Dandrazol 2% Shampoo
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dandrazol 2% Shampoo
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 20mg/g.
For excipients see 6.1
3. PHARMACEUTICAL FORM
Shampoo.
Clear, pink solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention and treatment of infections in which the yeast Pityrosporum is likely to be involved, such as dandruff, seborrhoeic dermatitis and pityriasis versicolor.
4.2 Posology and method of administration
Adolescents and Adults:
Dandrazol 2% Shampoo is for use in adolescents and adults.
Shake the bottle well. Wash the hair or affected areas of the skin with Dandrazol shampoo. Leave in contact for 3-5 minutes before rinsing thoroughly.
* Seborrhoeic dermatitis and dandruff:
Treatment of: Use Dandrazol 2% shampoo twice weekly for 2-4 weeks. Prophylaxis of: Use Dandrazol 2% shampoo once every 1-2 weeks.
* Pityriasis versicolor:
Treatment of: Use Dandrazol 2% Shampoo once daily for a maximum of 5 days.
Prophylaxis of: As patches of pityriasis versicolor become more apparent on exposure to the sun, Dandrazol 2% 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 other ingredients of the preparation.
4.4 Special warning and precautions for use
To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with Dandrazol 2% Shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported, although rarely, with the use of ketoconazole containing shampoos (see Undesirable Effects).
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with cold water.
4.5 Interaction with other medicinal products and other forms of interaction
Topical corticosteroids: To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with Dandrazol 2% Shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
4.6 Pregnancy and lactation
Since no ketoconazole is detected in plasma following topical administration, pregnancy and lactation are not a contraindication for the use of Dandrazol 2% Shampoo.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported, although rarely, with the use of ketoconazole containing shampoos.
As with other shampoos, a local burning sensation, itching, irritation and oily/dry hair may occur, but are rare, when using shampoos containing ketoconazole.
In some patients with permanently waved, “permed” hair, use of ketoconazole containing shampoos results in loss of the curl.
In rare instances, mainly in patients with chemically damaged hair or grey hair, discolouration of the hair has been observed.
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 national reporting system in the United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
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
ATC Code: D01A C08 (Topical use). Ketoconazole is an imidazole-dioxolane antimycotic.
Ketoconazole has a potent antimycotic activity against pathogenic dermatophytes and yeasts including Pityrosporum spp.
5.2. Pharmacokinetic properties
Ketoconazole does not appear to be appreciably absorbed systemically following topical application of a 2% shampoo to skin. Ketoconazole was not detected in plasma of patients receiving topical application of 2% shampoo 4-10 times weekly for 6 months, or in patients using 2% shampoo 2-3 times weekly for an average of 16 months. Following a single topical application, substantial amounts of the drug were detected in hair 12 hours after application; however only 5% of the applied ketoconazole was detected in hair keratin. Following repeated (twice weekly for 2 months) application, 20% of the applied dose was detected in hair keratin.
5.3. Preclinical safety data
In vitro studies using ketoconazole in a microbial system (i.e., Ames test) have not shown the drug to be mutagenic. In addition, there was no evidence of mutagenicity in any stage of germ cell development in a dominant lethal mutation test in mice who received single oral doses of ketoconazole as high as 80 mg/kg. There was no evidence of carcinogenicity in a long-term feeding study in mice and rats. Hepatotoxicity featured prominently in high dose toxicology studies in animals and occurs in about 1 in 10,000 patients.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium laureth sulfate Disodium laureth sulfosuccinate PEG-120 Methyl glucose dioleate PEG-7-Glyceryl Cocoate Imidurea
Lauryldimonium hydroxypropyl hydrolysed collagen
Cocamide DEA
Sodium hydroxide
Sodium chloride
Erythrosine C.I. 45430 (E127)
Hydrochloric acid concentrated Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
2 years
6.4
Special precautions for storage
Do not store above 25 °C
6.5 Nature and contents of container
White opaque HDPE bottle with PP closure.
Pack sizes 60, 80, 100, 120, 125, 150ml (Dandrazol 2% Shampoo).
6.6 Instructions for use and handling
No special instructions
7. MARKETING AUTHORISATION HOLDER
Transdermal Limited
Grimwade Avenue
Croydon
Surrey
CR0 5DJ
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 14308/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 30/01/2009
10 DATE OF REVISION OF THE TEXT
15/06/2015