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Celestone Soluspan (Betamethasone Acetate / Betamethasone Sodium Phosphate Injection) - Summary

 
 



SUMMARY

CELESTONE® SOLUSPAN® Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate.

When oral therapy is not feasible, the intramuscular use of CELESTONE® SOLUSPAN® Injectable Suspension is indicated as follows:

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, transfusion reactions.

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, 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 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.

The intra-articular or soft tissue administration of CELESTONE SOLUSPAN Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

The intralesional administration of CELESTONE SOLUSPAN Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum.

CELESTONE SOLUSPAN Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).


See all Celestone Soluspan indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Celestone Soluspan (Betamethasone Injection)

Pharmacokinetics of betamethasone and betamethasone 17-monopropionate in Chinese healthy volunteers after intramuscular injection of betamethasone phosphate/betamethasone dipropionate. [2011]
The aim of this study was to evaluate the pharmacokinetic profiles of betamethasone (BOH, CAS 378-44-9) and betamethasone 17-monopropionate (B17P), the active metabolites of betamethasone phosphate (BSP) and betamethasone dipropionate (BDP), respectively, after administration of betamethasone i.m...

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.

The effects of betamethasone treatment on clinical and laboratory features of pregnant women with HELLP syndrome. [2008.12.14]
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.

Analgesic and antiemetic effect of ketorolac vs. betamethasone or dexamethasone after ambulatory surgery. [2007.03]
BACKGROUND: Glucocorticoids are known to provide slower onset and more prolonged duration of analgesic effect than ketorolac. In the present study, we wanted to evaluate the effect over time from a single dose of either intravenous (i.v.) dexamethasone or an intramuscular (i.m.) depot formulation of betamethasone compared with i.v. ketorolac... CONCLUSION: Dexamethasone 4 mg or bethamethasone 12 mg did not provide prolonged post-operative analgesic effect compared with ketorolac 30 mg, which was superior for analgesia and antiemesis in the PACU.

Oral betamethasone versus intramuscular dexamethasone for the treatment of mild to moderate viral croup: a prospective, randomized trial. [2006.08]
OBJECTIVE: Intramuscular dexamethasone is an effective, but painful, treatment for croup. The effectiveness of betamethasone, an oral, palatable, and equally potent glucocorticoid has not been studied. The purpose of this study was to compare the effectiveness of a single oral dose of betamethasone with intramuscular dexamethasone in the outpatient treatment of mild to moderate croup... CONCLUSION: There is no difference between oral betamethasone and intramuscular dexamethasonein the management of mild to moderate viral croup. It is palatable and does not require a nurse for administration, making it a good alternative for ambulatory management.

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Clinical Trials Related to Celestone Soluspan (Betamethasone Injection)

Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4) [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.

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%.

Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA) [Recruiting]
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.

Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI) [Recruiting]
This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion

LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs) [Not yet recruiting]
The purpose of this study is to compare the efficacy and safety of LEO 80185 topical suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of LEO 80185 topical suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).

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Page last updated: 2011-12-09

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