24 hours. |
Tested in phosphate buffer and peritoneal dialysis concentrate with dextrose 50% (McGaw). Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Strong et al., 1989
|
15 mcg/mL |
24 hours |
Room temperature of 25 °C exposed to fluorescent room light.
|
No information available
|
Tested in two peritoneal dialysis solutions: (1) Dianeal with dextrose 2.5% and (2) Dianeal with dextrose 4.25%, both with heparin sodium 0.5 to 14.3 units/mL. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution. |
|
Sewell et al., 1982
|
15 mcg/mL |
24 hours |
Room temperature of 25 °C.
|
Antimicrobial activity was retained throughout the study period.
|
Tested in two peritoneal dialysis solutions: (1) Dianeal 137 with dextrose 1.5% and (2) Dianeal 137 with dextrose 4.25%. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Sewell et al., 1983
|
20 mcg/mL |
48 hours |
Room temperature of 25 °C.
|
Stable. About 95 +/- 12% of the antibiotic activity remained after 24 hours but about 85 +/- 9% remained after 48 hours at room temperature. The presence of heparin sodium and insulin had no effect on antibiotic activity.
|
Tested in two peritoneal dialysis solutions: (1) Dianeal 137 (Travenol) and (2) PD-2 (Travenol) with and without heparin sodium 0.5 unit/mL and with and without insulin 0.02 unit/mL (20 units/L). Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Dooley et al., 2003
|
25 mcg/mL |
14 days |
Room temperature about 20 °C exposed to ambient room light and refrigerated at 4 °C.
|
Chemically stable. Little or no loss of vancomycin hydrochloride by immunoassay in 14 days at either temperature. Bioactivity was found to be about 90% in 14 days refrigerated and 79% in 14 days at room temperature.
|
Tested in Delflex peritoneal dialysis bags (Fresenius) with dextrose 2.5%. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Mawhinney et al., 1992
|
25 mcg/mL |
42 days |
Refrigerated at 4 °C, room temperature of 20 °C, and body temperature of 37 °C.
|
Chemically stable. Less than 4% vancomycin hydrochloride loss occurred in 42 days under refrigeration in both solutions. At room temperature, about 5% loss occurred in 28 days and about 9% loss occurred in 42 days in solution (1) with 1.36% dextrose. In solution (2) with 3.86% dextrose, little or no loss of dextrose occurred in 42 days at room temperature. At 37 °C, about 10% loss occurred in 7 days.
|
Tested in two peritoneal dialysis solutions: (1) Dianeal 137 with dextrose 1.36% and (2) Dianeal 137 with dextrose 3.86%. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Glew et al., 1981
|
50 mcg/mL |
24 hours |
Room temperature. |
Unstable. About 7% or less antibiotic activity loss occurred in 24 hours.
|
Tested in phosphate buffer and peritoneal dialysis concentrate with dextrose 50% (McGaw). Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Vaughan et al., 1994
|
50 mcg/mL |
6 days |
Stored under ambient light conditions refrigerated at 4 °C, at room temperature of 25 °C, and at body temperature of 37 °C.
|
Chemically stable. Little or no vancomycin hydrochloride losses occurred in 7 days under refrigeration or at room temperature if no heparin sodium was present. About 5 to 7% losses occurred in 7 days under refrigeration or at room temperature if heparin sodium was present. Losses of 10% or less occurred in 5 days and losses of about 12% loss occurred in 6 days at 37 °C with or without heparin sodium.
|
Tested in Dianeal PD-2 with dextrose 1.5% with and without heparin sodium 1 unit/mL. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Voges et al., 2004
|
1 mg/mL |
Room temperature for 24 hours followed by body temperature for 4 hours.
|
Room temperature of 25 °C and 60% relative humidity followed by 37 °C and 60% relative humidity to simulate storage after removing from the overwrap followed by body temperature to simulate in-use conditions.
|
Stable. Little or no vancomycin hydrochloride loss occurred within the study period. No change in the chemical composition of the peritoneal dialysis solutions occurred.
|
Tested in four peritoneal dialysis solutions: 1. Dianeal PD4 2. Extraneal 3. Nutrineal 4. Physioneal 40 Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Nornoo et al., 2006
|
1 mg/mL |
7 days under refrigeration or at room temperature and 24 hours at body temperature.
|
Stored refrigerated at about 5 °C, room temperature of about 24 °C, and body temperature of 37 °C protected from exposure to light.
|
Chemically stable. After 7 days of storage, little or no loss of vancomycin occurred in the refrigerated samples and about 2 to 3% loss occurred in the room temperature samples. At body temperature, about 6% vancomycin loss occurred in 24 hours.
|
Vancomycin stability was evaluated in icodextrin 7.5% PD solution (Extraneal, Baxter). Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
| Drake et al., 1990 |
1 mg/mL |
48 hours under refrigeration and at room temperature; 8 hours at 37 °C.
|
Refrigerated at 4 °C, room temperature of 20 to 25 °C, and body temperature of 37 °C.
|
Stable. Antimicrobial activity was retained under refrigeration and at room temperature for 48 hours and at 37 °C for 8 hours.
|
Tested in Dianeal PD-2 with dextrose 1.5%. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|
|
Strong et al., 1989
|
5.3 mg/mL |
24 hours |
Room temperature of 25 °C exposed to fluorescent room light. |
No information available.
|
Tested in two peritoneal dialysis solutions: (1) Dianeal with dextrose 2.5% and (2) Dianeal with dextrose 4.25%, both with heparin sodium 0.5 to 14.3 units/mL. Variable compatibility results have been reported for this combination depending on the vancomycin hydrochloride concentration and the peritoneal dialysis solution.
|