Orrepaste

Orrepaste

triamcinolone acetonide

Manufacturer:

HOE Pharma

Distributor:

Ni Lay Naing
Full Prescribing Info
Contents
Triamcinolone acetonide.
Description
Triamcinolone Acetonide 0.1% w/w with Methyl Paraben 0.2% w/w and Propyl Paraben 0.1% w/w as preservatives.
Action
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.
Indications/Uses
Adjunctive treatment and for temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.
Dosage/Direction for Use
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.
Overdosage
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 If the hypothalamic-pituitary-adrenal axis suppression is found, then the drug should be withdrawn, frequency of application reduced or a weaker steroid used.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.
Contraindications
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.
Special Precautions
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.
Use In Pregnancy & Lactation
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.
Adverse Reactions
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.
Drug Interactions
Not known.
Storage
Store below 30°C. For external use only.
Recommended shelf-life: 3 years.
ATC Classification
A01AC01 - triamcinolone ; Belongs to the class of local corticosteroid preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Oral paste 0.1% w/w (light green paste with mint flavour and odour) x 5 g.
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