Celestone (Betamethasone) - Summary

CELESTONE SUMMARY

CELESTONE^® Oral Solution, for oral administration, contains 0.6 mg betamethasone in each 5 mL.

CELESTONE (Betamethasone) is indicated for the following:

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness.

Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance.

Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, selected cases of secondary thrombocytopenia.

Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Neoplastic Diseases For the palliative management of leukemias and lymphomas.

Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.

Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.

Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

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NEWS HIGHLIGHTS

Media Articles Related to Celestone (Betamethasone)

clotrimazole and betamethasone, Lotrisone
Source: MedicineNet Ringworm Specialty [2009.01.09]
Title: clotrimazole and betamethasone, Lotrisone
Category: Medications
Created: 12/31/1997
Last Editorial Review: 1/9/2009

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Published Studies Related to Celestone (Betamethasone)

Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. [2009.09]
BACKGROUND: Genetic defects leading to skin barrier dysfunction were recognized as risk factors for atopic dermatitis (AD). It is essential that drugs applied to patients with AD restore the impaired epidermal barrier to prevent sensitization by environmental allergens. OBJECTIVES: We investigated the effect of 2 common treatments, a calcineurin inhibitor and a corticosteroid, on the skin barrier... CONCLUSION: The present study demonstrates that both betamethasone and pimecrolimus improve clinical and biophysical parameters and epidermal differentiation. Because pimecrolimus improved the epidermal barrier and did not cause atrophy, it might be more suitable for long-term treatment of AD.

Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial. [2009.08]
BACKGROUND: Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed. OBJECTIVE: To assess the impact of treatment with either calcipotriol plus betamethasone dipropionate scalp formulation or calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups)... CONCLUSION: The two-compound scalp formulation was superior to calcipotriol scalp solution in improving QoL in patients with scalp psoriasis.

Efficacy and safety of calcipotriol plus betamethasone dipropionate scalp formulation compared with calcipotriol scalp solution in the treatment of scalp psoriasis: a randomized controlled trial. [2009.07]
BACKGROUND: Current topical therapies for scalp psoriasis are difficult or unpleasant to apply, resulting in decreased adherence and efficacy. OBJECTIVES: To compare the efficacy and safety of once-daily treatment with a combination of calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate) (Xamiol; LEO Pharma A/S, Ballerup, Denmark) and twice-daily calcipotriol 50 microg mL(-1) scalp solution in patients with scalp psoriasis... CONCLUSIONS: A once-daily combination of calcipotriol plus betamethasone dipropionate was significantly more effective and better tolerated than twice-daily calcipotriol scalp solution in the treatment of scalp psoriasis.

The effects of betamethasone treatment on clinical and laboratory features of pregnant women with HELLP syndrome. [2009.07]
AIM: The present study aims to investigate the effects of betamethasone treatment on clinical outcome and laboratory data of pregnant women diagnosed with HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome... CONCLUSIONS: The betamethasone treatment has ended up with insignificant alterations in clinical outcomes and laboratory data of women with HELLP syndrome except beneficial effects on metabolic complications and need for platelet transfusion. Further investigation is required to assess the efficiency of betamethasone in management of HELLP syndrome.

Different effects of pimecrolimus and betamethasone on the skin barrier in patients with atopic dermatitis. [2009.05]
BACKGROUND: Genetic defects leading to skin barrier dysfunction were recognized as risk factors for atopic dermatitis (AD). It is essential that drugs applied to patients with AD restore the impaired epidermal barrier to prevent sensitization by environmental allergens. OBJECTIVES: We investigated the effect of 2 common treatments, a calcineurin inhibitor and a corticosteroid, on the skin barrier... CONCLUSION: The present study demonstrates that both betamethasone and pimecrolimus improve clinical and biophysical parameters and epidermal differentiation. Because pimecrolimus improved the epidermal barrier and did not cause atrophy, it might be more suitable for long-term treatment of AD.

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Clinical Trials Related to Celestone (Betamethasone)

Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM1) [Recruiting]
This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema:

- Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole and gentamicin

sulfate)

- Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream

- Arm C: Betamethasone diproprionate cream

At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1: 1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile.

Betamethasone Dosing Interval - 12 or 24 Hours? [Recruiting]
The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section [Recruiting]
This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and <40 weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design is to determine the efficacy and safety of betamethasone in the prevention of breathing problems commonly seen in this population.

In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to 8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for >30 minutes from 4. 5% to 2. 5%.

Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva) [Recruiting]
The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis.

It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris [Recruiting]
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).

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