displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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:
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.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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 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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Triamcinolone acetonide injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see
Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
alphabetically under each subsection)
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
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
200 mg 5 mL Label
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
200 mg/5 mL (40 mg/mL)
For Intramuscular Use
5 mL Multidose Vial