ORACORT Paste (2020)

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1. Name of the medicinal product

Oracort.

2. Qualitative and quantitative composition

Triamcinolone Acetonide Topical Paste, 0.1%. <u>Excipients:</u> Mineral oil, fine gelatin powder, pectin, sodium carboxymethylcellulose, polyethylene. Oracort (triamcinolone acetonide topical paste, 0.1%), ...

3. Pharmaceutical form

Topical paste.

4.1. Therapeutic indications

Oracort (triamcinolone acetonide topical paste, 0.1%) is indicated for adjunctive treatment and the temporary relief of symptoms associated with oral inflammatory and ulcerative lesions.

4.2. Posology and method of administration

Press a small dab 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 ...

4.3. Contraindications

Oracort is contraindicated in those patients with a history of hypersensitivity to the active substance or to any of the excipients; it is also contraindicated in the presence of fungal, viral, or bacterial ...

4.4. Special warnings and precautions for use

General Oracort may cause local adverse reactions. If irritation develops, Oracort should be discontinued and appropriate therapy instituted. Allergic contact sensitization with corticosteroids is usually ...

4.6. Pregnancy and lactation

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 ...

4.8. Undesirable effects

The following local adverse reactions may occur with corticosteroidcontaining dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, ...

5.1. Pharmacodynamic properties

Like other topical corticosteroids, triamcinolone acetonide has antiinflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, ...

5.2. Pharmacokinetic properties

The extent of absorption through the oral mucosa is determined by multiple factors including the vehicle, the integrity of the mucosal barrier, the duration of therapy, and the presence of inflammation ...

5.3. Preclinical safety data

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 ...

6.3. Shelf life

The expiry date of the products is printed on the package materials. Shelf-life after first opening: 3 months.

6.4. Special precautions for storage

Store below 25°.

6.5. Nature and contents of container

Oracort (triamcinolone acetonide topical paste, 0.1%) is supplied in tubes containing 5 g of dental paste. Light, beige, odorless paste with fine gritty texture, having no lumps.

7. Marketing authorization holder

Taro International Ltd., 14 Hakitor St., Haifa Bay 2624761, Israel

8. Marketing authorization number(s)

Oracort 016-08-24803-21

10. Date of revision of the text

December 2020