Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Sandoz Inc
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 40 mg in 1 mL
INTRA-ARTICULAR
PRESCRIPTION DRUG
Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP 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
Triamcinolone acetonide injectable suspension, USP in vials providing 40 mg triamcinolone acetonide per mL, are supplied as follows: NDC 0781-3245-72 40 mg/mL, 1 mL vial NDC 0781-3245-75 40 mg/mL, 5 mL multiple dose vial NDC 0781-3245-70 40 mg/mL, 10 mL multiple dose vial Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Avoid freezing and protect from light. Revised – October 2018 Manufactured in Canada by Avara Boucherville Pharmaceutical Services, Inc. for Sandoz Inc., Princeton, NJ 08540
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION SANDOZ INC ---------- TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL FOR INTRAMUSCULAR OR INTRA-ARTICULAR USE ONLY NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE DESCRIPTION Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRA-DERMAL INJECTION. Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with sodium chloride for isotonicity, 0.94% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4- diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: M.W. 434.50 Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed 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. Synthetic analogs such as triamcinolone are primarily used for their anti-inflammatory effects in disorders of many organ systems. Triamcinolone acetonide injectable suspension has an extended duration of effect which may be sustained over a period of several weeks. Studies indicate that following a single intramuscular dose of 60 mg to 100 mg of triamcin Perskaitykite visą dokumentą