Daktarin 20mg / 1g Cream

Dermatomycoses, e.g.:
- Tinea pedis (athlete's foot)
- Tinea corporis (Tinea circinata)
- Tinea manuum
- Tinea cruris due to:
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Microsporum audouinii
- Epidermophyton floccosum
Candidial infections:
Infections of the skin (.e.g. intertrigo)
Perianal infections
Stomatitis angularis (cheilitis, perleche)
Balanoposthitis

For external use only. DAKTARIN cream should be applied to the lesion twice daily and thoroughly rubbed into the skin with a finger. When all lesions have disappeared (usually after 2 to 5 weeks), treatment should be continued for a further 10 to 14 days to prevent relapse.

DAKTARIN cream is contra-indicated in individuals with a known hypersensitivity to miconazole or another ingredient of the formulation.

If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued. DAKTARIN cream must not come into contact with the eyes.

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application (see Pharmacokinetic properties), clinically relevant interactions occur very rarely. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and the anticoagulant effect should be monitored. The effects and side effects of some other drugs (e.g., oral hypoglycemics and phenytoin), when co-administered with DAKTARIN cream, can be increased and caution should be exercised.

Pregnancy
Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, safety in human pregnancy has not been demonstrated.
Lactation
It is not known whether miconazole is excreted in human breast milk. Therefore, safety has not been demonstrated in breastfeeding women.

Not applicable

Clinical trial data
Adverse drug reactions reported among 834 patients who received miconazole 2% cream and/or placebo cream base in 21 double-blind clinical trials are presented in Table 1 below. Included in the table are all adverse events considered to be related to study medicine. A dash indicates that the adverse reaction was not reported by patients in the specified treatment group.
Table 1: Adverse drug reactions reported by patients in either treatment group in 21 double-blind clinical trials of miconazole 2% cream versus placebo.
System Organ Class Adverse drug reaction Miconazole 2% cream (n= 426), % Placebo cream base (n=408), % Overall adverse drug reactions 1.9 1.2 Skin and subcutaneous tissue disorders Skin burning sensation Skin inflammation Skin hypopigmentation General disorders and administration site conditions Application site irritation Application site burning Application site pruritus Application site reaction (Not otherwise specified) Application site warmth 0.2 0.2 0.2 0.7 0.2 0.2 0.2 0.2 0.7 -- -- 0.5 0.2 -- -- --
Note: Individual patients may have reported more than a single event.

Symptoms
Topical use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment
Accidental ingestion: DAKTARIN cream is intended for topical use, not for oral use. Should accidental oral ingestion of large quantities of this product occur, an appropriate method of gastric emptying may be used if considered necessary.