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PubMed1998

Development of a coupled-column liquid chromatographic-tandem mass spectrometric method for the direct determination of betamethasone in urine.

Different hyphenated liquid chromatographic (LC) and mass spectrometric (MS) techniques were investigated in order to set-up a method for the fast, direct analysis of betamethasone in hydrolysed and non-hydrolysed urine using large-volume sample injection. After the optimisation of the LC parameters using a traditional UV detector and of the thermospray and mass spectrometric parameters by flow injection, urine samples (0.5 ml) were submitted to analysis by either LC combined with tandem mass spectrometry (MS-MS), coupled-column LC (LC-LC) combined with single quadrupole MS, and LC-LC-MS-MS. Both the three-step configurations (LC-MS-MS and LC-LC-MS) did not provide satisfactory results: loss of sensitivity was noted in the case of LC-MS-MS (likely due to reduced efficiency in the ionisation of betamethasone in the thermospray owing to the presence of large amounts of matrix interference), while in the case of LC-LC-MS a high chemical noise resulting in insufficient selectivity of detection was observed. On the contrary, LC-LC-MS-MS analysis proved to meet the demand of high speed of analysis (sample throughput, 4.5 h(-1)), selectivity, and sensitivity (LOQ, 1 ng/ml; LOD, 0.2 ng/ml). Notwithstanding the complex analytical system adopted, the developed procedure was manageable and very robust, provided that at the beginning of each analytical session the performance of the system was controlled by checking the retention time of the analytes on the first analytical column with UV detection and by optimising vaporiser temperature of the thermospray by flow injection.

Betamethasone↗

PubMed1992

Adrenal suppression with intranasal betamethasone drops.

Intranasal betamethasone sodium phosphate drops (Betnesol) are frequently used to relieve nasal congestion due to polyposis. We report a case of significant hypothalamic-pituitary-adrenal suppression secondary to the long-term use of intranasal betamethasone drops. This case emphasizes that the topical application of potent corticosteroids may produce systemic effects.

Administration, Intranasal↗

PubMed1978

Strongyloides ratti: the effect of betamethasone on the course of infection in rats.

Rats were treated with betamethasone at different stages of infection with Strongyloides ratti. Treatment caused a diminution in the number of adult worms recovered but this residual population was not expelled as were worms from untreated rats. If treatment was started after expulsion had already begun adult worm numbers increased--suggesting that autoinfection occurred. Treatment throughout a primary infection prevented the development of an immune response which expelled, or killed, a challenge infection. Treatment, just before and just after challenge, prevented the expulsion of the challenge infection. Worm expulsion up to day 35 was prevented by treating rats with betamethasone 4, 6, 8 and 10 days after infection.

Animals↗

PubMed1992

Feasibility of measuring the bioavailability of topical betamethasone dipropionate in commercial formulations using drug content in skin and a skin blanching bioassay.

An in vivo technique has been developed which simultaneously compares a skin blanching bioassay with drug content in human stratum corneum following topical application of four 0.05% betamethasone dipropionate formulations. Bioavailability of drug from commercial cream and ointment formulations was assessed by quantification of drug content in tape-stripped stratum corneum and skin blanching in the treated skin site under occluded conditions. Tape-stripping removed stratum corneum to a varying degree between individuals but was consistent (35%) within an individual with all formulations, day to day. A correlation (r = 0.9935) between the amount of drug in the treated stratum corneum normalized for surface area and the corresponding skin blanching score was observed with four 0.05% betamethasone dipropionate formulations. Increasing the amount of drug in the tape-stripped stratum corneum correlated with an increased skin blanching score. Ointment formulations delivered more drug to the skin and produced greater blanching scores than the cream formulations. Topical corticosteroid content in the treated skin site can therefore be quantified and correlates well with the resulting pharmacodynamic activity.

Administration, Topical↗

PubMed1990

Penetration of topically applied betamethasone sodium phosphate into human aqueous humour.

Gas Chromatography combined with Negative Chemical Ionisation Mass Spectrometry (GCMS) was used to determine the absorption of topically applied beta-methasone sodium phosphate into the aqueous humour of human subjects undergoing routine intraocular surgery. The Betamethasone concentration was greatest in the interval 91-120 minutes following topical administration (mean peak concentration = 7.7 ng/ml). At twelve hours post instillation the mean concentration of Betamethasone was 2.5 ng/ml and detectable levels were recorded in the aqueous humour 24 hours after application (mean concentration 0.4 ng/ml).

Administration, Topical↗

PubMed2003

Phase II study of cyclophosphamide, interferon-alpha and betamethasone (CIB) as induction therapy for patients 60-75 years of age with multiple myeloma stages II and III.

Cyclophosphamide, interferon-alpha and betamethasone are all effective agents for the treatment of multiple myeloma (MM) with different mechanisms of action. The clinical effect of a combination of cyclophosphamide 725 mg/m(2) i.v. days 1 and 3, interferon-alpha 7 x 10(6) IE/m(2) s.c./day, days 1-4 and betamethasone 30 mg orally days 1-4 (CIB) was studied in patients aged 60-75 years with previously untreated MM stages II and III. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 5 microg/kg/day s.c. was administered to all patients from day 5 until the day the granulocyte count exceeded 1.0 x 10(9)/l. CIB was repeated every fourth week. Interferon-alpha 3 x 10(6) IE s.c. t.i.w. was given as maintenance therapy in responding patients.A total of 28 patients (median age: 67 years) entered the study. In all, 12 patients had stage II and 16 had stage III MM. A total of 22 patients (79%) showed an objective response, including five complete remissions (CR) and 17 partial remissions (PR). All seven patients with Bence-Jones MM responded (five CR and two PR). The median response duration time was 14 months (range 5-38+). CIB was relatively well tolerated although febrile neutropenia or septicaemia occurred in 5% of the cycles and a dose-reduction of cyclophosphamide due to grade IV neutropenia was performed in 11% of the patients.CIB seems to be an effective regimen for remission induction in MM patients aged up to 75 years as an alternative to VAD (vincristine, doxorubicin, dexamethasone) if a regimen with intensity higher than that of oral melphalan/prednisone is warranted.

Aged↗

PubMed2002

Efficacy and safety of a new combination of calcipotriol and betamethasone dipropionate (once or twice daily) compared to calcipotriol (twice daily) in the treatment of psoriasis vulgaris: a randomized, double-blind, vehicle-controlled clinical trial.

BACKGROUND: Calcipotriol and betamethasone dipropionate are both widely used, effective treatments for psoriasis. Vitamin D analogues and topical corticosteroids have different mechanisms of action in the treatment of psoriasis. A new vehicle has been developed in order to contain both calcipotriol (50 micro g g-1) and betamethasone dipropionate (0.5 mg g-1) in an ointment form. By using calcipotriol and a corticosteroid together, greater efficacy may be achieved than by using either compound alone. OBJECTIVES: The present study was conducted in order to compare the clinical efficacy and safety of the combined ointment formulation used once daily with the vehicle ointment used twice daily, calcipotriol ointment used twice daily and the combined formulation used twice daily in psoriasis vulgaris. METHODS: This was an international, multicentre, prospective, randomized, double-blind, vehicle-controlled, parallel group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. Patients were randomized to one of four treatment groups: combined formulation once daily, combined formulation twice daily, calcipotriol twice daily or vehicle twice daily. Efficacy and safety were assessed. RESULTS: There was no statistically significant difference in the mean percentage change in the Psoriasis Area and Severity Index (PASI) from baseline to end of treatment between the two combined formulation groups, but the difference in PASI reduction was significantly higher in the combined formulation groups (68.6% once daily, 73.8% twice daily) than in both the twice daily calcipotriol group (58.8%) and the vehicle group (26.6%). Safety data showed the frequency of adverse events to be less in the combined formulation groups than in both the calcipotriol group and the vehicle group. The proportion of patients with lesional/perilesional adverse reactions was less in the combined formulation groups and vehicle group than in the calcipotriol group (9.9% combined formulation once daily, 10.6% combined formulation twice daily, 19.8% calcipotriol, 12.5% vehicle). CONCLUSIONS: No statistically significant nor clinically relevant difference in efficacy was seen between the combined formulation used once daily and twice daily. When compared to vehicle ointment or calcipotriol ointment alone, the combined formulation was shown to be clearly more efficacious.

Adolescent↗

PubMed2003

Efficacy of betamethasone valerate mousse in comparison with standard therapies on scalp psoriasis: an open, multicentre, randomized, controlled, cross-over study on 241 patients.

BACKGROUND: The scalp is a common area for plaque psoriasis. Corticosteroid-based lotions are the most widely used therapy in this clinical setting. A new formulation of betamethasone valerate 0.12% in a thermophobic, low-residue foam vehicle (Bettamousse trade mark, Mipharm, Italy; BVM) is available for the treatment of scalp dermatoses. OBJECTIVES: In an open, investigator-blinded, multicentre (28 dermatology clinics), randomized, cross-over study, the efficacy, safety and patient acceptability of BVM in scalp psoriasis were evaluated in comparison with standard therapies (ST, i.e. corticosteroids or vitamin D analogues). ST were chosen by each centre according to its usual therapeutic protocols. METHODS: In total, 241 patients with moderate to severe scalp psoriasis participated in the trial. After a 2-week run-in period, each active treatment (BVM or ST) was applied for 4 weeks, with a wash-out period between the two active treatment phases of at least 4 weeks. Efficacy was evaluated by investigators unaware of treatment sequence analysing a 'target' lesion for erythema, scaling, itching and burning using a five-point grading score. Patient treatment acceptability and assessment of the influence on Psoriasis Disability Index were evaluated using an eight-item modified Finlay-Khan questionnaire at baseline and at the end of each treatment period. Safety was evaluated by recording any adverse event occurring during the study duration. BVM was applied twice daily, and ST were applied once or twice daily, according to the approved scheduled regimens. RESULTS: Analyses were by intention-to-treat. Two hundred and ten patients concluded the study. Fifteen patients withdrew from the study during BVM treatment, and 16 during ST (not significantly different). Both treatments were well tolerated. At baseline, the mean +/- SD clinical global score (the 'Sum' score = erythema + scaling + itching + burning) was 7.6 +/- 2.6. The ST chosen were topical corticosteroids (55% of cases; mainly mometasone and betamethasone dipropionate) or calcipotriol lotion (45% of cases). At the end of active treatments, BVM was significantly superior to ST (P < 0.001) in reducing, as compared with baseline, the mean +/- SD Sum score (1.5 +/- 1.9 with BVM and 3.1 +/- 2.7 with ST). During BVM treatment, 88% (95% confidence interval, CI 82-94%) of patients had a complete or nearly complete resolution of scaling in comparison with 66% (95% CI 58-74%) during ST therapy (P < 0.001). BVM was also considered an easier and more convenient formulation to use in comparison with ST (P < 0.01). CONCLUSIONS: BVM is more effective than lotion-based ST commonly used in the treatment of scalp psoriasis, and has higher patient acceptability.

Administration, Topical↗

PubMed1999

Mononuclear cell subpopulations in preterm and full-term neonates: independent effects of gestational age, neonatal infection, maternal pre-eclampsia, maternal betamethason therapy, and mode of delivery.

Blood samples from 29 preterm (24-32 weeks of gestation) and 21 full-term (37-42 weeks of gestation) neonates were analysed for surface markers of lymphocyte subtypes and macrophages, and the effects of gestational age, neonatal infection, maternal pre-eclampsia, maternal betamethason therapy and mode of delivery were assessed with multiple regression analysis. Gestational age alone had few independent effects (increase in CD3+, CD8+CD45RA+, and CD11alpha+ cells, and decrease in CD14+, HLA-DR- cells) during the third trimester on the proportions of the immune cell subtypes studied. Neonatal infection and mother's pre-eclampsia had the broadest and very opposite kinds of effects on the profile of immune cells in the blood. Infection of the neonate increased the proportions of several 'immature' cells (CD11alpha-CD20+, CD40+CD19-, and CD14+HLA-DR-), whereas mother's pre-eclampsia decreased the proportions of naive cell types (CD4+CD8+, CD5+CD19+). In addition, neonatal infection increased the proportion of T cells (CD3+, CD3+CD25+, and CD4+/CD8+ ratio, and CD45RA+ cells), while maternal pre-eclampsia had a decreasing effect on the proportion of CD4+ cells, CD4+/CD8+ ratio, and proportions of CD11alpha+, CD14+ and CD14+HLA-DR+ cells. Maternal betamethason therapy increased the proportion of T cells (CD3+) and macrophages (CD14+, CD14+HLA-DR+), but decreased the proportion of natural killer (NK) cells. Caesarean section was associated with a decrease in the proportion of CD14+ cells. We conclude that the 'normal range' of proportions of different mononuclear cells is wide during the last trimester; further, the effect of gestational age on these proportions is more limited than the effects of other neonatal and even maternal factors.

Antigens, CD↗

PubMedDate not supplied

Hypothalamic-pituitary-adrenal axis function in premature neonates after extensive prenatal treatment with betamethasone: a case history.

Tests of hypothalamic-pituitary-adrenal axis function were performed on a set of 32-weeks' gestation triplets whose mother received 16 injections of betamethasone over 8 weeks prior to delivery to induce fetal lung maturation. The purpose of these studies was to determine if clinically significant suppression of fetal adrenocortical function occurred as a result of this repeated and prolonged prenatal exposure to glucocorticoids. Serum cortisol levels were measured on cord blood from each patient. Morning serum cortisol and 11-deoxycortisol levels were measured before and after an oral dose of metyrapone given at midnight on day 5. All three infants were clinically well at birth and had no evidence of hyaline membrane disease. Cord blood cortisol levels were low in each infant (1.97 +/- 0.25 micrograms/dl). By day 5, morning cortisol levels had become normal for each infant (10.77 +/- 2.42 micrograms/dl). Following the metyrapone dose, the 11-deoxycortisol levels rose 10- to 20-fold for each infant, indicating normal function of the hypothalamic-pituitary-adrenal axis by day 6. Adrenocortical suppression following multiple courses of prenatal betamethasone appears to be similar in degree and duration to that reported following brief antenatal therapy with this medication. Further studies are needed to confirm these anecdotal observations.

Adult↗

PubMed1986

Effect of ritodrine and betamethasone on metabolism, respiration, and circulation.

In order to obtain information on pharmacologic side effects of the most commonly used betamimetic in obstetrics, ritodrine (R) was infused under standardized, controlled conditions in one male and four nonpregnant female volunteers in increasing doses from 0.9 to 7.2 micrograms/kg/min. In second series, the same was done after premedication with 12 mg betamethasone (B), intravenously, 30 minutes before the start of the R infusion. Ritodrine caused increases in cardiac and respiratory work that were associated with rises in energy requirements and impaired efficiency of breathing. Premedication with betamethasone potentiated all side effects with the exception of diffusion capacity.

Adult↗

PubMed2000

The use of betamethasone and hyaluronidase injections in the treatment of Peyronie's disease.

OBJECTIVE: The aim of this study was to assess the effect of local injections of betamethasone, hyaluronidase and lidocaine in patients with Peyronie's disease. MATERIAL AND METHODS: A total of 112 men who had a palpable plaque at the penis and suffered from painful erection and bending of penis was treated with a total of 12 injections containing betamethasone, hyaluronidase and lidocaine. Patients were classified into groups according to the duration of the disease (<6 months, 6-12 months or >12 months) as well as the size of the plaque (<10 mm, 10-20 mm or >20 mm). Pretreatment evaluation of patients and assessment of outcome were based on subjective criteria as well as measurement of the size of the plaque by means of ultrasound. Results were correlated to patients' characteristics. RESULTS: The overall response rate was 86%. Cure or improvement was noticed in 31% and 55% of patients respectively. Most of the patients (83%) had a duration of disease less than 12 months. Painful erection, bending of penis and plaque were absent in 97%, 32% and 31% of patients, respectively, after treatment. No severe complications were observed. The effect of treatment was strongly related to the duration of disease and the size of the plaque. CONCLUSIONS: The method is safe, well tolerated by patients and characterized by a high response rate in patients with a history of less than 12 months and a plaque not exceeding 20 mm.

Adult↗

PubMedDate not supplied

Water-soluble betamethasone-loaded poly(lactide-co-glycolide) hollow microparticles as a sustained release dosage form.

In this study, betamethasone disodium phosphate-loaded microparticles were fabricated for sustained release using poly(lactide-co-glycolide) (PLGA) by spray drying and emulsion solvent evaporation/extraction techniques. Encapsulation efficiencies ranged from 59-80% using a water-in-oil-in-oil (W/O/O) double emulsion technique and more than 90% for a spray-drying method were obtained. This was a significant improvement compared to fabrication by a water-in-oil-in-water (W/O/W) double emulsion process, which had an encapsulation efficiency of less than 15%. Multiple-phase and biphasic release profiles were observed for microparticles of PLGA 50/50 and PLGA of higher lactide contents, respectively. The PLGA 50/50 hollow microparticles fabricated using the W/O/O double emulsion technique provided a sustained release of betamethasone disodium phosphate over 3 weeks.

Betamethasone↗

PubMed1991

A controlled trial of beclomethasone versus betamethasone enemas in distal ulcerative colitis.

Steroid enemas are widely used in distal inflammatory bowel disease (IBD). They are partly absorbed and suppress adrenocortical function. Beclomethasone dipropionate (BD) is a topically active steroid that undergoes rapid first-pass inactivation in the liver and is practically devoid of systemic side effects. We treated 32 consecutive patients with active distal ulcerative colitis (40 attacks) with 0.5 mg BD and/or 5 mg betamethasone phosphate (BP) enemas for 28 days. Clinical, laboratory, sigmoidoscopic, and histologic data were recorded before, during, and after the trial. The clinical efficacy of both treatments was similar. Betamethasone was slightly more effective in relation to the histologic improvement and disappearance of blood from the stools. Clinical signs of steroid overdosage were noted in patients on BP but not in patients on BD. Mean fasting plasma cortisol at the end of the trial was 2.9 micrograms/dl in the BP group and 15.3 micrograms/dl in the BD group. The adrenocorticotropin test was markedly suppressed in the BP group but not in the BD group. The absence of systemic steroid side effects makes BD enemas a useful addition in the therapy of IBD. Its oral administration should also be considered.

Adult↗

PubMed1998

Effect of systemic pretreatment with betamethasone on the bacterial flora, inflammatory response, and polyp formation in experimentally infected rabbit maxillary sinus mucosa.

To investigate possible effects of corticosteroids on polyp formation and local bacterial colonization, pneumococcal sinusitis was experimentally induced in rabbits pretreated with betamethasone or saline. After 7 days, macroscopic polyps were counted post-mortem and on histologic slides after serial sectioning. Histologic sections were also examined with light microscopy. Macroscopic polyps were significantly fewer in animals given betamethasone, while there was no difference regarding the number of microscopic polyps. Ingrowth of pathogenic microorganisms was found in five of eight rabbits given placebo but in none of the animals treated with corticosteroids (P < 0.05). The reduced number of pathogenic strains in these animals may be explained by a better-preserved local host defense. The lower number of macroscopic polyps in the same animals could be because of a delayed mucosal repair and subsequent polyp formation.

Animals↗

PubMed2002

Intentional ablation of vestibular function using commercially available topical gentamicin-betamethasone eardrops in patients with Meniere's disease: further evidence for topical eardrop ototoxicity.

OBJECTIVE: To determine whether the controversial findings of suspected ototoxicity from commercially available gentamicin sulfate and betamethasone sodium phosphate eardrops can be used in a therapeutic fashion to ablate (or attenuate) vestibular function in patients with unilateral Meniere's disease. STUDY DESIGN: Prospective case review. METHODS: At a tertiary care dizziness unit at the University Health Network, Toronto General Hospital, University of Toronto (Toronto, Ontario, Canada), adults with unilateral Meniere's disease undergoing intratympanic ablation therapy were studied. After insertion of a tympanostomy tube with the patient under local anesthesia, patients instilled gentamicin containing eardrops three times daily until they became vertiginous for longer than 24 hours and then for an additional 2 days longer or for 1 month, whichever came first. Electronystagmographic caloric test responses were measured before treatment using bithermal water caloric and after treatment using air caloric tests. Main outcome measures included clinical titration of drops to the onset of prolonged vertigo. As well, post-treatment findings on electronystagmography and audiometry were compared with pretreatment testing. RESULTS: Twenty patients were available for review. Fifteen patients had a significant reduction in caloric test responses compared with pretreatment values; among them, 10 patients had absent air caloric test responses on the treated side. In 10 patients hearing worsened according to the 1995 American Academy of Otolaryngology-Head and Neck Surgery Committee on Hearing and Equilibrium Guidelines for reporting in Meniere's disease. CONCLUSIONS: Topical gentamicin-betamethasone eardrops can pass through a tube into the middle ear, where they may prove primarily vestibulo-ototoxic patients with Meniere's disease. The study further confirms clinical observations that gentamicin-containing eardrops might prove ototoxic, especially in noninflamed ears with a tympanic membrane defect.

Administration, Topical↗

PubMed1995

Analgesic effect of topical diclofenac versus betamethasone after posterior segment surgery.

BACKGROUND: In clinical use, topical diclofenac, a nonsteroidal antiinflammatory, was found to be remarkably effective as an analgesic. A trial was therefore conducted to quantify and compare this effect with that of other drugs commonly used after posterior segment surgery. METHODS: A single-blind, randomized study of 37 patients undergoing posterior segment surgery was conducted. On the day of surgery and for 30 days thereafter, one group received topical diclofenac 0.1% and one group received topical betamethasone 0.1%. Pain intensity was assessed by two standard psychologic tests, the McGill Pain Questionnaire (MPQ) and Scott's Visual Analogic Scale (VAS). RESULTS: The group receiving diclofenac had significantly lower pain scores on the MPQ at days 1 and 15 (P < 0.05 and P < 0.03, respectively). The VAS scores were also statistically lower for this group on day 15 (P < 0.03). CONCLUSION: Topical diclofenac 0.1% has greater analgesic action than topical betamethasone 0.1% without the side effects of steroids, and may be useful after posterior segment surgery.

Administration, Topical↗

PubMed2004

Single doses of local betamethasone do not suppress allergic patch test reactions to nickel sulfate.

Topical corticosteroids are usually banned on test areas prior to patch testing. The previous literature on the effect of topical corticosteroids is conflicting. Patients allergic to nickel sulfate were patch tested on 4 sites with nickel on day (D) 0. Intracutaneous betamethasone was injected to test sites on D-1, D0 and D1. NaCl injection on D-1 was control. The patch test reactions were evaluated clinically and with laser Doppler. There were no differences in patch test reaction intensities on sites treated with intracutaneous betamethasone as compared to control. A single local dose of potent corticosteroid does not suppress allergic patch reactions to nickel. The current practice of avoiding topical corticosteroid use prior to patch testing should be re-evaluated.

Allergens↗