DIPROFOS* Sterile Aqueous Suspension Schering-Plough

1 INDICATIONS AND USAGE:DIPROFOS Suspension is indicated for the treat-ment of acute and chronic corticosteroidresponsive disorders. Corticosteroid hormone therapy is an adjunct to, and not a replacement for, conventional and Soft Tissue Conditions: Rheumatoid arthritis; osteoarthritis; bursitis; ankylos-ing spondylitis; epicondylitis; radiculitis; coccydynia; sciatica; lumbago; torticollis; ganglion cyst; exosto-sis; fasciitis. Allergic Conditions: Chronic bronchial asthma (including adjunctive therapy for status asth-maticus); hay fever; angioneurotic edema; allergic bronchitis; seasonal or perennial allergic rhinitis; drug reactions; serum sickness; insect Conditions: Atopic dermatitis (num-mular eczema); neurodermatitis (circumscribed lichen simplex); contact dermatitis; severe solar der-matitis; urticaria; hypertrophic lichen planus; necro-biosis lipoidica diabeticorum.

2 Alopecia areata; dis-coid lupus erythematosus; psoriasis; keloids; pem-phigus; dermatitis herpetiformis; cystic Diseases: Disseminated lupus erythema-tosus; scleroderma; dermatomyositis; periarteritis Diseases: For palliative management of leukemias and lymphomas in adults; acute leukemia of Conditions: Adrenogenital syndrome; ulcer-ative colitis; regional ileitis; sprue; podiatric condi-tions (bursitis under heloma durum, hallux rigidus, digiti quinti varus); affections requiring subconjuncti-val injection; corticosteroid-responsive blood dyscra-sias; nephritis and nephrotic or secondary adrenocortical insufficiency may be treated with DIPROFOS Suspension but should be supplemented with mineralocorticoste-roids, if applicable.

3 DIPROFOS Suspension is rec-ommended for (1) intramuscular injection in con-Brand of betamethasone dipropionate and beta-methasone sodium phosphateFOR INTRAMUSCULAR, INTRA-ARTICULAR, PERIARTICULAR, INTRABURSAL, INTRADERMAL, INTRALESIONAL AND SOFT TISSUE INJECTIONDESCRIPTION:DIPROFOS Suspension is a Sterile Aqueous injectable Suspension of betamethasone dipropionate and beta-methasone sodium phosphate. Each ml of DIPROFOS Suspension contains betamethasone dipropionate equivalent to 5 mg betamethasone and betamethasone sodium phosphate equivalent to 2 mg betamethasone in a Sterile buffered and preserved ingredients: sodium phosphate, sodium chloride, disodium edetate, polysorbate 80, benzyl alcohol, methyl paraben, propyl paraben, sodium carboxymethylcellulose, polyethylene glycol and water for.

4 DIPROFOS Suspension is a combination of soluble and very slightly soluble betamethasone esters that provides potent anti-inflammatory, antirheumatic and antiallergic effects in the treatment of corticosteroid-responsive disorders. Prompt therapeutic activity is achieved by the soluble ester, betamethasone sodi-um phosphate, which is absorbed quickly after injec-tion. Sustained activity is provided by betametha-sone dipropionate, which is only slightly soluble and becomes a repository for slow absorption, thereby controlling symptoms over a prolonged period.

5 The small crystal size of betamethasone dipropionate permits the use of a fine-gauge needle (up to 26 gauge) for intradermal and intralesional adminis-tration. Glucocorticosteroids, such as betametha-sone, cause profound and varied metabolic effects and modify the body s immune response to diverse stimuli. Betamethasone has high glucocorticosteroid activity and slight mineralocorticosteroid * Sterile Aqueous Suspension schering -Ploughtion of a local anesthetic is desired, DIPROFOS Suspension may be mixed (in the syringe, not the vial) with 1% or 2% procaine hydrochloride or lido-caine, using formulations which do not contain para-bens.

6 Similar local anesthetics may also be used. Anesthetics containing methylparaben, propylpara-ben, phenol, etc. should be avoided. The required dose of DIPROFOS Suspension is first withdrawn from the vial into the syringe. The local anesthetic is then drawn in, and the syringe is shaken briefly. In acute subdeltoid, subacromial, olecranon, and pre-patellar bursitis, an intrabursal injection of 1 to 2 ml of DIPROFOS Suspension may relieve pain and restore full range of movement within a few hours.

7 Chronic bursitis may be treated with reduced dos-age once acute symptoms are controlled. In acute tenosynovitis, tendinitis, and peritendinitis, one injection of DIPROFOS Suspension should allevi-ate the condition. In chronic forms of these condi-tions, it may be necessary to repeat the injection as the patient s condition requires. Following to 2 ml intra-articular administration of DIPROFOS Suspension , relief from pain, soreness, and stiffness associated with rheumatoid arthritis and osteoar-thritis may be experienced within two to four hours.

8 Duration of relief, which varies widely in both diseas-es, is four or more weeks in the majority of cases. An intraarticular injection of DIPROFOS Suspension is well tolerated in the joint and periarticular tissues. Recommended doses for intra-articular injection are: large joints (knee, hip, shoulder), 1 to 2 ml; medium joints (elbow, wrist, ankle), to 1 ml; small joints (foot, hand, chest), to conditions may respond to intral-esional administration of DIPROFOS Suspension .

9 Response of some lesions not treated directly may be due to a slight systemic effect of the drug. In intralesional treatment, an intradermal dosage of ml/cm2 of DIPROFOS Suspension evenly inject-ed with a tuberculin syringe and a 26-gauge needle is recommended. The total amount of DIPROFOS Suspension injected at all sites each week should not exceed 1 responsive to systemic corticosteroids; (2) injection directly into the affected soft tissues where indicated; (3) intra-articular and periarticular injec-tion in arthritides; (4) intralesional injection in various dermatologic conditions.

10 And (5) local injection in certain inflammatory and cystic disorders of the AND ADMINISTRATION:DOSING REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE SPECIFIC DISEASE, ITS SEVERITY AND THE RESPONSE OF THE initial dose should be maintained or adjusted until a satisfactory response is observed. If a satis-factory clinical response does not occur after a rea-sonable period of time, treatment with DIPROFOS Suspension should be discontinued and other appropriate therapy Administration: For systemic therapy, treatment is initiated with 1 to 2 ml in most condi-tions and repeated as necessary.