Daktarin Cream

/ Janssen

Route of administration: Cutaneous use.
Recommended dosage:
For all ages: Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully
penetrated. The duration of therapy varies from 2 to 6 weeks depending on the
localisation and the severity of the lesion. Treatment should be continued at
least one week after disappearance of all signs and symptoms.

Broad spectrum antimycotic.

Hypersensitivity to the active substances, other imidazole derivatives or to any
of the excipients.

Daktarin Cream must not come into contact with the mucosa of the eyes.
Severe hypersensitivity reactions, including anaphylaxis and angioedema,
have been reported during treatment with Daktarin Cream and with other
miconazole topical formulations (see Adverse Reactions).
If a reaction suggesting hypersensitivity or irritation should occur, the
treatment should be discontinued.
Benzoic acid (E210) is mildly irritant to the skin, eyes and mucous
membranes.
Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact
dermatitis), or irritation to the eyes and mucous membranes.

See prescribing information for full details.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due
to the limited systemic availability after topical application, clinically relevant
interactions are rare. However, in patients on oral anticoagulants, such as
warfarin, caution should be exercised and anticoagulant effect should be
monitored.

Pregnancy: In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are
absorbed following topical administration. However, as with other imidazoles,
miconazole nitrate should be used with caution during pregnancy.
Breast-feeding: Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied
miconazole products during lactation.

Symptoms: Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment: Daktarin cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.