Boots Anti-Dandruff Ketoconazole 2% w / w Shampoo

1. Name Of The Medicinal Product

Ketopine Dandruff Shampoo

Superdrug Anti-Dandruff Shampoo

Numark Anti-Dandruff Shampoo

Boots Anti-Dandruff Ketoconazole 2% w/w Shampoo

2. Qualitative And Quantitative Composition

Each gram of shampoo contains 20 milligrams of Ketoconazole.

For excipients see 6.1

3. Pharmaceutical Form

Shampoo

Clear, pink, viscous solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Ketopine Dandruff Shampoo is indicated for the prevention and treatment of dandruff.

4.2 Posology And Method Of Administration

For topical administration.

Adults including the elderly and children

Wet hair and scalp thoroughly with water.

Apply sufficient shampoo to wash the scalp and hair and lather well.

Leave for 3-5 minutes before rinsing thoroughly.

Use shampoo every 3-4 days for 2-4 weeks. There should be a minimum of 3 days between applications.

Prophylaxis: Use shampoo once every 1-2 weeks

4.3 Contraindications

Hypersensitivity to ketoconazole or any of the excipients.

4.4 Special Warnings And Precautions For Use

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

On rare occasions when using Ketopine Dandruff Shampoo to treat pityriasis capitis (dandruff), an increase in normal hair loss and irritation associated with this condition may occur.

If the scalp is not cleared within 4 weeks of treatment a doctor or pharmacist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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 ketoconazole. This is to prevent the condition flaring up.

4.6 Pregnancy And Lactation

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

Ketopine Dandruff shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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 Dandruff shampoo.

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

4.9 Overdose

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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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).

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

27 months

6.4 Special Precautions For Storage

Do not store above 25 °C.

Store in the original container.

Keep the container tightly closed.

6.5 Nature And Contents Of Container

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

Pack sizes: 60 ml and 100 ml.

All pack sizes may not be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Pinewood Laboratories Limited,

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland

8. Marketing Authorisation Number(S)

PL 04917/0063

9. Date Of First Authorisation/Renewal Of The Authorisation

10^th October, 2003

10. Date Of Revision Of The Text

July 2007