Kusum Healthcare


Kusum Healthcare
Full Prescribing Info
External liquid contains: Ketoconazole USP 2% w/v (20 mg/mL).
Excipients: 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, purified water.
Pharmacotherapeutic group: Imidazole and triazole derivatives. ATC Code: D01AC08.
Pharmacology: Pharmacodynamics: Ketoconazole is a synthetic imidazole dioxolane antimycotic active against yeasts, including Malassezia, and dermatophytes. Its broad spectrum of activity is already well known.
Ketoconazole also has a direct anti-inflammatory action independent from its antifungal activity which may contribute to symptom relief in dandruff and seborrhoeic dermatitis.
Pharmacokinetics: Plasma concentrations of ketoconazole were not detectable after topical administration of Dermazole shampoo on the scalp. Plasma levels were detected after topical administration of Dermazole shampoo on the whole body.
In the prevention and treatment of the scalp conditions dandruff and seborrhoeic dermatitis.
Dosage/Direction for Use
Adults and adolescents aged over 12 years: Wash affected areas and leave for 3 to 5 minutes before rinsing.
Treatment: Wash the hair every 3 or 4 days for 2 to 4 weeks.
Prophylaxis: Use once, every 1 to 2 weeks.
Do not use more often than directed.
Method of administration: For topical administration.
Wet hair thoroughly. Apply a small amount of Dermazole Shampoo to the scalp and massage into a lather. Leave the lather on the scalp for 3-5 minutes. Rinse thoroughly.
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
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.
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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Dermazole Shampoo, to prevent any potential rebound effect.
If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted.
Effects on ability to drive and use machines: None likely.
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.
Plasma concentrations of ketoconazole were not detectable after topical administration of Dermazole shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Dermazole shampoo on the whole body. There are no known risks associated with the use of Dermazole shampoo in pregnancy or lactation.
Adverse Reactions
The following table displays ADRs that have been reported with the use of Dermazole 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); and not known (cannot be estimated from 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.
Drug Interactions
None known.
Store at temperatures not exceeding 30°C.
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 (bottle) 20 mg/mL (2% w/v) (clear viscous liquid of pink color with specific odor) x 50 mL, 100 mL.
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