Summary of medicine characteristics - KETOCONAZOLE 2% W/W SHAMPOO
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. Excipients with known effect
Benzyl Alcohol 5.00 mg/g
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
Clear, pink to orange/red, viscous solution.
4 CLINICAL PARTICULARS
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 weeks
Pityriasis 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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 – 3 weeks, while using Ketoconazole 2% w/w shampoo, to prevent any potential rebound effect.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.
This medicine contains 5.00 mg benzyl alcohol in each g which is equivalent to 0.50 % w/w. Benzyl alcohol may cause allergic reactions and mild local irritation.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed
4.6 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseIn 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 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
5.2 Pharmacokinetic propertiesKetoconazole 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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.1 List of excipientsSodium Laureth Sulfate Paste 70 %
Disodium Laureth Sulfosuccinate Liquid 40%
Sodium Chloride
Citric Acid Monohydrate
Benzyl Alcohol
Tetrasodium EDTA
Imidazolidinyl Urea (Imidurea)
Polyquaternium-7
Dexpanthenol
Laureth-2
Sodium Hydroxide
Erythrosine (E127)
Purified water
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.