Oralone Triamcinolone Acetonide 1 mg/g Paste — NDC 51672-1335-5 (Billing 51672-1335-05)

ADVERSE REACTIONS The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption.

PRECAUTIONS General 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. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician or dentist.

It is for oral use only; it is not intended for ophthalmic or dermatological use. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. Patients should report any signs of adverse reactions.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician or dentist. Laboratory Tests 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 Teratogenic effects 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. Nursing Mothers 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 prescrib… [Excerpted — this section continues on DailyMed.]