(i)
ROUTE OF ADMINISTRATION
Topical
DOSAGE AND ADMINISTRATION
Health
2000 Ketoconazole 2% Shampoo should be applied to the wet
scalp, worked into a lather and left on for three to five minutes before rinsing
thoroughly with water. The use of unnecessarily large quantities of Health
2000 Ketoconazole 2% Shampoo during treatment should be avoided.
The duration of treatment should be limited to twice weekly for no longer
than four weeks at any one time. An interval of at least four weeks should
be allowed between consecutive courses.
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Topical
treatment of severe seborrhoeic dermatitis and severe dandruff of the scalp
in adults.
For both conditions, Health 2000 Ketoconazole 2% Shampoo
provides only temporary relief during the period of its use. Both conditions
relapse soon after discontinuation of treatment. The relapse rate for seborrhoeic
dermatitis is not known, but for dandruff it is high within a short time after
cessation of treatment.
(iii) DESCRIPTION OF DOSAGE FORM
Ketoconazole is a broad-spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes (Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M gypseum and Epidermophyton floccosum) and yeasts (Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and P. orbiculare (M furfur) by altering the permeability of the cell membrane.
(iv) CONTRAINDICATIONS
Hypersensitivity to any ingredient.
WARNING AND PRECAUTIONS
Irritation
may occur when Health 2000 Ketoconazole 2% Shampoo is used
immediately after prolonged treatment with topical corticosteroids on the
same area. Therefore, it is recommended to wait about two weeks after stopping
treatment with topical corticosteroids before using Health 2000 Ketoconazole
2% Shampoo.
If a reaction suggesting sensitivity or chemical irritation should occur,
use of Health 2000 Ketoconazole 2% Shampoo should be discontinued.
Seborrhoeic dermatitis and dandruff are often associated with increased hair
shredding, and this has also been reported, although rarely, with the use
of ketoconazole 2% shampoo.
Safety of use beyond four weeks has not been adequately established.
Avoid contact with the eyes. If the shampoo should get into the eyes, they
should be bathed with cold water.
USE IN PREGNANCY:
Ketoconazole shampoo does not produce detectable blood levels after topical
application. However, due to the teratogenic nature of the active ingredient
in rats when given orally, it should only be used in pregnant or lactating
women if in the judgment of the treating doctor the expected benefits outweigh
the potential risk.
(v) SIDE EFFECTS
Ketoconazole
shampoo is generally well tolerated. Reported adverse events included allergic
reaction, itchy, irritated or greasy skin and scalp, rash and erythema. As
with other shampoos, a local burning sensation, oiliness and dryness of the
hair and scalp have also been reported. In rare instances, mainly in patients
with chemically damaged hair or grey hair, a discolouration of the hair has
been observed. One case of exfoliative dermatitis has been reported but its
relationship to the use of the shampoo is uncertain.
Overdosage:
Symptoms: Oral ingestion is usually followed
by nausea and vomiting due to the detergent.
Treatment: In the event of accidental ingestion,
only supportive measures should be employed. To avoid aspiration, neither
emesis nor gastric lavage should be performed.
(vi) TOXIC EFFECTS
MUTAGENICITY, CARCINOGENICITY, TERATOGENICITY