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Oralone® may cause local adverse reactions. If
irritation develops, Oralone® should be discontinued and appropriate
therapy instituted. Allergic contact sensitization with corticosteroids is usually
diagnosed by observing failure to heal rather than noting a clinical exacerbation
as with most topical products not containing corticosteroids. Such an observation
should be corroborated with appropriate diagnostic patch testing.
If concomitant mucosal infections are present or develop,
an appropriate antifungal or antibacterial agent should be used. If a favorable
response does not occur promptly, use of Oralone® should be discontinued until
the infection has been adequately controlled. 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.
Systemic absorption of topical corticosteroids has
produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression,
manifestations of Cushing's syndrome, hyperglycemia, glucosuria, and other adverse
effects known to occur with parenterally-administered steroid preparations;
therefore, it may be advisable to periodically evaluate patients on prolonged
therapy with corticosteroid-containing dental pastes for evidence of HPA axis
suppression (see PRECAUTIONS, Laboratory Tests ). If HPA axis suppression
is noted, an attempt should be made to withdraw the drug or to reduce the
frequency of application. Recovery of HPA axis function is generally prompt and
complete upon discontinuation of therapy.
A urinary free cortisol test and ACTH stimulation test
may be helpful in evaluating HPA axis suppression.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Animal studies have not been performed to evaluate
triamcinolone acetonide for potential to induce carcinogenesis, mutagenesis, or
impairment of fertility.
Pregnancy Category C
Triamcinolone acetonide has been shown to induce
teratogenic effects in several species. In mice and rabbits, triamcinolone
acetonide induced an increased incidence of cleft palate at dosages of approximately
120 μg/kg/day and 24 μg/kg/day, respectively (approximately 12 times
and 10 times the amount in a typical daily human dose of Oralone® when compared
following normalization of the data on the basis of body surface area
estimates, respectively). In monkeys, triamcinolone acetonide induced cranial
skeletal malformations at the lowest dosage studied (500 μg/kg/day), which
was approximately 200 times the amount in a typical daily human dose of Oralone®
when compared following normalization of the data on the basis of body surface
area estimates. There are no adequate and well controlled studies in pregnant
women. However, a retrospective analysis of birth defects among children born
to mothers that used drugs of the same class as Oralone® (corticosteroids)
during pregnancy found an approximately 3 times increased incidence of cleft
palate. Oralone® should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
It is not known whether oral application of
corticosteroids could result in sufficient systemic absorption to produce
detectable quantities in breast milk. Caution should be exercised when
corticosteroid containing dental pastes are prescribed for a nursing woman.
The safety and efficacy of Oralone® in children is
unknown. Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid-induced HPA axis suppression and Cushing's Syndrome than mature
patients because of a larger skin surface area to body weight ratio.
Administration of corticosteroid-containing dental pastes to children should be
limited to the least amount compatible with an effective therapeutic regimen.
Chronic corticosteroid therapy may interfere with the growth and development of
Clinical studies of Oralone® did not include sufficient
numbers of subjects age 65 and older to determine whether they respond
differently from younger subjects. Other reported clinical experience has not
identified differences in responses between the elderly and younger patients.