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Determination of betamethasone dipropionate and salicylic acid in pharmaceutical preparations by high-performance liquid chromatography.

The simultaneous determination of betamethasone dipropionate (BD) and salicylic acid (SA) in both ointment and topical solution was developed using high-performance liquid chromatography (HPLC). The method was standardized using a LiChrospher 100 RP-18 (125 x 4 mm, 5 microns) column, acetonitrile-tetrahydrofuran-acetic acid 1% (25:20:55 v/v), apparent pH 3.3, as mobile phase, and UV detection at 254 nm. The peak area response versus concentration was linear in a concentration range from 5.0 to 50.0 micrograms/ml of BD and from 20.0 to 200.0 micrograms/ml of SA. The correlation coefficients were 0.9997 for BD and 0.9987 for SA, and the relative standard errors of estimates were 1.38% for BD and 3.27% for SA. The coefficient of variation and the recovery average were, respectively, 0.41-1.15% and 100.09% for BD, and 0.57-0.95% and 99.79% for SA.

Administration, Topical↗

Mononuclear leukocyte ADP-ribosylation as an indicator of immune function in malignant-glioma patients treated with betamethasone for cerebral edema.

Glioma patients receiving corticosteroids (16 mg/day betamethasone) were examined for evidence of immune cell dysfunction by using quantitative estimates of adenosine diphosphate (ADP)-ribosylation in peripheral mononuclear leukocytes as the physiological indicator. The duration of daily treatment with corticosteroids varied from 0 to 35 days at the time of collection of the blood samples. Even after adjustment for covariate factors such as age, sex, smoking habits, alcohol use, antiepileptic medications, and tumor grade, there still remained a highly significant dose-dependent inverse relationship between constitutive and hydrogen peroxide-induced mononuclear leukocyte ADP-ribosylation levels and the duration of corticosteroid treatment (beta coefficients -0.40 and -0.29, respectively; p less than 0.03). No other variable under consideration significantly influenced ADP-ribosylation levels after statistical adjustment. These data support a mutual interdependence of mononuclear leukocyte ADP-ribosylation and corticosteroid-induced immune cell dysfunction in vivo.

Betamethasone↗

Therapeutic effect of topical application of linoleic acid and lincomycin in combination with betamethasone valerate in melasma patients.

Melasma is an acquired symmetric hypermelanosis characterized by irregular light-to gray-brown macules and patches on sun-exposed areas. Many therapeutic agents are available but are unsatisfactory. Recently, it has been demonstrated that lincomycin (LM) and linoleic acid (LA) can inhibit melanogenesis in vitro. Our purpose was to investigate the clinical efficacy of topical application of LM and LA in combination with betamethasone valerate (BV) in melasma patients. Forty-seven Korean female adults with clinically diagnosed melasma were enrolled in a 6-week, double-blind, randomized clinical trial. Patients were treated with one application of the vehicle (group A), 2% LM mixed with 0.05% BV (group B), or 2% LM mixed with 0.05% BV and 2% LA (group C) on the face every night. Determination of efficacy was based on the Melasma Area and Severity Index (MASI) score and objective assessment (no effect, mild, moderate, or excellent) at intervals of 2 weeks until the end of the study at 6 weeks. After 6 weeks, in comparison with the pre-treatment MASI score, the average MASI score of group C decreased to 68.9%, compared with 98% in group A (p<0.05) and 85.4% in group B. There was no statistically significant difference between group A and group B. Seven patients (43.7%) in group C revealed more than moderate improvement in objective assessment, compared with none in group A and two patients (12.5%) in group B. There were no significant side effects. Topical application of linoleic acid is considered to be effective in the treatment of melasma patients.

Administration, Topical↗

[Comparative studies in man on the percutaneous absorption of diflucortolone valerate, betamethasone-17-valerate, beclomethasone dipropionate and fluocinolone acetonide].

Percutaneous absorption of 6alpha,9-difluor-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadience-3,20-dione (diflucortolone valerate, DFV, Nerisona), betamethasone 17-valerate (BV), beclomethasone dipropionate (BDP) and fluocinolone acetonide (FA) by damaged skin was examined on the backs of 4 healthy males from whom the stratum corneum had been removed by "stripping". The determination of percutaneous absorption was performed on the one hand by a method employing radioactive labelled compounds (DFV, BV) and measuring the elimination with the urine and faeces and on the other hand by photometric determination (DFV, BV, BD, fa) of the corticoid remaining on the skin immediately following application and at the end of a 24-h period of exposure. Direct measurement of the radioactivity in the urine and faeces revealed that percutaneous absorption from a new W/O emulsion takes place up to 2.2+/-0.8% in the case of DFV (0.1%) and to at least 12.2+/-3.3% in the case of BV (0.12%) within 24 h. The determination of percutaneous absorption via recovery from the skin produced the following results for the 4 corticoid preparations examined: DFV (14.8+/-4.2%) and BDP (14.0+/-4.3%) approximately equal, BV (23.5+/-4.1%) a marked increase and FA (39.2+/-2.4%) the highest level of absorption. This order for percutaneous absorption appears to correlate to the frequency of systemic side effects.

Administration, Topical↗

Double-blind comparison of halcinonide and betamethasone valerate. Use with occlusive dressings in psoriasis treatment.

In a double-blind, paired-comparison study of the effectiveness of corticosteroid creams used under occlusion for the treatment of moderate to severe psoriasis, a new drug, halcinonide cream, was superior to betamethasone valerate cream, a steroid widely and effectively used for the treatment of psoriasis. This superiority was demonstrated in patients after both one and two weeks of treatment.

Administration, Topical↗

[Pharmacological study of 9 alpha-fluoro-11 beta, 17, 21-trihydroxy-16 beta-methylpregna-1, 4-diene-3,20-dione-17-benzoate (betamethasone-17-benzoate, MS-1112), a local anti-inflammatory agent. (1). Its anti-inflammatory and other pharmacological properties].

The anti-inflammatory activity and the other pharmacological properties of MS-1112, a new steroid compound, were examined and compared with other glucocorticoid analogues such as hydrocortisone acetate (Hydr), betamethasone 17-valerate (Val) and dexamethasone (Dexa). Systemically administered MS-1112 and glucocorticoids had a significant effect in inhibiting rat paw edema induced by various phlogistic stimulations and increasing vascular permeabilities and granuloma formation by cotton pellet or granuloma pouch. The order of those inhibiting activity was, in general, Dexa greater than MS-1112 greater than Val greater than Hydr. Concomitantly, Xthymolysis and adrenal weight suppression and reduced rate of body weight gain after multiple systemical administration were also observed. Locally administered MS-1112 caused an inhibiting activity, without systemic side-effects. This activity was approximately 3 to 5 times more potent than that of Dexa in rat carrageenin paw edema and cotton pellet granuloma. MS-1112 was less active than Dexa in glycogen liver deposition activity and in the depression of plasma level of corticosterone but more active than Val and Hydr. In the dose administered, MS-1112 had neither androgenic and anabolic nor estrogenic and anti-estrogenic activity. From this data, it concluded that MS-1112 is a very potent agent applicable regarding permeability and retention of steroids in a local site.

Administration, Topical↗

Calcipotriol and betamethasone dipropionate (Dovobet, Daivobet): a new formulation for the treatment of psoriasis.

A new compound product containing calcipotriol 50 nanograms per gm and betamethasone dipropionate 0.5mg per gm (Dovobet, LEO Pharma) in an ointment base was recently introduced in Canada for the treatment of psoriasis. Known as Daivobet in Europe, it was introduced to the Danish Market in 2001, and approved for marketing by the European Union. This compound has been shown to be more active than either agent used along. The efficacy of once daily application was not shown to be different from that of twice daily use.

Administration, Topical↗

Using oral tetracycline and topical betamethasone valerate to treat acrodermatitis continua of hallopeau.

Acrodermatitis continua of Hallopeau (ACH) is a rare type of localized pustular psoriasis. We report the case of a 65-year-old alcoholic woman who had severe inflammatory ACH for 10 years. Initial therapy with sulfasalazine was unsuccessful. The patient was then treated with oral tetracycline and topical betamethasone valerate with occlusive dressing. Her condition improved dramatically after one week.

Acrodermatitis↗

Pharmaceutical availability of betamethasone dipropionate and gentamicin sulfate from cream and ointment.

Kinetics of drug release from both compared preparations occuring as a cream and ointment, was in vitro studied. A reversed-phase HPLC method was developed for the determination of betamethasone dipropionate in lipophylic bases. Analyses were performed using a PLRP column with a mobile phase of methanol-acetonitrile-water and ultraviolet detection at lambda = 254 nm. The calibration curve was constructed for concentration (.0-50.0 microg/ml. The method is simple, accurate and precise. For the determination of gentamicin sulfate the FPIA method was used.

Betamethasone↗

Pediatricians who prescribe clotrimazole-betamethasone diproprionate (Lotrisone) often utilize it in inappropriate settings regardless of their knowledge of the drug's potency.

Clotrimazole-betamethasone diproprionate (C-BMV) is a fluorinated, high potency topical steroid that has been formulated with clotrimazole in the brand-named product, Lotrisone. The product is frequently used inappropriately in intertriginous areas, particularly in children. The following evaluates the use of this combination based upon a survey of 106 US-based pediatricians with at least two years post-residency, who attended the 1999 American Academy of Pediatrics. Of pediatricians who prescribe C-BMV, 23% prescribe it for diaper dermatitis. 11% of C-BMV prescriptions exceed the recommended duration of therapy. Only 18% of prescribing pediatricians correctly identify "Lotrisone" as a high potency steroid. There is no significant association between knowledge of C-BMV potency and frequency of use (p>.1). These self-reported data confirm and complement the findings of previous studies that used representative national data to assess the use of C-BMV. Pediatricians continue to utilize C-BMV in inappropriate settings, such as diaper dermatitis, regardless of their knowledge of the agent's potency. Our advice is to refrain from using high-potency steroids, such as C-BMV, in pediatric cases as there are more appropriate, safer alternatives with many fewer side effects.

Administration, Topical↗

Can roxithromycin and betamethasone induce acute pancreatitis? A case report.

CONTEXT: Acute pancreatitis has been reported in a few cases treated with macrolides or glucocorticoids. CASE REPORT: We report the case of a 58 year old patient who, after 2 days of treatment with roxithromycin and betamethasone, manifested acute pancreatitis. Other causes of the disease were ruled out. No re-occurrence of pancreatitis was observed in a 16 month follow-up. CONCLUSION: Our case sheds new light on glucocorticoid pancreatotoxicity and confirms the role of macrolides as potential pancreatotoxic drugs.

Acute Disease↗

Once daily application of a combination of calcipotriol and betamethasone dipropionate (Dovobet, Daivobet) for the treatment of psoriasis.

This new compound product containing 50 micrograms/gram calcipotriol and 0.5 milligrams/gram betamethasone dipropionate was recently introduced in Canada for the treatment of psoriasis. Clinical trials demonstrated that this compound was more active than either agent used alone. Recent changes in the product monograph involving the reduction in dose to once daily use has raised questions about the relevance of some previous comparisons of twice daily Dovobet. Pooling the available data from 5,500 patients in clinical trials for Dovobet will allow an inter-trial comparison of the various treatment arms, demonstrating that Dovobet, when applied once daily is significantly more effective than with twice daily applications of either its individual components used alone.

Adult↗

[Comparative studies on Bi-Nerisona cream (diflucortolone valerinate + chlorquinaldol) and on a combination preparation (betamethasone valerinate + gentamicin + tolnaftate + clioquinol) in a double-blind trial].

Bi-Nerisone cream and a control preparation, also in the form of a cream, have been clinically tested on 343 patients by means of a double blind study. Equilvalent results were obtained without registering any significant statistical differences, a finding, however, proving to be of great importance as Bi-Nerisone only contains two active substances (Diflucortolone valerat + Chlorquinaldol), whereas the control preparation contains a total of four (Betamethasone valerate + Gentamycin + Tolnaftate + Clioquinol).

Betamethasone Valerate↗

Efficacy and local safety of a calcipotriol/ betamethasone dipropionate ointment in elderly patients with psoriasis vulgaris.

The proportion of elderly patients with psoriasis vulgaris is set to increase in the future due to an ageing population. This descriptive analysis assessed the efficacy and safety of a new ointment containing calcipotriol and betamethasone dipropionate (Daivobet/Dovobet in a pooled analysis of patients aged 60 years and over. A total of 1534 patients, including 357 aged > or = 60 years, with psoriasis vulgaris received the two-compound ointment once-daily in four randomised, double-blind, studies. After 4 weeks treatment the mean reduction in PASI was 67.8% in patients < 60 years compared with 72.6% in patients > or = 60 years. "Controlled disease" (i.e. a global assessment of "absence of disease" or "very mild disease"), according to the investigators, was achieved by 52.1% of patients < 60 years and 58.2% of patients > or = 60 years. Patients in both age groups reported a similar number of lesional/perilesional adverse drug reactions; 6.4% in patients < 60 years vs 5.0% in patients > or = 60 years. Thus, the new two-compound ointment is effective and well-tolerated in the treatment of psoriasis vulgaris, regardless of age group.

Adult↗

Acute generalized lichen planus treated with weekly betamethasone 5-mg oral mini-pulse therapy.

A 54-year-old male presented with a sudden generalized eruption of itchy violaceous papules, annular plaques, superficial vesicles, and erosions involving his trunk, limbs, oral cavity, and genitalia. The biopsy showed features of lichen planus (LP). Direct and indirect immunofluorescence (IF) was negative. Systemic treatment with oral corticosteroids in the form of 10 tablets of betamethasone 0.5 mg in a single dose was given after breakfast on 2 consecutive days every week. Complete arrest of progression, control of itching, and flattening of lesions was achieved within 3 weeks allowing tapering of the dose of corticosteroid by 0.5 mg every 2 weeks over next 10 weeks. No side effects of corticosteroid therapy were noted and the patient is in remission.

Acute Disease↗

An open label study of clobetasol propionate 0.05% and betamethasone valerate 0.12% foams in the treatment of mild to moderate acne keloidalis.

Acne keloidalis (AK) is a disease affecting primarily African American men. Topical steroids are a widely accepted treatment of AK; however, no studies have been published investigating their effectiveness. The purpose of this open-label study was to assess the efficacy and tolerability of clobetasol propionate 0.05% and betamethasone valerate 0.12% foams in the treatment of AK in 20 African American patients. These patients were treated for 8 to 12 weeks using a pulsed-dose regimen. We found topical clobetasol propionate foam to be effective in improving AK, and our patients found the foam vehicle to be cosmetically acceptable.

Acne Keloid↗

[The calcipotriol-betamethasone dipropionate association].

The topical treatment of psoriasis benefits from the alternate use of dermocorticosteroids and vitamin D3 analogues. A new galenic formulation allows to combine them in a single application. Dovobet (LEO Pharma) ointment is the association of calcipotriol 50 microg/g with betamethasone dipoprionate 0.5 mg/g. This formulation boosts the therapeutic activity of calcipotriol. It also decreases the irritative inflammatory reaction due to calcipotriol without increasing the atrophogenic risk of the dermocorticoid.

Administration, Topical↗

[How I treat...topical treatment of plaque type psoriasis by the combination of calcipotriol and betamethasone dipropionate].

The combination of calcipotriol and betamethasone dipropionate in a single topical formulation is a recent advance in treatment of plaque type psoriasis. Studies rooted on evidence-based medicine have been recently published. We report a synthesis and a critical analysis, critical analysis of these investigations, and translate their data with a view to apply them in daily practice.

Administration, Topical↗