Kenalog-10 (Page 4 of 4)

Intra-Articular Administration

Dosage

The initial dose of Kenalog-10 Injection for intra-articular administration may vary from 2.5 mg to 5 mg for smaller joints and from 5 mg to 15 mg for larger joints, depending on the specific disease entity being treated. Single injections into several joints, up to a total of 20 mg or more, have been given.

Intralesional

For intralesional administration, the initial dose per injection site will vary depending on the specific disease entity and lesion being treated. The site of injection and volume of injection should be carefully considered due to the potential for cutaneous atrophy.

Multiple sites separated by one centimeter or more may be injected, keeping in mind that the greater the total volume employed the more corticosteroid becomes available for systemic absorption and systemic effects. Such injections may be repeated, if necessary, at weekly or less frequent intervals.

Localization of Doses

The lower dosages in the initial dosage range of triamcinolone acetonide may produce the desired effect when the corticosteroid is administered to provide a localized concentration. The site and volume of the injection should be carefully considered when triamcinolone acetonide is administered for this purpose.

Administration

STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, inject without delay to prevent settling in the syringe.

Injection Technique

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 Kenalog-10 Injection 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.

Intralesional

For treatment of dermal lesions, Kenalog-10 Injection should be injected directly into the lesion, ie, intradermally or subcutaneously. For accuracy of dosage measurement and ease of administration, it is preferable to employ a tuberculin syringe and a small-bore needle (23-25 gauge). Ethyl chloride spray may be used to alleviate the discomfort of the injection.

HOW SUPPLIED

Kenalog® -10 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in 5 mL multiple-dose vials (NDC 54868-0234-0) providing 10 mg triamcinolone acetonide per mL.

Storage

Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light.

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

1221154A4

Rev November 2010

Relabeling of “Additional” barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

—————————————– PRINCIPAL DISPLAY PANEL — REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available packages of KENALOG-10.

5 mL MULTIPLE DOSE
NDC 54868-0234-0
Rx only
10 mg per mL
KENALOG® -10
Triamcinolone Acetonide
Injectable Suspension, USP

image of package label
(click image for full-size original)
KENALOG-10
triamcinolone acetonide injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0234(NDC:0003-0494)
Route of Administration INTRA-ARTICULAR, INTRALESIONAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE) TRIAMCINOLONE ACETONIDE 10 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:54868-0234-0 1 VIAL, MULTI-DOSE (VIAL) in 1 CARTON contains a VIAL, MULTI-DOSE
1 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (54868-0234-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012041 05/02/2000
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 11/2010 Physicians Total Care, Inc.

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