NOVALE SCALP LOTION
In a Non-Aqueous base.
For topical use only.
NOVALE SCALP LOTION 2% w/v contains the synthetic broad-spectrum antifungal agent Ketoconazole. One ml. contains 20 mg. Ketoconazole I.P. in a cleansing lotion base.
CLINICAL PHARMACOLOGY :
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).
Percutaneous absorption of ketoconazole lotion is negligible since blood levels cannot be detected even after chronic use. Systemic effects therefore are not expected.
Treatment and prophylaxis of infections such as seborrhoeic dermatitis and pityriasis capitis (dandruff), where the yeast Pityrosporum is involved.
- Pityriasis capitis (dandruff)
- Seborrhoeic dermatitis of scalp
Known hypersensitivity to ketoconazole or the excipient.
WARNING AND PRECAUTIONS :
Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported although rarely, with the use of NOVALE SCALP LOTION 2% w/v.
Pregnancy and Lactation :
Since ketoconazole is not absorbed through the skin after topical application, pregnancy & lactation are not a contraindication for the use of NOVALE SCALP LOTION 2% w/v.
DOSAGE AND ADMINISTRATION :
The entire area of the scalp skin or the hair should be washed with NOVALE SCALP LOTION 2% w/v which should be left for 3 to 5 minutes before rinsing.
Seborrhoeic dermatitis and pityriasis capitis : twice weekly for 4 weeks.
Seborrhoeic dermatitis and pitysiasis capitis: once every one week.
ADVERSE REACTIONS :
Topical treatment with NOVALE SCALP LOTION 2% w/v is generally well tolerated. As with other topical ketoconazole preparations, a local burning sensation, itching, irritation and oily/dry hair may occur, but are rare, during the period of use of NOVALE SCALP LOTION 2% w/v. In rare instances, mainly in patients with chemically damaged hair or grey hair, a discoloration of the hair has been observed.
Not expected as NOVALE SCALP LOTION 2% w/v 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.
STORAGE INSTRUCTIONS :
Protect from heat and light.
Keep out of reach of children