NOVALE Scalp Lotion (TOPICAL ANTIFUNGAL )

COMPOSITION
NOVALE SCALP LOTION
Ketoconazole                  2%w/v
In a Non-Aqueous base.

For topical use only.

DESCRIPTION :
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 :
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 lotion is negligible since blood levels cannot be detected even after chronic use. Systemic effects therefore are not expected.

INDICATIONS :
Treatment and prophylaxis of infections such as seborrhoeic dermatitis and pityriasis capitis (dandruff), where the yeast Pityrosporum is involved.

  1. Pityriasis capitis (dandruff)
  2. Seborrhoeic dermatitis of scalp

CONTRAINDICATIONS :

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.

Treatment :
Seborrhoeic dermatitis and pityriasis capitis : twice weekly for 4 weeks.

Prophylaxis :
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.

OVERDOSAGE :
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