国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TRIAMCINOLONE HEXACETONIDE (UNII: I7GT1U99Y9) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Sandoz Inc
TRIAMCINOLONE HEXACETONIDE
TRIAMCINOLONE HEXACETONIDE 5 mg in 1 mL
INTRALESIONAL
PRESCRIPTION DRUG
The intralesional administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL 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. Aristospan may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). Aristospan is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
Aristospan® (triamcinolone hexacetonide injectable suspension, USP), 5 mg/mL is available as follows: NDC 0781-3084-75 5 mL fill in a 10 mL vial Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from light. DO NOT FREEZE. 04-2014M U 100XXXX Manufactured in Canada by Sandoz Canada Inc. for Sandoz Inc., Princeton, NJ 08540
New Drug Application
ARISTOSPAN- TRIAMCINOLONE HEXACETONIDE INJECTION, SUSPENSION SANDOZ INC ---------- ARIS TOS PAN® (TRIAMCINOLONE HEXACETONIDE INJECTABLE SUSPENSION, USP) 5 MG/ML PARENTERAL NOT FOR USE IN NEWBORNS FOR INTRALESIONAL ADMINISTRATION NOT FOR INTRAVENOUS USE DESCRIPTION A sterile suspension containing 5 mg/mL of micronized triamcinolone hexacetonide in the following inactive ingredients: Polysorbate 80 0.20% w/v Sorbitol Solution USP 50.00% w/v Water for Injection qs ad 100.00% V Hydrochloric Acid and Sodium Hydroxide, if required, to adjust pH to 4.0-8.0 Benzyl Alcohol 0.90% w/v Chemically triamcinolone hexacetonide USP is 9α-Fluoro-11β,16α, 17,21-tetrahydroxypregna-1,4- diene-3,20-dione cyclic 16,17-acetal with acetone 21-(3,3-dimethylbutyrate). The molecular weight is 532.65. The structural formula is: The hexacetonide ester of the glucocorticoid triamcinolone is relatively insoluble (0.0002% at 25°C in water). CLINICAL PHARMACOLOGY Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Preservative: 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. When injected intralesionally or sublesionally, triamcinolone hexacetonide can be expected to be absorbed slowly from the injection site. INDICATIONS AND USAGE The intralesional administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL 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. Aristospan may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). CONTRAINDICATIONS Arist 阅读完整的文件