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Drug information

Ketoconazole

POM
Read time: 1 mins
Last updated: 05 Oct 2015

Summary of product characteristics


1. Name of the medicinal product

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

ShampooClear, pink, viscous solution.


4.1. Therapeutic indications

Ketoconazole 2% w/w Shampoo 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 adolescents: 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 Ketoconazole 2% w/w shampoo twice weekly for 2-4 weeks.Prophylaxis: Use Ketoconazole 2% w/w shampoo once every 1-2 weeksPityriasis versicolor: Use Ketoconazole 2% w/w shampoo once daily for a maximum of 5 days. Prophylaxis: As patches of pityriasis versicolor become more apparent on exposure to the sun. Ketoconazole 2% w/w shampoo 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

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 – 3 weeks, while using Ketoconazole 2% w/w shampoo, to prevent any potential rebound effect.Ketoconazole 2% w/w shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If Ketoconazole 2% w/w shampoo does get into the eyes, they should be bathed gently with cold water.


4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed


4.6. Fertility, pregnancy and lactation

Ketoconazole 2% w/w shampoo is not detected in plasma after chronic shampooing or topical application.Ketoconazole 2% w/w shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.


4.7. Effects on ability to drive and use machines

Not relevant


4.8. Undesirable effects

The safety of Ketoconazole 2% Shampoo was evaluated in 2980 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 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 Not known (cannot estimate from the available clinical trial data).

System Organ Class

Adverse Drug Reactions

Frequency Category

Uncommon

(≥1/1,000 and <1/100)

Rare

(≥1/10,000 and <1/1,000)

Not Known

Immune System Disorders

Hypersensitivity

Nervous System Disorders

Dysgeusia

Infections and Infestations

Folliculitis

Eye Disorders

Increased lacrimation

Eye irritation

Skin and Subcutaneous Tissue Disorders

Alopecia

Dry Skin

Hair texture abnormal

Rash

Skin burning sensation

Acne

Dermatitis contact

Skin disorder

Skin exfoliation

Angioedema

Urticaria

Hair colour changes

General Disorders and Administration Site Conditions

Application site erythema

Application site irritation

Application site pruritus

Application site reaction

Application site hypersensitivity

Application site pustules

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.


4.9. Overdose

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.


5.1. Pharmacodynamic properties

Pharmacotherapeutic (ATC) Classification: D01A C08Ketoconazole 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.


6.1. List of excipients

Sodium Laureth Sulfate Paste 70 %Disodium Laureth Sulfosuccinate Liquid 40%Sodium Chloride Citric Acid Monohydrate Benzyl AlcoholTetrasodium EDTA Quaternium-15Polyquaternium-7DexpanthenolLaureth-2Sodium Hydroxide Erythrosine (E127)PerfumePurified 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

16/09/2015

4.1 Therapeutic indications

Ketoconazole 2% w/w Shampoo 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 adolescents: 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 Ketoconazole 2% w/w shampoo twice weekly for 2-4 weeks.Prophylaxis: Use Ketoconazole 2% w/w shampoo once every 1-2 weeksPityriasis versicolor: Use Ketoconazole 2% w/w shampoo once daily for a maximum of 5 days. Prophylaxis: As patches of pityriasis versicolor become more apparent on exposure to the sun. Ketoconazole 2% w/w shampoo 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

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 – 3 weeks, while using Ketoconazole 2% w/w shampoo, to prevent any potential rebound effect.Ketoconazole 2% w/w shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If Ketoconazole 2% w/w shampoo does get into the eyes, they should be bathed gently with cold water.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

4.6 Fertility, pregnancy and lactation

Ketoconazole 2% w/w shampoo is not detected in plasma after chronic shampooing or topical application.Ketoconazole 2% w/w shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.

4.7 Effects on ability to drive and use machines

Not relevant

4.8 Undesirable effects

The safety of Ketoconazole 2% Shampoo was evaluated in 2980 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 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 Not known (cannot estimate from the available clinical trial data).

System Organ Class

Adverse Drug Reactions

Frequency Category

Uncommon

(≥1/1,000 and <1/100)

Rare

(≥1/10,000 and <1/1,000)

Not Known

Immune System Disorders

Hypersensitivity

Nervous System Disorders

Dysgeusia

Infections and Infestations

Folliculitis

Eye Disorders

Increased lacrimation

Eye irritation

Skin and Subcutaneous Tissue Disorders

Alopecia

Dry Skin

Hair texture abnormal

Rash

Skin burning sensation

Acne

Dermatitis contact

Skin disorder

Skin exfoliation

Angioedema

Urticaria

Hair colour changes

General Disorders and Administration Site Conditions

Application site erythema

Application site irritation

Application site pruritus

Application site reaction

Application site hypersensitivity

Application site pustules

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

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Reporting of suspected adverse reactions 

Drug Licencing

Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).