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Odessy

Odessy5 ml

Shampoo

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Medicine overview

Indications of Odessy 5 ml

such as dandruffseborrhoeic dermatitis and tinea (pityriasis) versicolor.

Theropeutic Class

Drugs for subcutaneous and mycoses

Pharmacology

Odessy 5 ml 2% shampoo is a broad spectrum imidazole-dioxolane, synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T.

Absorption

mentagrophytes, T. tonsurans, Microsporum canis, M.

Distribution

audouini, M. gypseum and Epidermophyton floc-cosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C.

Metabolism

tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).

Dosage & Administration of Odessy 5 ml

Notes:For topical administration of adults, elderly and children. Wash affected areas and leave for 3-5 minutes before rinsing
Treatment
Dosage:Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks
Tinea versicolor
Dosage:Once daily for a maximum of 5 days
Prophylaxis
Dosage:Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks
Tinea versicolor
Dosage:Once daily for a maximum of 3 days before exposure to sunshine
Notes:If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined

Interaction of Odessy 5 ml

No information was found for Shampoo form of Odessy 5 ml.

Contraindications

Odessy 5 ml therapeutic shampoo is contraindicated in persons who have shown hypersensitivity to Odessy 5 ml or any of the excipient.

Side Effects of Odessy 5 ml

In 11 double-blind trials in 264 patients using Odessy 5 ml 2% shampoo for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of Odessy 5 ml 2% Shampoo (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups. In worldwide experience with Odessy 5 ml 2% Shampoo there have been rare reports of hair discoloration.

Pregnancy & Lactation

Pregnancy Category C. 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 Odessy 5 ml 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 Odessy 5 ml. No effects on the breastfed newborn/infant are anticipated. Plasma concentrations of Odessy 5 ml were not detectable after topical administration of Odessy 5 ml  shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Odessy 5 ml shampoo on the whole body. There are no known risks associated with the use of Odessy 5 ml shampoo in pregnancy or lactation. Odessy 5 ml shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

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 Odessy 5 ml therapeutic shampoo, to prevent any potential rebound effect. Avoid contact with eyes. If the shampoo enters to the eyes, rinse immediately with plenty ofwater.

Overdose Effects of Odessy 5 ml

No specific information is available on the treatment of overdosage with Odessy 5 ml shampoo unless taken at doses higher than the recommended dose. 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.

Storage Conditions

Store at temperature below 25°C away from heat and light. Do not store in the bathroom. Keep away from children and pets.

Use In Special Populations

Pediatric Use: Safety and effectiveness in children have not been established.Geriatric Use: Normal adult dosage is appropriate.

Frequently Asked Questions

What is Odessy 5 ml used for?

Ketoconazole 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.

What is the dosage of Odessy 5 ml?

For topical administration of adults, elderly and children. Wash affected areas and leave for 3-5 minutes before rinsing.Treatment: Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks. Tinea versicolor: Once daily for a maximum of 5 days. Prophylaxis: Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks. Tinea versicolor: Once daily for a maximum of 3 days before exp…

What are the side effects of Odessy 5 ml?

In 11 double-blind trials in 264 patients using ketoconazole 2% shampoo for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustu…

Who should not take Odessy 5 ml?

Ketoconazole therapeutic shampoo is contraindicated in persons who have shown hypersensitivity to Ketoconazole or any of the excipient.

What precautions should be taken with Odessy 5 ml?

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 therapeutic shampoo, to prevent any potential rebound effect. Avoid contact with eyes. If the shampoo enters to the eyes, rinse immediately with plenty ofwater.

Is Odessy 5 ml safe during pregnancy and breastfeeding?

Pregnancy Category C. 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 …

Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.

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