Kenalog-40 Injection (Triamcinolone Acetate) 5mL

NDC: 70121-1168-1

Triamcinolone Acetonide 40 mg/mL Injectable Suspension, 5 mL Vial — Amneal Pharmaceuticals

Active ingredients	Triamcinolone acetonide 40 mg/mL
Dosage form	Injectable suspension
Route	Intramuscular and intra-articular
Size	5 mL vial
Manufacturer	Amneal Pharmaceuticals
NDC	70121-1168-1

Indications and Usage

Injectable corticosteroid indicated for intramuscular use in allergic states and in dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory, and rheumatic disorders. Also indicated for intra-articular or soft tissue administration in acute gouty arthritis, bursitis, tenosynovitis, and osteoarthritis.

Dosage and Administration

The initial dose varies from 2.5 mg to 100 mg depending on the condition being treated. For systemic therapy, a typical dose is 60 mg injected deeply into the gluteal muscle, adjusted within a range of 40 to 80 mg based on response. Intra-articular doses generally range from 2.5 to 5 mg for smaller joints and 5 to 15 mg for larger joints.

Warnings and Precautions

• Serious neurologic events, some fatal, have been reported with epidural injection; not for epidural, intrathecal, intravenous, intradermal, or intraocular use
• Contains benzyl alcohol, which has been associated with serious toxicity in neonates
• May cause adrenal suppression and immunosuppression, increasing susceptibility to infection and masking its signs
• May cause increased intraocular pressure, elevated blood pressure, and psychiatric disturbances

Contraindications

Contraindicated in patients with known hypersensitivity to any component; intramuscular use is contraindicated in idiopathic thrombocytopenic purpura.

Adverse Reactions

Reported reactions include anaphylaxis, cardiac arrhythmias and hypertension, hyperglycemia, skin atrophy, osteoporosis and aseptic necrosis, increased intraocular pressure, psychiatric effects, and gastrointestinal perforation.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). Protect from light. Do not refrigerate or freeze. Store upright.

How Supplied

Supplied as a sterile aqueous suspension containing 40 mg per mL of triamcinolone acetonide in a 5 mL multiple-dose vial.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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