1. Name Of The Medicinal Product
Daktacort™ Cream
Daktacort™ Ointment
2. Qualitative And Quantitative Composition
Miconazole nitrate 2% w/w and hydrocortisone 1% w/w.
3. Pharmaceutical Form
Cream: White, homogenous cream.
Ointment: White, odourless, fatty ointment.
4. Clinical Particulars
4.1 Therapeutic Indications
For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema.
Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne.
Intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis.
Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.
The properties of Daktacort indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with Daktarin™ Cream or Daktarin™ Powder.
4.2 Posology And Method Of Administration
For topical administration.
Cream:
Apply the cream two or three times a day to the affected area, rubbing in gently until the cream has been absorbed by the skin.
Ointment:
Daktacort Ointment should be applied topically two or three times daily.
The same dosage applies to both adults and children.
Use in elderly:
Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time.
In infants, long term continuous topical corticosteroid therapy should be avoided.
If after about 7 days' application, no improvement has occurred, cultural isolation of the offending organism should be followed by appropriate local or systemic antimicrobial therapy.
4.3 Contraindications
True hypersensitivity to any of the ingredients. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria.
4.4 Special Warnings And Precautions For Use
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.
In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
In animals, miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses and administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of these findings to humans has not been established. However, combinations of topical steroids with imidazoles should be used in pregnant women only if the practitioner considers it to be necessary.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Rarely, local sensitivity may occur requiring discontinuation of treatment.
4.9 Overdose
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Miconazole nitrate is a potent broad-spectrum antifungal and antibacterial agent with marked activity against dermatophytes, pathogenic yeasts (eg Candida spp) and many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus.
Hydrocortisone is a widely used topical anti-inflammatory of value in the treatment of inflammatory skin conditions including atrophic and infantile eczema, contact sensitivity reactions and intertrigo.
5.2 Pharmacokinetic Properties
Following topical administration of 100 mg miconazole nitrate cream, plasma concentrations of 0.01 µg/ml were never exceeded. Allowing for a 100 fold increase due to the occlusive effects of the ointment base, if the whole of a 30 g tube (containing 600 mg miconazole) was applied at once, maximum plasma levels would be of the order of 6 µg/ml. This would correspond approximately to an iv dose of 5 mg/kg.
Similar plasma levels are achieved in rabbits after an oral dose of 40 mg/kg and in rats and rabbits after an intravenous dose of 20 mg/kg (extrapolated value).
Reproduction studies showed that there were no effects at these doses.
5.3 Preclinical Safety Data
Not applicable.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cream:
PEG-6, PEG-32 and glycol stearate
Polyoxyethylene glycol glycerides
Mineral oil
Benzoic acid
Disodium edetate
Butylated hydroxyanisole
Purified water
Ointment:
Polyethylene 5.5% liquid paraffin gel
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Cream: Store in a refrigerator (2-8°C).
Ointment: Store at or below 25°C.
6.5 Nature And Contents Of Container
Aluminium tube with polypropylene cap.
Cream: Each tube contains 30 g cream.
Ointment: Each tube contains 30 g ointment.
6.6 Special Precautions For Disposal And Other Handling
None.
Administrative Data
7. Marketing Authorisation Holder
Janssen-Cilag Ltd
Saunderton
High Wycombe
Buckinghamshire
HP14 4HJ
8. Marketing Authorisation Number(S)
Cream: 0242/0042
Ointment: 0242/0130
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation:
Cream: 04/02/77
Ointment: 05/03/87
Renewal of Authorisation:
Cream: 16/04/97
Ointment: 28/02/97
10. Date Of Revision Of The Text
Cream: Not applicable.
Ointment: April 1998.
Legal category POM.
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