1. Name Of The Medicinal Product
Daktarin Gold 2% Cream
2. Qualitative And Quantitative Composition
Ketoconazole 2% w/w.
Excipients: Propylene glycol; Cetyl alcohol; Stearyl alcohol
For a 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
For the treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch) and candidal intertrigo (sweat rash).
For tinea pedis, Daktarin Gold 2 % cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet), treatment should be continued for 2–3 days after all signs of infection have disappeared to prevent relapse.
For tinea cruris and candidal intertrigo, apply cream to the affected areas once or twice daily until 2-3 days after all signs of infection have disappeared to prevent relapse. Treatment for up to 6 weeks may be necessary. If no improvement in symptoms is experienced after 4 weeks treatment, a doctor should be consulted.
Method of administration: Cutaneous use.
4.3 Contraindications
Daktarin Gold 2 % cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.
4.4 Special Warnings And Precautions For Use
Not for ophthalmic use.
If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using Daktarin Gold 2 % cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.
Propylene glycol may cause skin irritation. Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 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 following oral administration of ketoconazole. (see Preclinical safety data, section 5.3). No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2..
4.7 Effects On Ability To Drive And Use Machines
None.
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 (
Very Common (
Common (
Uncommon (
Rare (
Very rare (<1/10,000)
Not Known (cannot be estimated form the available clinical trial data).
|
| ||
| |||
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
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.
5. 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
Since ketoconazole administered topically as a cream is not systemically absorbed and does not produce detectable plasma concentrations, there is no specific relevant information.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Propylene Glycol
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
60 months.
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 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 15513/0184
9. Date Of First Authorisation/Renewal Of The Authorisation
01/04/2009
10. Date Of Revision Of The Text
30/11/2009
No comments:
Post a Comment