Prescription Required
In stock
Manufacturer
TOLMAR INC.
SKU
63646001004

ketoconazole 2% shampoo

Generic
$10.55 / bottle
$23.58 / bottle
$13.03 / bottle
+ -
1,000 bottles Available
Total Price:

Uses

Dermatophytoses

Ketoconazole is used topically as a 2% cream for the treatment of tinea corporis, tinea cruris, and tinea pedis caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum. The drug also has been used effectively for the topical treatment of tinea manuum caused by Trichophyton and tinea corporis caused by Microsporum. Like other imidazole derivatives (e.g., clotrimazole, econazole, miconazole, oxiconazole, sulconazole) and ciclopirox olamine, ketoconazole has an advantage over some other topical antifungal agents (e.g., nystatin, tolnaftate) in the treatment of mixed infections or for empiric treatment pending identification of the causative organism since the drug is active against both dermatophytes and Candida.

Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; however, an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised because of coexisting disease or concomitant therapy. Many clinicians consider topical imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) or topical allylamine antifungals (e.g., naftifine, terbinafine) the drugs of first choice for the topical treatment of tinea corporis or tinea cruris, although other antifungals (e.g., ciclopirox olamine, butenafine hydrochloride, tolnaftate, undecylenic acid) also can be effective in the treatment of these infections. While topical antifungals usually are effective for the treatment of uncomplicated tinea manuum and tinea pedis, an oral antifungal usually is necessary for the treatment of hyperkeratotic areas on the palms and soles, for chronic moccasin-type (dry-type) tinea pedis, and for the treatment of tinea unguium (onychomycosis).

Clinical studies indicate that ketoconazole 2% cream generally is effective when used once daily for the treatment of tinea corporis, tinea cruris, or tinea pedis. However, in one controlled study, twice-daily application of the cream was more effective than once-daily application for the topical treatment of tinea corporis and tinea cruris. In several controlled studies, ketoconazole 2% cream used twice daily was as effective as clotrimazole 1% cream used twice daily for the treatment of tinea corporis, tinea cruris, or tinea pedis. Ketoconazole 2% cream has been effective in a few patients for the topical treatment of tinea pedis extending beyond interdigital areas (e.g., moccasin-type tinea pedis).

Cutaneous Candidiasis

Ketoconazole is used topically as a 2% cream for the treatment of cutaneous candidiasis caused by C. albicans. Like other imidazole derivatives (e.g., clotrimazole, econazole, miconazole, oxiconazole, sulconazole) and ciclopirox olamine, ketoconazole has an advantage over some other topical antifungals (e.g., nystatin, tolnaftate) in the treatment of mixed infections or for empiric treatment pending identification of the causative organism since the drug is active against both dermatophytes and Candida.

Clinical studies indicate that ketoconazole 2% cream generally is effective when used once daily for the treatment of cutaneous candidiasis. In several controlled studies, ketoconazole 2% cream used twice daily was as effective as clotrimazole 1% cream used twice daily for the treatment of cutaneous candidiasis.

Pityriasis (Tinea) Versicolor

Ketoconazole is used topically as a 2% cream or 2% shampoo for the treatment of pityriasis (tinea) versicolor, a superficial infection caused by or presumed to be caused by Malassezia furfur.

Pityriasis (tinea) versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%). However, an oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical agent, in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.

Clinical studies indicate that ketoconazole 2% cream generally is effective when used once daily for the treatment of pityriasis (tinea) versicolor. Safety and efficacy of ketoconazole 2% shampoo for the topical treatment of pityriasis (tinea) versicolor was evaluated in a double-blind, placebo-controlled study in patients with moderately severe, mycologically confirmed infections. A successful response was attained in 73% of those who received a 3-day regimen of once-daily application of 2% ketoconazole shampoo, 69% of those who received a single application of the shampoo, and 5% of those who received placebo; the mycologic clearance rates were 84, 78, and 11%, respectively. The difference in efficacy between the 2 shampoo regimens was not statistically significant.

Seborrheic Dermatitis and Dandruff

Ketoconazole is used topically for the treatment of seborrheic dermatitis, including seborrheic dermatitis of the scalp. Ketoconazole also is used topically for self-medication for the reduction of flaking, scaling, and itching associated with dandruff.

Ketoconazole 2% cream is effective when used alone for the topical treatment of seborrheic dermatitis of the face, scalp, chest, or back. The drug has reduced Malassezia ovalis (Pityrosporum ovale) cell counts in affected treated areas, and has improved manifestations of dermatitis (e.g., scaling, pruritus, erythema).

Ketoconazole 2% foam is used for the treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age or older. In a phase 3 randomized, double-blind study in adults and children 12 years of age or older with mild, moderate, or severe seborrheic dermatitis involving the scalp, face, chest, or ears, ketoconazole 2% foam twice daily for 4 weeks was more effective than vehicle foam and noninferior to ketoconazole 2% cream. The foam improved manifestations of dermatitis (erythema, scaling, induration).

Ketoconazole 2% gel is used for the treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age or older. In a phase 3 randomized, double-blind study in adults and children 12 years of age or older with moderate to severe seborrheic dermatitis, ketoconazole 2% gel once daily for 14 days was more effective than gel vehicle and resulted in improvements in manifestations of dermatitis (scaling, erythema, pruritus).

Ketoconazole 1% shampoo is used for self-medication to reduce flaking, scaling, and itching associated with dandruff.

Ketoconazole 2% shampoo has been used for the topical treatment of scalp seborrheic dermatitis and dandruff. Following response to treatment, a prophylactic regimen (e.g., once-weekly application of the 2% shampoo) has prevented relapse.

Other Uses

Ketoconazole 2% cream has been used with good results in combination with a topical corticosteroid (beclomethasone dipropionate or clobetasone butyrate) and an antibacterial agent (fusidate sodium) for the treatment of a variety of dermatoses that frequently involve fungal or bacterial superinfections (e.g., atopic dermatitis, diaper rash, eczema, folliculitis, impetigo, intertrigo, lichenoid dermatitis, psoriasis).

An extemporaneously prepared ophthalmic suspension containing ketoconazole 2% has been used with some success in a limited number of patients for the topical treatment of fungal keratitis caused by Alternaria, Aspergillus, Fusarium, or Mycelia sterilia. However, in rabbits, ketoconazole has generally been ineffective for the topical treatment of Aspergillus fumigatus keratitis or C. albicans corneal infections.Commercially available ketoconazole cream, foam, gel, and shampoo should not be applied to the eye.

For other uses of ketoconazole,

Dosage and Administration

Administration

Ketoconazole is applied topically to the skin as a 2% cream, foam, gel, or shampoo.

Ketoconazole is applied topically to the hair and scalp as a 1% shampoo. The drug also has been applied topically to hair and scalp as a 2% shampoo.

Ketoconazole topical cream, foam, gel, and shampoo are for external use only. These topical preparations should not be applied to the eyes and should not be administered orally or intravaginally.

If contact with eyes, mouth, or vagina occurs, the exposed areas should be rinsed thoroughly with water.

Fire, flame, and/or smoking should be avoided during and immediately after application of ketoconazole 2% foam or gel. (See Cautions: Precautions and Contraindications.)

Dosage

Dermatophytoses

For the topical treatment of tinea corporis, tinea cruris, or tinea pedis, a sufficient amount of ketoconazole 2% cream should be applied and rubbed gently into the affected and surrounding area of skin once daily. The cream also has been applied twice daily, and there is some evidence that a twice-daily regimen may occasionally be more effective than a once-daily regimen for the treatment of tinea corporis or tinea cruris.

Although clinical improvement and relief of symptoms usually occur within the first week of therapy, tinea corporis and tinea cruris generally should be treated for 2 weeks and tinea pedis should be treated for 6 weeks to reduce the possibility of recurrence. If clinical improvement does not occur after the recommended treatment period, the diagnosis should be reevaluated. Patients with chronic moccasin-type (dry-type) tinea pedis may require more prolonged therapy.

Cutaneous Candidiasis

For the topical treatment of cutaneous candidiasis, a sufficient amount of ketoconazole 2% cream should be applied and rubbed gently into the affected and surrounding area of skin once daily. The cream also has been applied twice daily.

Although clinical improvement may be seen earlier, cutaneous candidiasis should be treated for 2 weeks to reduce the possibility of recurrence. If clinical improvement does not occur after the recommended treatment period, the diagnosis should be reevaluated.

Pityriasis (Tinea) Versicolor

For the topical treatment of pityriasis (tinea) versicolor, a sufficient amount of ketoconazole 2% cream should be applied and rubbed gently into the affected and surrounding area once daily for 2 weeks.

Alternatively, ketoconazole 2% shampoo should be applied to the damp skin of the affected area and a wide margin surrounding this area and lathered; after 5 minutes, the area should be rinsed with water. A single application of ketoconazole 2% shampoo should be sufficient, although once-daily application for 3 days also has been used.

If clinical improvement does not occur after the recommended treatment period, the diagnosis should be reevaluated. Pityriasis (tinea) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that 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 sun exposure. Although pityriasis (tinea) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

Seborrheic Dermatitis and Dandruff

2% Cream

For the treatment of seborrheic dermatitis, a sufficient amount of ketoconazole 2% topical cream should be applied and rubbed gently into affected areas twice daily for 4 weeks or until clinical clearing. If clinical improvement is not evident after 4 weeks of therapy, the diagnosis should be reevaluated.

2% Foam

For the treatment of seborrheic dermatitis in adults and children 12 years of age or older, a sufficient amount of ketoconazole 2% topical foam should be applied to affected areas twice daily for 4 weeks.

The can containing ketoconazole 2% foam should be held upright and a small amount of the foam sprayed into the cap of the can or other cool surface. The foam should not be dispensed directly onto the affected areas or onto hands since the foam will begin to melt immediately on contact with warm skin. If the fingers are warm, they should be rinsed in cold water and dried before handling the foam. Using the fingertips, small amounts of the foam should be massaged gently onto affected areas until the foam disappears and the entire affected area has been treated.

2% Gel

For the treatment of seborrheic dermatitis in adults and children 12 years of age or older, ketoconazole 2% topical gel should be applied sparingly in a thin film to affected areas once daily for 2 weeks.

Hands should be washed before and after applying the gel. Sunscreen or cosmetics should not be applied to the affected area until at least 20 minutes after application of ketoconazole gel. Patients should not wash the affected area for at least 3 hours after application of the gel.

1% Shampoo

For self-medication in the control of dandruff in adults and children older than 12 years of age, a sufficient amount of ketoconazole 1% shampoo should be applied to thoroughly wet hair, generously lathered, rinsed thoroughly, and then application, lathering, and rinsing repeated. Application should be repeated every 3 or 4 days for up to 8 weeks as needed or as directed by a clinician. Thereafter, the 1% shampoo should be used as needed to control dandruff.

2% Shampoo

For the treatment of scalp seborrheic dermatitis and dandruff, ketoconazole 2% shampoo has been used to wash the hair and scalp 2 or 3 times weekly for 2-4 weeks. After a response was obtained, the shampoo has been used once weekly every other week to prevent relapse.

Cautions

Adverse Effects

Topically applied ketoconazole appears to have a low order of toxicity and is generally well tolerated.

Adverse effects have been reported in up to 5% of patients receiving topical ketoconazole 2% cream and have consisted principally of local reactions such as severe irritation, pruritus, and stinging. A painful allergic reaction, consisting of localized swelling and inflammation, occurred in at least one patient receiving ketoconazole 2% cream.

Rarely, ketoconazole 2% cream or one of its excipients (e.g., sodium sulfite, prophylene glycol) has been associated with contact dermatitis. Topical application of ketoconazole 2% foam may cause contact sensitization or photoallergenicity.

Contact dermatitis has been reported following topical application of other imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, miconazole, oxiconazole, sulconazole, tioconazole). Cross-sensitization appears to occur among the imidazole derivatives; however, cross-sensitivity appears to be unpredictable. The fact that patients with contact sensitivity to one imidazole-derivative azole antifungal may be sensitive to other similar drugs should be considered.

Some formulations of ketoconazole 2% cream contain sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown, but probably low; such sensitivity appears to occur more frequently in asthmatic than in nonasthmatic individuals.

The most frequently reported adverse effects in patients using topical ketoconazole 2% foam include burning and application site reactions. Application site reactions reported in up to 1% of patients include dryness, erythema, irritation, paresthesia, pruritus, rash, and warmth.

The most frequently reported adverse effects in patients using topical ketoconazole 2% gel are burning at the application site and headache. In studies evaluating the potential of topical ketoconazole 2% gel for causing dermal irritation, contact sensitization, or phototoxic or photoallergenic reactions, the gel caused irritation, but did not cause contact sensitization, phototoxicity, or photoallergenicity.

Following topical application of ketoconazole 2% shampoo to the skin, adverse effects include pruritus, application site reaction, and dry skin. Adverse effects reported following topical application of ketoconazole 2% shampoo to the scalp include increased hair loss, irritation, abnormal hair texture, scalp pustules, dry skin, pruritus, and oiliness or dryness of the hair and scalp. In some patients with permanently waved (''permed'') hair, use of ketoconazole 2% shampoo resulted in loss of the curl.

Although hepatotoxicity, decreased testosterone concentrations, and decreased corticotropin (ACTH)-induced corticosteroid concentrations have been reported with oral ketoconazole, these adverse effects have not been reported with topical ketoconazole and are unlikely since the drug does not appear to be appreciably absorbed following topical application to skin.

Precautions and Contraindications

Ketoconazole 2% cream, gel, and shampoo are contraindicated in individuals with known hypersensitivity to the drug or any ingredient in the formulation.

Patients should be instructed to contact their clinician if signs or symptoms of irritation or sensitization occur. If a reaction suggesting sensitivity or chemical irritation occurs during treatment with ketoconazole cream, foam, gel, or shampoo, the drug should be discontinued.

Patients should be instructed to use topical ketoconazole for the full, prescribed treatment period, even if symptoms improve, and to contact their clinician if their skin condition does not improve after a full course of therapy.

Ketoconazole 2% gel or foam is used only for the treatment of seborrheic dermatitis. The safety and efficacy of the foam or gel for the treatment of fungal infections have not been established.

Commercially available ketoconazole 2% cream, foam, or gel is intended for topical application to the skin only and should not be applied to the eyes and should not be administered intravaginally. The 1 and 2% shampoos also are intended for topical application only and should not be applied to the eyes; if contact with the eyes occurs, the eyes should be rinsed thoroughly with water.

Patients receiving ketoconazole 1% shampoo for self-medication of dandruff should be advised to not use the shampoo if the scalp is broken or inflamed and to avoid contact with the eyes. They also should be advised to discontinue the shampoo and contact a clinician if rash occurs or the condition worsens or does not improve within 2-4 weeks since these may be signs of a serious condition.

Ketoconazole 2% foam and gel are flammable. Patients should be advised to avoid fire, flame, and/or smoking during and immediately after application of the gel or foam.

Pediatric Precautions

Safety and efficacy of ketoconazole 2% cream have not been established in children. Topical ketoconazole 2% cream has been used without unusual adverse effect in a limited number of children 2 days to 12 years of age.

Safety and efficacy of ketoconazole 2% foam or gel have not been established in children younger than 12 years of age.

Safety and efficacy of ketoconazole 2% shampoo have not been established in children. Safety and efficacy of ketoconazole 1% shampoo for self-medication have not been established in children younger than 12 years of age.

Mutagenicity and Carcinogenicity

In vitro studies using ketoconazole in a microbial system (i.e., Ames test) have not shown the drug to be mutagenic. In addition, there was no evidence of mutagenicity in any stage of germ cell development in a dominant lethal mutation test in mice who received single oral doses of ketoconazole as high as 80 mg/kg. There was no evidence of carcinogenicity in a long-term feeding study in mice and rats.

Pregnancy and Lactation

Ketoconazole 2% cream, foam, gel, or shampoo should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Pregnant women considering self-medication with ketoconazole 1% shampoo should consult a clinician before using the preparation.

Ketoconazole has been teratogenic and has caused webbing of the feet and absence of toes in the fetus when given orally to pregnant rats in a dosage of 80 mg/kg daily (10 times the maximum recommended human oral dosage). The drug has also been found to be embryotoxic in rats when given during the first trimester of pregnancy and has caused dystocia when given during the third trimester. Although these effects may reflect a particular sensitivity of female rats to ketoconazole (maternal toxicity), there are no adequate and controlled studies to date using ketoconazole in pregnant women.

Since it is not known whether ketoconazole is distributed into milk following topical application, the manufacturers of ketoconazole 2% cream recommend that a decision be made to discontinue nursing or the cream. The manufacturers of ketoconazole 2% foam and gel state the drugs should be used with caution in nursing women. Although ketoconazole 2% shampoo is not detected in plasma following chronic application, the shampoo should be used with caution in nursing women. Nursing women considering self-medication with the 1% shampoo should consult a clinician before using the preparation.

Pharmacokinetics

Absorption

Ketoconazole does not appear to be appreciably absorbed systemically following topical application to skin or scalp.

In one study in healthy adults with intact skin, ketoconazole was not detected (lower limits of detection 5 ng/mL) in blood during the 72-hour period immediately following a single topical application to the chest, back, and arms of 10 g of ketoconazole 2% cream (200 mg of ketoconazole). Following topical application of 80 mg of ketoconazole 2% cream to intact or abraded skin of beagles once daily for 28 days, ketoconazole was not detected in plasma (lower limits of detection 2 ng/mL). In an in vitro model using human skin, ketoconazole was retained in the stratum corneum and boundary of the stratum corneum and stratum granulosum for up to 16 hours following topical application of radiolabeled ketoconazole cream; little or no drug appeared to penetrate into deeper layers of the epidermis.

In a study in patients with moderate to severe seborrheic dermatitis, topical application of ketoconazole 2% foam (3 g of ketoconazole) twice daily for 4 weeks resulted in plasma ketoconazole concentrations that were less than 6 ng/mL in 75% of patients; the maximum plasma concentration reported was 11 ng/mL.

In a study in patients with severe seborrheic dermatitis (1-14% of body surface area), topical application of ketoconazole 2% gel once daily for 2 weeks (daily dose 0.05-3.47 g), the mean peak plasma concentration was 1.35 ng/mL on day 7 and 0.8 ng/mL on day 14.

Ketoconazole was not detected in plasma of patients who shampooed with ketoconazole 2% shampoo 4-10 times weekly for 6 months or 2-3 times weekly for an average of 16 months (range: 3-26 months). Following topical application of ketoconazole 2% shampoo (50 mg/kg) daily for 28 days to intact or abraded skin of rabbits (drug remained on skin for 1 hour before being washed away), ketoconazole was not detected in plasma (lower limits of detection 5 ng/mL). Following a single topical application of ketoconazole 2% shampoo, substantial amounts of the drug were detected on hair 12 hours after application; however only 5% of the applied ketoconazole was detected in hair keratin. Following repeated (twice weekly for 2 months) application of ketoconazole 2% shampoo, 20% of the applied dose was detected in hair keratin.

Small amounts of ketoconazole are absorbed systemically when the drug is administered intravaginally. Following intravaginal administration of 400 mg of ketoconazole as a vaginal suppository in healthy women, peak plasma ketoconazole concentrations ranged from undetectable to 20.7 ng/mL.

For information on absorption following oral administration and information on the distribution and elimination of ketoconazole, see Pharmacokinetics in Ketoconazole 8:14.08.

Write Your Own Review
You're reviewing:KETOCONAZOLE 2% SHAMPOO
Your Rating