DESCRIPTION
id: 648f10e3-4284-1ac9-e053-2991aa0a54e2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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.
CLINICAL PHARMACOLOGY
id: 648f10e3-4285-1ac9-e053-2991aa0a54e2
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Like other topical corticosteroids, triamcinolone
acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the
topical steroids, in general, is unclear. However, corticosteroids are
thought to act by the induction of phospholipase A
2
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the biosynthesis of potent mediators of
inflammation such as prostaglandins and leukotrienes by inhibiting the
release of their common precursor, arachidonic acid. Arachidonic acid
is released from membrane phospholipids by phospholipase A
2.
INDICATIONS AND USAGE
id: 648f10e3-4287-1ac9-e053-2991aa0a54e2
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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.
CONTRAINDICATIONS
id: 648f10e3-4288-1ac9-e053-2991aa0a54e2
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
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.
PRECAUTIONS
id: 648f10e3-4289-1ac9-e053-2991aa0a54e2
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
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.
ADVERSE REACTIONS
id: 648f10e3-4291-1ac9-e053-2991aa0a54e2
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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.
DOSAGE AND ADMINISTRATION
id: 648f10e3-4292-1ac9-e053-2991aa0a54e2
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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.
HOW SUPPLIED
id: 648f10e3-4293-1ac9-e053-2991aa0a54e2
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Triamcinolone Acetonide Dental Paste USP, 0.1%
Tubes containing 5 g of dental paste
NDC 42291-840-05
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:
AvKARE, Inc.
Pulaski, TN 38478
Manufactured by:
Lyne Laboratories, Inc.
Brockton, MA 02301
RO-04/12
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
id: 648f10e3-4296-1ac9-e053-2991aa0a54e2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
AvKARE NDC 42291-840-05
Triamcinolone Acetonide
Dental Paste USP, 0.1%
5g Rx Only
Read all sides
5g
Triamcinolone
Acetonide
Dental Paste
USP, 0.1%
EACH GRAM CONTAINS: 1mg triamcinolone acetonide (0.1%) in an emolient dental paste composed of gelatin, pectin and carboxymethylcellulose sodium in a plasticized hydrocarbon gel (a polyethylene and mineral oil gel base).
FOR TOPICAL USE IN ADJUNCTIVE TREATMENT OF ORAL LESIONS.
USUAL DOSAGE: Apply a thin film to affected area, preferably at bedtime, See Insert.
KEEP TIGHTLY CLOSED.
Store at 20o-25oC (68o-77oF) excursions permitted to 15o-30oC (59o-86oF) [See USP Controlled Room Temperature]. For lot number and expiry date see flap of carton or crimp of tube.
AvKARE NDC 42291-840-05
Triamcinolone Acetonide
Dental Paste USP, 0.1%
5g Rx Only
Read all sides
Manufactured by:
Lyne Laboratories, Inc.,
Brockton, MA 02301
Distributed by:
AvKARE, Inc.,
Pulaski, TN 38478
3 42291 84005 8
R1 – 10/16
