Ketoconazole Information
Ketoconazole ()
Ketoconazole () Description
Ketoconazole () Shampoo, 2% is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent Ketoconazole () in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium laureth sulfosuccinate, FD & C Red No. 40, hydrochloric acid, imidurea, laurdimonium hydroxypropyl hydrolyzed collagen, PEG-120 methyl glucose dioleate, purified water, sodium chloride, sodium hydroxide, and sodium lauryl ether sulfate.
Ketoconazole () is -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:
Ketoconazole () Clinical Pharmacology
Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by (). This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and 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 restoration 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 skin exposure. The rate of recurrence of infection is variable.
Ketoconazole () was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months).
An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of Ketoconazole () shampoo, 2% was significantly less than that of 2.5% selenium sulfide shampoo.
A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to Ketoconazole () shampoo, 2%.
Ketoconazole () Indications And Usage
Ketoconazole () Shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by (also known as or ).
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.
Ketoconazole () Contraindications
Ketoconazole () Shampoo, 2% is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
Ketoconazole () Precautions
Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Ketoconazole () shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Patients should be advised of the following:
● Ketoconazole () Shampoo, 2% 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 () shampoo, 2%: 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 Ketoconzole Shampoo, 2% and contact their physician immediately.
Ketoconazole () Adverse Reactions
In 11 double-blind trials in 264 patients using Ketoconazole () shampoo, 2% 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 Ketoconazole () shampoo, 2% (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 () shampoo, 2% there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, 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.
Ketoconazole () Overdosage
Ketoconazole () Shampoo, 2% 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 () 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.
Ketoconazole () How Supplied
Ketoconazole () Shampoo, 2% is a red-orange liquid and is available as follows:
4 fl. oz. nonbreakable plastic bottle (NDC 45802--64)
Ketoconazole ()
Ketoconazole ()
Ketoconazole () Principal Display Panel
Rx Only
Ketoconazole () Shampoo, 2%
For Topical
Application Only
