ARISTOCORT- triamcinolone diacetate injection, suspension
40 mg/mL PARENTERAL
NOT FOR USE IN NEONATES
NOT FOR INTRAVENOUS USE
CONTAINS BENZYL ALCOHOL
Aristocort® Forte is a sterile suspension of 40 mg/mL of triamcinolone diacetate (micronized) suspended in a vehicle consisting of:
|Water for Injection q.s.||100%|
Hydrochloric acid and/or sodium hydroxide may be used during manufacture to adjust pH of suspension to approximately 6.
Triamcinolone diacetate is practically insoluble in water; soluble in chloroform; sparingly soluble in alcohol and in methanol; and slightly soluble in ether. This preparation is suitable for parenteral administration through a 23-gauge needle (or larger), but NOT suitable for intravenous use. It may be administered by the intramuscular, intra-articular, or intrasynovial routes, depending upon the situation.
Irreversible clumping occurs when this product is frozen.
Chemically triamcinolone diacetate is 9-fluoro-11ß,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,21-diacetate.
The molecular weight is 478.51. Its structural formula is:
Triamcinolone diacetate occurs as a white to off-white, microcrystalline powder.
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily adsorbed from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems.
Triamcinolone diacetate is essentially devoid of mineralocorticoid activity when administered in therapeutic doses, causing little or no sodium retention with potassium excretion minimal or absent.
Where oral therapy is not feasible, Aristocort® Forte (triamcinolone diacetate injectable suspension), 40 mg/mL, is indicated for intramuscular use as follows:
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.
Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).
Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.
To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.
Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.
Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.
For palliative management of leukemias and lymphomas.
Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.
Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.
To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
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 Aristocort® Forte 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 Aristocort® Forte 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.
It may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
Aristocort® Forte is contraindicated in patients who are hypersensitive to any components of this product.
Intramuscular corticosteriod preparations are contraindicated for idiopathic thrombocytopenic purpura.
Aristocort® Forte is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.
Arisotcort Forte is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections:Fungal Infections).
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