Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
triamcinolone acetonide (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Dispensing Solutions, Inc.
triamcinolone acetonide
triamcinolone acetonide 10 mg in 1 mL
INTRA-ARTICULAR
PRESCRIPTION DRUG
The intra-articular or soft tissue administration of Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) 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, or osteoarthritis. The intralesional administration of Kenalog-10 Injection 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. Kenalog-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). Kenalog-10 Injection is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: General ). Intramuscular corticosteroid preparations are contraind
Kenalog® -10 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in 5 mL multiple-dose vials (NDC 0003-0494-20) providing 10 mg triamcinolone acetonide per mL. Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light. Do not refrigerate.
New Drug Application
KENALOG-10- TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION DISPENSING SOLUTIONS, INC. ---------- KENALOG -10 INJECTION (TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP) NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL FOR INTRA-ARTICULAR OR INTRALESIONAL USE ONLY NOT FOR INTRAVENOUS, INTRAMUSCULAR, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE DESCRIPTION Kenalog -10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY. Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with 0.65% sodium chloride for isotonicity, 0.9% (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: MW 4 34 .50 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. ® ® INDICATIONS AND USAGE THE INTRA-ARTICULAR OR SOFT TISSUE ADMINISTRATION of Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) Izlasiet visu dokumentu