Product Elements:
Triamcinolone acetonide triamcinolone acetonide triamcinolone acetonide triamcinolone acetonide gelatin pectin, citrus carboxymethylcellulose sodium
Indications and Usage:
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.
Dosage and Administration:
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.
Contraindications:
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.
Adverse Reactions:
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.
Use in Pregnancy:
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 a
Read more...mong 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.
Pediatric Use:
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:
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.
Description:
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
Clinical Pharmacology:
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:
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.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
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.
How Supplied:
How supplied triamcinolone acetonide dental paste usp, 0.1% tubes containing 5 g of dental paste ndc 64980-320-05
Information for Patients:
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.
Package Label Principal Display Panel:
Rising® ndc 64980-320-05 triamcinolone acetonide dental paste usp, 0.1% rx only 5g read all sides traimcinolone-paste