Compatibility of granisetron hydrochloride with selected alkaline drugs.
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Biomedical subjects
Publications and source records attributed to J F Martinez.
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The compatibility of paclitaxel injection vehicle with a variety of i.v. administration and extension sets was studied in terms of the amount of diethylhexyl phthalate (DEHP) leached from the sets. Test solutions of paclitaxel injection vehicle corresponding to paclitaxel injection 0.3 and 1.2 mg/mL were prepared in polyolefin bags of 5% dextrose injection. The solutions were delivered in triplicate over 24 hours through 26 models of administration sets and 24 models of extension sets and collected in glass containers. Portions were removed after delivery and analyzed in duplicate for DEHP concentration by high-performance liquid chromatography. All the extension sets were compatible with paclitaxel injection vehicle. Most of the administration sets were also compatible. However, two administration sets were incompatible with paclitaxel vehicle corresponding to either drug concentration, and five sets were incompatible with the vehicle simulating the high (1.2-mg/mL) concentration. Some of the incompatible sets were labeled as not containing polyvinyl chloride (PVC). Solutions of paclitaxel vehicle leached DEHP from administration sets containing PVC and from some sets labeled as not containing PVC.
The physical compatibility and chemical stability of ondansetron hydrochloride 0.1 and 1 mg/mL with morphine sulfate 1 mg/mL and with hydromorphone hydrochloride 0.5 mg/mL in 0.9% sodium chloride injection were studied. Test solutions of the drugs in 0.9% sodium chloride injection were prepared in triplicate and stored at 4, 22, and 32 degrees C. Samples were removed immediately and at various time points over 31 days and stored at -70 degrees C until analyzed. Physical compatibility was assessed visually and by measuring turbidity with a color-correcting turbidimeter and particle content with a light-obscuration particle sizer and counter. Chemical stability was determined by measuring the concentration of each drug in duplicate with stability-indicating high-performance liquid chromatography. There were no visual or subvisual changes in turbidity or particle content in any of the test solutions at any of the time points. There was little or no loss of any of the drugs. When admixed in 0.9% sodium chloride injection, ondansetron hydrochloride 0.1 and 1 mg/mL plus morphine sulfate 1 mg/mL or hydromorphone hydrochloride 0.5 mg/mL were compatible and stable for at least 7 days at 32 degrees C and for at least 31 days at 4 and 22 degrees C.
The compatibility of filgrastim with selected drugs during simulated Y-site injection was studied. Five-milliliter samples of filgrastim 30 micrograms/mL in 5% dextrose injection were combined with 5-mL samples of solutions of each of 97 other drugs in 5% dextrose injection at clinically used concentrations at 22 degrees C. Immediately after and one and four hours after the samples were combined, visual examinations were performed in fluorescent light with the unaided eye and with a high-intensity monodirectional light (Tyndall beam) to enhance the visualization of small particles and low-level turbidity. The turbidity of each drug combination was measured as well. Combinations yielding inconclusive results were subjected to particle sizing and counting. Most of the drugs tested were compatible with filgrastim 30 micrograms/mL during the observation period. However, 22 drugs showed various incompatibilities with filgrastim, including filament formation, particulate formation and precipitation, and color change. Filgrastim 30 micrograms/mL in 5% dextrose injection was compatible with 75 drugs for up to four hours at 22 degrees C; 22 drugs were not compatible with filgrastim.
The compatibility of allopurinol sodium with selected drugs during simulated Y-site injection was studied. Five-milliliter samples of allopurinol sodium 3 mg/mL in 0.9% sodium chloride injection were combined with 5-mL samples of solutions of 92 other drugs in 0.9% sodium chloride injection at clinically used concentrations at 22 degrees C (5% dextrose injection was used as the diluent for one drug, amphotericin B). Immediately after and one and four hours after the samples were combined, visual examinations were performed in fluorescent light with the unaided eye and with a high-intensity monodirectional light (Tyndall beam) to enhance the visualization of small particles and low-level turbidity. The turbidity of each drug combination was measured as well. Combinations yielding inconclusive results were subjected to particle sizing and counting. Most of the drugs tested were compatible with allopurinol sodium 3 mg/mL during the observation period. However, 34 drugs showed various incompatibilities with allopurinol sodium, including dense turbidity, particulate formation and precipitation, color change, and effervescence. Allopurinol sodium 3 mg/mL in 0.9% sodium chloride injection was compatible with 58 drugs for up to four hours at 22 degrees C; 34 drugs were not compatible with allopurinol sodium.
The compatibility of piperacillin sodium plus tazobactam with selected drugs during simulated Y-site administration was studied. A 5-mL sample of piperacillin sodium 40 mg/mL plus tazobactam 5 mg/mL (Zosyn) in 5% dextrose injection was combined with a 5-mL sample of each of 75 other drugs at concentrations used clinically. Each combination was prepared in duplicate in glass culture tubes, with the order of mixing being reversed between the duplicates; storage was in constant fluorescent light at 22 degrees C. The admixtures were examined visually in normal fluorescent light and in high-intensity light zero, one, and four hours after preparation. A turbidimeter was used to measure the turbidity of each drug combination at the same intervals. Samples showing visual or turbidimetric evidence of incompatibility were subjected to particle sizing and counting. The majority of the drugs tested were compatible with Zosyn injection; most combinations had a turbidity of less than 0.1 nephelometric turbidity unit. However, 24 drugs exhibited various incompatibilities, including increased turbidity, particulate formation and precipitation, and color change. Piperacillin sodium 40 mg/mL plus tazobactam in 5% dextrose injection was visually compatible with the majority of the drugs tested for up to four hours at 22 degrees C but incompatible with 24 drugs.
The compatibility of vinorelbine tartrate with selected drugs during simulated Y-site administration was studied. A 5-mL sample of vinorelbine tartrate 1 mg/mL in 0.9% sodium chloride injection was combined with a 5-mL sample of each of 91 other drugs at concentrations used clinically. Each combination was prepared in duplicate, with the order of mixing being reversed between the two; storage was in constant fluorescent light at 22 degrees C. The admixtures were examined visually in normal fluorescent light and with a Tyndall beam at zero, one, and four hours after preparation. A turbidimeter was used to measure the turbidity of each drug combination at the same intervals. Samples showing visual or turbidimetric evidence of incompatibility were subjected to particle counting and sizing. The majority of the drugs tested were compatible with vinorelbine tartrate; most combinations had a turbidity of less than 0.1 nephelometric turbidity unit. Turbidity measurements showed that cefazolin sodium, ceforanide, and cefuroxime sodium were incompatible with vinorelbine tartrate. Visual observation showed incompatibility of vinorelbine tartrate with acyclovir sodium, aminophylline, amphotericin B, ampicillin sodium, cefoperazone sodium, ceforanide, cefotetan sodium, ceftriaxone sodium, fluorouracil, furosemide, ganciclovir sodium, methylprednisolone sodium succinate, mitomycin, piperacillin sodium, sodium bicarbonate, thiotepa, and trimethoprimsulfamethoxazole. Vinorelbine tartrate 1 mg/mL in 0.9% sodium chloride injection was compatible with the majority of the drugs tested for up to four hours at 22 degrees C but was incompatible with 19 drugs.
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The physical compatibility of melphalan injection with selected drugs during simulated Y-site administration was studied. A 5-mL sample of melphalan 0.1 mg/mL in 0.9% sodium chloride injection was combined with a 5-mL sample of each of 91 drugs at concentrations used clinically. Each combination was prepared in duplicate, with the order of mixing reversed between the two. The samples were inspected visually in normal fluorescent light and in high-intensity light at zero, one, and three hours after preparation. A turbidimeter was used to measure the turbidity of each drug combination at the same intervals. Samples showing a change in the visually or turbidimetrically determined haze level were subjected to particle counting and sizing. None of the drug combinations resulted in visual evidence of precipitation, color change, or gas production. Most combinations had a measured turbidity of < 0.1 nephelometric turbidity unit (NTU) and were compatible. A few combinations had turbidities of > or = 0.1 NTU, but the turbidity did not change over the study period and the combinations were considered compatible. Combinations of melphalan with methylprednisolone sodium succinate, prochlorperazine edisylate, or daunorubicin hydrochloride had a very small increase in turbidity but were compatible. Melphalan did not increase the doubling of turbidity that idarubicin hydrochloride shows upon simple dilution. Neither the total particle burden nor the number of particles of > or = 10 microns increased in any combination that was tested. However, combinations with amphotericin B or chlorpromazine hydrochloride showed large increases in measured turbidity and were incompatible.(ABSTRACT TRUNCATED AT 250 WORDS)
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15 aged patients with clinical and laboratory evidence of cerebrovascular insufficiency and/or myocardial sclerosis were given suloctidil (Locton) at the daily dose of 200 mg X 3, for 180 days, under the conditions of an open trial. Blood and plasma viscosity, red cell deformability, total lipids, cholesterol, triglycerides, fibrinolysis (plasminogen, antiplasmin, euglobulins with and without activator, fibrinogen), and capillaroscopic parameters in the small conjunctival vessels (artery, vein, and capillary diameter, appearance of collaterals, red cell aggregation and flow homogeneity) were evaluated. After 30 days of treatment and particularly at the end of the trial a significant improvement of almost all these parameters was observed. Tolerance was always excellent.
OBJECTIVE: To evaluate the physical compatibility of gemcitabine hydrochloride (Gemzar-Eli Lilly and Company) with 107 selected drugs. DESIGN: Controlled experimental trial. SETTING: Laboratory. INTERVENTIONS: Samples of 5 mL gemcitabine (as the hydrochloride salt) 10 mg/mL in 0.9% sodium chloride injection were mixed with 5 mL samples of the selected drugs diluted in 0.9% sodium chloride injection or, if necessary to avoid incompatibilities with the diluent, 5% dextrose injection. MAIN OUTCOME MEASURES: Visual examinations of the samples were performed in normal fluorescent light with the unaided eye and using a Tyndall beam (high-intensity monodirectional light) to enhance visualization of small particles and low-level haze. The turbidity of each sample was measured as well. In selected samples, electronic particle content assessment was performed. All of the samples were assessed initially and at 1 and 4 hours. RESULTS: Most of the drugs were physically compatible with gemcitabine hydrochloride during the 4-hour observation period. However, 15 drug combinations had incompatibilities that included color change, increase in haze or turbidity, particulate formation, and gross precipitation: acyclovir sodium, amphotericin B, cefoperazone sodium, cefotaxime sodium, furosemide, ganciclovir sodium, imipenem-cilastatin sodium, irinotecan, methotrexate sodium, methylprednisolone sodium succinate, mezlocillin disodium, mitomycin, piperacillin sodium, piperacillin sodium/tazobactam sodium, and prochlorperazine edisylate. CONCLUSION: Gemcitabine hydrochloride 10 mg/mL admixed in a compatible infusion solution is physically compatible for 4 hours at room temperature with 92 of 107 tested drugs. Simultaneous Y-site administration of gemcitabine hydrochloride with the 15 drugs resulting in incompatibilities should be avoided.
OBJECTIVE: To evaluate the physical compatibility of etoposide phosphate with 101 selected secondary drugs, including antineoplastic chemotherapy agents, anti-infectives, and supportive care drugs, during simulated Y-site injection. DESIGN: Five-milliliter samples of etoposide 5 mg/mL as phosphate in 5% dextrose injection were mixed with 5 mL of the selected drugs diluted in 5% dextrose injection or, if necessary to avoid incompatibilities with the diluent, 0.9% sodium chloride injection. Samples were examined visually in normal fluorescent light with the unaided eye and using a Tyndall beam (high-intensity monodirectional light) to enhance the visibility of small particles and low-level haze. Turbidity of each sample was measured. In selected samples, electronic particle content assessment was performed. All of the samples were assessed initially and at one and four hours. RESULTS: Most of the secondary drugs were physically compatible with etoposide phosphate during the four-hour observation period. However, seven drug combinations had incompatibilities that included color change, increase in haze or turbidity, particulate formation, and gross precipitation. The drugs that were observed to be physically incompatible with etoposide phosphate were amphotericin B, cefepime hydrochloride, chlorpromazine hydrochloride, imipenem-cilastatin sodium, methylprednisolone sodium succinate, mitomycin, and prochlorperazine edisylate. CONCLUSION: Etoposide 5 mg/mL as phosphate in 5% dextrose injection is physically compatible for four hours at room temperature during simulated Y-site administration with 94 of the 101 drugs selected. Simultaneous Y-site administration of etoposide phosphate with the seven incompatible drugs should be avoided.
BACKGROUND: The absence of drug compatibility information with 3-in-1 parenteral nutrition admixtures has been problematic. The purpose of this project was to evaluate the physical compatibility of 106 selected drugs during simulated Y-site injection into nine different 3-in-1 parenteral nutrition admixture formulations. METHODS: Four-milliliter samples of each of the representative 3-in-1 parenteral nutrition admixture formulations were combined in a 1:1 ratio with 4-mL samples of each of 106 drugs, including supportive care drugs, anti-infectives, and antineoplastic drugs. Six replicate samples of each combination were prepared. Two samples were evaluated initially after mixing, two more after 1 hour, and the last two after 4 hours at 23 degrees C. At each test interval, the samples were subjected to centrifugation, causing the fat to rise to the top. The top fat layer and most of the aqueous phase were removed, and the remaining liquid was diluted with about 7 mL of particle-free, high-performance liquid chromatography-grade water to facilitate observation of any particulates that might have formed. Visual examinations were performed in normal diffuse fluorescent laboratory light and under high-intensity, monodirectional light. RESULTS: Most of the drugs tested were physically compatible with the 3-in-1 parenteral nutrition admixtures for 4 hours at 23 degrees C. However, 23 drugs exhibited various incompatibilities with one or more of the parenteral nutrition admixtures. Six drugs resulted in the formation of precipitate with some or all of the admixtures. Seventeen drugs caused disruption of the emulsion, usually with oiling out. CONCLUSIONS: Most of the test drugs were physically compatible with the nine representative 3-in-1 parenteral nutrition admixtures. However, the 23 drugs that resulted in incompatibilities should not be administered simultaneously with the incompatible parenteral nutrition admixtures via a Y injection site.
OBJECTIVE: To study the physical compatibility and chemical stability of fluorouracil 1 and 16 mg/mL with morphine sulphate 1 mg/ml and with hydromorphone hydrochloride 0.5 mg/mL in dextrose 5% injection and in NaCl 0.9% injection. DESIGN: Test solutions of the drugs in dextrose 5% and in NaCl 0.9% were prepared in triplicate and stored at -20, 4, 23, and 32 degrees C. Samples were removed immediately and at various time points over 35 days and stored at -70 degrees C until analyzed. Physical compatibility was assessed visually and by measuring turbidity with a color-correcting turbidimeter and particle content with a light-obscuration particle sizer and counter. Chemical stability was determined by measuring the concentration of each drug in the test solutions in duplicate with stability-indicating HPLC. RESULTS: The morphine test solutions all rapidly developed crystalline precipitation when admixed with fluorouracil. Further, substantial loss of morphine content, usually around 60-80%, occurred in all samples within 24 hours at all temperatures. There were no visual or subvisual changes in turbidity or particle content in any of the fluorouracil with hydromorphone test solutions at any of the time points. Further, there was no loss of fluorouracil over 7 days at 32 degrees C and 35 days at 23, 4, and -20 degrees C. Hydromorphone also was stable for 7 days at 32 degrees C and for 35 days at the other temperatures when combined with fluorouracil 1 mg/mL and at -20 and 4 degrees C with fluorouracil 16 mg/mL. However, with fluorouracil 16 mg/mL, hydromorphone was stable only for 3 days at 32 degrees C and for 7 days at 23 degrees C, exhibiting approximately 10% loss after those times. CONCLUSIONS: When admixed in dextrose 5% injection and NaCl 0.9% injection, fluorouracil 1 and 16 mg/mL and morphine 0.5 mg/mL were immediately physically incompatible in all samples resulting in substantial loss of morphine content as precipitated crystals. Fluorouracil 1 mg/mL plus hydromorphone 0.5 mg/mL were compatible and stable for at least 7 days at 32 degrees C and for at least 35 days at 23, 4 and -20 degrees C. Admixed with fluorouracil 16 mg/mL, hydromorphone was stable for 3 days at 32 degrees C, 7 days at 23 degrees C, and 35 days at 4 and -20 degrees C.
The appearance of thrombosis in the vascular access (VA) for haemodialysis (HD) is one of the most important complications of HD, with a great impact on the survival of definitive VA-both autologous internal arteriovenous fistulae (IAVFs) and prostheses (Gore-tex).