Schering

CELESTONE is betamethasone, a new corticosteroid discovered by Schering research. It is the most active corticosteroid available and offers the advantage of greatly enhanced antiinflammatory effects with lower dosages than other corticosteroids. Abnormal sodium and water retention and potassium loss are not discernible in most patients receiving therapeutic dosages. CELESTONE appears to differ significantly from other corticosteroids in that it increases sodium excretion. No new side effects have been observed with CELESTONE, and reactions associated with certain other corticosteroids such as anorexia, protracted weight loss, vertigo, severe headache and muscle weakness do not appear to be characteristic of CELESTONE. CELESTONE is available as 0.6 mg. tablets, scored for convenient fractional dosage. INDICATIONS: CELESTONE is indicated in the management of conditions generally responsive to corticosteroids; allergic conditions - bronchial asthma (including status asthmaticus), allergic rhinitis, intractable hay fever (pollenosis), angio-edema, transfusion reactions, drug and serum reactions, atopic and contact dermatitis, neurodermatitis, allergic eczema, exfoliative dermatitis, urticaria and dermatitis herpetiformis; inflammatory eye diseases (of posterior segment) - uveitis, chorioretinitis, sympathetic ophthalmia, iritis, iridocyclitis, retinitis centralis, herpes zoster ophthalmicus (not herpes simplex), optic neuritis and retrobulbar neuritis; collagen diseases - rheumatoid arthritis, acute rheumatic fever, disseminated lupus erythematosus, scleroderma and dermatomyositis; lymphomatous neoplastic diseases (for temporary remission)-pulmonary granulomatosis, lymphomas and Hodgkin's disease; soft tissue conditions - bursitis, synovitis and tenosynovitis; blood dyscrasias-idiopathic thrombocytopenic purpura, allergic purpura and acquired hemolytic anemia; and miscellaneous conditions adrenogenital syndrome, acute gouty arthritis, pemphigus, ulcerative colitis, nephrotic syndrome, pulmonary emphysema, pulmonary fibrosis, nasal polyps, Bell's palsy, sarcoidosis, ileitis, psoriasis and dental surgery. CELESTONE is particularly recommended for patients who have shown a diminution in response to other anti-inflammatory corticosteroids.

ADMINISTRATION AND DOSAGE: The dosage of CELESTONE must be adjusted to the individual requirements of the patient; i.e., severity of the condition, anticipated duration of therapy, tolerance to the steroid and the response obtained. The lowest dose that will produce the desired clinical effect should be employed. Patients may be transferred to CELESTONE from other corticosteroids with proper adjust

ment of dosage. In dermatologic conditions, initial dosage ranges between 4 and 8 tablets (2.4 to 4.8 mg.) daily until satisfactory control is achieved. Daily dosage is then reduced 1⁄2 to 1 tablet (0.3 to 0.6 mg.) every two or three days until maintenance level is determined. Initial therapy in inflammatory eye diseases is 4 to 8 tablets (2.4 to 4.8 mg.) daily until satisfactory control is obtained or for an arbitrary period of seven days. Dosage should then be reduced by 1 tablet (0.6 mg.) daily until a maintenance level is reached. In rheumatoid arthritis and other rheumatic disorders initial dosage of 2 to 4 tablets (1.2 to 2.4 mg.) daily is suggested. After satisfactory response is observed, maintenance dosage may be determined by decreasing the daily dosage by 1⁄2 tablet (0.3 mg.) every two or three days. Usual maintenance dosage is 1 to 2 tablets (0.6 to 1.2 mg.) daily. Initial dosage in acute rheumatic fever is between 10 and 14 tablets (6.0 to 8.4 mg.) daily. Proper maintenance level is determined by decreasing total daily dose by 1⁄2 or 1 tablet (0.3 to 0.6 mg.) daily. In bursitis, initial dosage of 2 to 4 tablets (1.2 to 2.4 mg.) daily is suggested. After satisfactory clinical response is obtained, dosage should be gradually reduced and then discontinued. In status asthmaticus an initial dosage of 6 to 8 tablets (3.6 to 4.8 mg.) daily may be required for one or two days to abate the attack. Dosage should then be reduced by 2 to 1 tablet (0.3 to 0.6 mg.) every other day until the maintenance level is reached or therapy discontinued. In chronic intractable asthma, usually 6 tablets (3.6 mg.) daily are given until satisfactory response is obtained or for an arbitrary period of seven days. Maintenance dosage is then determined by reducing the daily dosage 1⁄2 to 1 tablet (0.3 to 0.6 mg.) per day. A daily dosage of 4 to 6 tablets (2.4 to 3.6 mg.) is recommended initially in pulmonary emphysema and pulmonary fibrosis. After satisfactory improvement is noted, daily dosage should be reduced by 1 tablet (0.6 mg.) every two or three days until the proper maintenance level is reached, usually from 2 to 4 tablets (1.2 to 2.4 mg.). In intractable hay fever 3 to 4 tablets (1.8 to 2.4 mg.) CELESTONE should be administered on the first day. Total daily dosage should then be decreased by 1 tablet (0.6 mg.) daily until symptoms recur. Dosage should then be adjusted and maintained during the peak season and discontinued thereafter. Dosage of 1 to 2 tablets three times daily is generally adequate initial therapy in disseminated lupus erythematosus. After satisfactory response is obtained dosage should be reduced step-wise to determine maintenance level, reported to range between 3 to 5 tablets (1.8 to 3.0 mg.) daily. The dosage for treatment of

Schering

adrenogenital syndrome is generally 1 to 2 tablets (0.6 to 1.2 mg.) daily.

PRECAUTIONS: Salt and water retention or excessive potassium loss are rarely problems with CELESTONE. Diuresis may occur in some patients transferred from other steroids to CELESTONE. Although CELESTONE differs significantly in potency and electrolyte effects from other corticosteroids, it is capable of causing any of the reported side effects associated with the corticosteroids. In certain conditions such as osteoporosis, marked emotional instability, peptic ulcer, tuberculosis, and acute or chronic infections, the physician must weigh anticipated clinical improvement against the possibility of undesirable effects. Adequate antiulcer regimen should be employed in patients with a positive or suspected history of peptic ulcer. In the presence of acute or chronic infection, CELESTONE may be administered if the condition is severe enough to warrant possible exacerbation of infection. In such instances, appropriate antibiotic therapy in adequate amounts should be employed concomitantly. In individuals exposed to, or in the active phase of, chickenpox or other exanthematous disease, it may be desirable to temporarily reduce or discontinue corticosteroid therapy. Discretion should be employed in administering

CELESTONE to pregnant patients, particularly in the early months, since appreciable amounts of adrenocortical hormones during pregnancy may result in the occurrence of a temporary postnatal hypoadrenalism in the infant. If corticosteroids are employed in the controlled diabetic patient, close observation should be maintained during therapy. Since long-term administration of corticosteroids results in some depression of the adrenal cortex, CELESTONE should be withdrawn gradually when treatment is discontinued, and in the event of severe stress (surgery, shock, trauma) within a year following withdrawal, a temporary course of corticosteroid therapy is advisable. Herpes simplex of the eye and active, questionably healed or suspected tuberculosis are usually absolute contraindications to the use of corticosteroids.

SUPPLY: CELESTONE Tablets, 0.6 mg., scored, bottles of 30 and 100.

REFERENCES: 1. Frank, L.: The Place of Betamethasone in Dermatologic Practice. Paper presented at First Symposium on the Clinical Application of Betamethasone: A New Corticosteroid, New York City, May 8, 1961. 2. Gant, J. Q., and Gould, A. H.: Betamethasone: A Clinical Study. Ibid. 3. Nierman, M. M.: The Use of Betamethasone in Dermatology. Ibid.

SCHERING CORPORATION BLOOMFIELD, N.J.

March, 1961

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