FLUODERM® OINTMENT; FLUODERM® CREAM

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

FLUODERM® OINTMENT
FLUODERM® CREAM

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

FLUODERM^® OINTMENT
FLUODERM^® CREAM

COMPOSITION:

	Each 5 g ointment contains 1,25 mg fluocinolone acetonide.
	Each 5 g cream contains 1,25 mg fluocinolone acetonide
	Fluoderm Cream is preserved with 0,1% m/m chlorocresol.

PHARMACOLOGICAL CLASSIFICATION:
A 13.4.1 Corticosteroids with a without anti-infective agent.

PHARMACOLOGICAL ACTION:
Fluocinolone acetonide is a potent topical corticosteroid which exhibits anti-inflammatory, vasoconstrictive, anti-pruritic and anti-allergic properties when applied locally to the skin and mucosa.

INDICATIONS:
Steroid responsive dermatoses.

CONTRA-INDICATIONS:
Corticosteroids have been shown to be teratogenic in animals following dermal application. As agents are absorbed percutaneously teratogenicity following topical application cannot be excluded. Therefore Fluoderm should not be used during pregnancy. Fluoderm is contra-indicated in the treatment of herpes simplex, vaccinia or varicella. Long-term use is contra-indicated in patients with diabetes mellitus or tuberculosis. Fluoderm should not be used on infants and young children.

WARNING:
FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:

Fluoderm Ointment:	Apply to the affected areas 2 to 3 times daily by gentle inunction or use with occlusive dressings.
Fluoderm Cream:	Apply to the affected areas 2 to 3 times daily by gentle inunction.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local effects include atrophy of the epidermis and dermal collagen (causing atrophic striae), drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. Increased fragility of cutaneous vessels may result in bruising and purpura. Rosacea-like dermatitis, perioral dermatitis, hypopigmentation and acneiform eruptions may occur. These changes are particularly likely to occur on the face and when occlusive dressings are used. Occlusive dressings are associated with maceration of the skin and miliaria. Local infection may be worsened and spread enhanced.
Systemic absorption of topically applied Fluoderm may occur, particularly under the following conditions: when large quantities are used or when application is made to wide areas of the body or to damaged skin, and when the occlusive dressing technique is applied. Depression of the hypothalmic - pituitary - adrenal axis with consequent suppression of the adrenal gland may occur, and may be precipitated by an infection or trauma. These effects are most likely to be severe in children. Growth retardation in children has been reported and a Cushingoid state may be produced. Benign intracranial hypertension has been reported.

Special Precautions:
Treatment should be discontinued if unfavourable reactions are seen. Regular review should be made of the necessity for continuing therapy.
If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted. Fluoderm should not be used to treat infections and ulcers of the leg. It causes delayed wound healing and increased liability to infections. Fluoderm should not be applied to any skin crease areas. Fluoderm should be used with caution near the eyes and should be used for short courses only. Application to the eyes has produced corneal ulcers, raised intraocular pressure, and reduced visual function. The treatment of psoriasis with Fluoderm may provoke the pustular form of the disease.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See 'Side-effects and Special Precautions'. Treatment is supportive and symptomatic.

IDENTIFICATION:

Fluoderm Ointment:	A soft white translucent ointment.
Fluoderm Cream:	A smooth white cream.

PRESENTATION:
Fluoderm Ointment & Cream: 15 g Tubes and 500 g Jars.

STORAGE INSTRUCTIONS:
Store below 25°C. Store in well closed containers. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

Fluoderm Ointment:	L/13.4.1/367.
Fluoderm Cream:	M/13.4.l/58.

NAME AND BUSINESS ADDRESS OF APPLICANT:
South African Druggists Limited, 7 Fairclough Road, PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

31/07/1992

K896