Label: TRIAMCINOLONE ACETONIDE injection, suspension
- NDC Code(s): 0143-9387-01, 0143-9387-25
- Packager: Hikma Pharmaceuticals USA Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 29, 2025
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONNOT FOR USE IN NEONATES - CONTAINS BENZYL ALCOHOL - For Intramuscular or Intra-articular Use Only - NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR INTRATHECAL USE
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DESCRIPTION
Triamcinolone Acetonide Injectable Suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR ...
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CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and ...
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INDICATIONS AND USAGE
Intramuscular - Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as ...
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CONTRAINDICATIONS
Triamcinolone acetonide injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: General). Intramuscular corticosteroid ...
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WARNINGS
Serious Neurologic Adverse Reactions - with Epidural Administration - Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see ...
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PRECAUTIONS
General - This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial. The lowest ...
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ADVERSE REACTIONS
(listed alphabetically under each subsection) The following adverse reactions may be associated with corticosteroid therapy: Allergic reactions: Anaphylaxis including death, and ...
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OVERDOSAGE
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 ...
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DOSAGE AND ADMINISTRATION
General - NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS). The initial dose of triamcinolone acetonide injectable suspension may vary from 2.5 mg to 100 mg per day depending on the specific ...
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HOW SUPPLIED
Triamcinolone Acetonide Injectable Suspension, USP is supplied in vials providing 40 mg triamcinolone acetonide per mL and packaged in a carton containing 25 vials. NDC 0143-9387-01: 40 mg/mL, 1 ...
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PRINCIPAL DISPLAY PANEL - 1 mL
NDC 0143-9387-01 Rx only - Triamcinolone Acetonide Injectable Suspension, USP - 40 mg per mL - For Intramuscular or Intra-articular Use ONLY - 1 mL Single-Dose Vial - NDC 0143-9387-25 Rx ...
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INGREDIENTS AND APPEARANCEProduct Information