Description
Generics:
Ketoconazole
Dosage Form:Â Shampoo.
Indications:
Shampoo: Ketoconazole shampoo is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).
Pharmacology:
Ketoconazole interacts with 14-α-sterol demethylase, a cytochrome P-450 enzyme necessary for the conversion of lanosterol to ergosterol. This results in inhibition of ergosterol synthesis and increased fungal cellular permeability due to reduced amounts of ergosterol present in the fungal cell membrane. This metabolic inhibition also results in accumulation of 14α-methyl-3,6-diol, a toxic metabolite. The increase in membrane fluidity is also thought to produce impairment of membrane-bound enzyme systems as components become less closely packed.
Dosage guideline:
Shampoo: The affected areas of the skin or the scalp should be washed with ketoconazole 2% shampoo, which should be left on the skin/scalp for 3 to 5 minutes before rinsing.
Treatment:
- Pityriasis versicolor: Once daily for 5 days.
- Seborrhoeic dermatitis and pityriasis capitis: Twice weekly for 2 to 4 weeks.
Prophylaxis:
- Pityriasis versicolor: Once daily for 3 days during a single treatment course before the summer.
- Seborrhoeic dermatitis and pityriasis capitis: Once every 1 or 2 weeks.
Route of administration: Scalp.
Interaction:
Shampoo and Cream:Â No information was found.
Contraindications:
Contraindicated in patients with known hypersensitivity to ketoconazole.
Side Effects:
Shampoo:Â Topical treatment with ketoconazole shampoo 2% is generally well tolerated. As with other shampoos, a local burning sensation, itching or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hair have been reported rarely with the use of ketoconazole shampoo 2%.
 Pregnancy & Lactation:
Shampoo: Since ketoconazole is not absorbed through the skin after topical application, pregnancy and lactation are not a contraindication for the use of ketoconazole shampoo 2%.
 Precautions & Warnings:
Shampoo: 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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole shampoo 2%, to prevent any potential rebound effect. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of ketoconazole shampoo 2%. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.
 Therapeutic Class:
Drugs for subcutaneous and mycoses
 Storage Conditions:
Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.
Manufactured by: Incepta Pharmaceuticals Ltd.
