PRESENTATIONKenalog in Orabase is a

PRESENTATION
Kenalog in Orabase is an opaque, light brown oral paste containing
0.1% triamcinolone acetonide.
INDICATIONS
Kenalog in Orabase (triamcinolone acetonide dental paste USP) is indicated for
adjunctive treatment and for the temporary relief of symptoms associated with oral
inflammatory lesions and ulcerative lesions resulting from trauma.
DOSAGE AND ADMINISTRATION
Press a small dab (about 6 mm) 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 a 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.
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. It should not be used in herpetic lesions of known viral origin such as Herpes
labialis or intraoral lesions such as primary herpetic gingival stomatitis and
herpanginas.
WARNINGS AND PRECAUTIONS
Use in Pregnancy:
Safe use of this preparation during pregnancy has not been established with respect
to possible adverse reactions upon foetal development; therefore it should not be
used in women of child-bearing potential and particularly during early pregnancy KENALOG in ORABASE – NEW ZEALAND DATA SHEET Page 2 of 3
unless in the judgement of the physician or dentist the potential benefits outweigh
the possible hazards.
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
micro-organisms 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 and any unusual
symptoms such as weakness or dizziness should be called to the physician’s
attention by the patient.
If local irritation or sensitisation 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 aetiology of the oral lesion is advised.
ADVERSE EFFECTS
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.
FURTHER INFORMATION
Actions
Kenalog in Orabase (triamcinolone acetonide) is a synthetic corticosteroid which
possess anti-inflammatory antipruritic, and anti-allergic action which may provide
prompt relief of oral tenderness, pain, inflammation and ulceration. The emollient
dental paste is an adhesive vehicle for applying medication to the oral surfaces. This
adhesive maintains the medication in close contact with the lesion and provides a
protective covering which augments the effects of the steroid.
Other
Excipients include gelatin, pectin and carmellose sodium in Plastibase® (Plastibase
hydrocarbon gel - a polyethylene and mineral oil gel base).
PHARMACEUTICAL PRECAUTIONS
Shelf life
24 months. Store below 25o
C. Keep tube tightly closed.KENALOG in ORABASE – NEW ZEALAND DATA SHEET Page 3 of 3
PACKAGE QUANTITIES
0.1% ointment: 5 g tube.
Packs of 1.
MEDICINE SCHEDULE
Prescription Medicine
(≤ 5 g Restricted Medicine)