ARISTOCORT

Triamcinolone Acetonide BP 0.1%

Cream/Ointment

Description:

Aristocort contains highly active steroid. Triamcinolone Acetonide (a derivative of Triamcinolone) in a compatible base.

Composition:

Aristocort Cream: Each gram cream contains Triamcinolone Acetonide BP 1 mg.

Aristocort Ointment: Each gram ointment contains Triamcinolone Acetonide BP 1 mg.

Action:

Topical steroids are primarily effective because of their anti-inflammatory, antipruritic & vasoconstrictive actions.

Indications:

Severe inflammatory skin disorders such as eczemas unresponsive to less potent corticosteroids; psoriasis & recalcitrant dermatoses such as chronic discoid lupus, erythematosus, lichen simplex chronicus, hypertrophic lichen planus & palmoplantar pustulosis.

Contraindications:

Untreated bacterial, fungal, or viral skin lesions, rosacae (acne rosacae), perioral dermatitis; not recommended for acne vulgaris. Also contraindicated in infants under one (1) year.

Moreover, Aristocort is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions:

Avoid prolonged use in infants and children. Avoid prolonged use on the face. Do not use in or around the eye. If irritation develops, the product should be discontinued and appropriate therapy instituted.

Use in Psoriasis:

Aristocort should be avoided or given only under specialist supervision in psoriasis because although it may suppress the psoriasis in short term, relapse or vigorous rebound occurs on withdrawal.

Pregnancy & Lactation:

The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effect from topically active corticosteroid. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Also caution should be exercised when topical corticosteroids are administered to a nursing woman.

Adverse Reactions:

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressing: burning, itching, irritation, hypertrichosis, acneiform eruptions, hypopigmentation, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria etc.

Administration:

Apply thinly to the affected areas 2-4 times daily or as directed by the physician.

Cautions:

·        Do not stop use of Aristocort except on medical advice

·        To be dispensed only on a prescription of a registered physician

·        For external use only

Storage:

§         Store in a cool and dry place (below 25º C). Protected from light.

§         The tube should be tightly closed.

§         Do not fuse.

§         Keep out of the reach of the children.

Packing:

Aristocort Cream: Tube containing 10 g cream.

Aristocort Ointment: Tube containing 10 g ointment.