Kenalog in Orabase

Kenalog in Orabase

triamcinolone acetonide

Manufacturer:

Taisho Pharmaceutical Indonesia
Full Prescribing Info
Contents
Triamcinolone acetonide.
Description
Kenalog in Orabase contains triamcinolone acetonide 0.1% in emollient paste containing bovine gelatin, pullulan and sodium carboxymethylcellulose in Plastibase, a polyethylene and mineral oil gel base.
Action
Pharmacology: Triamcinolone acetonide is a synthetic corticosteroid which possesses anti-inflammatory, antipruritic and antiallergic actions. 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/Uses
For adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.
Dosage/Direction for Use
Press a small dab (about ¼ inch) to the lesions 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 lesions with a thin film. Do not rub-in. Attempting to spread this preparation may result in a granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops. Do not rub in.
Kenalog in Orabase 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 Kenalog in Orabase 2 or 3 times a day, preferably after meals. If significant repair or regeneration has not occurred in 7 days, further investigation is advisable.
Contraindications
Patients with a history of hypersensitivity to any of the components of Kenalog in Orabase. Because it contains a corticosteroid, Kenalog in Orabase is contraindicated in the presence of fungal, viral or bacterial infections of the mouth or throat.
Warnings
Use in pregnancy: Safe use of Kenalog in Orabase during pregnancy has not been established with respect to possible adverse reactions upon fetal development; therefore, it should not be used in women of childbearing potential and particularly during early pregnancy unless, in the judgment of the physician or dentist, the potential benefits outweigh the possible hazards.
Special Precautions
Patients with tuberculosis, peptic ulcer or diabetes mellitus should not be treated with any corticosteroid preparation without the advice of the 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 Kenalog in Orabase is used as recommended makes systemic effects very unlikely; however, these are a possibility when topical corticosteroid preparations are used over a long period of time.
If local irritation or sensitization should develop, Kenalog in Orabase should be discontinued and appropriate therapy instituted. If significant regeneration or repair of oral tissues has not occurred in 7 days, additional investigation into the oral lesion is advised.
Use In Pregnancy & Lactation
Use in pregnancy: Safe use of Kenalog in Orabase during pregnancy has not been established with respect to possible adverse reactions upon fetal development; therefore, it should not be used in women of childbearing potential and particularly during early pregnancy unless, in the judgment of the physician or dentist, the potential benefits outweigh the possible hazards.
Adverse Reactions
Prolonged administration may elicit the adverse reactions known to occur with systemic steroid preparations eg, adrenal suppression, alteration of glucose metabolism, protein catabolism, peptic ulcer activations and others. These are usually reversible and disappear when the hormone is discontinued.
Storage
Store below 30°C.
Shelf-Life: 2 years.
ATC Classification
A01AC01 - triamcinolone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Emollient dental paste 0.1% x 5 g x 25's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in