Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

Vavo Shampoo is for topical administration.

Vavo Shampoo (Ketoconazole shampoo 2%) is for use in adolescents and adults:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment

- Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.

- Tinea versicolor: Once daily for a maximum of 5 days.

Prophylaxis

- Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.

- Tinea versicolor: Once daily for a maximum of 3 days before exposure to sunshine.

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recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks,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 Vavo shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

No interaction studies have been performed

There are no adequate and well-controlled studies in pregnant or lactating women. Data on a

limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on

pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive

toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on

the breastfed newborn/infant are anticipated. (See Pharmacokinetic properties, section 5.2).

Plasma concentrations of ketoconazole were not detectable after topical administration of

Ketoconazole Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected

after topical administration of Ketoconazole Shampoo 2% on the whole body. There are no

known risks associated with the use of Ketoconazole Shampoo 2% in pregnancy or lactation.

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22

clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin.

Based on pooled safety data from these clinical trials, there were no ADRs reported with an

incidence ≥1%.

The following table displays ADRs that have been reported with the use of Ketoconazole 2%

Shampoo from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention: Very common (≥1/10)

Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very

rare (<1/10,000) Not known (cannot be estimated form the available clinical trial data).

To report any side effect(s):

• Saudi Arabia:

National Pharmacovigilance and Drug Safety Center (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222

Exts: 2317-2356-2353-2354-2334-2340

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

Website: www.sfda.gov.sa/npc

• Other GCC States:

Please contact the relevant competent authority.

In the event of accidental ingestion, supportive and symptomatic measures should be carried out.

In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Pharmacotherapeutic group: Imidazole and triazole derivatives. ATC Code: D01AC08

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia

and dermatophytes. Its broad spectrum of activity is already well known.

Plasma concentrations of ketoconazole were not detectable after topical administration of

Ketoconazole shampoo on the scalp. Plasma levels were detected after topical administration of

Ketoconazole shampoo on the whole body.

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess

of the maximum human exposure indicating little relevance to clinical use.

Not applicable

Store below 30°C.

100 ml white oval plastic bottle with 24 mm flip cap; each labelled bottle packed in carton with

folded leaflet.

No special requirements