ODESSY SHAMPOO® – Ketoconazole BP

Chemical Name:
cis-1-acetyl-4-[4-[2-(2,4-dichlorophenyl)-2-(1H-imidazole-1-ylmethyl)-1,3-dioxolan-4-ylmethyl] phenyl] piperazine

Description:ODESSY SHAMPOO® is an antifungal medication used to treat a number of fungal infections. Applied to the skin it is used for fungal skin infections such as tinea, cutaneous candidiasis, pityriasis versicolor, dandruff, and seborrheic dermatitis.

— 5ml x 60 Sachet
— 60 ml Bottle

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ODESSY SHAMPOO® – Ketoconazole BP

COMPOSITION
Each ml shampoo contains Ketoconazole BP 20 mg.

PHARMACOLOGY
Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the growth of dermatophytes, such as Trichophyton sp. Epidermophyton sp. Microsporum sp. and yeasts, such as Candida sp. and Malassezia sp. (Pityrosporum sp.).

INDICATION
ODESSY® Shampoo is indicated in the treatment of * Dandruff (Pityriasis capitis)
* Pityriasis versicolor (localized)
* Inflammatory skin condition with greasy, red and scaly areas (Seborrheic dermatitis).

DOSAGE AND ADMINISTRATION
* Apply a small quantity of Odessy shampoo to the scalp.
* Use only a small amount of water to ensure a high concentration of Odessy shampoo in the Scalp.
* Massage the shampoo in to the all parts of the scalp.
* Leave the medicated Odessy shampoo in contact with the scalp for 5 minutes before rinsing with water.

SIDE EFFECT
Topical treatment with ketoconazole BP 2% shampoo 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 may occur rarely.

PRECAUTION
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy should be gradually withdrawn over a period of 2 or 4 weeks, while using Ketoconazole BP 2% shampoo to prevent any potential rebound effect. Avoid contact with the eyes, if the shampoo enters into the eyes, rinse immediately with plenty of water.

CONTRAINDICATION
It is contraindicated for known hypersensitivity to Ketoconazole or any of the excipients.

DRUG INTERACTION
No information was found for the shampoo form of ketoconazole.

USE IN PREGNANCY & LACTATION
Ketoconazole is not detected in plasma after chronic shampooing that’s why Ketoconazole BP 2% shampoo is not contraindicated in pregnancy and lactation.

USE IN CHILDREN
Safety and efficacy have not been established.

STORAGE
Store tablet and powder for suspension at or below 30°C. Protect from light & moisture. Keep out of the reach of children.

PACKAGING
ODESSY® SHAMPOO: Bottle: Each plastic bottle containing 60 ml shampoo.
ODESSY® SHAMPOO: Sachet: Each sachet contains 5 ml shampoo.

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