Antasone

Each gram of Antasone cream/ointment contains Betamethasone (Antasone) dipropionate 640 mcg equivalent to Betamethasone (Antasone) 500 mcg and gentamicin sulfate equivalent to gentamicin base 1 mg.

Antasone cream is an oil-in-water emulsion. It contains mineral oil, white petrolatum and cetostearyl alcohol for its oil phase in emulsion base and chlorocresol as preservative.

Antasone ointment contains white petrolatum as its excipient.

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 or craniotomy.

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 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 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.

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

A thin film of Antasone should be applied to cover completely the affected area twice daily, in the morning and at night.

Frequency of application should be determined by the physician according to the severity of the condition. For some patients, adequate maintenance therapy may be achieved with less frequent application.

Duration of Treatment: Duration of therapy varies depending upon the extent and location of disease and patient response. However, if clinical improvement is not achieved by 3-4 weeks, diagnosis should be reviewed.

History of sensitivity reactions to Betamethasone (Antasone), gentamicin or to any of the components of Antasone.

Topical corticosteroids are contraindicated in vaccinia, varicella and tuberculosis of the skin.

Concurrent use of Phenobarbital, Phenytoin, rifampin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.

Patients receiving both a corticosteroid an estrogen should be observed for excessive corticosteroid effects.

Concurrent use of corticosteroids with potassium-depleting diuretics may enhance

Hypokalemia with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B. In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels should be monitored closely.

Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects possibly requiring adjustment in dosage.

Combined effects of non-steroidal anti-inflammatory drugs or alcohol with glucocorticosteroids may result in an increased occurrence or increased severity of gastrointestinal ulceration.

Corticosteroids may decrease blood salicylate concentrations. Acetylsalicylic acid should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Dosage adjustments of an antidiabetic drug may be necessary when corticosteroids are given to diabetics.

Concomitant glucocorticosteroid therapy may inhibit the response to somatotropin.

Laboratory test interactions: corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.

Adverse reactions to Antasone cream or ointment therapy have been reported very rarely and include hypersensitivity and skin discoloration.

Treatment with gentamicin has produced transient irritation (erythema and pruritus) that usually did not require discontinuance of treatment.

Reported adverse reactions with the use of topical corticosteroids, especially under occlusive dressings, include: Burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.