TRIAMCINOLONE ACETONIDE- triamcinolone acetonide injection, suspension

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Sandoz Inc

Administracija rute:

INTRA-ARTICULAR

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

The intra-articular or soft tissue administration of 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 of osteoarthritis. The intralesional administration of triamcinolone acetonide injectable suspension, USP 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. Triamcinolone acetonide injectable suspension, USP may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). Triamcinolone acetonide injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: Genera

Proizvod sažetak:

Triamcinolone acetonide injectable suspension, USP in multiple dose vials provides 10 mg triamcinolone acetonide per mL, and is supplied as follows: NDC 0781-3243-75 10 mg/mL, 5 mL multiple dose vial Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Avoid freezing and protect from light. XXXXXX Revised – September 2018 Manufactured in Canada by Avara Boucherville Pharmaceutical Services, Inc. for Sandoz Inc., Princeton, NJ 08540

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE INJECTION, SUSPENSION
SANDOZ INC
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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
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 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. 4 34 .5
M.W. 434.5
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 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 nonspec