KENALOG-10- triamcinolone acetonide injection, suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

triamcinolone acetonide (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Dostępny od:

Dispensing Solutions, Inc.

INN (International Nazwa):

triamcinolone acetonide

Skład:

triamcinolone acetonide 10 mg in 1 mL

Droga podania:

INTRA-ARTICULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

KENALOG-10- TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION
DISPENSING SOLUTIONS, INC.
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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.
®
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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)