Injectable Drugs : Compatibility Information of Paclitaxel

Paclitaxel - AHFS 10:00
Products  Paclitaxel is available as 6-mg/mL non-aqueous concentrated solutions that must be diluted for use. Taxol is available in 5-, 16.7-, and
50-mL multiple-dose vials while Onxol is available in 5-, 25-, and 50-mL multiple-dose vials. One milliliter of either formulation provides paclitaxel 6
mg with polyoxyl 35 castor oil (Cremophor EL; polyoxyethylated castor oil) surfactant 527 mg and dehydrated alcohol 49.7% (v/ v). The Onxol
formulation also incorporates citric acid anhydrous 2 mg/mL. (1-2/06) (4)
pH  Paclitaxel admixtures at concentrations of 0.6 and 1.2 mg/mL in dextrose 5%, sodium chloride 0.9%, and dextrose 5% in lactate d Ringer's
injection have a pH of 4.4 to 5.6. (4)
Trade Name(s)  Onxol, Taxol
Administration  Paclitaxel is administered by intravenous infusion. The concentrate must be diluted to a final paclitaxel concentration of 0. 3 to 1.2
mg/mL in dextrose 5%, sodium chloride 0.9%, dextrose 5% in sodium chloride 0.9%, or dextrose 5% in lactated Ringer's injectio n. Administration
over three hours is often recommended (1-2/06) (4), although other duration periods have been used. (4) An inline 0.22-m filter should be used for
administration. The intravenous solution containers and administration sets should be free of the plasticizer diethylhexyl ph thalate (DEHP). (1-2/06)
See Plasticizer Leaching under Stability below.
Use of self-venting sets spiked into glass bottles of paclitaxel admixtures has occasionally resulted in solution dripping from the air v ent. Presumably,
the surfactant content wetted the hydrophobic filter, allowing the solution to drip. (1843) In another observation, the spikes of administration sets
were made sufficiently slippery by surfactant in the paclitaxel formulation that the spike slipped out after it had been seat ed through the rubber
bung of the glass bottle. The admixture also leaked due to a poor seal. The authors recommend use of non -PVC plastic solution containers (Excel,
McGaw) to avoid the problem. (2052)
Stability  Intact vials should be stored between 20 and 25 C and protected from light. Stability is not adversely affected by refrigeration or
freezing. Refrigeration may result in the precipitation of formulation components. However, warming to room temperature redis solves the material
and does not adversely affect the product. If a precipitate is insoluble, the product should be discarded. (1-2/06)
Turbidity  Paclitaxel concentrate is a clear, colorless to slightly yellow viscous liquid. After dilution in an infusion solution, the d rug may exhibit
haziness because of the surfactant content of the formulation. (1528) This haziness increases until the maximum turbidity of around 6 to 8
nephelometric turbidity units occurs between 0.3 and 0.9 mg/mL. This level of haze may be visible in normal room light. Conti nued dilution below
0.3 mg/mL results in a continual decline of measured turbidity through 0.01 mg/mL, the lowest concentration evaluated. ( 1528)
Precipitation  Although paclitaxel in aqueous solutions is chemically stable for 27 hours (1-2/06) or longer (1746) (1842) (2708), precipitation has
occurred irregularly and unpredictably. Such precipitation occurs within the recommended range of 0.3 to 1.2 mg/mL and at eve n lower paclitaxel
concentrations. These precipitates often have been observed in the infusion tubing distal to the pump chamber. ( 1716) Although the precipitation of
insoluble drugs in an aqueous medium is a foregone conclusion, the time to precipitation is irregular. It may be accelerated by various factors
including the presence or formation of crystallization nuclei, agitation, and contact with incompatible drugs or materials. ( 1374) (1521) Since the
mechanism of this irregular paclitaxel precipitation has not been identified (1739), care and vigilance throughout its infusion are required.
Sorption  No paclitaxel loss due to sorption to containers or sets has been observed. (1520) (2230) (2231) (2232)
Plasticizer Leaching  Contact of undiluted paclitaxel concentrate with plasticized PVC equipment and devices is not recommended. (1-2/06) (4)
With use of infusion bags and tubing that are free of DEHP plasticizer and the elimination of PVC precision flow regulators, a reduction in leached
DEHP of up to 96% has been reported. (2679)
Paclitaxel vehicle equivalent to paclitaxel 1.2 mg/mL in dextrose 5% in VISIV polyolefin bags was tested at room temperature near 23 C for 24 hours.
HPLC analysis found no leached plastic components within the 24-hour study period. (2660)
Paclitaxel itself does not contribute to the extraction of the plasticizer DEHP. (1520) However, the surfactant, Cremophor EL, in the paclitaxel
formulation extracts DEHP from PVC containers and sets. The amount of DEHP extracted increases with time and drug concentrati on. (1520) (1683)
(2146) Consequently, the use of DEHP-plasticized PVC containers and sets is not recommended for infusion of paclitaxel solutions. Instead, the
manufacturer recommends the use of glass, polypropylene, or polyolefin containers and non-PVC administration sets such as those that are
polyethylene lined. (1-2/06)
The use of inline filters, such as the Ivex-2 filter set that incorporates about 10 inches of PVC inlet and outlet tubing, has resulted in a small amount
of DEHP extraction. Since the extracted DEHP is at a sufficiently low level, however, the manufacturer considers the Ivex -2 filter set to be acceptable.
(1-2/06)
A study was performed on the compatibility of paclitaxel 0.3- and 1.2-mg/mL infusions with various non-PVC infusion sets. The paclitaxel infusions
Handbook on Injectable Drugs - 15th Ed. (2009)
Thursday, January 21, 2016
11:01 AM
Unfiled Notes Page 1

A study was performed on the compatibility of paclitaxel 0.3- and 1.2-mg/mL infusions with various non-PVC infusion sets. The paclitaxel infusions
were run through the study sets, and the effluent was then analyzed by HPLC for leached DEHP plasticizer. The following sets had significant and
unacceptable amounts of leached DEHP: Baxter vented nitroglycerin (2C7552S), Baxter vented basic solution (1C8355S), McGaw Ho rizon pump
vented nitroglycerin (V7450), and McGaw Intelligent pump vented nitroglycerin (V7150). Although these sets were largely non -PVC, their highly
plasticized pumping segments contributed the DEHP. The administration and extension sets cited in Tables 1 and 2 exhibited no more leached DEHP
than the Ivex-2 filter set specified in the product labeling. (1843)
Table 1. Administration Sets Compatible with Paclitaxel Infusions by Manufacturer 1843
Abbott LifeCare 5000 Plum PVC specialty set (11594)
Life Shield anesthesia pump set OL with cartridge (13503)
LifeCare model 4P specialty set, non-PVC (11434)
Omni-Flow universal primary intravenous pump short minibore patient line (40527)
Baxter Vented volumetric pump nitroglycerin set (2C1042)
Block Medical Verifuse nonvented administration set with 0.22-m filter, check valve, injection site, and non-DEHP PVC tubing (V021015)
I-Flow Vivus-4000 polyethylene-lined infusion set (5000-784)
IMED Standard PVC set (9215)
Closed-system non-PVC fluid path nonvented quick-spike administration set (9635)
Non-PVC set with inline filter (9986)
Gemini 20 nonvented primary administration set for nitroglycerin and emulsions (2262)
IVAC Universal set with low-sorbing tubing (52053, 59953, and S75053)
Ivion/Medex WalkMed spike set (SP-06) with pump set (PS-401, PS-360, FPS-560, or FPX-560)
Siemens Reduced-PVC full set MiniMed Uni-Set macrobore (28-60-190)
Table 2. Extension Sets Compatible with Paclitaxel Infusions by Manufacturer 1843
Abbott Ivex-HP filter set (4524)
Ivex-2 filter set (2679)
Becton-Dickinson Intima intravenous catheter placement set (38-6918-1)
J-loop connector (38-1252-2)
E-Z infusion set shorty (38-53741)
E-Z infusion set (38-53121)
Baxter Polyethylene-lined extension set with 0.22-m air-eliminating filter (1C8363)
Braun 0.2-m filter extension set (FE-2012L)
Small-bore 0.2-m filter extension set (PFE-2007)
Whin-winged extension set with 90 Huber needle (HW-2267)
Whin extension set with Y-site and Huber needle (HW-2276 YHR)
Y-extension set with valve (ET-08-YL)
Small-bore extension set with T-fitting (ET-04T)
Small-bore extension set with reflux valve (ET-116L)
Gish Biomedical VasTack noncoring portal-access needle system (VT-2022)
IMED 0.2-m add-on filter set (9400 XL)
IVAC Spec-Sets extension set with 0.22-m inline filter (C20028 and C20350)
Ivion/Medex Extension set with 0.22-m filter (IV4A07-IV3)
PALL SetSaver extended-life disposable set with 0.2-m filter (ELD-96P and ELD-96LL)
SetSaver extended-life disposable microbore extension tubing with 0.2-m Posidyne filter (ELD-96LYL and ELD-96LYLN)
Pfizer/Strato Medical Lifeport vascular-access system infusion set with Y-site (LPS 3009)
Mazzo et al. evaluated the leaching of DEHP plasticizer by paclitaxel 0.3 and 1.2 mg/mL in dextrose 5% and in sodium chloride 0.9%. PVC bags of the
solutions were used to prepare the admixtures. The leaching of the plasticizer was found to be time and concentration depende nt; however, there
was little difference between the two infusion solutions. After storage for eight hours at 21 C, HPLC analysis found leached DEHP in the range from
73 to 108 g/mL for the 1.2 mg/mL concentration and from 21 to 30 g/mL for the 0.3 mg/mL concentration. During a simulated one-hour infusion
using DEHP plasticized administration sets, the amount of leached DEHP did not exceed 18 g/mL at the 0.3 mg/mL paclitaxel concentration but
resulted in a maximum of 114 g/mL with the 1.2 mg/mL concentration. (1825)
Allwood and Martin confirmed the leaching of DEHP plasticizer from PVC containers and administration sets, and the amount of DEHP leached was

Allwood and Martin confirmed the leaching of DEHP plasticizer from PVC containers and administration sets, and the amount of DEHP leached was
again found to depend on surfactant concentration and length of contact period. They also reported leaching of up to 30 mg of DEHP per dose from
Flo-Gard Low Adsorption Sets (Baxter), a set with a reduced amount of PVC present in its construction. (2146)
An acceptability limit of no more than 5 parts per million (5 g/mL) for DEHP plasticizer released from PVC containers, administration sets, and other
equipment has been proposed. The limit was proposed based on a review of metabolic and toxicologic considerations. ( 2185)
The acceptability of two reduced-phthalate administration sets for the Acclaim (Abbott) pump was evaluated. Administration set model 11993-48
(Abbott) is composed of polyethylene tubing but has a DEHP-plasticized pumping segment. Administration set model L-12060 (Abbott) is composed
of tris(2-ethylhexyl)trimellitate (TOTM)-plasticized PVC tubing and a DEHP-plasticized pumping segment. Paclitaxel diluent at concentrations
equivalent to 0.3 and 1.2 mg/mL in dextrose 5% delivered rapidly over three hours at 23 C did not leach detectable levels of TOTM from model
L-12060 or DEHP from either set using HPLC analysis. Similarly, slow delivery over four days of the 0.3 -mg/mL concentration yielded detectable but
not quantifiable amounts of plasticizer. However, slow delivery of the equivalent of 1.2 mg/mL over four days yielded large b ut variable amounts of
DEHP from both sets; DEHP concentrations ranged from 30 to 150 g/mL. Consequently, these two reduced-phthalate sets are suitable for short-
term delivery up to three hours of paclitaxel at concentrations up to 1.2 mg/mL. However, these sets should not be used for s low delivery of higher
concentrations. (2198)
The admonition of the paclitaxel labeling to avoid PVC administration sets was found not to extend to a TOTM -plasticized PVC set (SoloPak).
Paclitaxel vehicle equivalent to paclitaxel 0.3 and 1.2 mg/mL in dextrose 5% did not leach TOTM plasticizer from the set duri ng simulated three-hour
administration. During extremely slow delivery at 5.2 mL/hr for four days, no detectable TOTM was found in the 0.3 -mg/mL equivalent
concentration, and only a barely detectable, unquantifiable, trace amount of TOTM was found with the 1.2 -mg/mL equivalent solution. (2232)
Paclitaxel (Faulding) 0.3 and 1.2 mg/mL in dextrose 5% or in sodium chloride 0.9% in ethylene vinyl acetate (EVA) plastic con tainers was found to
leach an unknown material after storage at 25 and 32 C for 24 hours. (2182)
Filtration  The manufacturer recommends the use of a 0.22-m inline filter for paclitaxel administration. (1-2/06) No loss of paclitaxel due to
filtration through 0.22-m filters has been observed. (1-2/06) (1520)
The acceptability of the 0.22-m IV Express Filter Unit (Millipore) for the administration of paclitaxel was evaluated. Paclitaxel vehicle equivalent to
paclitaxel 1.2 mg/mL (for plasticizer leaching) and paclitaxel 0.3 mg/mL (for sorption potential) in 500 mL of dextrose 5% in polyolefin containers
(McGaw) was delivered through the filter units over a three-hour period at a rate of 167 mL/hr at about 23 C to simulate paclitaxel administration.
HPLC analysis found no leached plasticizer and no loss of paclitaxel due to sorption. The filter unit was determined to be ac ceptable for the
administration of paclitaxel infusions. (2231)
Central Venous Catheter  The acceptability of the Arrow-Howes triple-lumen, 7 French, 30-cm polyurethane central catheter (Arrow International)
for the administration of paclitaxel was evaluated. Paclitaxel vehicle equivalent to paclitaxel 0.3 and 1.2 mg/mL (for catheter component leaching)
and paclitaxel 0.3 mg/mL (for sorption potential) were prepared in polyolefin bags of dextrose 5% (McGaw). The solutions were delivered through
the polyurethane central venous catheters for periods of three hours and of 24 hours at 23 C to simulate rapid and slow administration. HPLC
analysis found no leached catheter components in the effluent solution and no loss of paclitaxel due to sorption. The Arrow -Howes polyurethane
central venous catheter was determined to be acceptable for the administration of paclitaxel infusions in the concentration r ange of 0.3 to 1.2
mg/mL over short or long delivery periods. (2230)
Compatibility Information
Solution Compatibility
Paclitaxel
Solution Mfr Mfr Conc/L Remarks Ref C/I
Dextrose 5% MG, TRa NCI 0.3, 0.6, 0.9
g
Visually compatible with no paclitaxel loss by HPLC over 12 hr at 22 C 1520 C
Dextrose 5% MGb NCI 0.6 g Visually compatible with no paclitaxel loss by HPLC over 25 hr at 22 C 1520 C
Dextrose 5% MG, TRc NCI 1.2 g Visually compatible with no paclitaxel loss by HPLC over 12 hr at 22 C 1520 C
Dextrose 5% BR 0.2 to 0.58
g
Fluffy, white precipitate forms occasionally in administration set just distal
to pump chamber
1716 I
Dextrose 5% MGb BR 0.1 and 1 g Physically compatible with no change in subvisual haze or particle content
and stable by HPLC for 3 days at 4, 22, and 32 C. Small, needlelike crystals
form after 3 days
1746 C
Dextrose 5% MGb BR 0.3 and 1.2
g
Physically compatible and chemically stable for 48 hr at 22 C 1842 C
Dextrose 5% BAd FAU 0.3 and 1.2
g
Physically compatible with no change in subvisual haze or particle content
and stable by HPLC for 3 days at 25 and 32 C. Unknown material leached
from EVA container by 24 hr
2182 ?

Dextrose 5% BAb, BRNb,
FREb, MACb
BMS 0.3 and 1.2
g
Physically compatible with less than 5% paclitaxel loss in 72 hr at 37 C in
the dark
2669 C
Dextrose 5% BRNe BMS 0.4 and 1.2
g
Physically compatible with little paclitaxel loss in 5 days at 23 and 4 C.
Precipitation occurred after that time
2673 C
Dextrose 5% BAf TE 0.3 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
and 13 days at 5 C
2708 C
Dextrose 5% BRNe TE 0.3 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Dextrose 5% BRNg TE 0.3 mg/mL Chemically stable until precipitation. Precipitate found after 7 days at 25C
2708 C
Dextrose 5% BAf TE 1.2 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Dextrose 5% BRNe TE 1.2 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Dextrose 5% BRNg TE 1.2 mg/mL Chemically stable until precipitation. Precipitate found after 7 days at 25C
2708 C
Sodium
chloride 0.9%
MG, TRa NCI 0.3, 0.6,
0.9, 1.2 g
Sodium
chloride 0.9%
MGb NCI 0.6 and 1.2
g
Sodium
chloride 0.9%
MGb BR 0.1 and 1 g Physically compatible with no change in subvisual haze or particle content
and stable by HPLC for 3 days at 4, 22, and 32 C. Small, needlelike crystals
form after 3 days
1746 C
Sodium
chloride 0.9%
MGb BR 0.3 and 1.2
g
Physically compatible and chemically stable for 48 hr at 22 C 1842 C
Sodium
chloride 0.9%
BAd FAU 0.3 and 1.2
g
Physically compatible with no change in subvisual haze or particle content
and stable by HPLC for 3 days at 25 and 32 C. Unknown material leached
2182 ?
Sodium
chloride 0.9%
BAb, BRNb,
FREb, MACb
BMS 0.3 and 1.2
g
Physically compatible with less than 5% paclitaxel loss in 72 hr at 37 C in
the dark
2669 C
Sodium
chloride 0.9%
BAf TE 0.3 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Sodium
chloride 0.9%
BRNe TE 0.3 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Sodium
chloride 0.9%
BRNg TE 0.3 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Sodium
chloride 0.9%
BAf TE 1.2 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Sodium
chloride 0.9%
BRNe TE 1.2 mg/mL Chemically stable until precipitation. Precipitate found after 3 days at 25C
2708 C
Sodium
chloride 0.9%
BRNg TE 1.2 mg/mL Chemically stable until precipitation. Precipitate found after 5 days at 25C
2708 C
aTested in both glass and PVC containers.
bTested in polyolefin containers.
cTested in glass, PVC, and polyolefin containers.
dTested in Baxter ethylene vinyl acetate (EVA) containers.
eTested in ECOFLAC low-density polyethylene plastic containers.
fTested in polyolefin containers.
gTested in glass containers.

gTested in glass containers.
Additive Compatibility
Paclitaxel
Drug Mfr Conc/L Mfr Conc/L Test
Soln
Remarks Ref C/I
Carboplati
n
BMS 2 g BMS 300 mg
and 1.2 g
NS No paclitaxel loss but carboplatin losses of 2, 5, and 7% at 4, 24,
and 32 C, respectively, in 24 hr by HPLC. Physically compatible for
24 hr but subvisual particulates of paclitaxel form after 3 to 5 days
2094 C
BMS 2 g BMS 300 mg
and 1.2 g
D5W No paclitaxel and carboplatin loss by HPLC at 4, 24, and 32 C in 24
hr. Physically compatible for 24 hr but subvisual particulates of
paclitaxel form after 3 to 5 days
2094 C
Cisplatin BMS 200 mg BMS 300 mg NS No paclitaxel loss and cisplatin losses of 1, 4, and 5% at 4, 24 and
32 C, respectively, in 24 hr by HPLC. Physically compatible for 24
hr but subvisual particulates of paclitaxel form after 3 to 5 days
2094 C
BMS 200 mg BMS 1.2 g NS No paclitaxel loss but cisplatin losses of 10, 19, and 22% at 4, 24,
and 32 C, respectively, in 24 hr by HPLC. Physically compatible for
24 hr but subvisual particulates of paclitaxel form after 3 to 5 days
2094 I
Doxorubic
in HCl
PH 200 mg BMS 300 mg D5W,
NS
Visually compatible for at least 1 day with microprecipitation
appearing in 3 to 5 days and gross precipitation in 7 days at 4, 23,
and 32 C protected from light. No paclitaxel loss and less than 8%
doxorubicin loss in 7 days
2247 C
PH 200 mg BMS 1.2 g D5W,
NS
Visually compatible for at least 1 day with microprecipitation
appearing in 3 to 5 days and gross precipitation in 7 days at 4, 23,
and 32 C protected from light. No paclitaxel loss and less than 7%
doxorubicin loss in 7 days
2247 C
Y-Site Injection Compatibility (1:1 Mixture)
Paclitaxel
Drug Mfr Conc Mfr Conc Remarks Ref C/I
Acyclovir sodium BW 7 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
turbidity in 4 hr at 22 C
1556 C
Amikacin sulfate BR 5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Aminophylline AB 2.5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Amphotericin B SQ 0.6 mg/mLa NCI 1.2 mg/mLa Immediate increase in measured turbidity followed by
separation into two layers in 24 hr at 22 C
1556 I
Amphotericin B
cholesteryl sulfate
complex
SEQ 0.83 mg/mLa MJ 0.6 mg/mLa Decreased natural turbidity occurs immediately 2117 I
Ampicillin sodium-
sulbactam sodium
RR 20 + 10
mg/mLb
NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Anidulafungin VIC 0.5 mg/mLa MJ 0.6 mg/mLa Physically compatible with no change in measured
turbidity or increase in particle content in 4 hr at 23 C
2617 C
Bleomycin sulfate MJ 1 unit/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Butorphanol tartrate BR 0.04 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Calcium chloride AST 20 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Carboplatin 5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Cefepime HCl BMS 20 mg/mLa BR 0.6 mg/mLa Physically compatible with no change in measured
1689 C
Cefotetan disodium STU 20 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C

Ceftazidime LIf 40 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Ceftriaxone sodium RC 20 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Chlorpromazine HCl ES 2 mg/mLa NCI 1.2 mg/mLa Normal inherent haze from paclitaxel decreases
immediately
1556 I
Cimetidine HCl 12 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Cisplatin 1 mg/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Cladribine ORT 0.015b and
0.5c mg/mL
BR 0.6 mg/mLb Physically compatible with no change in measured
1969 C
Cyclophosphamide 10 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Cytarabine 50 mg/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Dacarbazine MI 4 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Dexamethasone
sodium phosphate
1 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Diphenhydramine HCl 2 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Doxorubicin HCl 2 mg/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Doxorubicin HCl
liposome injection
SEQ 0.4 mg/mLa MJ 0.6 mg/mLa Partial loss of measured natural turbidity 2087 I
Droperidol JN 0.4 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Etoposide 0.4 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Etoposide phosphate BR 5 mg/mLa MJ 1.2 mg/mLa Physically compatible with no change in measured
2218 C
Famotidine MSD 2 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Floxuridine RC 3 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Fluconazole RR 2 mg/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
PF 2 mg/mL BR 0.3 and 1.2
mg/mLa
Visually compatible with no loss of either drug by HPLC
in 4 hr at 23 C
1790 C
Fluorouracil 16 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Furosemide AST 3 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Ganciclovir sodium SY 20 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Gemcitabine HCl LI 10 mg/mLb MJ 1.2 mg/mLa Physically compatible with no change in measured
2226 C
Gentamicin sulfate ES 5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Granisetron HCl SKB 1 mg/mL MJ 0.3 mg/mLb Physically compatible with little or no loss of either drug
by HPLC in 4 hr at 22 C
1883 C
SKB 0.05 mg/mLa MJ 1.2 mg/mLa Physically compatible with no change in measured
2000 C

Haloperidol lactate 0.2 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Heparin sodium WY 100 units/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Hydrocortisone
sodium succinate
AB 1 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Hydromorphone HCl KN 0.5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Hydroxyzine HCl ES 4 mg/mLa NCI 1.2 mg/mLa Normal inherent haze from paclitaxel decreases
immediately
1556 I
Ifosfamide BR 25 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Linezolid PHU 2 mg/mL MJ 0.6 mg/mLa Physically compatible with no change in measured
2264 C
Lorazepam 0.1 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Magnesium sulfate AST 100 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Mannitol BA 15% NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Meperidine HCl WY 4 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Mesna MJ 10 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Methotrexate sodium 15 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Methylprednisolone
sodium succinate
UP 5 mg/mLa NCI 1.2 mg/mLa Normal inherent haze from paclitaxel decreases
immediately
1556 I
Metoclopramide HCl 5 mg/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Mitoxantrone HCl LE 0.5 mg/mLa NCI 1.2 mg/mLa Normal inherent haze from paclitaxel decreases
immediately
1556 I
Morphine sulfate WY 1 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Nalbuphine HCl AST 10 mg/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Ondansetron HCl GL 0.5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
GL 0.03 and 0.3
mg/mLa
BR 0.3 mg/mLa Visually compatible with no loss of either drug in 4 hr at
23 C
1741 C
GL 0.03 and 0.3
mg/mLa
23 C
1741 C
Ondansetron HCl with
ranitidine HCl
GL GL 0.3 mg/mLa 2
mg/mLa
BR 1.2 mg/mLa Visually compatible with no loss of any drug by HPLC in 4
hr at 23 C
1741 C
Oxaliplatin SS 0.5 mg/mLa MJ 0.6 mg/mLa Physically compatible with no change in measured
2566 C
Palonosetron HCl MGI 50 g/mL MJ 1.2 mg/mLa Physically compatible with no change in measured haze
level or increase in particle content and little or no loss
of either drug in 4 hr
2533 C
Pemetrexed disodium MJ 0.6 mg/mLa LI 20 mg/mLb Physically compatible with no change in measured
2564 C
Pentostatin NCI 0.4 mg/mLb NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Potassium chloride AB 0.1 mEq/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured 1556 C

Potassium chloride AB 0.1 mEq/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Prochlorperazine
edisylate
0.5 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Propofol ZEN 10 mg/mL MJ 1.2 mg/mLa
Physically compatible for 1 hr at 23 C with no increase
in particle content
2066 C
Ranitidine HCl 2 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
GL 0.5 and 2
mg/mLa
23 C
1741 C
GL 0.5 and 2
mg/mLa
23 C
1741 C
Sodium bicarbonate LY 1 mEq/mL NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Thiotepa IMMd 1 mg/mLa MJ 0.6 mg/mLa Physically compatible with no change in measured
1861 C
TNA #218 to #226e MJ 1.2 mg/mLa Visually compatible with no precipitate or emulsion
damage apparent in 4 hr at 23 C
2215 C
Topotecan HCl SKB 56 g/mLab MJ 0.54
mg/mLab
Visually compatible with little or no loss of either drug
by HPLC in 4 hr at 22 C under fluorescent light
2245 C
TPN #212 to #215e MJ 1.2 mg/mLa Physically compatible with no change in measured
2109 C
Vancomycin HCl 10 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1528 C
Vinblastine sulfate LI 0.12 mg/mLb NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Vincristine sulfate LI 0.05 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
Zidovudine BW 4 mg/mLa NCI 1.2 mg/mLa Physically compatible with no change in measured
1556 C
aTested in dextrose 5%.
bTested in sodium chloride 0.9%.
cTested in bacteriostatic sodium chloride 0.9% preserved with benzyl alcohol 0.9%.
dLyophilized formulation tested.
eRefer to Appendix I for the composition of parenteral nutrition solutions. TNA indicates a 3-in-1 admixture, and TPN indicates a 2-in-1 admixture.
fSodium carbonate-containing formulation tested.
Additional Compatibility Information
Infusion Solutions  The manufacturer recommends dilution of paclitaxel to a concentration between 0.3 and 1.2 mg/mL in dextrose 5%, dextrose
5% in sodium chloride 0.9%, dextrose 5% in Ringer's injection, or sodium chloride 0.9%. These solutions are stated to be phys ically and chemically
stable for up to 27 hours at room temperature (about 25 C) under normal room light. (1-2/06)
Other Information
Microbial Growth  Paclitaxel (Bristol) 0.7 mg/mL diluted in sodium chloride 0.9% did not exhibit an antimicrobial effect on the growth of three of
four organisms (Enterococcus faecium, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) inoculated into the solution. S.
aureus remained viable for 4 hours. E. faecium and P. aeruginosa remained viable for 48 hours, and C. albicans remained viable to the end of the
study at 120 hours. The author recommended that diluted solutions of paclitaxel be stored under refrigeration whenever possib le and that the
potential for microbiological growth be considered when assigning expiration periods. (2160)
References
For a list of references cited in the text of this monograph, search the monograph titled HID references.

© 2009 American Society of Health-System Pharmacists, Inc. All rights reserved.
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○ LAWRENCE A. TRISSEL, F.A.S.H.P.
• Author:
○ © 2009 American Society of Health-System Pharmacists, Inc. All rights reserved.
• Copyright:
○ STAT!Ref Online Electronic Medical Library
• Database Title:
○ ISBN-13: 978-1-58528-213-5
• ISBN:
○ Bethesda, MD
• Publication City:
○ 2008
• Publication Year:
○ American Society of Health-System Pharmacists
• Publisher:
○ Handbook on Injectable Drugs - 15th Ed. (2009)
• Title:
○ 11/4/2009 4:31:06 PM CDT (UTC -05:00)
• Date Posted:
○ http://online.statref.com/document.aspx?fxid=141&docid=261
• Electronic Address:
○ 8/21/2010 3:54:55 AM CDT (UTC -05:00)
• Date Accessed:
○ HANDBOOK ON INJECTABLE DRUGS - 15th Ed. (2009)
"P" Monographs
Paclitaxel - AHFS 10:00
• Location In Title:
LAWRENCE A. TRISSEL, F.A.S.H.P.. 2009. Handbook on Injectable Drugs. Bethesda, MD. American Society of Health -System Pharmacists. ISBN-13:
978-1-58528-213-5. STAT!Ref Online Electronic Medical Library. http://online.statref.com/document.aspx?fxid=141&docid=261. 8/21/2010 3:54:55
AM CDT (UTC -05:00).
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