Now im confused.
Indications and Usage for Ketoconazole Shampoo
Ketoconazole 2% shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).
Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
Contraindications
Ketoconazole 2% shampoo is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
Precautions
Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Ketoconazole Shampoo. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Information for Patients:
Patients should be advised of the following:
Ketoconazole 2% shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided.
The following have been reported with the use of ketoconazole 2% shampoo: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.
Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, or shortness of breath should discontinue ketoconazole and contact their physician immediately.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term studies to assess the carcinogenic potential of ketoconazole 2% shampoo have not been conducted. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg were not genotoxic. The Ames Salmonella microsomal activator assay was also negative.
Pregnancy: Teratogenic effects: Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp.
Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
Nursing mothers: There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when ketoconazole 2% shampoo is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children have not been established.
Adverse Reactions
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***8211;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 ketoconazole 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 ketoconazole 2% shampoo there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
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Overdosage
Ketoconazole 2% shampoo is intended for external use only. In the event of accidental ingestion, supportive measures should be employed. Induced emesis and gastric lavage should usually be avoided.
Ketoconazole Shampoo Dosage and Administration
Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.
One application of the shampoo should be sufficient.
How is Ketoconazole Shampoo Supplied
Ketoconazole 2% shampoo is a red-orange liquid supplied in a 4-fluid ounce (120 mL) nonbreakable plastic bottle (NDC 10147-0750-4).
