Nizoder Cream 30g

Product Information

NIZODER CREAM

Nizoder® 2% cream(Ketoconazole 2% w/w)

Presentation

Nizoder 2% cream: Non-greasy, white cream; each gram cream contains Ketoconazole BP 20 mg.

Indication

Nizoder 2% cream (Ketoconazole 2% w/w) is used for topical application in the treatment of dermatophyte infections of the skin

such as tinea corporis, tinea cruris (dhobie itch), tinea manus and tinea pedis (athlete’s foot) infections due to Trichophyton

spp, Microsporon spp and Epidermophyton spp. Nizoder 2% cream (Ketoconazole 2% w/w) is also indicated for the treatment of

cutaneous candidosis (including vulvitis), candidal intertrigo (sweat rash), tinea (pityriasis) versicolor and seborrhoeic

dermatitis caused by Malassezia (previously called Pityrosporum) spp.

Dosage and administration

Tinea pedis: Nizoder 2% (Ketoconazole 2% w/w) 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 (e.g. 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: Nizoder 2% (Ketoconazole 2% w/w) 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.

Method of administration: For topical administration

Contra-indications, warnings, etc.

Contra-indication: Ketoconazole 2% w/w cream is contra-indicated in patients with known hypersensitivity to Ketoconazole.

Warnings & precautions: 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 Ketoconazole 2% w/w cream, as an increased

incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.

Drug interactions: None known.

Use in pregnancy & 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. No effects on the breastfed newborn/infant are anticipated.

Side effects: Commonly observed adverse reactions to Ketoconazole cream in clinical trials were skin application site burning

sensation, erythema and pruritus. Uncommon adverse reactions are application site bleeding, discomfort, dryness, inflammation,

irritation, paraesthesia and reaction; bullous eruption, dermatitis contact, rash, skin exfoliation and sticky skin.

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 2% w/w cream occurs, no special measures have to be

taken.

Pharmaceutical precautions

Store in below 250 C and dry place, protected from light.

Packaging quantity

Nizoder 2% cream: Cartons containing 15 gram cream in tube