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1. Name Of The Medicinal Product
Daktarin Aktiv Cream
2. Qualitative And Quantitative Composition
Miconazole nitrate 2.0% w/w
(Each gram of cream contains 20mg of miconazole nitrate)
For excipients, see Section 6.1
3. Pharmaceutical Form
Cream
White homogeneous cream
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of athlete's foot.
4.2 Posology And Method Of Administration
For all ages.
Apply the cream twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.
Method of administration: Cutaneous application.
4.3 Contraindications
Daktarin Aktiv Cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient in this product.
4.4 Special Warnings And Precautions For Use
Daktarin Aktiv Cream must not come into contact with the eyes.
If a reaction suggesting sensitivity or irritation should occur, the treatment should be discontinued.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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.
4.6 Pregnancy And Lactation
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.
Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included. 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, < 1/1,000
Very rare < 1/10,000, including isolated reports
The frequencies provided below reflect reporting rates for adverse drug reactions from spontaneous reports, and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.
Immune system disorders
Very rare: anaphylactic reaction, hypersensitivity, angioneurotic edema.
Skin and subcutaneous tissue disorders
Very rare: urticaria, contact dermatitis, rash, erythema, pruritus, skin burning sensation.
General disorders and administration site conditions
Rare: application site reactions, including application site irritation.
4.9 Overdose
Symptoms
Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Treatment
Daktarin Aktiv Cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered necessary.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
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.
6. Pharmaceutical Particulars
6.1 List Of Excipients
PEG-6, PEG 32 and glycol stearate
Oleoyl macroglycerides
Liquid paraffin
Benzoic acid (E210)
Butylated hydroxyanisole (E320)
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
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.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0304
9. Date Of First Authorisation/Renewal Of The Authorisation
01 July 2008
10. Date Of Revision Of The Text
10 July 2008
Daktarin Aktiv Cream McNeil Products Ltd
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