Contains Triamcinolone Acetonide 0.1% w/w.
Excipients/Inactive Ingredients: Other ingredients are Briliant Blue, Quinoline Yellow, Propylparaben, Methylparaben, Peppermint Oil, Sodium Polyacrylate, Pectin, Propylene Glycol, Sorbitol 70% Solution, Sodium Carboxymethylcellulose and Purified Water.
Pharmacology: Pharmacodynamics: Triamcinolone Acetonide is a synthetic corticosteroid which possesses anti-inflammatory, antipruritic and anti-allergic action. The emollient dental paste acts as an adhesive vehicle for applying the active medication to the oral tissues. The vehicle provides a protective covering which may serve to temporarily reduce the pain associated with oral irritation.
Pharmacokinetics: When administered topically, particularly under occlusive dressings or when the skin is broken, sufficient corticosteroid may be absorbed to give systemic effects. Corticosteroids are extensively bound to plasma proteins. Only unbound corticosteroid has pharmacological effects or is metabolized. They are metabolized mainly in the liver, also in the kidney, and are excreted in the urine.
Adjunctive treatment and for temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.
RECOMMENDED DOSAGE: Apply a small dab (about ¼ inch) to the lesion at bedtime. Depending on the severity of symptoms, it may be necessary to apply twice to three times daily.
ROUTE OF ADMINISTRATION: Oral.
SYMPTOMS AND TREATMENT FOR OVERDOSE AND ANTIDOTE(S): Corticosteroid applied to the skin can be absorbed in sufficient amount to produce systemic effect such as hypothalamic-pituitary-adrenal axis suppression, manifestation of Cushing's syndrome, hyperglycaemia and glycosuria. Tests which may be helpful in evaluating hypothalamic-pituitary-adrenal axis suppression include urinary free cortisol test and ACTH stimulation test. If the hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or a weaker steroid used. Supplemental systemic corticosteroid may be required if signs and symptoms of steroid withdrawal occur.
This preparation is contraindicated in patients with a history of hypersensitivity to any of its components and propylene glycol. Because it contains a corticosteroid, the preparation is contraindicated in the presence of fungal, viral or bacterial infections of the mouth or throat.
When applied topically, particularly to large areas, when the skin is broken, or under occlusive dressings, corticosteroid may be absorbed in sufficient amounts to cause systemic effects. Discontinue use if local reactions develop. Review treatment in 7 days is required if significant regeneration or repair of oral tissues has not occurred. Normal body responses decreased in patients receiving topical corticosteroid therapy. Patients with TB, peptic ulcer or diabetes mellitus should not be treated with any corticosteroid preparation without the advice of the patient's physician. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patients should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Safety of its use during pregnancy and lactation has not been established. Thus it should be used only if the potential benefit justifies the potential risk to the foetus or nursing infant.
Prolonged administration may elicit the adverse reactions known to occur with systemic steroid preparations; for example, adrenal suppression, alteration of glucose metabolism, protein catabolism, peptic ulcer activation, and others. These are usually reversible and disappear when the hormone is discontinued. Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
A01AC01 - triamcinolone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
Orrepaste dental paste 0.1 % w/w
5 g x 1's
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