NOVALE Bar 2% w/w contains the synthetic broad spectrum antifungal agent Ketoconazole.
Pharmacodynamics : Ketoconazole, a synthetic imidazole derivative has a potent antifungal activity against dermatophytes, such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts such as Candida sp., Malessezia ovale (Pityrosporum ovale), and Malessezia furfur ( Pityrosporum orbiculare).
Pharmacokinetics : Percutaneous absorption of ketoconazole is negligible since blood levels cannot be detected even after chronic use. Systemic effects therefore are not expected.
NOVALE Bar 2% w/w offers freedom from and protects against Tinea Versicolor, and also effective as an adjuvant therapy along with topical and oral antifungal drugs to treat tinea and candida skin infections.
Known hypersensitivity to ketoconazole or the excipient.
Warnings and Precautions :
To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying the topical corticosteroid together with the use of NOVALE Bar 2% w/w and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
Pregnancy and Lactation :
Since Ketoconazole is not absorbed through the skin after topical application, pregnancy and lactation are not a contraindication for the use of NOVALE Bar 2% w/w.
Dosage and Administration :
~ Pityriasis versicolor : once daily for maximum 5 days.
The affected areas as well as the whole of torso (neck-down) should be washed with NOVALE Bar 2% w/w, and applied so as to form lather, which should be left for 5 minutes before rinsing.
~ Tinea and candida skin infections : as adjuvant therapy, along with topical and oral antifungal drug.
The affected areas of the skin should be washed with NOVALE Bar, applied so as to form lather, which should be left for 5 minutes before washing off.
~ Pityriasis versicolor : once daily for maximum 3 days during a single treatment course before the summer.
Adverse Reaction :
Topical treatment with NOVALE Bar 2% w/w is generally well tolerated. As with other topical Ketoconazole preparations, a local burning sensation, itching, and irritation may occur, but are rare, during the period of use of NOVALE Bar 2% w/w.
Not expected as NOVALE Bar 2% w/w is intended for external use only. In the event of accidental ingestion only supportive measures should be carried out.
Induced emesis and gastric lavage should usually be avoided.