Indications of Ketoral 200 mg

Ketoral 200 mg 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.

Theropeutic Class

Drugs for subcutaneous and mycoses

Pharmacology

Ketoral 200 mg 2percent 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. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floc-cosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).

Dosage and Administration of Ketoral 200 mg

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 exposure to sunshine. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Interaction of Ketoral 200 mg

No information was found for Shampoo form of Ketoral 200 mg.

Contraindications

Ketoral 200 mg therapeutic shampoo is contraindicated in persons who have shown hypersensitivity to Ketoral 200 mg or any of the excipient.

Side Effects of Ketoral 200 mg

In 11 double-blind trials in 264 patients using Ketoral 200 mg 2percent shampoo for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1percent 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 Ketoral 200 mg 2percent Shampoo (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5percent), 7 (7percent) and 4 (4percent) 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 3percent of the patients in any one of the three groups. In worldwide experience with Ketoral 200 mg 2percent Shampoo there have been rare reports of hair discoloration.

Pregnancy and 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 Ketoral 200 mg 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 Ketoral 200 mg. No effects on the breastfed newborn/infant are anticipated. Plasma concentrations of Ketoral 200 mg were not detectable after topical administration of Ketoral 200 mg shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoral 200 mg shampoo on the whole body. There are no known risks associated with the use of Ketoral 200 mg shampoo in pregnancy or lactation. Ketoral 200 mg shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Precautions and 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 Ketoral 200 mg 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 Ketoral 200 mg

No specific information is available on the treatment of overdosage with Ketoral 200 mg 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.