Full Prescribing Info
Each ml of shampoo contains: Ketoconazole USP 20 mg/ml (2% w/v).
Excipients/Inactive Ingredients: Cocodiethanolamide, sodium lauryl ether sulphate, disodium monolauryl ether sulfosuccinates, macrogol 120 methyl glucose dioleate, propylene glycol, conc. hydrochloric acid, sodium chloride, sodium hydroxide, butylated hydroxytoluene, imidurea, colour ponceau 4R, fragrance CK D00923 and purified water.
Pharmacotherapeutic group: Imidazole and triazole derivatives. ATC Code: D01AC08.
Pharmacology: Pharmacodynamics: Dermazole contains ketoconazole, which is an synthetic imidazole dioxolane antimycotic active against yeasts, including Malassezia, and dermatophytes. Its broad spectrum of activity is already well known.
Pharmacokinetics: Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole 2% shampoo on the scalp. Plasma levels were detected after topical administration of ketoconazole 2% shampoo on the whole body.
Dermazole is indicated in 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.
Dosage/Direction for Use
Dosage: Ketoconazole shampoo 2% is for use in adolescents and adults.
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 to 2 weeks.
Paediatric population: The safe and effective use of Ketoconazole 2% shampoo in infants and children under the age of 12 years has not been established.
Method of administration: For topical administration.
Wash affected areas and leave for 3 - 5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash.
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.
Special Precautions
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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole shampoo 2% to prevent any potential rebound effect.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.
Effects on Ability to Drive and Use Machines: Not relevant.
Use In Pregnancy & Lactation
There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated (see Pharmacology: Pharmacokinetics under Actions).
Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoconazole shampoo 2% on the whole body. There are no known risks associated with the use of Ketoconazole shampoo 2% in pregnancy or lactation.
Adverse Reactions
The following 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).
Immune System Disorders: Rare: Hypersensitivity.
Nervous System Disorders: Rare: Dysgeusia.
Infections and Infestations: Uncommon: Folliculitis.
Eye Disorders: Uncommon: Increased lacrimation.
Rare: Eye irritation.
Skin and Subcutaneous Tissue Disorders: Uncommon: Alopecia, dry skin, hair texture abnormal, rash, skin burning sensation.
Rare: Acne, dermatitis contact, skin disorder, skin exfoliation.
Not Known: Angioedema, urticaria, hair colour changes.
General Disorders and Administration Site Conditions: Uncommon: Application site erythema, application site irritation, application site pruritus, application site reaction.
Rare: Application site hypersensitivity, application site pustules.
Adverse Drug Reaction: Inform doctors about unexpected reactions after using drugs.
Drug Interactions
No interaction studies have been performed.
Store below 30°C in dry place. Protect from direct sunlight.
Shelf-Life: 48 months.
MIMS Class
Topical Antifungals & Antiparasites
ATC Classification
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
Shampoo 2% (clear viscous liquid of pink colour with specific odour) (bottle) x 50 mL x 1's, 100 mL x 1's.
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