KENALOG-40 (Page 5 of 5)

SYSTEMIC

For systemic therapy, injection should be made deeply into the gluteal muscle (see WARNINGS). For adults, a minimum needle length of 1½ inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections.

LOCAL

For treatment of joints, the usual intra-articular injection technique should be followed. If an excessive amount of synovial fluid is present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of the steroid.

With intra-articular administration, prior use of a local anesthetic may often be desirable. Care should be taken with this kind of injection, particularly in the deltoid region, to avoid injecting the suspension into the tissues surrounding the site, since this may lead to tissue atrophy.

In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating the preparation into the area of greatest tenderness.

HOW SUPPLIED

Kenalog® -40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL.

40 mg/mL, 1 mL vial NDC 0003-0293-05
40 mg/mL, 5 mL vial NDC 0003-0293-20
40 mg/mL, 10 mL vial NDC 0003-0293-28

Storage

Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light. Do not refrigerate.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA
Product of Italy

1221153A5

Rev August 2011

—————————————– REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available packages of KENALOG-40.

NDC 55045-3248-04
(click image for full-size original)

NDC 55045-3248-04
Rx only
KENALOG® -40
(Triamcinolone Acetonide Injectable Suspension, USP)
200 mg per 5 mL
40 mg per mL
5 mL Multiple Dose Vial

KENALOG-40
triamcinolone acetonide injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55045-3248(NDC:0003-0293)
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
triamcinolone acetonide (TRIAMCINOLONE ACETONIDE) triamcinolone acetonide 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
benzyl alcohol
carboxymethylcellulose sodium
polysorbate 80
sodium hydroxide
hydrochloric acid
nitrogen
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55045-3248-4 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:55045-3248-1 1 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA014901 06/01/2009
Labeler — Dispensing Solutions, Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel (55045-3248), repack (55045-3248)

Revised: 09/2012 Dispensing Solutions, Inc.

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