eMC - trusted, up to date and comprehensive information about medicines

This page has been designed specifically for printing. The full document can be found on the eMC - where you will find trusted, up to date and comprehensive information about medicines.

The eMC provides the latest approved prescribing information (SPCs) and patient information leaflets (PILs) for UK licensed medicines.


Pinewood Healthcare

Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
Telephone: +353 52 6186000
Fax: + 353 52 6136311
WWW: http://www.pinewood.ie
Medical Information Direct Line: +44 1978 661 261
Medical Information e-mail: drug.safety@wockhardt.co.uk
Medical Information Fax: +44 1978 661 702

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?


Summary of Product Characteristics last updated on the eMC: 14/04/2011

Ketopine (Ketoconazole) 2% w/w Shampoo



1. Name of the medicinal product

Ketopine (Ketoconazole) 2% w/w Shampoo

Ketoconazole 2% w/w Shampoo


2. Qualitative and quantitative composition

Each gram of shampoo contains 20 milligrams of Ketoconazole.

For a full list of excipients, see Section 6.1.


3. Pharmaceutical form

Shampoo

Clear, pink, viscous solution.


4. Clinical particulars

4.1 Therapeutic indications

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.


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 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.


4.3 Contraindications

Hypersensitivity to ketoconazole or any of the excipients.


4.4 Special warnings and precautions for use

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.


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 Ketopine (Ketoconazole) Shampoo. This is to prevent the condition flaring up.


4.6 Pregnancy and lactation

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.


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 (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 GREATER-THAN OR EQUAL TO (8805)1/10

Common GREATER-THAN OR EQUAL TO (8805)1/100 and < 1/10

Uncommon GREATER-THAN OR EQUAL TO (8805)1/1,000 and <1/100

Rare GREATER-THAN OR EQUAL TO (8805)1/10,000, <1/1,000

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

Table 1. Adverse Drug Reactions Identified During Postmarketing Experience with Ketoconazole Shampoo by Frequency Category Estimated from Spontaneous Reporting Rates

 

Immune System Disorders

Very rare

Hypersensitivity

 

Skin and Subcutaneous Tissue Disorder

Very rare

Alopecia (Also see Section 4.4 under Special Warnings and Special Precautions For Use), Rash, Urticaria, Skin irritation, Dry skin

 

General Disorders and Administration Site Conditions

Very rare

Application site reaction


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 original container.

Keep 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: 120 ml.


6.6 Special precautions for disposal and other handling

Not applicable.


7. Marketing authorisation holder

Pinewood Laboratories Limited trading as Pinewood Healthcare

Ballymacarbry,

Clonmel,

Co. Tipperary,

Ireland


8. Marketing authorisation number(s)

PL 04917/0039


9. Date of first authorisation/renewal of the authorisation

09/02/2009


10. Date of revision of the text

14/08/2009