When Daktacort is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktacort and with other miconazole topical formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Daktacort must not come into contact with the mucosa of the eyes.
As with any topical corticosteroid, caution 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.
Long term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a recurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and medical advice is recommended in these cases or other treatment options should be considered.
Because of its corticosteroid content avoid long-term treatment with Daktacort. Once the inflammatory symptoms have disappeared treatment may be continued with miconazole nitrate 20mg/g cream or powder. (See Section 4.2)
Daktacort can damage certain synthetic materials. Therefore, it is recommended to wear cotton underwear if this clothing comes into contact with the affected area.
The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Daktacort should not be used concurrently with a latex condom or latex diaphragm.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Daktacort cream contains benzoic acid. Benzoic acid may cause local irritation.
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Daktacort cream contains butylated hydroxanisole, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.