RESUMO
BACKGROUND: Measuring the seroprevalence of antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is central to understanding infection risk and fatality rates. We studied Coronavirus Disease 2019 (COVID-19)-antibody seroprevalence in a community sample drawn from Santa Clara County. METHODS: On 3 and 4 April 2020, we tested 3328 county residents for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to SARS-CoV-2 using a rapid lateral-flow assay (Premier Biotech). Participants were recruited using advertisements that were targeted to reach county residents that matched the county population by gender, race/ethnicity and zip code of residence. We estimate weights to match our sample to the county by zip, age, sex and race/ethnicity. We report the weighted and unweighted prevalence of antibodies to SARS-CoV-2. We adjust for test-performance characteristics by combining data from 18 independent test-kit assessments: 14 for specificity and 4 for sensitivity. RESULTS: The raw prevalence of antibodies in our sample was 1.5% [exact binomial 95% confidence interval (CI) 1.1-2.0%]. Test-performance specificity in our data was 99.5% (95% CI 99.2-99.7%) and sensitivity was 82.8% (95% CI 76.0-88.4%). The unweighted prevalence adjusted for test-performance characteristics was 1.2% (95% CI 0.7-1.8%). After weighting for population demographics, the prevalence was 2.8% (95% CI 1.3-4.2%), using bootstrap to estimate confidence bounds. These prevalence point estimates imply that 53 000 [95% CI 26 000 to 82 000 using weighted prevalence; 23 000 (95% CI 14 000-35 000) using unweighted prevalence] people were infected in Santa Clara County by late March-many more than the â¼1200 confirmed cases at the time. CONCLUSION: The estimated prevalence of SARS-CoV-2 antibodies in Santa Clara County implies that COVID-19 was likely more widespread than indicated by the number of cases in late March, 2020. At the time, low-burden contexts such as Santa Clara County were far from herd-immunity thresholds.
Assuntos
COVID-19 , Anticorpos Antivirais , California/epidemiologia , Humanos , SARS-CoV-2 , Estudos SoroepidemiológicosRESUMO
The physical compatibility of cefiderocol for injection (prepared as a diluted 2% cefiderocol solution) with potential co-administration drug products is presented. The compatibility of cefiderocol with a selection of 91 intravenous drugs was tested at clinically relevant concentrations using the admixed volume ratio 1:1. Compatibility of the mixtures was determined by visual observations, turbidity, and particulate-matter measurements. The mixtures were examined immediately after mixing, and then at 1 hour and 4 hours thereafter at room temperature. When using 0.9% sodium chloride or 5% dextrose injection for diluents, solutions of dobutamine hydrochloride, esomeprazole sodium, methylprednisolone acetate, propofol, rocuronium bromide, amiodarone hydrochloride, famotidine, labetalol hydrochloride, mycophenolate mofetil, acyclovir sodium, amphotericin B, caspofungin acetate, doxycycline, posaconazole, diphenhydramine hydrochloride, and phenytoin sodium were found to cause visible cloudiness upon mixing with 2% cefiderocol in both diluents. Solutions of lorazepam, tobramycin sulfate, and vancomycin hydrochloride were determined incompatible by examining the mixtures with the aid of a Tyndall light. These 19 drugs were clearly incompatible with cefiderocol for injection by visual examination. In addition, solutions of iron sucrose and albumin were incompatible with 2% cefiderocol based on sub-visual tests for turbidity and/or particulate matter. Based on sub-visual data, the 0.9% sodium chloride admixture of aminophylline and 2% cefiderocol was incompatible, while inconclusive results were obtained for the 0.9% sodium chloride admixtures of 2% cefiderocol with amikacin sulfate. Similarly, the 5% dextrose admixtures of either ciprofloxacin or polymyxin B sulfate with 2% cefiderocol were incompatible, whereas data for phenylephrine hydrochloride morphine sulfate, or undiluted sodium bicarbonate were inconclusive. Overall, the 2% cefiderocol solution was physically compatible with 63 of 91 drugs challenged at 1:1 volume ratio in both 0.9% sodium chloride and 5% dextrose diluents for at least 4 hours at the concentrations tested in this study.
Assuntos
Cefalosporinas , Preparações Farmacêuticas , Incompatibilidade de Medicamentos , Estabilidade de Medicamentos , Injeções Intravenosas , CefiderocolRESUMO
A stage I non-small cell lung cancer (NSCLC) serum profiling platform is presented which is highly efficient and accurate. Test sensitivity (0.95) for stage I NSCLC is the highest reported so far. Test metrics are reported for discriminating stage I adenocarcinoma vs squamous cell carcinoma subtypes. Blinded analysis identified 23 out of 24 stage I NSCLC and control serum samples. Group-discriminating mass peaks were targeted for tandem mass spectrometry peptide/protein identification, and yielded a lung cancer phenotype. Bioinformatic analysis revealed a novel lymphocyte adhesion pathway involved with early-stage lung cancer.
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Adenocarcinoma/sangue , Biomarcadores Tumorais/sangue , Carcinoma Pulmonar de Células não Pequenas/sangue , Carcinoma de Células Escamosas/sangue , Neoplasias Pulmonares/sangue , Proteômica/métodos , Espectrometria de Massas em Tandem , Adenocarcinoma/imunologia , Adenocarcinoma/patologia , Adenocarcinoma de Pulmão , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/imunologia , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma de Células Escamosas/imunologia , Carcinoma de Células Escamosas/patologia , Estudos de Casos e Controles , Adesão Celular , Biologia Computacional , Bases de Dados de Proteínas , Diagnóstico Diferencial , Feminino , Humanos , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/patologia , Linfócitos/imunologia , Linfócitos/metabolismo , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Fenótipo , Valor Preditivo dos TestesRESUMO
Topical metered-dosing dispensers are designed for dosing accuracy and ease-of-use by the patients while protecting the packaged products from environmental exposure and contamination. The objective of this study was to evaluate the accuracy, precision, and residual of available topical metered-dosing dispensers with different types of topical cream for practical application. Triplicate samples of five different dispensers were tested. This test was completed using three types of commercial topical cream-bases of dissimilar Total Active Pharmaceutical Ingredient Load Percentages, Transdermal Penetration Percentages, and Specific Gravities. The dispensers were evaluated according to specified dose-uniformity criteria for a total dispensing capacity of 30 mL at 0.5 mL per dose for 60 doses. The study shows Topi-CLICK performed with the best precision and accuracy of dosing in comparison to the airless-pump type dispensers. While the dispensing was highly variable with airless pumps and may require calibration for each packaged product, remarkably the performance of Topi-CLICK was not affected by different types of cream-bases and does not require additional metering calibration.
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Preparações Farmacêuticas/administração & dosagem , Administração TópicaRESUMO
Cases of contaminated nonsterile products have been reported in increasing numbers. Often, these contaminated products are associated with the presence of objectionable microorganisms. The major contaminants of nonsterile pharmaceutical products and ingredients are bacteria, yeasts, and molds. The combination of parts 1 and 2 of this series of articles provides a thorough examination of microbiological quality testing for nonsterile products.
Assuntos
Contaminação de Medicamentos , Preparações Farmacêuticas/análise , Controle de Qualidade , Bactérias/isolamento & purificação , Fungos/isolamento & purificação , Farmacopeias como AssuntoRESUMO
Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Cases of contaminated nonsterile products have been reported in increasing numbers, and often associated with the presence of objectionable microorganisms. Methods for detection of these organisms are described in three major Pharmacopeias. Their functions and their limitations in the examination of microbiological quality for nonsterile products will be reviewed in this report.
Assuntos
Bactérias/isolamento & purificação , Técnicas Bacteriológicas/normas , Contaminação de Medicamentos/prevenção & controle , Assistência Farmacêutica/normas , Humanos , Segurança do Paciente , Farmacopeias como Assunto , Garantia da Qualidade dos Cuidados de Saúde/normas , Controle de QualidadeRESUMO
Antimicrobial preservatives are excipients added to multi-dose containers of both sterile and non-sterile drug products. Antimicrobial preservatives are used primarily to inhibit growth of microbial contamination occurring during the period of use. Demonstration of antimicrobial preservative effectiveness is required for these functional excipients. This article reviews key factors for consideration in the selection of preservatives, principles of the preservative-effectiveness test, and the significance of requirements for preservative-effectiveness testing in the compounding practice.
Assuntos
Anti-Infecciosos/normas , Bactérias/efeitos dos fármacos , Composição de Medicamentos/normas , Contaminação de Medicamentos/prevenção & controle , Testes de Sensibilidade Microbiana/normas , Farmacopeias como Assunto/normas , Conservantes Farmacêuticos/normas , Anti-Infecciosos/classificação , Bactérias/crescimento & desenvolvimento , Fidelidade a Diretrizes , Guias como Assunto , Conservantes Farmacêuticos/classificação , Fatores de Tempo , Estados UnidosRESUMO
Serum mass profiling can discern physiological changes associated with specific disease states and their progression. Sera (86 total) from control individuals and patients with stage I nonsmall cell lung cancer or benign small pulmonary nodules were discriminated retrospectively by serum changes discerned by mass profiling. Control individuals were distinguished from patients with Stage I lung cancer or benign nodules with test sensitivities of 89% and 83%. Lung cancer patients versus those with benign nodules were distinguished with 80% sensitivity. This study exhibits progress toward a minimally-invasive aid in early detection of lung cancer and monitoring small pulmonary nodules for malignancy.
Assuntos
Biomarcadores Tumorais/sangue , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Neoplasias Pulmonares/diagnóstico , Nódulos Pulmonares Múltiplos/diagnóstico , Proteômica , Nódulo Pulmonar Solitário/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biópsia , Carcinoma Pulmonar de Células não Pequenas/sangue , Carcinoma Pulmonar de Células não Pequenas/patologia , Diagnóstico Diferencial , Detecção Precoce de Câncer , Feminino , Humanos , Neoplasias Pulmonares/sangue , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Nódulos Pulmonares Múltiplos/sangue , Nódulos Pulmonares Múltiplos/patologia , Estadiamento de Neoplasias , Valor Preditivo dos Testes , Proteômica/métodos , Estudos Retrospectivos , Nódulo Pulmonar Solitário/sangue , Nódulo Pulmonar Solitário/patologia , Espectrometria de Massas por Ionização por Electrospray , Tomografia Computadorizada por Raios X , Carga TumoralRESUMO
PURPOSE: The physical compatibility of ceftaroline fosamil with commonly used medications and diluents (a total of 73 drugs in 219 admixtures) during simulated Y-site administration was evaluated. METHODS: Duplicate 5-mL samples of ceftaroline fosamil (2.22 mg/mL) in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection were combined at a 1:1 ratio with samples of 73 drugs (diluted or undiluted). Visual examinations were performed with the unaided eye in fluorescent light and with the aid of a Tyndall beam; the turbidity and particulate content of each sample were also measured. The compatibility of ceftaroline fosamil with propofol was evaluated by visually inspecting for emulsion separation and particle formation after centrifugation. All evaluations were performed within 15 minutes of sample preparation and at one and four hours after preparation. RESULTS: Ceftaroline fosamil was physically compatible with 64 drugs in a combination of 196 admixtures for at least four hours, exhibiting color, clarity, turbidity, and microparticle content similar to those of control solutions. Signs of physical incompatibility, including visible precipitation, increased turbidity, and microparticle formation, were observed with 9 drugs in 23 admixtures during the four-hour observation period. CONCLUSION: Of the 73 drugs evaluated, 64 were compatible and 7 were incompatible with ceftaroline fosamil 2.22 mg/mL in 3 standard infusion solutions. Nine drugs in 23 admixtures were observed to exhibit signs of incompatibility with ceftaroline fosamil within four hours of mixing; those drugs should not be simultaneously administered via a Y-site with ceftaroline preparations.
Assuntos
Cefalosporinas/administração & dosagem , Incompatibilidade de Medicamentos , Antibacterianos/administração & dosagem , Antibacterianos/química , Cefalosporinas/química , Simulação por Computador , Solução Hipertônica de Glucose , Humanos , Infusões Intravenosas , Injeções Intravenosas , Soluções Isotônicas , Solução de Ringer , Solução Salina Hipertônica , CeftarolinaRESUMO
A 6-year-old male child was scheduled for a dental procedure requiring conscious sedation. Prior to the procedure, the child was administered a dental cocktail containing chloral hydrate, hydroxyzine, and methadone. After returning from the dentist, the child appeared groggy and was allowed to sleep. A few hours later, he was found unresponsive, and following resuscitation attempts at a local medical center, he was pronounced dead. Toxicological analyses of femoral blood indicated the presence of hydroxyzine at less than 0.54 µg/mL, trichloroethanol (TCE) at 8.3 µg/mL, and methadone at 0.51 µg/mL. No meperidine was detected. The cause of death was reported to be due to the toxic effects of methadone. The toxicological analysis was corroborated by the analysis of the contents of the dental cocktail, which revealed the presence of hydroxyzine, chloral hydrate, and methadone. Residue from a control sample obtained from the same pharmacy, but administered to a different subject, was found to contain hydroxyzine, chloral hydrate, and meperidine. This report represents the first known fatality due to accidental substitution of methadone in a dental cocktail.
Assuntos
Anestesia Dentária , Sedação Consciente , Erros de Medicação , Metadona/intoxicação , Acidentes , Anestesia Dentária/métodos , Criança , Hidrato de Cloral/administração & dosagem , Hidrato de Cloral/análise , Hidrato de Cloral/sangue , Sedação Consciente/métodos , Combinação de Medicamentos , Evolução Fatal , Humanos , Hidroxizina/administração & dosagem , Hidroxizina/análise , Hidroxizina/sangue , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/análise , Hipnóticos e Sedativos/sangue , Masculino , Metadona/administração & dosagem , Metadona/sangueRESUMO
The goal of this study was to evaluate the usefulness of electrospray ionization-mass spectrometry (ESI-MS) technology to distinguish sera of early-stage lung cancer patients from control individuals. ESI-MS m/z (mass divided by charge) data were generated from sera of 43 non-small cell lung cancer patients (pathological stages I and II) and 21 control individuals. Identifications of m/z peak area significances between cancer and control ESI-MS sera spectra were performed using t-tests. A "leave one out" cross validation procedure, which mimics blinded sera analysis and corrects for "over-fitting" of data, yielded discriminatory cancer versus control distribution p value and ROC curve area value of <0.001 and 0.87, respectively. Analysis without the "leave one out" cross validation procedure yielded a ROC curve area of 0.99 for discrimination of sera from lung cancer patients versus control individuals. Predictive value measurements revealed overall test efficiency and sensitivity for distinguishing sera from lung cancer patients from controls (using "leave one out" cross validation) of 80% and 84%, respectively. ESI-MS serum analysis between control individuals and lung cancer patients who smoked or did not smoke had p values in ranges indicating that smoking effects are not pronounced in our analysis. These studies indicate that ESI-MS analyses of sera from early stage non-small cell lung cancer patients were helpful in distinguishing these patients from control individuals.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Neoplasias Pulmonares/diagnóstico , Espectrometria de Massas por Ionização por Electrospray , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores Tumorais/sangue , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/fisiopatologia , Diagnóstico Diferencial , Detecção Precoce de Câncer , Estudos de Viabilidade , Feminino , Humanos , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Valor Preditivo dos Testes , Curva ROC , Sensibilidade e EspecificidadeAssuntos
Neoplasias da Mama/patologia , Emolientes/administração & dosagem , Estrogênios/administração & dosagem , Administração Cutânea , Neoplasias da Mama/metabolismo , Cromatografia Líquida de Alta Pressão , Emolientes/química , Estradiol/análise , Estriol/análise , Estrogênios/análise , Estrona/análise , Feminino , Humanos , Pessoa de Meia-Idade , Receptores de Estrogênio/metabolismoRESUMO
PURPOSE: The stability of fentanyl 5 microg/mL in 0.9% sodium chloride solution packaged in polypropylene syringes was studied. METHODS: Samples of fentanyl 5 microg (as the citrate) per milliliter in 0.9% sodium chloride injection were prepared and assessed for chemical stability using a validated, stability-indicating high- performance liquid chromatographic (HPLC) assay. A total of 12 syringe samples were submitted for chemical stability testing by HPLC. The syringes were protected from light and stored in controlled ambient conditions (23-27 degrees C and 55-65% relative humidity) in an environmental chamber. Three samples were tested initially and at each 30-day interval. Each syringe sample was tested with two determinations, using the average of the determinations for the assay result. Samples were assessed for pH and inspected for color and visible particulate matter. Stability was defined as the retention of 90-110% of the initial drug concentration at 30, 60, and 90 days. RESULTS: Fentanyl citrate injection maintained the appearance of a clear, colorless solution, with mean +/- S.D. pH values ranging from 4.13 +/- 0.01 to 4.52 +/- 0.02 throughout the study period. Recovery of fentanyl ranged from 99.86% +/- 0.29% to 102.74% +/- 1.60% of the initial concentration, with no detectable changes in the chromatographic profiles of all tested samples. CONCLUSION: Fentanyl 5 microg (as the citrate) per milliliter in 0.9% sodium chloride injection, packaged in polypropylene syringes and stored protected from light, was stable for at least 90 days in controlled ambient conditions.
Assuntos
Fentanila/química , Polipropilenos , Cloreto de Sódio/química , Seringas , Estabilidade de Medicamentos , Fentanila/administração & dosagem , Soluções Farmacêuticas/administração & dosagem , Soluções Farmacêuticas/química , Polipropilenos/normas , Cloreto de Sódio/administração & dosagem , Seringas/normasRESUMO
Severe dry eye syndrome can adversely affect a patient's quality of life. When preservative-free artificial tear solutions are not adequate to reduce symptons, the patient's own serum can be compounded into eye drops that improve the ocular surface. The aim of our study was to test the sterility of autologous serum eye drops in refrigerator conditions for up to 30 days and in freezer conditions for up to 180 days. It was determined that sterility was maintained throughout this period.
RESUMO
Palonosetron hydrochloride is a longer-acting, selective 5-HT3 receptor antagonist that has been approved for prevention of chemotherapy-induced nausea and vomiting and is being evaluated for prevention of postoperative nause and vomiting. The objective of this study was to evaluate the physical and chemical stablity of palonosetron hydrochloride 50 mcg/mL when mixed with undiluted propofol 1% during simulated Y-site administation. Duplicate samples of this mixture were tested. Samples were stored and evaluated for up to 4 hours at room temperature. Physical stability was assessed by visual inspection. Chemical stability was assessed by high-performance liquid chromatographic analysis. All of the admixtures were opaque white when viewed in normal fluorescent room light and when viewed with a Tyndall beam. After centrifugation, no evidence of precipitation was found. The drug concentrations were essentially unchanged in all of the samples throughout the study. Palonosetron hydrochloride is physically and chemically stable when mixed with propofol as undiluted injections during simulated Y-site administration over 4 hours at ambient room temperature.
RESUMO
Slow-release dosage forms are designed to release active drugs at slower rates for prolonging drug effects. These unconventional dosage forms are complex drug delivery systems, which require specialized technical knowledge and skills in their formulation. Verification of the compounding process for slow-release oral dosage forms can be accomplished through quality-control testing of pilot batches to ensure acceptable preparation and patient safety.
RESUMO
A new generation of VISIV polyolefin intravenous solution containers, made of a new and different proprietary polymer, were evaluated for sorption and leaching potential with a cadre of drugs known to exhibit those phenomena with polyvinylchloride containers. Sorption potential was evaluated for amiodarone hydrochloride, carmustine, regular human insulin, lorazepam, nitroglycerin, sufentanil citrate, and thiopental sodium. Leaching potential was evaluated for tacrolimus and teniposide as well as the vehicles of docetaxel and paclitaxel. Representative concentrations of the drugs in infusion solutions or undiluted were placed into the new generation of VISIV containers and left in contact for up to 24 hours at room temperature. High performance liquid chromatography was used to determine drug concentrations and the presence of plasticizer or other plastic components, if any. Only regular human insulin exhibited any substantial loss of concentration in the polyolefin containers that could be attirbuted to sorption. Other drugs' concentrations were consistent with their stabilities over the test periods. No evidence of leaching of plasiticizer or other plastic components was observed.
RESUMO
PURPOSE: The physical compatibility of the new cephalosporin ceftobiprole medocaril with 70 other drugs during simulated Y-site injection was studied. METHODS: Ceftobiprole was reconstituted with sterile water for injection. Dilutions of ceftobiprole 2 mg/mL (as ceftobiprole medocaril 2.67 mg/mL) were prepared in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection. For testing compatibility with the other drugs, a 5-mL sample of the ceftobiprole 2-mg/mL admixtures was combined with a 5-mL sample of the other drug either undiluted or diluted with one of the three vehicles. Each combination was prepared in duplicate, switching the order of drug addition, and kept at room temperature. At intervals up to four hours after preparation, samples were examined visually and with the aid of a Tyndall beam and measured with a turbidimeter and a particle sizer and counter. Compatibility with propofol was evaluated by checking for emulsion separation and particles after centrifugation. RESULTS: In all three vehicles, ceftobiprole was compatible with 31 other drugs and incompatible with 32. With 7 drugs, compatibility was dependent on the vehicle used. Signs of incompatibility included the presence of visible and subvisible particles, haze, and turbidity. No incompatibilities were related to the order of mixing. CONCLUSION: Of the 70 drugs evaluated for compatibility with ceftobiprole 2 mg/ mL (as medocaril) in 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection, 31 were found to be compatible and 32 were found to be incompatible in all three of the infusion solutions. For 7 of the drugs, compatibility was dependent on which infusion solution was used. Ceftobiprole medocaril should not be simultaneously administered via a Y site with drugs with which it was shown to be incompatible.
Assuntos
Antibacterianos/química , Cefalosporinas/química , Antibacterianos/administração & dosagem , Cefalosporinas/administração & dosagem , Incompatibilidade de Medicamentos , Glucose/química , Humanos , Infusões Intravenosas , Soluções Isotônicas/química , Tamanho da Partícula , Veículos Farmacêuticos/química , Solução de Ringer , Cloreto de Sódio/química , Fatores de TempoRESUMO
BACKGROUND: Esomeprazole sodium (Nexium IV, AstraZeneca) is the S-isomer of omeprazole and acts as a proton pump inhibitor gastric antisecretory agent indicated for the short-term treatment of gastroesophageal reflux disease in patients with a history of erosive esophagitis. Currently, there is no information on the long-term stability of esomeprazole sodium in infusion solutions beyond 12 hours. OBJECTIVE: To evaluate the stability of esomeprazole sodium in 5% dextrose, 0.9% sodium chloride, and lactated Ringer's injection, at 2 concentrations, at room temperature and when refrigerated. METHODS: Triplicate samples of esomeprazole 0.4 and 0.8 mg/mL as the sodium salt were prepared in the solutions required. Stability evaluations were performed initially, over 2 days stored at 23 degrees C, and over 5 days stored at 4 degrees C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual observation. Chemical stability was evaluated by stability-indicating high-performance liquid chromatography. RESULTS: The samples in all 3 infusion solutions were physically stable throughout the study. None of the samples had evidence of visible haze or particulates. Most samples developed a slight yellow discoloration within 24 hours, but this discoloration was not accompanied by an excessive loss of drug content. The esomeprazole sodium samples in all 3 infusion solutions exhibited less than 7% loss over 2 days at 23 degrees C and over 5 days at 4 degrees C. CONCLUSIONS: Esomeprazole 0.4 and 0.8 mg/mL as the sodium salt in the infusion solutions tested is chemically and physically stable for at least 2 days at room temperature and 5 days under refrigeration.
Assuntos
Antiulcerosos/química , Esomeprazol/química , Estabilidade de Medicamentos , Armazenamento de Medicamentos , Glucose/química , Humanos , Soluções Isotônicas/química , Omeprazol/química , Cloreto de Polivinila/química , Lactato de Ringer , Cloreto de Sódio/química , Soluções/química , Fatores de TempoRESUMO
PURPOSE: The compatibility of doripenem diluted for infusion with 82 other drugs during simulated Y-site administration was studied. METHODS: Five-milliliter samples of doripenem 5 mg/mL in 5% dextrose injection and separately in 0.9% sodium chloride injection were combined with 5 mL of 82 other drugs, undiluted or diluted in 5% dextrose injection or 0.9% sodium chloride injection. Visual examinations were performed with the unaided eye in fluorescent light and using a Tyndall beam to enhance visualization of small particles and low-level turbidity. The turbidity of each sample was measured, and particulate content was evaluated. Samples were inspected initially and one and four hours after preparation. RESULTS: Of the drugs tested, doripenem 5 mg/mL in 5% dextrose injection and in 0.9% sodium chloride injection was incompatible with diazepam, potassium phosphates, and undiluted propofol. Doripenem 5 mg/mL in 0.9% sodium chloride injection but not in 5% dextrose injection was incompatible with amphotericin B-containing drugs due to the diluent. Doripenem was found to be compatible when combined with the other 75 drugs for at least four hours. CONCLUSION: Doripenem 5 mg/mL in 5% dextrose injection or in 0.9% sodium chloride injection was physically compatible for four hours at room temperature with 75 drugs during simulated Y-site administration. Three drugs combined with doripenem in 5% dextrose injection or 0.9% sodium chloride injection and 7 drugs combined with doripenem in 0.9% sodium chloride injection resulted in unacceptable precipitation or an increase in measured haze and should not be simultaneously administered with doripenem admixtures.