entration gradient between DIANEAL solutions compared to blood capillary glucose level.
Absorption per unit time will be the highest at the start of an exchange and decreases over time. The rate of glucoseabsorption will be dependent upon the transport characteristics of the patient’s peritoneal membrane as determined by a peritoneal equilibration test (PET). Glucose absorption will also depend upon the concentration of glucose usedfor the exchange and the length of the dwell. Transport of other molecules will be dependent upon the molecularsize of the solute, the concentration gradient, and the effective peritoneal surface area as determined by the PET.
Metabolism and Elimination
Glucose is metabolized by normal cellular pathways (i.e., glycolysis). Metabolism of lactate occurs in the liver andresults in the generation of the bicarbonate. Glucose not absorbed during PD exchange procedure is removed bydrainage of the PD solution from the peritoneal cavity.
Drug Interaction Studies
Heparin
No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence ofincompatibility of heparin with DIANEAL solutions.
Antibiotics
No formal clinical drug interaction studies have been performed. In vitro studies of the following medications havedemonstrated stability with DIANEAL solutions: amphotericin B, ampicillin, cefazolin, cefepime, cefotaxime,ceftazidime, ceftriaxone, ciprofloxacin, clindamycin, deferoxamine, erythromycin, gentamicin, linezolid,
mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin,sulfamethoxazole/trimethoprim, ticarcillin, tobramycin, and vancomycin. However, aminoglycosides should not bemixed with penicillins due to chemical incompatibility.
16 HOW SUPPLIED/STORAGE AND HANDLING
DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes asshown in Tables 7-8:
Table 7 - DIANEAL Peritoneal Dialysis Solutions for CAPD therapyContainer Fill Volume (mL) Container
Size (mL)
Product Code NDC
ULTRABAG
Container
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
2000
2500
3000
2000
3000
5000
5B9866
5B9868
5B9857
0941-0426-52
0941-0426-53
0941-0426-55
DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
2000
2500
3000
2000
3000
5000
5B9876
5B9878
5B9858
0941-0427-52
0941-0427-53
0941-0427-55
DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
2000
2500
3000
2000
3000
5000
5B9896
5B9898
5B9859
0941-0429-52
0941-0429-53
0941-0429-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
1500
2000
2500
3000
2000
2000
3000
5000
5B9765
5B9766
5B9768
5B9757
0941-0424-51
0941-0424-52
0941-0424-53
0941-0424-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
1500
2000
2500
3000
2000
2000
3000
5000
5B9775
5B9776
5B9778
5B9758
0941-0430-51
0941-0430-52
0941-0430-53
0941-0430-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
1500
2000
2500
3000
2000
2000
3000
5000
5B9795
5B9796
5B9798
5B9759
0941-0433-51
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