Efedrina versus fenilefrina: prevenção de hipotensão arterial durante anestesia raquídea para cesariana e efeitos sobre o feto / Efedrina versus fenilefrina: prevención de hipotensión arterial durante anestesia raquidea para cesárea y efectos sobre el feto / Ephedrine versus phenylephrine: prevention of hypotension during spinal block for cesarean section and effects on the fetus

JUSTIFICATIVA E OBJETIVOS: A hipotensão arterial durante a anestesia raquídea para cesariana deve-se ao bloqueio simpático e compressão aorto-cava pelo útero e pode ocasionar efeitos deletérios para o feto e a mãe. A efedrina e fenilefrina melhoram o retorno venoso após bloqueio simpático durante anestesia raquídea. O objetivo deste estudo foi comparar a eficácia da efedrina e da fenilefrina em prevenir e tratar a hipotensão arterial materna durante anestesia raquídea e avaliar seus efeitos colaterais e alterações fetais. MÉTODO: Sessenta pacientes, submetidas à anestesia raquídea com bupivacaína e sufentanil para cesariana, foram divididas aleatoriamente em dois grupos para receber, profilaticamente, efedrina (Grupo E, n = 30, dose = 10 mg) ou fenilefrina (Grupo F, n = 30, dose = 80 µg). Hipotensão arterial (pressão arterial menor ou igual a 80 por cento da medida basal) foi tratada com bolus de vasoconstritor com 50 por cento da dose inicial. Foram avaliados: incidência de hipotensão arterial, hipertensão arterial reativa, bradicardia e vômitos, escore de Apgar no primeiro e quinto minutos e gasometria do cordão umbilical. RESULTADOS: A dose média de efedrina foi 14,8 ± 3,8 mg e 186,7 ± 52,9 µg de fenilefrina. Os grupos foram semelhantes quanto aos parâmetros demográficos e incidência de vômitos, bradicardia e hipertensão arterial reativa. A incidência de hipotensão arterial foi de 70 por cento no Grupo E e 93 por cento no Grupo F (p < 0,05). O pH arterial médio do cordão umbilical e o escore de Apgar no primeiro minuto foram menores no grupo E (p < 0,05). Não houve diferença no escore do quito minuto. CONCLUSÕES: A efedrina foi mais eficiente que fenilefrina na prevenção de hipotensão arterial. Ambos os fármacos apresentaram incidência semelhante de efeitos colaterais. As repercussões fetais foram menos freqüentes com o uso da fenilefrina e apenas transitórias com a utilização da efedrina.

JUSTIFICATIVA Y OBJETIVOS: La hipotensión arterial durante la anestesia raquídea para cesárea se debe al bloqueo simpático y a la compresión aortocava por el útero y puede ocasionar efectos malignos para el feto y su madre. La efedrina y fenilefrina mejoran el retorno venoso después del bloqueo simpático durante la anestesia raquídea. El objetivo de este estudio fue comparar la eficacia de la efedrina y de la fenilefrina en prevenir y tratar la hipotensión arterial materna durante la anestesia raquídea y evaluar así sus efectos colaterales y las alteraciones fetales. MÉTODO: Sesenta pacientes, sometidas a la anestesia raquídea con bupivacaína y sufentanil para cesárea, se dividieron aleatoriamente en dos grupos para recibir, profilácticamente, efedrina (Grupo E, n = 30, dosis = 10mg) o fenilefrina (Grupo F, n = 30, dosis = 80 µg). Hipotensión arterial (presión arterial menor o igual a un 80 por ciento de la medida basal) fue tratada con bolo de vasoconstrictor con un 50 por ciento de la dosis inicial. Se evaluaron: incidencia de hipotensión arterial, hipertensión arterial reactiva, bradicardia y vómitos, puntuación de Apgar en el 1º y 5º minutos y gasometría del cordón umbilical. RESULTADOS: La dosis promedio de efedrina fue 14,8 mg (± 3,8) y 186,7 µg (± 52,9) de fenilefrina. Los grupos fueron similares en cuanto a los parámetros demográficos y a la incidencia de vómitos, bradicardia e hipertensión arterial reactiva. La incidencia de hipotensión arterial fue de un 70 por ciento en el Grupo E y un 93 por ciento en el Grupo F (p < 0,05). El pH arterial promedio del cordón umbilical y el puntaje de Apgar en el 1º minuto fueron menores en el grupo E (p < 0,05). No se registró diferencia en el puntaje del 5º minuto. CONCLUSIONES: La efedrina fue más efectiva que la fenilefrina en la prevención de la hipotensión arterial. Los dos fármacos presentaron una incidencia similar de efectos colaterales. Las repercusiones fetales fueron menos frecuentes...

BACKGROUND AND OBJECTIVES: Hypotension during spinal block for cesarean section is secondary to the sympathetic blockade and aorto-caval compression by the uterus and it can be deleterious to both the fetus and the mother. Ephedrine and phenylephrine improve venous return after sympathetic blockade during the spinal block. The objective of this study was to compare the efficacy of ephedrine and phenylephrine in the prevention and treatment of maternal hypotension during spinal block and to evaluate their side effects and fetal changes. METHODS: Sixty patients undergoing spinal block with bupivacaine and sufentanil for cesarean section were randomly divided in two groups to receive prophylactic ephedrine (Group E, n = 30, dose = 10 mg) or phenylephrine (Group P, n = 30, dose = 80 µg). Hypotension (blood pressure equal or lower than 80 percent of baseline values) was treated with bolus administration of the vasoconstrictor at 50 percent of the initial dose. The incidence of hypotension, reactive hypertension, bradycardia, and vomiting, and Apgar scores on the 1st and 5th minutes, and blood gases of the umbilical cord blood were evaluated. RESULTS: The mean dose of ephedrine used was 14.8 ± 3.8 mg and of phenylephrine was 186.7 ± 52.9 µg. Demographic parameters and the incidence of vomiting, bradycardia, and reactive hypertension were similar in both groups. Hypotension had an incidence of 70 percent in Group E and 93 percent in Group P (p < 0.05). The mean arterial pH of the umbilical cord blood and the Apgar score in the 1st minute were lower in Group E (p < 0.05). Differences in the Apgar score in the 5th minute were not observed. CONCLUSIONS: Ephedrine was more effective than phenylephrine in the prevention of hypotension. Both drugs had similar incidence of side effects. Fetal repercussions were less frequent with phenylephrine and were transitory with the use of ephedrine.

[Improvement of the process of producing pseudoephedrine hydrochloride].

OBJECTIVE: To improve the design of the technological process so as to solve the long existing quality problem in the process of producing pseudoephedrine hydrochloride. METHOD: Pseudoephedrine hydrochloride was developed on basis of developing pseudoephedrine. And its preparation condition was observed. RESULT: Pseudoephedrine hydrochloride obtained in the improved process didn't show tendency to agglomerate, which solves the quality problem of the product and the rate of production was raised. CONCLUSION: The improved process of producing pseudoephedrine hydrochloride has great application value.

Controlling the proliferation of Zygosaccharomyces bailii in ephedrine anti-phlegm cough mixture.

BACKGROUND AND OBJECTIVE: To explain a reported proliferation of Zygosaccharomyces bailii in a commercially available ephedrine anti-phlegm cough mixture preserved with 0.1% sodium benzoate, and to present a strategy for controlling its growth. METHODS: A yeast strain was isolated from the cough mixture and identified using biochemical tests, selective media and 18S rDNA sequencing. Preservative minimum inhibitory concentrations (MICs) were determined based on the broth microdilution technique. The cough mixture was reproduced using benzoate and a number of other candidate preservatives. Bottles were challenged with the yeast using the test for antimicrobial efficacy outlined in the monographs of the European Pharmacopoeia. RESULTS: The contaminating yeast was identified as Z. bailii. The yeast MIC value for benzoate was close to or above the concentration used in the commercially available cough mixture. Reintroduction of the strain into bottles preserved with benzoate or sorbate, gave an initial reduction in the inoculum concentration (>1 log) followed by growth to values close to those found in the contaminated product. Furthermore, yeast cells taken from bottles at the end of the challenge test, suffered no initial reduction in numbers and grew in fresh bottles of the product, possibly suggesting adaptation to weak-acid preservatives. Two paraben-based preservative systems passed the challenge test. CONCLUSION: Preservatives of the weak-acid type do not control the growth of Z. bailii in ephedrine cough mixture for reasons discussed in this article. If the raw juice used in production of the product cannot be treated to eliminate the yeast, other preservatives must be sought. We show that paraben-based systems are effective in this role, and these are discussed as possible replacements for benzoate in the cough mixture.

Implementation of the Methamphetamine Anti-Proliferation Act; thresholds for retailers and for distributors required to submit mail order reports; changes to mail order reporting requirements. Final rule.

This regulation implements the new threshold requirements and mail order reporting requirements of the Methamphetamine Anti-Proliferation Act of 2000 (MAPA), which was enacted on October 17, 2000. DEA is amending its regulations to reduce the thresholds for pseudoephedrine and phenylpropanolamine for retail distributors and for distributors required to submit mail order reports. Also, DEA is amending its regulations to require mail order reports for certain export transactions. DEA is codifying exemptions from the mail order reporting requirements for certain distributions to nonregulated persons and certain export transactions. This rule is consistent with the intent of MAPA to prevent the diversion of drug products to the clandestine manufacture of methamphetamine and amphetamine, and simultaneously reduce the industry reporting burden.

Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis.

A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled-release) (T/Ps) and clemastine fumarate, 1.34 mg (immediate-release)/phenylpropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom scores recorded in the diaries of 175 patients showed that both therapies had a highly significant overall treatment effect when compared with placebo (P < or = .02). The overall level of improvement, as well as improvement of individual symptoms, was similar with the two therapies. Total symptom scores assigned by physicians to 170 patients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies were also similar on physicians' evaluations of overall effectiveness. Both therapies relieved most histamine-mediated symptoms as well as nasal congestion, although only T/Ps showed improvement of the latter symptom in both the patients' diaries and physicians' evaluations. Among 178 patients, drowsiness and fatigue occurred more often in the C/Ph group (25% and 11.7% for the two adverse events, respectively) than in the T/Ps group (10.2% and 1.7%, respectively). The incidence of insomnia and dry mouth/nose/throat was higher with T/Ps (23.7% and 11.9%, respectively) than with C/Ph (6.7% and 3.3%, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in the treatment of symptoms of seasonal allergic rhinitis.(ABSTRACT TRUNCATED AT 250 WORDS)