Tuesday, September 11, 2012

Kenalog Orabase




Generic Name: triamcinolone acetonide

Dosage Form: Dental Paste USP

Kenalog Orabase Description


Each gram of Kenalog in Orabase provides 1 mg (0.1%) triamcinolone acetonide in emollient dental paste containing gelatin, pectin, and carboboxymethylcellulose sodium in Plastibase® (Plasticized Hydrocarbon Gel), a polyethylene and mineral oil gel base.



ACTIONS


Kenalog (Triamcinolone Acetonide) is a synthetic corticosteroid which possesses anti-inflammatory, antipruritic, and antiallergic action. The emollient dental paste acts as an adhesive vehicle for applying the active medication to the oral tissues. The vehicle provides a protective covering which may serve to temporarily reduce the pain associated with oral irritation.



INDICATIONS


Kenalog in Orabase is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.



Contraindications


This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.


Because it contains a corticosteroid, the preparation is contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.



Warning



Usage in Pregnancy


Safe use of this preparation during pregnancy has not been established with respect to possible adverse reactions upon fetal development; therefore, it should not be used in women of child-bearing potential and particularly during early pregnancy unless, in the judgement of the physician or dentist, the potential benefits outweigh the possible hazards.



Precautions


Patients with tuberculosis, peptic ulcer or diabetes mellitus should not be treated with any corticosteroid preparation without the advice of the patient’s physician.


It should be borne in mind that the normal defensive responses of the oral tissues are depressed in patients receiving topical corticosteroid therapy. Virulent strains of oral microorganisms may multiply without producing the usual warning symptoms of oral infections.


The small amount of steroid released when the preparation is used as recommended makes systemic effects very unlikely; however, they are a possibility when topical corticosteroid preparations are used over a long period of time.


If local irritation or sensitization should develop, the preparation should be discontinued and appropriate therapy instituted.


If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.



Adverse Reactions


Prolonged administration may elicit the adverse reactions known to occur with systemic steroid preparations; for example, adrenal suppression, alteration of glucose metabolism, protein catabolism, peptic ulcer activations, and others. These are usually reversible and disappear when the hormone is discontinued.



Kenalog Orabase Dosage and Administration


Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops.


The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.



How is Kenalog Orabase Supplied


Kenalog® in Orabase® (Triamcinolone Acetonide Dental Paste USP) is available in 5 g tubes (NDC 0003-0496-20).



APOTHECON®

A Bristol-Myers Squibb Company

Princeton, NJ 08540 USA


J2-482G

Revised May 1994








KENALOG 
triamcinolone acetonide  paste, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0003-0496
Route of AdministrationDENTALDEA Schedule    




















INGREDIENTS
Name (Active Moiety)TypeStrength
triamcinolone acetonide (triamcinolone)Active1 MILLIGRAM  In 1 GRAM
gelatinInactive 
pectinInactive 
carboboxymethylcellulose sodiumInactive 
plasticized hydrocarbon gelInactive 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10003-0496-205 g (GRAM) In 1 TUBENone

Revised: 06/2006APOTHECON

More Kenalog Orabase resources


  • Kenalog Orabase Use in Pregnancy & Breastfeeding
  • Kenalog Orabase Drug Interactions
  • Kenalog Orabase Support Group
  • 22 Reviews for Kenalog Orabase - Add your own review/rating


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