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PubMed1978

Analysis of betamethasone and its organic esters in pharmaceutical products.

A rapid, quantitative analysis for betamethasone and its organic esters at room temperature is described. The method is similar to the official blue tetrazolium reaction for corticosteroids, except that methylene chloride is used as the solvent. The reaction is complete in 27-69 min, and the formazans produced are stable for at least 90 min after the addition of tetramethylammonium hydroxide. The results of the analysis of 13 different pharmaceutical formulations by the proposed method are reported. The degradation of betamethasone and its esters caused by strong bases is a pseudo-first-order reaction in methylene chloride. The average half-life of the corticosteroids studied is 56 min under the basic conditions described.

Aerosols↗
PubMed2006

Simple determination of betamethasone and chloramphenicol in a pharmaceutical preparation using a short monolithic column coupled to a sequential injection system.

This contribution describes the use of a new separation method based on a reversed-phase sequential injection chromatography (SIC) technique for simultaneous determination of chloramphenicol and betamethasone in pharmaceutical eye drops. A short monolithic column coupled with a sequential injection analysis (SIA) system enabled separation of two compounds in one step. A Chromolith Flash RP-18e, 25 x 4.6 mm column with a 5 mm precolumn (Merck, Germany) and a FIA1ab 3000 system (USA) with a 6-port selection valve and 5 mL syringe were used for sequential injection chromatographic separations in this study. The mobile phase used was acetonitrile-water (30:80, v/v), flow rate 0.48 mL/min; UV detection was at two wavelengths, i.e., 241 and 278 nm (absorption maxima of betamethasone and chloramphenicol, respectively). The basic validation parameters showed good results: linearity of determination for both compounds including internal standard (propylparaben) >0.999; repeatability of determination (RSD) in the range 0.8-1.7% at two different concentration levels, and detection limits in the range 0.5-1.0 mg/mL. The chromatographic resolution between compound peaks was greater than 2.1 and the analysis time was less than 8 min under optimal conditions. The developed sequential injection chromatography method was compared with the HPLC method and was found to be applicable for routine analysis of active compounds in pharmaceutical preparations.

Betamethasone↗
PubMed1996

Analysis of dexamethasone and betamethasone in bovine urine by purification with an "on-line" immunoaffinity chromatography-high-performance liquid chromatography system and determination by gas chromatography-mass spectrometry.

A method for the immunoaffinity extraction of dexamethasone and betamethasone in bovine urine, followed by high-pressure liquid chromatography (HPLC) fractionation and gas chromatography-mass spectrometry determination, is described. A commercial immunoaffinity gel, containing antibodies raised against dexamethasone, was used to prepare an immunoaffinity cartridge which was inserted in an automatic HPLC system for on-line extraction and purification. By injecting urine samples (spiked with flumethasone as internal standard) directly into the system, it was possible to collect purified fractions, containing the analytes of interest. The fractions were dried and derivatized to yield the tetra-trimethylsilyl derivatives of the three corticosteroids, which were analyzed by selected ion monitoring gas chromatography-mass spectrometry. The method allowed a very good purification of samples and reached a detection limit of 0.1 ng/ml for dexamethasone and 0.2 ng/ml for betamethasone. Several samples, coming from a steer treated with dexamethasone and from other bovines coming from breedings in northern Italy, were analyzed with the method described. Dexamethasone levels ranged from 0.12 to 146 ng/ml.

Animals↗
PubMed1990

Failure of betamethasone to alter the radiation response of two cultured human glioma cell-lines.

Glucocorticoids, such as betamethasone, are often used to prevent possible acute reactions during radiation therapy of intracranial tumors (for example gliomas). The effect of the glucocorticoids is probably due to vascular changes decreasing the development of edemas. The radiosensitivity of two studied cell-lines of human malignant glioma origin did not significantly change when they were continuously exposed to betamethasone in the concentration range of 1-25 micrograms/ml. The radiosensitivity was measured with the extrapolation method, which gave an estimate of cell survival, and through direct measurements of growth delays from growth curves. The results obtained are in conformity with previously published results where clonogenic survival tests showed that the isomer dexamethasone did not change the radiosensitivity of these cells. Thus, no direct effects on the radiosensitivity of glioma cells are expected from glucocorticoid treatment and it is therefore unlikely that the poor results obtained from radiation therapy of malignant gliomas are due to an increased radioresistance brought on by the glucocorticoid treatment.

Betamethasone↗
PubMed1976

Effect of bilateral adrenalectomy and parenteral betamethasone on gastric mucosal mast cell population in albino rats.

The histamine-laden mast cells of gastric mucosa in albino rats are shown to degranulate on administration of Betamethasone, but they increase in number in adrenalectomized rats. It is concluded that Betamethasone, and also adrenal glucocorticoids increase gastric secretion by liberating histamine from mast cells and histamine in turn acts on the gastric glands.

Adrenalectomy↗
PubMed1975

Impact of betamethasone load given to pregnant women on endocrine balance of fetoplacental unit.

Corticosteroid administration to pregnant women for attempted prevention of the respiratory distress syndrome in infants (IRDS) involves the hazard of seriously altering the endocrine status in the fetoplacental unit. The effect of a betamethasone load (12 mg. daily for three days) to 19 pregnant women in the last trimester was studied, and a comparison was made with 13 control subjects. Amniocentesis was performed twice in most patients. There was a sharp reduction of cortisol in maternal serum and a significant decrease in cortisol concentration in amniotic fluid (p less than 0.05) after betamethasone treatment. Maternal urinary estriol excretion decreased; this was strongly correlated to the basal estriol excretion (r equals 0.945). A residual fraction of estriol excretion, not less than 2 mg. per 24 hour urine specimen, remained despite the high corticosteroid dose. The origin of the nondepressed part of urinary estriol might be multifactorial, e.g., nonadrenal production of estriol precursors and functional inhomogeneity of the fetal adrenal in response to adrenocorticotropic hormone stimulation. The corticosteroid treatment for prevention of IRDS transiently excludes the use of urinary estriol for assessment of fetoplacental integrity but does not influence the plasma level of human chorionic somatomammotropin.

Amniocentesis↗
PubMed1980

The effects of betamethasone on fetal development in the rabbit.

Pregnant rabbits were injected with either 0.8 mg of betamethasone or with a comparable volume of saline on days 24 and 25 of gestation and delivered by cesarean section on day 26. There was a significant reduction in the weight of fetuses and in the weights of fetal brain, lungs, liver, and placenta in betamethasone-treated animals. With respect to the fetal brain, the concentration of DNA, the average of cell number, cell size, cell weight, and cell phospholipids were unaffected whereas the concentrations of phospholipids and protein were elevated in the treatment group.

Animals↗
PubMed1982

Hypertensive crisis associated with ritodrine infusion and betamethasone administration in premature labor.

A case is reported of hypertensive crisis associated with treatment of premature labor with intravenous ritodrine hydrochloride and betamethasone. Ritodrine has been in clinical use for over 10 yr in Europe, and recently also in the U.S.A. The drug has proved to be efficient and relatively safe. Yet, a few cases of severe side effects, all related to its effect on the cardiovascular system, have already been reported. The pathophysiology of this episode is unclear, but it is most likely related to the treatment, and should be added to the list of reported side effects of treatment with ritodrine and betamethasone.

Adult↗
PubMed1994

Pathogenicity of Enterococcus hirae for chicken embryos and betamethasone-treated chicks.

An isolate Enterococcus hirae was used to determine its pathogenicity for chicken embryos and for chicks treated with betamethasone. E hirae was inoculated intravenously into four-day-old chicks which had been treated for three consecutive days with betamethasone, and chick embryos were inoculated into the allantoic cavity with 10(2) and 10(3) bacteria. E hirae was not pathogenic for the chicks or for the embryos.

Allantois↗
PubMed1982

Intrathecal anti-tetanus serum (ATS) and parenteral betamethasone in the treatment of tetanus.

217 cases of tetanus admitted to Christian Medical College and Brown Memorial Hospital, Ludhiana, from June 1977 to April 1980 were studied. Three treatment regimes were used during this period. The addition of intrathecal horse antitetanus serum (ATS) (Group II) to the routine treatment (Group I) reduced the mortality from 63% to 53% but this was not statistically significant. Following a further addition of parenteral betamethasone to the regimen (Group III) the mortality decreased to 27% which was significantly lower than in Groups I and II. A similar trend in mortality was demonstrated when the severe cases were analysed separately. Groups I and III were comparable in terms of various prognostic factors and the nursing care received but Group II had a higher incidence of unfavourable prognostic factors, which may have obscured the benefit of intrathecal ATS. The combination of parenteral betamethasone and intrathecal ATS seems to be beneficial in the treatment of tetanus.

Adult↗
PubMed1991

A comparative, multicenter, double blind trial of 0.05% halobetasol propionate ointment and 0.1% betamethasone valerate ointment in the treatment of patients with chronic, localized plaque psoriasis.

In a double-blind, parallel-group, multicenter comparative trial in 84 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment proved significantly superior (p = 0.02) to 0.1% betamethasone valerate ointment with respect to the success rate, as indicated by ratings of "healed" or "marked improvement" (88.1% versus 64.3%). The therapeutic effect was observed within 5 days of the start of treatment in 76% and 67% of the patients treated with halobetasol propionate and betamethasone valerate ointments, respectively. Both preparations were well tolerated. Minor adverse effects at the site of application were reported in only 2% of the patients in each treatment group. Neither skin atrophy nor systemic adverse effects were observed.

Adult↗
PubMed1996

Uterine activity after betamethasone administration for the enhancement of fetal lung maturation.

OBJECTIVE: To assess the effect of steroids administered for the enhancement of fetal lung maturation on uterine activity. DESIGN: A retrospective analysis. SETTING: High-risk Pregnancy Unit, Golda Medical Center, Petah Tikvah, Israel. PATIENTS: Fifty-nine courses of betamethasone therapy prescribed for various indications other than premature contractions were studied in 29 pregnant women at 26-34 weeks' gestation. MEASUREMENTS: Uterine activity was monitored on the day of the first (but prior to) beta-methasone injection, then daily for the next 3 consecutive days. The number of uterine contractions during the first 30 min of each tocodynamometric tracing was assessed. RESULTS: The frequency of uterine activity after steroid administration is significantly higher in multiple pregnancies as compared to singletons, and significantly increases as the duration of pregnancy increases. However, labor was not induced and all women delivered at least 1 week after the last betamethasone injection. CONCLUSIONS: Since the increased uterine activity after administration of steroids for the enhancement of fetal lung maturation does not provoke labor, it is suggested that this increase in uterine activity seems to act as a temporary phenomenon. Therefore conservative management, rather than tocolysis, would seem appropriate.

Adult↗
PubMed2005

Antenatal corticosteroid therapy: a comparative study of dexamethasone and betamethasone effects on fetal Doppler flow velocity waveforms.

OBJECTIVE: To compare the effects of antenatal administration of dexamethasone and betamethasone, used in two different regimens, on fetal Doppler flow velocities. STUDY DESIGN: Sixty-seven women at risk for preterm delivery received course of corticosteroids by means of a computer-generated randomization table. The Doppler examination of the pulsatility index (PI) of the umbilical artery (UA), the middle cerebral artery (MCA) and the middle cerebral artery/umbilical artery PI ratio (MCA PI/UA PI) were performed before treatment, 24 and 72 h after the first dose of corticosteroids. The SAS system was used to perform statistical analysis. RESULTS: No significant change was observed in UA PI through dexamethasone therapy. In MCA there was a significant decrease in PI at 72 h (2+/-0.43 before and 1.68+/-0.31 after, p=0.0001). Similarly a significant decrease in MCA PI/UA PI ratio was noted (2.09+/-0.51 before and 1.83+/-0.4 after, p=0.0137). No significant changes were observed in UA PI, MCA PI and MCA PI/UA PI ratio during betamethasone treatment. CONCLUSIONS: Our results indicate significant decrease in fetal middle cerebral artery impedance at 72 h after maternal administration of the first dose of dexamethasone. Effects of dexamethasone on fetal brain warrants further research.

Betamethasone↗
PubMed2006

Glucose transporter proteins GLUT1 and GLUT3 like immunoreactivities in the fetal sheep brain are not reduced by maternal betamethasone treatment.

Synthetic glucocorticoids administered to accelerate fetal lung maturation in threatened preterm delivery change electrocortical brain activity in the human and sheep fetus and alter structural neuronal proteins in fetal baboon and sheep. We hypothesized that these changes are due to a decreased amount of glucose transporter proteins (GLUT). Glucose uptake into cerebral neurons is selectively facilitated by glucose transporter protein GLUT1 in the blood brain barrier and GLUT3 in neuronal membranes. GLUT1 and GLUT3 immunoreactivity was examined in fetal sheep brain sections of the frontal neocortex, caudate putamen and hippocampus at 0.73 gestation after fetal exposure to betamethasone by direct fetal intravenous infusion or maternal intramuscular injections at the clinically relevant dosage. Betamethasone did not alter GLUT1 and GLUT3 immunoreactivity in any of the brain regions investigated, independently of the dose and route of administration. These data indicate that alteration of GLUT expression is unlikely to explain the cerebral functional effects of antenatal glucocorticoids.

Animals↗
PubMed1981

Long-term effects of betamethasone on fetal development.

In previous studies, we noted that treatment of pregnant rhesus monkeys with betamethasone resulted in a marked increase in fetal lung distensibility. The purpose of the present study was to determine whether these changes persisted during subsequent in utero development. Pregnant rhesus monkeys were treated with 2 mg of betamethasone intramuscularly from day 120 to day 133 and underwent delivery by cesarean section one month later. The treated fetuses were found to have smaller lungs (-31%; p less than 0.005), and lower alveolar stability (-14%; p less than 0.025) than the control fetuses. Additional findings included smaller weights for the brain (p less than 0.01), liver, pancreas, and heart (p less than 0.05). Smaller adrenal (p less than 0.025) and larger pituitary weights (p less than 0.05) and lower plasma corticoid concentrations (p less than 0.001) indicated long-standing adrenal insufficiency in the treated fetuses. These persistent sequelae caution the indiscriminate and prolonged use of these potent glucocorticoids during pregnancy.

Adrenal Cortex↗
PubMed1994

A randomized, controlled trial of antepartum thyrotropin-releasing hormone and betamethasone in the prevention of respiratory disease in preterm infants.

OBJECTIVE: The objective was to investigate whether the addition of thyrotropin-releasing hormone to antepartum betamethasone further reduces the incidence of respiratory disease in preterm infants. STUDY DESIGN: A randomized, placebo-controlled, double-blind trial of antepartum thyrotropin-releasing hormone (400 micrograms given intravenously four times) and betamethasone (5 mg given intramuscularly four times) was conducted in 378 mothers likely to be delivered between 24 and 32.6 weeks' gestation. Statistical analysis was by relative risk, chi 2, t tests, and multiple logistic regression analysis. RESULTS: Four hundred five live-born infants were delivered. In infants without lethal abnormalities delivered between 24 hours and 10 days from entry (n = 175) the incidence of respiratory distress syndrome was reduced from 52% to 31% (relative risk 0.61, 95% confidence interval 0.41 to 0.89) and that of severe respiratory distress syndrome from 42% to 20% (relative risk 0.48, 95% confidence interval 0.29 to 0.78) in the placebo and thyrotropin-releasing hormone groups, respectively. The number of deaths fell from 14 to one (relative risk 0.08, 95% confidence interval 0.01 to 0.63). The incidence of chronic lung disease was not significantly different, but that of an adverse outcome (chronic lung disease or death by 36 weeks' gestation) fell from 29% in the placebo group to 16% with thyrotropin-releasing hormone (relative risk 0.55, 95% confidence interval 0.31 to 0.99). CONCLUSION: The addition of thyrotropin-releasing hormone to antepartum glucocorticoid treatment reduces the incidence of respiratory distress syndrome and improves survival in preterm infants.

Betamethasone↗
PubMed1979

Prenatal administration of betamethasone for prevention of respiratory distress syndrome.

The outcome of 114 infants of birth weight 750 to 1,750 gm who received prenatal betamethasone therapy was compared retrospectively to that of 138 infants delivered to untreated women. The incidence of respiratory distress syndrome in all treated infants was 37.7% compared with 50.7% (P = 0.05) in untreated infants. There was no apparent benefit of therapy among infants delivering less than 48 hours after the first dose and among infants less than 750 gm birth weight. Among infants delivering two to ten days after therapy, RDS 25.0 vs 50.7%) and mortality (8.9 vs 22.5%) were significantly reduced. Among surviving infants with RDS, fewer infants in the two to ten-day treated group required oxygen at FIO2 greater than 0.5 for more than 24 hours. Our findings confirm previous reports that prenatal glucocorticoid treatment reduces the incidence of RDS and mortality in premature infants. In addition, they indicate that therapy is more effective when delivery is delayed at least two days, that very small premature infants do not benefit from treatment, and that RDS may be less severe after prenatal exposure to betamethasone.

Betamethasone↗