Hot Articles Directory Kiribati: Daktarin Gold (Nizoral Cream)

1. Name Of The Medicinal Product

POM: Nizoral Cream

P: Daktarin Gold

2. Qualitative And Quantitative Composition

Ketoconazole 2% w/w.

For excipients, see 6.1.

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

POM

For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

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

POM

Tinea pedis:

Nizoral 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 until a few days after all signs and symptoms have disappeared in order to prevent relapse.

For other infections:

Nizoral cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.

The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2–3 weeks, tinea corporis 3–4 weeks.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection.

Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

For the treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch) and candidal intertrigo (sweat rash).

For tinea pedis, Daktarin Gold 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: Topical administration.

4.3 Contraindications

Ketoconazole cream is contra-indicated in patients who have shown 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 Nizoral cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

After topical application, ketoconazole cream is not systematically absorbed and does not produce detectable plasma concentrations. However, as with any medication, ketoconazole cream should only be used in pregnant women if its use is considered essential by a doctor. Since no ketoconazole is detected in plasma following topical administration, use of ketoconazole cream is not contra-indicated for breast feeding women.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Topical treatment with Nizoral cream/daktarin Gold is generally well tolerated.

A few instances of irritation and burning sensation have been observed during treatment with ketoconazole cream. Also in rare circumstances allergic local skin phenomena, such as contact dermatitis, have been reported.

There have been very rare reports of eczema.

4.9 Overdose

Exaggerated topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.

If accidental ingestion of ketoconazole cream occurs, No special measures have to be taken.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: ATC Code: D01AC08

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

After topical application, ketoconazole is not systematically absorbed and does not produce detectable plasma concentrations.

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 5g, 15g and 30g.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

8. Marketing Authorisation Number(S)

PL 00242/0107

9. Date Of First Authorisation/Renewal Of The Authorisation

Renewed 3 December 2002

10. Date Of Revision Of The Text

June 2008

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