País: Canadá
Língua: inglês
Origem: Health Canada
TRIAMCINOLONE ACETONIDE
STERIMAX INC
H02AB08
TRIAMCINOLONE
40MG
SUSPENSION
TRIAMCINOLONE ACETONIDE 40MG
INTRA-ARTICULAR
1ML/5ML
Prescription
ADRENALS
Active ingredient group (AIG) number: 0106310006; AHFS:
APPROVED
2015-09-15
_Triamcinolone Acetonide Injectable Suspension USP _ _ _ _Page 1 of 11 _ PRESCRIBING INFORMATION PR TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP 40 MG/ML STERILE CORTICOSTEROID SteriMax Inc Date of Revision: 2770 Portland Drive June 08, 2022 Oakville, ON, L6H 6R4 Canada Control Number: 261894 _Triamcinolone Acetonide Injectable Suspension USP _ _ _ _Page 2 of 11 _ PR TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION USP 40 MG/ML THERAPEUTIC CLASSIFICATION Corticosteroid NOTE: Triamcinolone Acetonide Injectable Suspension USP (triamcinolone acetonide) is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intramuscular, intra-articular, and intrabursal injection. THIS FORMULATION IS NOT SUITABLE FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL OR INTRATHECAL INJECTION. ACTION AND CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (e.g., hydrocortisone), 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 potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli. Triamcinolone Acetonide Injectable Suspension USP has an extended duration of effect which may be permanent, or sustained over a period of several weeks. Studies indicate that following a single I.M. dose of 60 to 100 mg of triamcinolone acetonide, adrenal suppression occurs within 24 to 48 hours and then gradually returns to normal, usually in 30 to 40 days. This finding correlates closely with the extended duration of therapeutic action achieved with the drug. INDICATIONS AND CLINICAL USE Intramuscular (I.M.): The I.M. administration is indicated for systemic corticosteroid therapy in such conditions as dermatoses, or generalized rheumatoid arthritis and other connective tissue disorders. It is also in Leia o documento completo