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

Logo DAKTACORT®

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME
(and dosage form)

DAKTACORT®
cream

COMPOSITION
Miconazole nitrate 20 mg/g and hydrocortisone 10 mg/g.
Benzoic acid 0,2% m/m as a preservative.

PHARMACOLOGICAL CLASSIFICATION
A. 13.4.1 Dermatological preparations. Corticosteroids with or without anti-infective agents.

PHARMACOLOGICAL ACTION
Pharmacodynamics
Miconazole has a broad antifungal spectrum and possesses some antibacterial activity against gram-positive organisms.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
Hydrocortisone is a low potency corticosteroid which on topical application has an effect on inflammatory, allergic and pruritic skin conditions.
Pharmacokinetics
Miconazole does not produce detectable blood levels after topical application.
Depending on the location and type of infection, hydrocortisone penetrates well into the skin and is partially absorbed. More than 90% of the absorbed fraction is bound to plasma proteins. The metabolism takes place in the liver and tissues and the metabolites are excreted with the urine, mostly as glucuronides, together with a very small fraction of unchanged hydrocortisone.

INDICATIONS
Daktacort cream is indicated for the treatment of steroid responsive dermatoses with fungal and bacterial superinfection, eg. inflammatory, allergic and pruritic conditions.
Once the inflammatory symptoms have cleared up, treatment may be continued, where necessary, with Daktarin (miconazole nitrate) cream.

CONTRA-INDICATIONS
Topical corticosteroid preparations are contra-indicated in the treatment of tuberculous skin affections, herpes simplex, vaccinia or varicella.
Daktacort is contra-indicated in those patients who have shown hypersensitivity to miconazole, hydrocortisone or any other ingredient of Daktacort cream.
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 Daktacort cream should not be used during pregnancy.

DOSAGE AND DIRECTIONS FOR USE
For external use only
Apply once or twice daily by rubbing the cream gently into the affected area so that it is completely absorbed by the skin. Treatment should continue until all signs of the lesion have disappeared – usually after 2 to 5 weeks. (As a precautionary measure application should continue depending on severity of infection for 14 days after the lesion has disappeared to avoid relapse).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Daktacort cream is well tolerated. Daktacort cream does not stain the skin. Occasional burning and itching due to miconazole have been reported. Long-term continuous treatment with topical corticosteroid should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasia and ecchymoses. These changes are particularly likely to occur on the face and when occlusive dressings are used.
Systemic absorption of topically applied corticosteroids 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; when potent topical corticosteroids are used; and when the occlusive dressing technique is applied. Therefore caution is recommended during the lactation period.
Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe in children as adrenal suppression can occur even without occlusion. Growth may be retarded and a Cushingoid state may be produced. Benign intra-cranial hypertension has been rarely reported. A steroid rosacea-like facies may be produced.
There have been isolated reports of irritation associated with the application of Daktacort cream. As with all substances applied to the skin, and allergic reaction to any of the ingredients of the cream may occur. If a reaction suggesting sensitivity should occur, the treatment should be discontinued.
The following special precautions are recommended: If a secondary microbial skin infection is present suitable concomitant anti-microbial therapy should be instituted.
Topical corticosteroids should be used with particular caution in facial dermatoses, and only for short periods.
Topical corticosteroid preparations should be used with caution near the eyes.
As with any topical corticosteroid, care is advised with infants and children when Daktacort is to be applied to extensive surface areas or under occlusive dressings including baby napkins. Similarly application to the face should be avoided. Daktacort can damage certain synthetic materials. Therefore it is recommended to wear cotton underwear if this clothing comes into contact with the affected skin.
Drug interaction:
Systemic absorption of miconazole, although low after topical administration, may potentiate the activity of warfarin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Ingestion of the amounts of the components contained in a tube of cream are unlikely to produce overdosage and toxic effects, however if accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.
Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.

IDENTIFICATION
White, homogeneous, odourless cream.

PRESENTATION
Daktacort cream is supplied in a tube containing 20 g of the cream.

STORAGE DIRECTIONS
Store in a refrigerator (2-8°C). Keep out of reach of children.

REGISTRATION NUMBER
M/13.4.1/173

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 1980/011122/07)
15th ROAD,
HALFWAY HOUSE
1685
© Janssen Pharmaceutica

DATE OF PUBLICATION OF THIS PACKAGE INSERT
28 February 1990
                Code No: 023925
                        2000H
                Britepak

® Trademark
Updated on this site: January 2001
Current: September 2004
Source: Community Pharmacy

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