DAKTARIN Cream (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Daktarin 2% Cream.
Qualitative and quantitative composition
Miconazole nitrate 2% w/w. Excipients: Benzoic acid, Butylated hydroxyanisole. For a full list of excipients, see Section 6.1.
Pharmaceutical form
Cream. White homogeneous cream.
Therapeutic indications
For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to the active substances(s), other imidazole derivatives or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
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 ...
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 ...
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, ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
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. ...
Overdose
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. ...
Pharmacodynamic properties
Pharmacotherapeutic classification: Antifungals for dermatological/topical use; imidazole derivative ATC code: D01AC02 Miconazole nitrate is an imidazole antifungal agent and may act by interfering with ...
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 ...
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.
List of excipients
PEG-6, PEG-32 and glycol stearate Oleoyl macroglycerides Liquid paraffin Benzoic acid (E210) Butylated hydroxyanisole (E320) Purified water
Incompatibilities
Not applicable.
Shelf life
Shelf life: 24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Aluminium tube inner lined with heat polymerised epoxy-phenol resin with a white polypropylene cap containing 15g, 30g or 70g of cream, or aluminium tube inner lined with heat polymerised epoxy-phenol ...
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom
Marketing authorization number(s)
PL 15513/0307
Date of first authorization / renewal of the authorization
01/04/2009
Date of revision of the text
08 August 2016
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