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Ketovid Shampoo

2% w/w

 

Description
Pink, opaque liquid


Composition
Ketoconazole (micronized) 2% w/w


Actions and Pharmacology
Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antifungal activity against dermatophytes, such as Trichophyton spp., Epidermophyton spp., Microsporum spp., and yeasts, such as Candida spp. and Malassezia spp. (Pityrosporum spp.).


Ketovid Shampoo 2% w/w rapidly relieves scaling and pruritus, which are usually associated with seborrhoeic dermatitis, pityriasis capitis (dandruff) and pityriasis versicolor.


Pharmacokinetics
Percutaneous absorption of ketoconazole is negligible as blood levels are not detected, even after chronic use. Systemic effects, therefore, are not expected.


Indications
Treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localised), seborrhoeic dermatitis and pityriasis capitis (dandruff).


Contraindications
It is contraindicated in persons who have shown hypersensitivity to the active ingredient or excipients of this formulation.


Warnings and Precautions
Keep out of eyes. Wash the eyes with water if the shampoo contacts the eyes.
Advise to consult doctor if the scalp has not cleared within 4 weeks.
Persons who are sensitive to miconazole or other imidazoles may be sensitive to ketoconazole also.

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketovid Shampoo 2 % w/w to prevent any potential rebound effect.
Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of Ketovid Shampoo 2% w/w.
 

Drug Interactions
None known
 

Pregnancy and Lactation
Ketovid Shampoo 2% w/w is not contraindicated during pregnancy and lactation as no ketoconazole is detected in the plasma following topical administration.


Main Side/Adverse Effects
Topical treatment with Ketovid Shampoo 2 % w/w is generally well tolerated.
A local burning sensation, itching, or contact dermatitis (due to irritation or allergy) may occur on exposed areas.

Dry skin, dryness or oiliness of the hair and scalp have been reported rarely.
A discolouration of the hair, mainly in patients with chemically damaged hair or grey hair has been observed.

There have been very rare reports of eczema and alopecia.


Overdosage
Ingestion of Ketovid Shampoo 2 % w/w may result in nausea and vomiting due to the detergent. Only supportive measures should be carried out in the event of accidental ingestion.
In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
 

Dosage and Administration
For topical administration,
The affected areas of the skin or the hair should be washed with Ketovid Shampoo, which should be left on the skin for 3 to 5 minutes before rinsing.


Treatment:
Pityriasis versicolor: once daily for 5 days
Seborrhoeic dermatitis and pityriasis capitis: twice weekly for 3 to 4 weeks.


Prophylaxis:
Pityriasis versicolor: once daily for 3 days during a single treatment course before exposure to sunshine.

Seborrhoeic dermatitis and pityriasis capitis: once every one or two weeks.


Storage : Store below 30C. Protect from light.

Presentation/Packing : 120 ml in HDPE Bottle

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