TRIAMCINOLONE ACETONIDE- triamcinolone acetonide injection, suspension

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Sandoz Inc

INN (Международно Name):

TRIAMCINOLONE ACETONIDE

Композиция:

TRIAMCINOLONE ACETONIDE 40 mg in 1 mL

Начин на приложение:

INTRA-ARTICULAR

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in

Каталог на резюме:

Triamcinolone acetonide injectable suspension, USP in vials providing 40 mg triamcinolone acetonide per mL, are supplied as follows: NDC 0781-3245-72 40 mg/mL, 1 mL vial NDC 0781-3245-75 40 mg/mL, 5 mL multiple dose vial NDC 0781-3245-70 40 mg/mL, 10 mL multiple dose vial Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Avoid freezing and protect from light. Revised – October 2018 Manufactured in Canada by Avara Boucherville Pharmaceutical Services, Inc. for Sandoz Inc., Princeton, NJ 08540

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

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 INTRAMUSCULAR OR INTRA-ARTICULAR USE ONLY
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR
INTRATHECAL
USE
DESCRIPTION
Triamcinolone acetonide injectable suspension, USP is a synthetic
glucocorticoid corticosteroid with
anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR
INTRAMUSCULAR AND
INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRA-DERMAL
INJECTION.
Each mL of the sterile aqueous suspension provides 40 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. 434.50
Triamcinolone acetonide occurs as a white to cream-colored,
crystalline powder having not more than a
slight odor and is practically insoluble in water and very soluble in
alcohol.
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.
Triamcinolone acetonide injectable suspension has an extended duration
of effect which may be
sustained over a period of several weeks. Studies indicate that
following a single intramuscular dose of
60 mg to 100 mg of triamcin