This information is intended for use by health professionals
Miconazole nitrate 2.0% w/w
(Each gram of cream contains 20mg of miconazole nitrate)
For excipients, see Section 6.1
White homogeneous cream
For the treatment of athlete's foot.
For all ages.
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.
Method of administration: Cutaneous application.
Hypersensitivity to the active substances(s), other imidazole derivatives or to any of the excipients listed in section 6.1.
Daktarin Aktiv 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 Aktiv Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued.
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.
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.
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.
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 in clinical trials and post-marketing experience
System Organ Class
|| Adverse Reactions
| Frequency Category
(≥1/1,000 to <1/100)
|| Not known
| Immune System Disorders
|| Anaphylactic reaction
| Skin and Subcutaneous Tissue Disorders
|| Skin burning sensation
| 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
Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Daktarin Aktiv Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.
Pharmacotherapeutic classification: (Antifungals for dermatological/topical use; imidazole derivative) ATC code: D01A C02.
Miconazole 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.
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.
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.
PEG-6, PEG 32 and glycol stearate
Benzoic acid (E210)
Butylated hydroxyanisole (E320)
Aluminium tube lined with epoxyphenol resin. Cap made of white polypropylene for the 15, 30 and 70g sizes. Cap for 5g size made of high density polyethylene.
Daktarin Aktiv Cream may be supplied in packs of 5, 15, 30 and 70g.
*Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
McNeil Products Limited