Diprospan

Per mL Betamethasone dipropionate 5 mg, betamethasone disodium phosphate 2 mg

Adjunct to conventional therapy for acute & chronic corticosteroid-responsive disorders. Musculoskeletal & soft tissue conditions: RA, OA, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccydynia, sciatica, lumbago, torticollis, ganglion cyst, exostasis, fasciitis. Allergic conditions: Chronic bronchial asthma, hay fever, angioneurotic edema, allergic bronchitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness, insect bites. Dermatologic conditions: Atopic dermatitis, neurodermatitis, contact dermatitis, severe solar dermatitis, urticaria, hypertrophic lichen planus, necrobiosis lipoidica diabeticorum, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus, dermatitis herpetiformis, cystic acne. Collagen diseases: Disseminated lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa. Neoplastic diseases: For palliative management of leukemias & lymphomas in adults; acute leukemia in childhood. Other conditions: Adrenogenital syndrome, ulcerative colitis, regional ileitis, sprue, podiatric conditions, affections requiring subconjunctival inj, corticosteroid-responsive blood dyscrasias, nephritis, & nephrotic syndrome.

Systemic administration 1-2 mL IM in most conditions, repeat as necessary. Dosage & frequency of administration will depend on the severity of patient's condition & therapeutic response. Severe illness eg, lupus erythematosus or status asthmaticus 2 mL might be required initially. Dermatologic conditions 1 mL IM. Bronchial asthma, hay fever, allergic bronchitis, allergic rhinitis, acute or chronic bursitis 1-2 mL IM. Local administration Acute subdeltoid, subacromial, oleocranon, prepatellar bursitis 1-2 mL IB inj. Acute tenosynovitis, tendinitis, peritendinitis 1 inj, repeat as necessary for chronic conditions. RA, OA 0.5-2 mL IA. Large joints (knee, hip, shoulder) 1-2 mL IA; medium joints (elbow, wrist, ankle) 0.5-1 mL IA; small joints (foot, hand, chest) 0.25-0.5 mL IA. Dermatologic conditions 0.2 mL/cm² intradermal. Max: 1 mL at all sites each wk. Bursitis under heloma durum or molle, synovial cyst, Morton's neuralgia 0.25-0.5 mL w/ approx 1 wk interval; bursitis under calcaneal spur, bursitis over hallux rigidus, bursitis over digiti quinti varus, tenosynovitis, periostitis of cuboid 0.5 mL w/ approx 1 wk interval; acute gouty arthritis 0.5-1 mL w/ approx 1 wk interval.

Hypersensitivity to betamethasone or to other corticosteroids. Systemic fungal infection.

Not for IV or SC use. Not for epidural administration. Strict aseptic technique is mandatory. Caution in patients w/ history of allergic reactions to corticosteroids. Potential for systemic effects. Administer IM inj w/ caution in patients w/ ITP. Give IM inj deep into the large muscle masses to avoid local tissue atrophy. Do not inj into unstable joints, infected areas or intervertebral spaces. Increased joint destruction w/ repeated inj into joints of OA. Avoid injecting directly into the substance of tendons. Dose adjustments may be required w/ remission or exacerbation of the disease process, patient's individual response to therapy & exposure of patient to emotional or physical stress. Monitoring may be necessary for up to 1 yr following cessation of long-term or high-dose corticosteroid therapy. May mask some signs of infection, & new infections may appear during use. Possible decreased resistance & inability to localize infection. Prolonged use may produce posterior subcapsular cataracts (especially in childn), glaucoma w/ possible damage to the optic nerves, & may enhance secondary ocular infections due to fungi or viruses. Elevation of BP, salt & water retention, & increased excretion of K w/ ave & large doses of corticosteroids. Do not vaccinate patients against smallpox. Other immunization procedures should not be undertaken in patients receiving corticosteroids, especially high doses (except in patients receiving corticosteroids as replacement therapy eg, for Addison disease). Avoid exposure to chickenpox or measles in patients who are on immunosuppressant doses of corticosteroids. Corticosteroid therapy in active TB should be restricted to those cases of fulminating or disseminated TB. Close observation for patients w/ latent TB or tuberculin reactivity. Drug-induced secondary adrenocortical insufficiency w/ too rapid corticosteroid w/drawal. Enhanced effect in patients w/ hypothyroidism or w/ cirrhosis. Caution in patients w/ ocular herpes simplex. Psychic derangements may appear. Existing emotional instability or psychotic tendencies may be aggravated. Use w/ caution in nonspecific ulcerative colitis; probability of impending perforation, abscess, or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; HTN; osteoporosis; & myasthenia gravis. Reports of visual disturbance. May affect nitro-blue tetrazolium test for bacterial infection. May alter motility & number of spermatozoa in some patients. Pregnancy & lactation. Monitor growth & development of infants & childn in prolonged therapy. Contains benzyl alcohol; avoid in childn <2 yr. Not to be used in neonates.

Na retention, K loss, hypokalemic alkalosis, fluid retention, CHF in susceptible patients, HTN; muscle weakness, corticosteroid myopathy, loss of muscle mass, aggravation of myasthenic symptoms in myasthenia gravis, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral & humeral heads, pathologic fracture of long bones, tendon ruptures, joint instability (from repeated IA inj); hiccups, peptic ulcer w/ possible subsequent perforation & hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis; impaired wound healing, skin atrophy, thin fragile skin, petechiae & ecchymoses, facial erythema, increased sweating, suppressed reactions to skin tests, allergic dermatitis, urticaria, angioneurotic edema; convulsions, increased ICP w/ papilledema, vertigo, headache; menstrual irregularities, development of cushingoid state, suppression of fetal intrauterine or childhood growth; secondary adrenocortical & pituitary unresponsiveness, decreased carbohydrate tolerance, manifestations of latent DM, increased requirement of insulin or oral hypoglycemic agents in diabetes; posterior subcapsular cataracts, increased IOP, glaucoma, exophthalmos, vision blurred; -ve nitrogen balance; euphoria, mood swings, severe depression to frank psychotic manifestations, personality changes, insomnia; anaphylactoid or hypersensitivity & hypotensive or shock-like reactions.

Enhanced metabolism w/ phenobarb, phenytoin, rifampin, ephedrine. Excessive effects w/ estrogen. Increased exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, cobicistat-containing products). Enhanced hypokalemia w/ K-depleting diuretics. Concurrent use w/ cardiac glycosides may enhance possibility of arrhythmias or digitalis toxicity associated w/ hypokalemia. Enhanced K depletion caused by amphotericin B. Increased/decreased anticoagulant effects of coumarin-type anticoagulants. Increased occurrence or severity of GI ulceration w/ NSAIDs or alcohol. Decreased blood salicylate conc. ASA should be used cautiously w/ corticosteroids in hypothrombinemia. Dosage adjustments of antidiabetic drug may be necessary. Inhibited response to somatotropin.

Corticosteroid Hormones

H02AB01 - betamethasone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.

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