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when warranted, electronic particlecontent measurement.
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Purpose. The physical compatibility of pemetrexed disodium with selected other drugs during simulated Y-site injection was studied. Methods. A 5-mL sample of pemetrexed disodium 20 mg/mL in 0.9% sodium chloride injection was combined with 5 mL of a solution of each of 79 other drugs. The other test drugs included antineoplastics, antiinfectives, and supportive care drugs used undiluted or diluted in 0.9% sodium chloride injection or 5% dextrose injection. Visual examinations were performed with the unaided eye in normal diffuse fluorescent light at intervals up to four hours after mixing. Combinations with no obvious incompatibility were examined further with a high-intensity monodirectional light source to enhance visualization of small particles and low-level turbidity. The combinations were also evaluated with a turbi-
18. Beydoun A, Sackellares JC, Shu V. Safety and efficacy of divalproex sodium monotherapy in partial epilepsy: a doubleblind, concentration-response design clinical trial. Neurology. 1997; 48:182-8.
pany, Indianapolis, IN. Presented at the ASHP Midyear Clinical Meeting, New Orleans,
LA, December 2003.
Copyright © 2004, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/1101-2289$06.00.
Address correspondence to Mr. Trissel at the Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, 1515
Holcombe Boulevard, Houston, TX 77030. Supported by research grant LS01-319-01 from Eli Lilly and Com-
LAWRENCE A. TRISSEL, B.S. PHARM., FASHP, is Director and CHRISTOPHER A. SAENZ is Pharmacy Technician, Clinical Pharmaceutics Research, Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, Houston. ABAYOMI B. OGUNDELE and DELSHALONDA S. INGRAM are pharmacy students, Texas Southern University, Houston.
Index terms: Antiinfective agents; Antineoplastic agents; Caloric agents; Color; Dextrose; Diluents; Incompatibilities; Injections; Pemetrexed disodium; Precipitation; Sodium chloride; Stability; Storage; Turbidity Am J Health-Syst Pharm. 2004; 61:2289-93
dimeter at one and four hours. All combinations without visual incompatibility were assessed with a particle sizer– counter. Results. Of the 79 pemetrexed–secondary drug combinations, 55 were compatible for at least four hours. However, mixture with 24 drugs resulted in precipitation (including microprecipitation) and color change. Conclusion. Pemetrexed disodium was incompatible with 24 drugs during simulated Y-site administration and should not be administered with them.
Am J Health-Syst Pharm—Vol 61 Nov 1, 2004
2289
REPORTS Pemetrexed disodium
istered simultaneously or sequentially with other drugs currently exists.
The purpose of this study was to evaluate the physical compatibility of pemetrexed diluted for infusion during simulated Y-site administration with 79 other drugs by visual observation, turbidity measurement, and,
LAWRENCE A. TRISSEL, CHRISTOPHER A. SAENZ, ABAYOMI B. OGUNDELE, AND DELSHALONDA S. INGRAM
Pemetrexed disodium is an investigational multitargeted antifolate antineoplastic agent being evaluated in clinical trials for use in the treatment of solid tumors.1 Pemetrexed is administered as an intravenous infusion in 0.9% sodium chloride injection. Along with pemetrexed, patients may be receiving other drugs by simultaneous or sequential Y-site administration, including other antineoplastics, antiemetics, antihistamines, diuretics, corticosteroids, and analgesics. The potential exists for the development of physical incompatibilities during Y-site administration of pemetrexed with other agents or components of their formulations. No compatibility information for pemetrexed admin-
22. Data on file. Abbott Laboratories, Abbott Park, IL; 2004 May.
23. Cloyd JC, Fischer JH, Kriel RL et al. Valproic acid pharmacokinetics in children. IV. Effects of age and antiepileptic drugs on protein binding and intrinsic clearance. Clin Pharmacol Ther. 1993; 53:22-9.
REPORTS Pemetrexed disodium
17. Cloyd JC, Dutta S, Cao G et al. Valproate unbound fraction and distribution volume following rapid infusions in patients with epilepsy. Epilepsy Res. 2003; 53:19-27.
19. Perucca E, Dulac O, Shorvon S et al. Harnessing the clinical potential of antiepileptic drug therapy—dosage optimization. CNS Drugs. 2001; 15:609-21.
24. Bourdet SV, Gidal BE, Alldredge BK. Pharmacologic management of epilepsy in the elderly. J Am Pharm Assoc. 2001; 41:421-36.
Physical compatibility of pemetrexed disodium with other drugs during simulated Y-site administration
20. Dutta S, Reed RC, Chun AH et al. Morning versus evening dosing of divalproex extended-release tablets does not make a difference: a biopharmaceutic and safety comparison. Epilepsia. 2003; 44(suppl 9):96. Abstract.
21. Yukawa E, To H, Ohdo S et al. Population-based investigation of valproic acid relative clearance using nonlinear mixed effects modeling: influence of drug–drug interaction and patient characteristics. J Clin Pharmacol. 1997; 37:1160-7.