Pink, opaque liquid
Ketoconazole (micronized) 2% w/w
Actions and Pharmacology
Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent
antifungal activity against dermatophytes, such as Trichophyton spp.,
Epidermophyton spp., Microsporum spp., and yeasts, such as Candida spp. and
Malassezia spp. (Pityrosporum spp.).
Ketovid Shampoo 2% w/w rapidly relieves scaling and pruritus, which are
usually associated with seborrhoeic dermatitis, pityriasis capitis
(dandruff) and pityriasis versicolor.
Percutaneous absorption of ketoconazole is negligible as blood levels are
not detected, even after chronic use. Systemic effects, therefore, are not
Treatment and prophylaxis of infections in which the yeast Malassezia
(previously called Pityrosporum) is involved, such as pityriasis versicolor
(localised), seborrhoeic dermatitis and pityriasis capitis (dandruff).
It is contraindicated in persons who have shown hypersensitivity to the
active ingredient or excipients of this formulation.
Warnings and Precautions
• Keep out of eyes. Wash the eyes with water if the shampoo contacts the
• Advise to consult doctor if the scalp has not cleared within 4 weeks.
• Persons who are sensitive to miconazole or other imidazoles may be
sensitive to ketoconazole also.
• In patients who have been on
prolonged treatment with topical corticosteroids, it is recommended that the
steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while
using Ketovid Shampoo 2 % w/w to prevent any potential rebound effect.
• Increased hair shedding is often associated with seborrhoeic dermatitis
and dandruff, and has been rarely reported with the use of Ketovid Shampoo
Pregnancy and Lactation
Ketovid Shampoo 2% w/w is not contraindicated during pregnancy and lactation
as no ketoconazole is detected in the plasma following topical
Main Side/Adverse Effects
• Topical treatment with Ketovid Shampoo 2 % w/w is generally well
• A local burning sensation, itching, or contact dermatitis (due to
irritation or allergy) may occur on exposed areas.
• Dry skin, dryness or oiliness
of the hair and scalp have been reported rarely.
• A discolouration of the hair, mainly in patients with chemically damaged
hair or grey hair has been observed.
• There have been very rare
reports of eczema and alopecia.
• Ingestion of Ketovid Shampoo 2 % w/w may result in nausea and vomiting due
to the detergent. Only supportive measures should be carried out in the
event of accidental ingestion.
• In order to avoid aspiration, neither emesis nor gastric lavage should be
Dosage and Administration
For topical administration,
The affected areas of the skin or the hair should be washed with Ketovid
Shampoo, which should be left on the skin for 3 to 5 minutes before rinsing.
• Pityriasis versicolor: once daily for 5 days
• Seborrhoeic dermatitis and pityriasis capitis: twice weekly for 3 to 4
• Pityriasis versicolor: once daily for 3 days during a single treatment
course before exposure to sunshine.
• Seborrhoeic dermatitis and
pityriasis capitis: once every one or two weeks.
Storage : Store below 30°C. Protect from light.
Presentation/Packing : 120 ml in