Odessy

Ketoconazole
Topical Preperations

Odessy

Description

Composition:

Each ml shampoo contains Ketoconazole BP 20 mg.

Description:

Ketoconazole is a synthetic imidazole dioxolane derivative, has a potent antifungal activity against dermatophytes, such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts, such as Candida sp. and Malassezia sp. Ketoconazole 2% shampoo rapidly relieves scaling and pruritus, which are usually associated with Seborrhoeic dermatitis, Pityriasis capitis (dandruff) and Pityriasis Versicolor.

Indication:

Odessy  therapeutic shampoo is used for prevention and treatment of infections in which the yeast Malassezia furfur (previously called Pityrosporum orbiculare) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

Dosage guideline:

Dandruff (Twice weekly for 2 to 4 weeks), Seborrhoeic dermatitis (Twice weekly for 2 to 4 Weeks), Pityriasis capitis (Twice weekly for 2 to 4 weeks), Pityriasis versicolor (Once daily for 5 days)

Application instructions:

Take small amount of shampoo in hand  »Apply the shampoo to the affected skin/scalp and a large area around it  »Use a small amount of water to wet the area  »Use fingers to rub the shampoo until it forms lather  »Leave the shampoo on skin/scalp for 5 minutes  »Rinse the shampoo from skin/scalp with water.

Side Effects:

Topical treatment with Ketoconazole 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. In rare instances, mainly in patients with chemically damaged hair or gray hair, a discoloration of the hair has been observed with the use of Ketoconazole 2% shampoo.

Precaution:

In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy is gradually withdrawn over a period of 2 to 3 weeks while using Ketoconazole 2% shampoo to prevent any potential rebound effect. Avoid contact with the eyes. If the shampoo enters the eyes, rinse immediately with plenty of water.

Use in Pregnancy & Lactation:

Since Ketoconazole is not absorbed through the skin after topical application, Ketoconazole 2% shampoo is not contraindicated in pregnancy and lactation.

Use in children:

Safety and efficacy have not been established.

Contraindication:

Odessy  (ketoconazole) 2% Shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

Drug Interaction:

Not known.

Overdosage:

Odessy  (ketoconazole) 2% Shampoo is intended for external use only. In the event of accidental ingestion, supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should not be performed to avoid aspiration.

Storage:

Keep this medication in the container it came in, tightly closed, and out of reach of the children. Store it at room temperature and do not allow it to freeze. Protect the medication from light and keep away from excess heat and moisture.

Commercial Packaging:

Odessy Shampoo Bottle:- Each plastic bottle contains 60 ml of shampoo.

Odessy Shampoo Sachet: Each Sachet contains 5 ml of shampoo.