ARISTOSPAN- triamcinolone hexacetonide injection, suspension

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

TRIAMCINOLONE HEXACETONIDE (UNII: I7GT1U99Y9) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Mevcut itibaren:

Sandoz Inc

INN (International Adı):

TRIAMCINOLONE HEXACETONIDE

Kompozisyon:

TRIAMCINOLONE HEXACETONIDE 5 mg in 1 mL

Uygulama yolu:

INTRALESIONAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

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

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

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