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
Not applicable.
Adverse drug reactions reported among 834 patients who received miconazole nitrate 2% cream (n=426) and/or placebo cream base (n=408) in 21 double-blind clinical trials are presented in Table 1 below. Moreover, adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included in Table 1. The adverse drug reactions are ranked by frequency, using the following convention:
Very common >1/10
Common >1/100 and <1/10
Uncommon >1/1,000 and <1/100
Rare >1/10,000 and <1/1,000
Very rare <1/10,000, including isolated reports
Adverse reactions obtained from clinical studies and post-marketing surveillance are presented by frequency category based on incidence in clinical trials or epidemiology studies, when known.
Table 1: Adverse reactions reported in clinical trials and post-marketing experience
| System Organ Class | Adverse Reactions | |
| Frequency Category | ||
| Uncommon (>1/1,000 to <1/100) | Not known | |
| Immune System Disorders | Anaphylactic reaction Hypersensitivity | |
| Skin and Subcutaneous Tissue Disorders | Skin burning sensation Skin inflammation Skin hypopigmentation | Angioedema Urticaria Contact dermatitis Rash Erythema Pruritus |
| General Disorders and Administration Site Conditions | Application site irritation Application site burning Application site pruritus Application site reaction NOS Application site warmth | |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction.
For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.
Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.
Miconazole nitrate is an imidazole antifungal agent and may act by interfering with the permeability of the fungal cell membrane. It possesses a wide antifungal spectrum and has some antibacterial activity.
Absorption: There is little absorption through skin or mucous membranes when miconazole nitrate is applied topically.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites.
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.
Not relevant.
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. If the powder is used with the cream, a once daily application of both formulations is recommended. 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.
Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
