KENALOG IN ORABASE

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

KENALOG IN ORABASE
PASTE

COMPOSITION:
KENALOG IN ORABASE contains 1,0mg triamcinolone acetonide per gram.

PHARMACOLOGICAL CLASSIFICATION:
Category A 13.4.1 Corticosteroids with or without anti-infective agents.

PHARMACOLOGICAL ACTION:
Triamcinolone acetonide is a glucocorticoid and has anti-inflammatory and antipruritic actions.

INDICATIONS:
Treatment of steroid responsive disorders of the oral mucosa, including inflammatory and ulcerative lesions.

CONTRA-INDICATIONS:
Patients with a history of hypersensitivity to any of its components.
Tuberculosis and viral lesions, including herpes simplex, vaccinia and varicella.
KENALOG IN ORABASE is not intended for ophthalmic use, nor should it be applied in the external auditory canal of patients with perforated eardrums.
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity, following topical application cannot be excluded. Therefore KENALOG IN ORABASE should not be used during pregnancy.

WARNINGS:
If significant regeneration or repair of oral tissue has not occurred in seven days, reassessment into the etiology of the oral lesion is advised.

DOSAGE AND DIRECTIONS FOR USE:
Coat the lesion with a thin film, preferably at bedtime. Do not rub in.
It may be necessary to apply the preparation 2 or 3 times a day, preferably after meals.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Prolonged and intensive treatment may cause atrophic changes in the skin, such loss of elasticity, thinning, dilation of superficial blood vessels, telangiectasis, ecchymosis and purpura particularly when occlusive dressings are used. The possibility of systemic absorption of the steroid and complications of steroid therapy cannot be excluded, especially growth retardation in children, suppression of pituitary-adrenal function, increased susceptibility to infection, hypoglycaemia, Cushingoid state and benign intracranial hypertension.
Prolonged use may result in overgrowth of organisms. Should infection occur, suitable antimicrobial therapy must be administered and KENALOG IN ORABASE discontinued.
KENALOG IN ORABASE should be used for short courses only.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment of overdosage should be symptomatic and supportive.

IDENTIFICATION:
Smooth, white to tan-coloured ointment with a faint mineral oil type odour. Mucilage-like almost bland taste.

PRESENTATION:
Tubes of 5g.

STORAGE INSTRUCTIONS:
Store at room temperature not exceeding 25°C.
Avoid excessive heat. Keep tightly closed.
KEEP OUT OF REACH OF CHILDREN

REFERENCE NUMBER:
G 1595 (Act 101 of 1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
BRISTOL-MYERS SQUIBB (PTY) LTD*
47 Van Buuren Road,
Bedfordview, 2008.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1994

* Authorised user of the TM KENALOG and ORABASE

96P11 SK135/1

Updated on this site: November 2000
Current: June 2005
Source: Pharmaceutical Industry