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.
Known hypersensitivity to ketoconazole or any of the excipients.
Not applicable
The safety of ketoconazole 2% shampoo was evaluated in 2890 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 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 | ||
| Frequency Category | |||
| Uncommon (>1/1,000 to <1/100) | Rare (>1/10,000 and <1/1,000) | Not Known | |
| Immune System disorders | Hypersensitvity | ||
| 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:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
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.
Pharmacotherapeutic group: Imidazole and triazole derivatives
ATC Code: D01AC08
Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.
Plasma concentrations of ketoconazole were not detectable after topical administration of Oronazol 2% shampoo on the scalp. Plasma levels were detected after topical administration of Oronazol 2% shampoo on the whole body.
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 to 3 weeks, while using Oronazol 2% shampoo, to prevent any potential rebound effect.
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.
Not relevant
For topical administration.
Ketoconazole shampoo 2% is for use in adolescents and adults:
Wash affected areas and leave for 3-5 minutes before rinsing.
Treatment:
| Dandruff and seborrhoeic dermatitis: | Wash hair twice weekly for 2-4 weeks. |
| Tinea versicolor: | Once daily for a maximum of 5 days. |
Prophylaxis:
| Dandruff and seborrhoeic dermatitis: | Use once every 1-2 weeks. |
| Tinea versicolor: | Once daily for a maximum of 3 days before exposure to sunshine. |
No special requirements
