888913

research-article2019
HPXXXX10.1177/0018578719888913Hospital PharmacyVallée et al

Original Article

Hospital Pharmacy

Compatibility of Lactated Ringer’s

2021, Vol. 56(4) 228­–234
© The Author(s) 2019
Article reuse guidelines:
Injection With 94 Selected Intravenous sagepub.com/journals-permissions
DOI: 10.1177/0018578719888913
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Drugs During Simulated Y-site journals.sagepub.com/home/hpx

Administration

Margaux Vallée1, Isabelle Barthélémy2, Mihaela Friciu3,

Élaine Pelletier4, Jean-Marc Forest4 , France Benoit5,
and Grégoire Leclair3

Abstract

Objective: To test the compatibility of intravenous (IV) lactated Ringer’s injection (LR) with 94 injectable (IV) drugs during
simulated Y-site administration. Methods: Ninety-four IV drugs were investigated for compatibility with LR (Baxter).
Each sample was prepared in duplicate and performed at room temperature. Two observers performed visual evaluation
independently immediately upon mixing and then 15 minutes, 1 hour, 2 hours, 3 hours, and 4 hours after admixture. Another
observer performed a particle counting test on 1 of the 2 duplicates of each admixture that did not immediately show
incompatibility and then after 4 hours by a light obscuration particle count test. Results: Of the 94 tested drugs, 86 were
found to be compatible with LR. A total of 8 drugs were found to be physically incompatible. Of these incompatible drugs,
7 were directly identified visually and 1 was confirmed by the light obscuration particle count test. Conclusion: Lactated
Ringer’s injection was physically compatible for 4 hours with 86 tested drugs during simulated Y-site administration. Eight
drugs, ciprofloxacin, cyclosporine, diazepam, ketamine, lorazepam, nitroglycerin, phenytoin, and propofol, were found to be
incompatible and should not be administered with LR.

Keywords
lactated Ringer’s injection, compatibility, Y-injection site

Introduction Methods
Lactated Ringer’s injection (LR) is a sterile, nonpyrogenic Lactated Ringer’s injection (lot W5I17C2) was provided by
solution that may be used for intravenous (IV) irrigation, Baxter in 250 mL bags. A selection of 94 drugs was tested
washing, and rinsing and also acts as a diluent for infusion of with LR. Details about the tested drugs and concentration
drugs. Lactated Ringer’s injection contains sodium chloride are provided in Table 1. Tested IV drugs were reconstituted
(Na+ 130 mEq/L), potassium chloride (K+ 4 mEq/L), calcium according to the manufacturer’s recommendation when
chloride (Ca+ 3 mEq/L), chloride (Cl− 109 mEq/L), and lac- required.
tate (28 mEq/L) in water for injection.1 Ninety-four drugs were tested in 1:1 admixture with LR
Questions about drug compatibility are recurrent, and in testing glass tubes at room temperature and under normal
bringing up available information is an essential part of phar-
macist assignment. Lactated Ringer’s injection is widely
1
used in Sainte-Justine University Teaching Hospital, espe- Pharmacist, Hôpitaux universitaires de Genève, Switzerland
2
Daniel Vermette Pharmacy, Montréal, QC, Canada
cially for patients receiving many other IV drugs by Y-site 3
Faculté de pharmacie, Université de Montréal, QC, Canada
administration. Compatibility data about LR are scarce, and 4
CHU Sainte-Justine, Montréal, QC, Canada
there is a need to evaluate the Y-site injection compatibility 5
CHSLD Vigi Yves-Blais, Mascouche, QC, Canada
of LR with other IV drugs.
Corresponding Author:
The purpose of this study was to determine Y-site injec- Jean-Marc Forest, CHU Sainte-Justine, 3175, Chemin de la Côte-Sainte-
tion compatibility of LR with 94 IV drugs using visual evalu- Catherine, Montréal, QC H3T 1C5, Canada.
ation and light obscuration particle counting. Email: [email protected]
Vallée et al 229

Table 1.  Drugs Tested for Physical Compatibility With Lactated Ringer’s Injection (Baxter) in Simulated Y-site Injection Administration
After Visual Inspection and Light Obscuration Particle Count Test.

Particle count test Visual

Concentration
mg/mL (or as Concentration
  Drug name specified) Manufacturer Lot mg/mL Manufacturer Lot
1 Acetazolamide sodium 100 Sterimax 01000A15 100 SteriMax 01000B11
01000B15A
2 Acetylcysteine 200 Alveda Pharma 14055056 200 Alveda Pharma 9075059
3 Acyclovir sodium 50 PPC 6008872 50 PPC 6002138
4 Albumin, human (Alburex-25) 250 CSL Behring 4309900011 250 CSL Behring 4309900011
5 Amikacin sulfate 250 Sandoz EZ9666 250 Sandoz BR9068
6 Aminophylline 25 Hospira 54-375-DK 50 Omega OK472
7 Amiodarone hydrochloride 50 Sandoz FJ2260 50 Sandoz BR5023
8 Amphotericin B liposomal 4 Astellas 20160416074 4 Bristol-Myers 93070TB31
Squibb
9 Amphotericin B deoxycholate 5 Bristol-Myers 51940TB24 5 Bristol-Myers 51940TB24
Squibb Squibb
10 Ampicillin sodium 100 Novopharm FF7340 100 Novopharm BP1879
DS8980
11 Atropine sulfate 0.4 Alveda Pharma 50587 0.4 Alveda Pharma 434
12 Azithromycin 500 Sterimax 7602823 500 Pfizer Z065606
7602657
13 Bretylium tosylate 50 Sandoz EF9361 50 Sandoz AY2120
14 Bupivacaine hydrochloride 0.5% Hospira 48-198-DK 20 mL Hospira 48-198-DK
15 Caffeine citrate 10 Sandoz EM6977 10 Sandoz BR2092
16 Calcium gluconate 100 Fresenius Kabi 6010000 100 PPC 6001828
17 Calcium chloride 100 Hospira 52-393-DK 100 Hospira 89458DK
42-315-DK
18 Caspofungin acetate 5 Merck 2195750 5 Merck 2070040
19 Cefazolin sodium 100 Hospira 117F003 100 Hospira 117B004
20 Cefotaxime 100 Sterimax 4CS1513CA 100 Sanofi 91846
4CS1512CA
21 Cefoxitin 100 Novopharm 0001D5 100 Hospira 123B002
22 Ceftazidime 100 PPC 105394C 100 PPC 103573C
23 Ceftriaxone sodium 100 Hospira H101HC4 100 Hospira 120B001
H103HC4
24 Cefuroxime 100 Sterimax 157012.1 100 PPC 8309
25 Chlorpromazine 25 Sandoz EF2262 25 Sandoz AY5529
hydrochloride DL5599
26 Ciprofloxacin 2 Hospira 50672 2 Hospira 4777201
27 Clindamycin phosphate 150 Sandoz FJ8765 150 Sandoz CS5861
28 Cloxacillin sodium 100 Sterimax 2CL1531CA 100 Novopharm BP5356
29 Cyclosporine 50 Novartis S0076 50 Novartis S0065
S0070
30 Dexamethasone sodium 4 Sandoz FM3580 4 Sandoz F20120216057
phosphate
31 Dexmedetomidine 0.1 Hospira 67-294-DK 0.100 Hospira 67-294-DK
hydrochloride 63-198-DK 63-198-DK
32 Dextrose 50% 500 Hospira 50-239-DK 500 Hospira 03399DK
33 Diazepam 5 Sandoz 350085 5 Sandoz BP9416
429070
34 Digoxin 0.25 Sandoz FG7843 0.05 Sandoz BK4807
35 Dimenhydrinate 10 Sandoz FL9838 10 Sandoz CB8792
ES0313
(continued)
230 Hospital Pharmacy 56(4)

Table 1. (continued)

Particle count test Visual

Concentration
mg/mL (or as Concentration
  Drug name specified) Manufacturer Lot mg/mL Manufacturer Lot
36 Diphenhydramine 50 Sandoz 4K152 50 Sandoz CC6193
hydrochloride EJ5196
37 Dobutamine hydrochloride 12.5 Hospira 57-245-DK 12.5 Sandoz BT5348
61-123-DK
38 Dopamine hydrochloride 3,2 Baxter P331496 3.2 Baxter 2BO846
39 Enalaprilat 1.25 Sterimax 143177.1 1.25 Sandoz CB8013
40 Epinephrine hydrochloride 1 Erfa F5E195 1 Hospira 107388E10
41 Erythromycin lactobionate 50 Amdipharm 44-906-TB-24 50 Amdipharm 88324TB26
42 Esmolol hydrochloride 10 Baxter 115376Z 10 Baxter 071310Z
43 Fentanyl citrate 0.050 Sandoz FU61144 0.050 Sandoz CD0281
44 Fluconazole 2 Sandoz EG3097 2 Sandoz BX9809
45 Furosemide 10 Omega 5J082 10 Sandoz BY8329
46 Gentamicin sulfate 10 Sandoz EZ8736 40 Sandoz BU6761
EW0069
47 Granisetron hydrochloride 1 Omega 4M838 1 Omega 4M838
48 Haloperidol lactate 5 Sandoz GB9093 5 Sandoz GB9093
FS6939 FS6939
FM6054 FM6054
49 Heparin sodium 1000 IU/mL Sandoz FU4871 1000 IU/mL PPC 6000130N
50 Hydralazine hydrochloride 20 Sterimax PLNG1518 20 Novartis 00501B10
PLNK1438
PLNK1440
51 Hydrocortisone sodium 50 Novopharm 0480514 50 Novopharm 9650310
succinate 4160115
52 Hydromorphone 10 Sandoz FA1043 10 Sandoz CC7651
hydrochloride
53 Hydroxyzine hydrochloride 50 Sandoz EF1703 N/A N/A N/A
54 Insulin regular (Humulin R) 100 IU/mL Lilly C358890H 100 IU/mL Lilly C001867D
C358890K
55 Isoproterenol hydrochloride 0.2 Sandoz FM8982 0.2 Sandoz BU3292
56 Ketamine hydrochloride 50 Sandoz FB4018 50 Sandoz BX2917
FK2313
57 Labetalol hydrochloride 5 Sandoz FD6396 5 Sandoz BW9642
58 Lidocaine hydrochloride 1% Alveda Pharma 15262021 1 AstraZeneca 10410
59 Linezolid 2 Pfizer 3770714 2 Pfizer 3770714
60 Lorazepam 4 Hospira 53275EV 4 Sandoz CZ3827
52170EV
61 Magnesium sulfate 500 Fresenius Kabi 6010611 500 PPC 6101127
62 Mannitol 250 Hospira 60-222-DK 250 Hospira 01485DK
63 Meropenem 50 Sterimax 2694106 50 AstraZeneca JD947
64 Methylprednisolone sodium 62.5 Novopharm 6000215 62.5 Pfizer G00030
succinate 4450915
65 Metoclopramide 5 Sandoz EM2979 5 Sandoz BY4533
hydrochloride EL7926
EL4390
EG3207
FG3415
66 Metronidazole 5 Hospira 58-011-JT 5 Hospira 7811853
67 Midazolam hydrochloride 5 Fresenius Kabi 6009861 5 PPC CB8867
68 Milrinone lactate 1 Sandoz FH8172 1 Sandoz CB2379
69 Morphine sulfate 50 Sandoz FC1902 50 Sandoz BR8368
(continued)
Vallée et al 231

Table 1. (continued)
Particle count test Visual

Concentration
mg/mL (or as Concentration
  Drug name specified) Manufacturer Lot mg/mL Manufacturer Lot
70 Multivitamins (Multi-12/K1 Sandoz FL5796 Sandoz CY0799
pediatric) (vial 1) et CY0797
FL6371
(vial 2)
71 Multivitamins (Multi-12) Sandoz FL5795 Sandoz CG5111
(vial 1)
FK1211
(vial 2)
72 Naloxone hydrochloride 0.4 Alveda Pharma 30209 0.4 Sandoz BL1147
30522
73 Nicardipine hydrochloride 0.2 Baxter NC096925 0.2 Baxter NC096925
74 Nitroglycerin 5 Omega 5GO44 5 Omega 1K775
5D948
75 Norepinephrine bitartrate 1 Sandoz FD2438 1 Sandoz BU3181
76 Octreotide acetate 0.500 Omega 5F008 0.500 Omega S0013
5J086
77 Oxytocin 10 IU/mL Hospira 521388E01 10 IU/mL Hospira 054528E01
78 Penicillin G sodium 500 000 IU/ Fresenius Kabi 303246 100 000 IU/mL Novopharm CG7189
mL
79 Phenytoin sodium 50 Sterimax 152079.1 50 Sandoz CJ8539
80 Piperacillin sodium 200 Hospira 1P301MC3 200 Mayne Pharma 1P301MC1
81 Piperacillin sodium / 200 Sandoz 20160428083 200 Sandoz BW5243
Tazobactam
82 Potassium chloride 2 mEq/mL Hospira 50-151-DK 2 mEq/mL Hospira 92180DK
83 Potassium phosphate 3 mmol/mL Sandoz 6109697 3 mmol/mL Sandoz BW8396
84 Propofol 10 Pharmascience A050374 10 Novopharm R10167B
85 Ranitidine hydrochloride 25 Sandoz F59330 25 GlaxoSmithKline C566822
FW1356
86 Rocuronium bromide 10 Sandoz FS6942 10 Hospira 12008DK
FM5396
87 Salbutamol 1 GlaxoSmithKline V972 1 GlaxoSmithKline L061
88 Sodium bicarbonate 1 mEq/mL Hospira 54-178-EV 1 mEq/mL Abbott 11138DK
89 Sodium nitroprusside 25 Hospira 531303A 25 Omega 1K775
90 Tobramycin sulfate 40 Sandoz 6009024 40 Sandoz C152865
91 Trimethoprim / 16/80 GlaxoSmithKline 20160422036 16/80 GlaxoSmithKline 1E531
Sulfamethoxazole
92 Vancomycin hydrochloride 50 Sandoz FF5576 50 Hospira 096588E02
FW3816
93 Verapamil hydrochloride 2.5 Sandoz FM1440 2.5 Sandoz CM0627
94 Voriconazole 10 Sandoz FY0203 10 Sandoz FY0203

room light. Each drug available in a breakable glass ampoule observation. Each admixture was visually observed immedi-
was passed through a 5-µm filter as it was introduced into the ately upon mixing and then at specified time points: 15 min-
testing glass tube. utes, 1 hour, 2 hours, 3 hours, and 4 hours. Visual compatibility
Step 1: Visual evaluations were performed independently was defined as the absence of any color change or visible
by 2 observers in accordance with the established procedure particle matter, gas bubble, substantial haze, or precipitate by
previously reported several times.2-8 Visual simulated Y-site a naked eye.
injection evaluation was accomplished by the 2 observers by Step 2: Another second observer performed the light
mixing 1 mL of LR with 1 mL of the tested drug in glass tube obscuration particle count test using the LS-20 Liquid Particle
and then switching the order of drug mixing for the second Counter (Lighthouse Worldwide Solutions, Medford, OR). At
232 Hospital Pharmacy 56(4)

the beginning of the experiment, the particle count test was Table 2.  Incompatibilities of Lactated Ringer’s Injection With
controlled by a standardized solution (Pharm-Trol Particle Other Drugs After Visual Inspection by the 2 Observers in
Count Control solution; Thermo Scientific, Saint-Laurent, Step 1.
QC, Canada, lot 44035) with a specific concentration of 15 Drug name Notes
µm particles. This allowed us to ascertain that the accuracy of
the particle counter is in agreement with the United States 1 Amiodarone Uncertain
Pharmacopeia (USP) Reference Standard for the duration of 2 Caspofungin Uncertain
3 Ciprofloxacin Incompatible
the observations. Furthermore, on each day of observation, a
4 Clindamycin Uncertain
control solution made of 10 mL of LR and 10 mL of sterile
5 Cyclosporine Precipitate
water for injection passed both the visual test and the particle
6 Diazepam Immediate precipitate
count test immediately upon mixing and after 4 hours. Then
7 Insulin (human regular) Uncertain
each admixture was tested in sterile plastic syringes by mix- (Humulin R)
ing 10 mL of LR with 10 mL of the tested drug. In the absence 8 Ketamine Incompatible
of visual incompatibility, the particle content of the first 9 Lorazepam Incompatible
admixtures was immediately analyzed and that of the second 10 Methylprednisolone Uncertain
was quantified by a final particle count test at 4 hours. 11 Multivitamins (adult) Uncertain
Admixtures that were visually incompatible were immedi- (Multi-12)
ately discarded without particle count test evaluation. Drug 12 Multivitamins (pediatric) Uncertain
admixtures were considered compatible if the average num- (Multi-12/K1 pediatric)
ber of particles did not exceed USP <788> Test 1.B guide- 13 Nitroglycerin Uncertain
lines.9 In this study, volumes are less than 100 mL, and the 14 Penicillin G Uncertain
limit allowed for particulate matter does not exceed 6000 par- 15 Phenytoin Incompatible
ticles ≥10 µm and 600 particles ≥25 µm per container. Thus, 16 Propofol Precipitate
with a container volume of 20 mL, 5 mL per test, the average 17 Verapamil Uncertain
number of particles equal to or greater than 10 µm does not
exceed 300 particles and no more than 30 particles equal to or
Table 3.  Incompatibilities of Lactated Ringer’s Injection With
greater than 25 µm to be considered compatible. Each mea-
Other Drugs After Step 2 With Light Obscuration Particle
sure was in triplicate, 3 times 5 mL, with 4 mL as a prime. Count Test.

Drug name Notes

Results
1 Nitroglycerin >30 × 25 µm particles/mL at T = 0
A total of 94 admixtures were visually inspected in step 1,
and 77 of them demonstrated no evidence of visual incom-
patibility immediately and throughout the 4-hour period.
Discussion
Seventeen drugs were described as being possibly or defini-
tively incompatible with LR when inspected visually by 2 Lactated Ringer’s injection is widely used as a drug diluent.
different observers. Table 2 illustrates the details associated Until now, no study has evaluated specifically the compati-
with the 17 admixtures that could possibly be visually bility of LR with drugs used in clinical practice. This study
incompatible. tested the compatibility of LR with 94 injectable drugs.
In step 2, just before the light obscuration particle count The simulated Y-site injection model used in this study is
test, 7 admixtures showed precipitation (ciprofloxacin, based on the model described by Allen et al in 1977. They
cyclosporine, diazepam, ketamine, lorazepam, phenytoin, established that when mixing 2 solutions in a Y-administration
propofol) and were discarded without particle count test set, the concentration ratio will be 1:1.10 As admitted, if 2
evaluation because there is evidence of incompatibility. All drugs are compatible at high concentration, they will also
the other 10 admixtures that were suspected to be visually probably be compatible at lower concentrations.11 This
incompatible and did not clearly precipitate were analyzed hypothesis reflects the condition in Y-site administration that
by the particle count test, including all the other 77 certain is used by nurses during drug administration.
results by visual inspection, to determine whether they were Results by visual control show that 10 drugs are possibly
really compatible or not. For 86 drugs, measurement of the incompatible with LR, whereas 7 are incompatible after
number of particles ≥25 and ≥10 µm was within specifica- visual test. Visual control can only detect particles greater
tion limit immediately upon admixture and after 4 hours. than 50 µm, whereas the light obscuration particle count test
Only for 1 drug, nitroglycerin, particle counting and sizing assesses particle within the range of 1 to 50 µm and permits
confirmed the incompatibility suspected (Table 3). to comply with USP <788> Test 1.B.9 This could explain
In summary, all the incompatible drugs are listed in Table 4, the difference seen between the results of the 2 testing meth-
with the corresponding reason. ods. This is why the results obtained with the particle count
Vallée et al 233

Table 4.  Incompatibilities of Lactated Ringer’s Injection With value of the light obscuration particle count test to assess
Other Drugs After All Analyses. compatibility between 2 drugs and complete visual inspec-
Drug name Incompatibility reason tion, eliminating hazardous results. Lactated Ringer’s injec-
tion and each other drug were tested at 1 concentration, and
1 Ciprofloxacin Directly by visual inspection it is possible that the incompatible combinations might be
2 Cyclosporine Directly by visual inspection compatible when mixed at lower concentrations.
3 Diazepam Directly by visual inspection
4 Ketamine Directly by visual inspection
5 Lorazepam Directly by visual inspection Conclusion
6 Nitroglycerin Especially with light obscuration
Lactated Ringer’s injection was compatible with 86 of the
particle count test
drugs tested and was found to be directly incompatible by
7 Phenytoin Directly by visual inspection
8 Propofol Directly by visual inspection
naked eye with ciprofloxacin, cyclosporine, diazepam, ket-
amine, lorazepam, phenytoin, and propofol and additionally
by light obscuration particle count test with nitroglycerin.
test are more reliable than those obtained by visual control. The light obscuration particle count test to assess compatibil-
However, when admixture leads to an obvious precipitation, ity between 2 drugs completes visual inspection, eliminating
the particle count test is not processed, thus becoming hazardous results.
useless.
Precipitate formation occurred when propofol was Declaration of Conflicting Interests
mixed with LR. Because propofol is an opaque white emul- The author(s) declared no potential conflicts of interest with respect
sion, particle count test could not be performed due to its to the research, authorship, and/or publication of this article.
dense turbidity. Propofol would require an alternative
approach to physical compatibility other than particle count Funding
test evaluation. The author(s) received no financial support for the research, author-
Concerning cyclosporine and nitroglycerin, the present ship, and/or publication of this article.
results are not congruent with published data.12-14 These 2
drugs are listed as compatible with LR in some visual ORCID iD
­studies12,13 where physical compatibility was evaluated only Jean-Marc Forest https://orcid.org/0000-0001-8451-5471
by the absence of changes in measured haze or turbidity, par-
ticulates, or color found. The light obscuration particle count References
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