Aristocort

ARISTOCORT- triamcinolone diacetate injection, suspension
Sandoz Inc

40 mg/mL PARENTERAL

NOT FOR USE IN NEONATES

NOT FOR INTRAVENOUS USE

CONTAINS BENZYL ALCOHOL

DESCRIPTION

Aristocort® Forte is a sterile suspension of 40 mg/mL of triamcinolone diacetate (micronized) suspended in a vehicle consisting of:

Polysorbate 800.20%
Polyethylene Glycol 3%
Sodium Chloride 0.85%
Benzyl Alcohol 0.90%
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 chemical structure
(click image for full-size original)

Triamcinolone diacetate occurs as a white to off-white, microcrystalline powder.

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Where oral therapy is not feasible, Aristocort® Forte (triamcinolone diacetate injectable suspension), 40 mg/mL, is indicated for intramuscular use as follows:

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

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.

Gastrointestinal Disease

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, 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.

For Intra-Articular or Soft Tissue Administration

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.

For Intralesional Administration

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).

CONTRAINDICATIONS

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 for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS: Pediatric Use).

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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