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Logo CORTODERM-C OINTMENT
CORTODERM-C CREAM

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CORTODERM-C OINTMENT
CORTODERM-C CREAM

COMPOSITION:
Each 5 g contains:
  Fluocinolone acetonide 1,25 mg
  Clioquinol 150 mg
  The cream is preserved with 0,1 % m/m chlorocresol.
PHARMACOLOGICAL CLASSIFICATION:
A 13.4.1 Dermatological preparation –corticosteroids with anti-infective agents.

PHARMACOLOGICAL ACTION:
Cortoderm-C exhibits
anti-inflammatory and anti-allergic properties with antifungal and antibacterial action when applied locally to the skin.

INDICATIONS:
Steroid responsive
dermatoses accompanied by bacterial or fungal infections susceptible to clioquinol.

CONTRA-INDICATIONS:
Cortoderm-C is contra-indicated in the treatment of bacterial (including tuberculous) viral or fungal infections not susceptible to clioquinol.
Application to ulcers of the leg.
Avoid use in ulcerative skin lesions and in rosacea.
Long-term use is contra-indicated in patients with diabetes mellitus or tuberculosis.
The more potent 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 Cortoderm-C should not be used during pregnancy.
Known sensitivity to corticosteroids, clioquinol or iodine.

WARNING:
FOR EXTERNAL USE ONLY.

DOSAGE AND DIRECTIONS FOR USE:
Ointment:
Apply 2 or 3 times daily sparingly to the affected area until improvement occurs. Therapy should be discontinued when control is achieved. In the more responsive conditions this may be within a few days. If a longer course is necessary, it is recommended that treatment should not be continued for longer than four weeks without the patient’s condition being reviewed. If continuous steroid treatment is necessary, a less potent preparation should be used.

In very resistant lesions, especially where there is hyperkeratosis, the treatment area may be occluded for part of each 24 hours. Thereafter improvement can usually be maintained by application without occlusion.

Cream:
Apply to the affected areas 2 or 3 times daily by gentle inunction.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Cortoderm-C may under certain circumstances, be absorbed through the skin in sufficient amounts to produce systemic effects. Systemic absorption may cause suppression of the pituitary-adrenal axis. Even small amounts absorbed may cause growth retardation in children. As Cortoderm-C contains a high highly potent corticosteroid the risk of absorption is enhanced. Absorption (and a risk of subsequent toxicity) is also enhanced by application for prolonged periods under occlusive dressings, by application to extensive areas or when the skin is broken.
Once absorbed through the skin the pharmacokinetic pathway is similar to systemically administered corticosteroids.
Depression of the hypothalamic pituitary-adrenal-axis with consequent suppression of the adrenal gland may occur.

Topical application of Cortoderm-C should not be made with an occlusive dressing to large areas of the body because of the increased risk of systemic toxicity.
Application of corticosteroids to the skin has led to loss of skin collagen and subcutaneous atrophy; local hypopigmentation of deeply pigmented skins has been reported.

In the treatment of severe psoriasis corticosteroids may induce generalised pustular psoriasis during therapy or on withdrawal.
Other local effects include atrophy of the epidermis and dermal collagen (causing atrophic stride), drying of the skin and telangiectasiae.
Increased fragility of cutaneous vessels may result in bruising and purpura.
Rosacea-like dermatitis, perioral dermatitis and acneiform eruptions may occur. Occlusive dressings are associated with maceration of the skin and miliaria.

Special care should be exercised in infants and children.
Areas of the body most likely to suffer local damage are the face and eyelids; the intertriginous areas, the neck, axillae, etc. are more permeable. The topical application of corticosteroids to the eyes has produced corneal ulcers, raised intra-ocular pressure, and reduced visual function.
Long-term topical use is best avoided, especially in children.
Children may absorb proportionally larger amounts of corticosteroids because of a larger skin surface area to bodymass ratio, and thus be more susceptible to systemic toxicity. Tight fitting nappies or plastic pants should not be used on an infant being treated in the nappy area, as these garments may constitute occlusive dressings. Benign intracranial hypertension has been reported.

Use with care in porphyrics.
If a secondary microbial skin infection is present suitable concomitant antimicrobial therapy should be instituted. Clioquinol may give rise to iodism. It may stain clothing and linen yellow and discolour fair hair.

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

IDENTIFICATION:
A soft, smooth, off-white ointment.
A soft, smooth, off-white cream.

PRESENTATION:
Tubes of 15 g.
Jars of 500 g.

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

REGISTRATION NUMBER:
Ointment:        M/l3.4.l/3
Cream:        M/13.4.1/45

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited,
7 Fairclough Road,
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24/09/1980 K832
  Len574044 Stop Press

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