Summary of Product Characteristics Updated 17-Dec-2019 | Transdermal Limited
Dandrazol 2% Shampoo
For excipients see 6.1
Clear, pink solution.
Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.
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.
* Tinea (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.
The safe and effective use of Dandrazol 2% Shampoo in infants and children under the age of 12 years has not been established.
Hypersensitivity to ketoconazole or any of the other ingredients of the preparation.
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.
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.
Since no ketoconazole is detected in plasma following topical administration, pregnancy and lactation are not a contra-indication for the use of Dandrazol 2% shampoo.
The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or post marketing experiences.
The displayed frequency categories use the following convention:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated form the available clinical trial data).
System Organ Class
Adverse Drug Reactions
(≥1/1,000 to <1/100)
(≥1/10,000 and <1/1,000)
Immune System disorders
Nervous System Disorders
Infections and Infestations
Skin and Subcutaneous Tissue Disorders
Hair texture abnormal
Skin burning sensation
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
ATC Code: D01A C08 (Topical use). Ketoconazole is an imidazole-diozolane antimycotic.
Ketoconazole has a potent antimycotic activity against pathogenic dermatophytes and yeasts including Pityrosporum spp.
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.
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.
Sodium laureth sulfate
Disodium laureth sulfosuccinate
PEG-120 Methyl glucose dioleate
Lauryldimonium hydroxypropyl hydrolysed collagen
Erythrosine C.I. 45430 (E127)
Hydrochloric acid concentrated
Do not store above 25 °C
White opaque HDPE bottle with PP closure.
Pack sizes 60, 80, 100, 120, 125, 150ml.
No special instructions
Reading RG7 4AB
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