Ketopine (Ketoconazole) 2% w/w Shampoo

Ketoconazole 2% w/w Shampoo

Each gram of shampoo contains 20 milligrams of Ketoconazole.

For a full list of excipients, see Section 6.1.

Shampoo

Clear, pink, viscous solution.

Ketopine (Ketoconazole) shampoo 2% is indicated for the treatment and prevention of seborrhoeic dermatitis, pityriasis capitis (dandruff) and pityriasis versicolor that may be associated with the fungus Pityrosporum.

For topical administration.

Adults including the elderly and children:

Wet hair and scalp thoroughly with water.

Apply sufficient shampoo to produce enough lather to wash the scalp and hair, gently massage it over the entire scalp and leave for 3-5 minutes before rinsing thoroughly.

Seborrhoeic dermatitis and dandruff: Use Ketopine (Ketoconazole) shampoo 2% twice weekly for 2-4 weeks.

Prophylaxis: Use Ketopine (Ketoconazole) shampoo 2% once every 1-2 weeks

Pityriasis versicolor: Use Ketopine (Ketoconazole) shampoo 2% once daily for a maximum of 5 days.

Prophylaxis: As patches of pityriasis versicolor become more apparent on exposure to the sun. Ketopine (Ketoconazole) shampoo 2% may be used once daily for a maximum of 3 days in a single treatment course before exposure to sunshine.

Hypersensitivity to ketoconazole or any of the excipients.

Ketopine (Ketoconazole) Shampoo 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If Ketopine (Ketoconazole) Shampoo 2% does get into the eyes, they should be bathed gently with cold water.

On rare occasions when using Ketopine (Ketoconazole) Shampoo 2% to treat pityriasis capitis (dandruff) and seborrhoeic dermatitis, an increase in normal hair loss and irritation associated with these conditions may occur.

Long-term treatment with steroids. Stopping prolonged treatment with steroids requires the gradual reduction of application of the steroid over a period of 2-3 weeks while simultaneously using Ketopine (Ketoconazole) Shampoo. This is to prevent the condition flaring up.

Ketopine (Ketoconazole) is not detected in plasma after chronic shampooing or topical application.

Ketopine (Ketoconazole) is not contraindicated for pregnancy or lactation, but caution should be exercised.

None known.

As with other shampoos, a local burning sensation, itching, or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of Ketopine (Ketoconazole) shampoo.

In rare instances, mainly in patients with chemically damaged hair or grey hair, a discolouration of the hair has been observed.

Additional adverse drug reactions reported in postmarketing reports with Ketoconazole Shampoo are included in Table 1. The frequencies are based on spontaneous reporting rates, according to the following convention:

Very common 1/10

Common 1/100 and < 1/10

Uncommon 1/1,000 and <1/100

Rare 1/10,000, <1/1,000

Very rare <1/10,000, including isolated reports

In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Pharmacotherapeutic (ATC) Classification: D01A C08

Ketoconazole is a synthetic imidazole-dioxalane derivative. It is a broad spectrum antifungal agent which inhibits the growth of common dermatophytes and yeasts by altering the permeability of the cell membrane:

Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T.tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum.

Yeasts: Candida albicans, C tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur).

Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months or in patients who shampooed 2-3 times per week for 3-26 months. Twelve hours after a single shampoo, hair samples taken from six patients showed that high amounts of ketoconazole were present on the hair; only about 5% had penetrated into the hair keratin. There were no detectable plasma levels after chronic shampooing twice weekly for two months with ketoconazole.

There is no relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Sodium Laureth Sulfate Paste 70 %

Disodium Laureth Sulfosuccinate Liquid 40%

Sodium Chloride

Citric Acid Monohydrate

Benzyl Alcohol

Tetrasodium EDTA

Quaternium-15

Polyquaternium-7

Dexpanthenol

Laureth-2

Sodium Hydroxide

Erythrosine (E127)

Perfume

Purified water

Not applicable.

27 months

Do not store above 25 °C.

Store in original container.

Keep container tightly closed.

White High-density polyethylene (HDPE) multi dose bottles with Polypropylene flip top closures.

Pack sizes: 120 ml.

Not applicable.

Pinewood Laboratories Limited trading as Pinewood Healthcare

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland

PL 04917/0039

09/02/2009

14/08/2009