Summary of medicine characteristics - DAKTARIN GOLD 2% CREAM
Daktarin Gold 2% Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2 QUALITATIVE AND QUANTITATIVE COMPOSITIONKetoconazole 2% w/w.
Excipients with known effect: Propylene glycol 20% w/w; Cetyl alcohol 2% w/w; Stearyl alcohol 7.5% w/w.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo.
4.2 Posology and method of administration
Ketoconazole cream is for use in adults.
For the treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie itch) and candidal intertrigo (sweat rash).
Tinea cruris, candidal intertrigo and tinea pedis: It is recommended that Daktarin Gold 2% Cream be applied once or twice daily to cover the affected and immediate surrounding area.
The usual duration of treatment is tinea cruris 2–4 weeks, candidal intertrigo 24 weeks, tinea pedis 4–6 weeks.
Treatment should be continued, until a few days after disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment.
Method of administration: Cutaneous use.
Paediatric patients
The safety and efficacy of Daktarin Gold 2% Cream in children (17 years and younger) has not been established.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
Daktarin Gold 2% cream is not for ophthalmic use.
To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Daktarin Gold 2% cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2–3 weeks.
This medicine contains cetyl alcohol and stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Also contains propylene glycol which may cause skin irritation.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child.
Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole.
Plasma concentrations of ketoconazole are not detectable after topical application of Daktarin Gold 2% cream to the skin of non-pregnant humans
(See Pharmacokinetic properties, section 5.2). There are no known risks associated with the use of Daktarin Gold 2% cream in pregnancy or lactation.
4.7 Effects on ability to drive and use machines
This medicine has no influence on the ability to drive and use machines.
4.8 Undesirable effects
The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin.
Based on pooled safety data from these clinical trials, the most commonly reported (>1% incidence) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%). Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:
Very Common Common Uncommon Rare
Very rare Not Known data).
(>1/10)
(>1/100 to <1/10)
(>1/1,000 to <1/100)
(>1/10,000 to <1/1,000)
(<1/10,000)
(cannot be estimated from the available clinical trial
| System Organ Class | Adverse Drug Reactions | ||
| Frequency Category | |||
| Common (>1/100 to <1/10) | Uncommon (>1/1,000 to <1/100) | Not Known | |
| Immune System Disorders | Hypersensitivity | ||
| Skin and Subcutaneous Tissue Disorders | Skin burning sensation | Bullous eruption Dermatitis contact Rash Skin exfoliation Sticky skin | Urticaria |
| General Disorders and Administration Site Conditions | Application site erythema Application site pruritus | Application site bleeding Application site discomfort Application site dryness Application site inflammation Application site irritation Application site paraesthesia Application site reaction | |
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Topical application
Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.
Ingestion
In the event of accidental ingestion, supportive and symptomatic measures should be carried out.
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Imidazole and triazole derivatives; ATC code: D01 AC08
Ketoconazole has a potent antimycotic action against dermatophytes and yeasts. Ketoconazole cream acts rapidly on the pruritus, which is commonly seen in dermatophyte and yeast infections. This symptomatic improvement often occurs before the first signs of healing are observed.
A study in 250 patients has shown that application twice daily for 7 days of ketoconazole 2% cream vs clotrimazole 1% cream for 4 weeks on both feet demonstrated efficacy in patients with tinea pedis (athlete’s foot) presenting lesions between the toes.
The primary efficacy endpoint was negative microscopic KOH examination at 4 weeks. Ketoconazole 2% treatment showed equivalent efficacy to 4 weeks clotrimazole 1% treatment. There was no evidence of relapse following treatment with ketoconazole cream at 8 weeks.
5.2 Pharmacokinetic properties
Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of ketoconazole cream was applied daily on 40 % of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL.
5.3 Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene Glycol
Version No: 8.1 Draft
BV 3000
Stearyl Alcohol
Cetyl Alcohol
Sorbitan Stearate
Polysorbate 60
Isopropyl Myristate
Sodium Sulphite Anhydrous (E221)
Polysorbate 80
Purified Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Tube made of 99.7% aluminum, lined on inner side with heat polymerised epoxyphenol resin with a latex coldseal ring at the end of the tube. The cap is made of 60% polypropylene, 30% calcium carbonate and 10% glyceryl monostearate.
Tubes of 5, 15 and 30g.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo Special requirements.
Any unused medicinal products or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
McNeil Products Limited
50 – 100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 15513/0184
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01/04/2009