Triamcinolone Acetonide

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.

CONTRAINDICATIONS Triamcinolone Acetonide Dental Paste USP, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

DESCRIPTION Triamcinolone Acetonide Dental Paste USP, 0.1% contains the corticosteroid triamcinolone acetonide in an adhesive vehicle suitable for application to oral tissues. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16,17-acetal with acetone. The structural formula of triamcinolone acetonide is as follows: Each gram of Triamcinolone Acetonide Dental Paste USP, 0.1% contains 1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base. LABEL

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.

INDICATIONS AND USAGE Triamcinolone Acetonide Dental Paste USP, 0.1% is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

CLINICAL PHARMACOLOGY Like other topical corticosteroids, triamcinoloneacetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of thetopical steroids, in general, is unclear. However, corticosteroids arethought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulatedthat these proteins control the biosynthesis of potent mediators ofinflammation such as prostaglandins and leukotrienes by inhibiting therelease of their common precursor, arachidonic acid. Arachidonic acidis released from membrane phospholipids by phospholipase A 2 .

Pharmacokinetics The extent of absorption through the oral mucosa isdetermined by multiple factors including the vehicle, the integrity ofthe mucosal barrier, the duration of therapy, and the presence ofinflammation and/or other disease processes. Once absorbed through themucous membranes, the disposition of corticosteroids is similar to thatof systemically administered corticosteroids. Corticosteroids are boundto the plasma proteins in varying degrees. Corticosteroids aremetabolized primarily in the liver and are then excreted by thekidneys; some corticosteroids and their metabolites are also excretedinto the bile.

20230301

1

Triamcinolone Acetonide Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE GELATIN, UNSPECIFIED PECTIN, CITRUS CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

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.

ANDA040771

Triamcinolone Acetonide

Triamcinolone Acetonide

68788-8386

HUMAN PRESCRIPTION DRUG

TOPICAL

Laboratory Tests A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Rising® NDC 68788-8386-5 Preferred Pharmaceuticals, Inc. Triamcinolone Acetonide Dental Paste USP, 0.1% Rx only 5g Read all sides Triamcinolone Acetonide Dental Paste USP 01%

Rx only

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.

Geriatric Use Clinical studies of Triamcinolone Acetonide Dental Paste USP, 0.1% 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.

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 prescribed for a nursing woman.

Pediatric Use The safety and efficacy of Triamcinolone Acetonide Dental Paste USP, 0.1% 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 children.

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 mcg/kg/day and 24 mcg/kg/day, respectively (approximately 12 times and 10 times the amount in a typical daily human dose of Triamcinolone Acetonide Dental Paste USP, 0.1% 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 mcg/kg/day), which was approximately 200 times the amount in a typical daily human dose of Triamcinolone Acetonide Dental Paste USP, 0.1% 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 Triamcinolone Acetonide Dental Paste USP, 0.1% (corticosteroids) during pregnancy found an approximately 3 times increased incidence of cleft palate. Triamcinolone Acetonide Dental Paste USP, 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

HOW SUPPLIED Triamcinolone Acetonide Dental Paste USP, 0.1% Tubes containing 5 g of dental paste NDC 68788-8386-5

Storage Keep tightly closed. Store at 20° - 25° C (68° - 77° F) excursion permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R6-09/21 Relabeled By: Preferred Pharmaceuticals, Inc.

PRECAUTIONS General: Triamcinolone Acetonide Dental Paste USP, 0.1% may cause local adverse reactions. If irritation develops, Triamcinolone Acetonide Dental Paste USP, 0.1% 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 Triamcinolone Acetonide Dental Paste USP, 0.1% 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 mcg/kg/day and 24 mcg/kg/day, respectively (approximately 12 times and 10 times the amount in a typical daily human dose of Triamcinolone Acetonide Dental Paste USP, 0.1% 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 mcg/kg/day), which was approximately 200 times the amount in a typical daily human dose of Triamcinolone Acetonide Dental Paste USP, 0.1% 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 Triamcinolone Acetonide Dental Paste USP, 0.1% (corticosteroids) during pregnancy found an approximately 3 times increased incidence of cleft palate. Triamcinolone Acetonide Dental Paste USP, 0.1% 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 prescribed for a nursing woman. Pediatric Use The safety and efficacy of Triamcinolone Acetonide Dental Paste USP, 0.1% 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 children. Geriatric Use Clinical studies of Triamcinolone Acetonide Dental Paste USP, 0.1% 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.