Ketoconazole

Ketoconazole is an antifungal medication used to treat dandruff, seborrheic dermatitis, ringworm, jock itch, and tinea versicolor caused by fungal and yeast infections. Ketoconazole is available as ketoconazole cream, shampoo, and tablets.

Ketoconazole works by damaging the fungal cell membrane and stopping fungal growth, which helps clear the fungal infection and improve symptoms of itching, redness, scaling, and discoloration. Ketoconazole is an imidazole antifungal.

Ketoconazole cream is applied once or twice daily to the affected area. Ketoconazole shampoo is used every 3 or 4 days for dandruff, or one application when treating Tinea versicolor:

Ketaconazole cream, tablets, and shampoo (2%) are prescription medicines. Ketoconazole 1% shampoo is available over the counter (OTC) without a prescription.

Ketoconazole Cream Uses

Ketoconazole cream is used treat common fungal skin infections, including:

• Ringworm (Tinea corporis) – red, scaly, circular rashes on the body
• Jock itch (Tinea cruris) – fungal infection of the groin or buttocks
• Athlete’s foot (Tinea pedis) – fungal infection of the feet and between toes
• Pityriasis (Tinea versicolor) – brown or light-colored patches on the chest, back, arms, legs, or neck
• Cutaneous yeast infections (cutaneous candidiasis) – yeast infections often affect warm, moist areas such as skin folds, diaper area, or corners of the mouth.

Ketoconazole Shampoo Uses

• Ketoconazole shampoo (2%) is used to treat tinea versicolor
• Ketoconazole shampoo (1%) is used for dandruff, flaky scalp, and seborrheic dermatitis.

Ketoconazole is not FDA-approved for use in treating fungal infections of the fingernails or toenails, cutaneous dermatophyte infections, or Candida infections

This medicine is not FDA-approved for use in treating prostate cancer or Cushing syndrome.

Ketoconazole mechanism of action is to inhibit the fungal cytochrome P450 enzyme 14-α-demethylase, which is required to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, this stops fungal growth, and may kill fungal cells if ketoconazole reaches high concentrations.

Ketoconazole should not be used in people who are allergic to it or any of the inactive ingredients. Ketoconazole cream contains a sulfite that may cause severe allergic reactions or asthma attacks in some people.

Pediatric Use: Safety and effectiveness in children have not been established.

You should not use ketoconazole cream or shampoo if you are allergic to it or any of the inactive ingredients. Do not use the shampoo on skin that is broken or inflamed. Avoid getting this medicine in your eyes, mouth, or vagina.

Pregnancy: It is not known whether ketoconazole cream or shampoo will harm an unborn baby. Ask your doctor before use.

Breastfeeding: Check with your doctor or healthcare professional before using this medicine if breastfeeding. If you are breastfeeding, do not apply this medicine directly to the nipple or areola to avoid exposing your baby to the drug.

Ketoconazole cream side effects include severe irritation, itching, stinging, and allergic reactions.

Ketoconazole shampoo side effects include itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, hair loss (alopecia), rash, urticaria, skin irritation, dry skin, hair discoloration and abnormal hair texture, application site reactions, and allergic reactions.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Ketoconazole Cream

Apply ketoconazole cream to the affected and surrounding area.

• Tinea versicolor: once daily, usually for 2 weeks.
• Tinea pedis: once daily, usually for 6 weeks.
• Seborrheic dermatitis: twice daily for 4 weeks or until clinical clearing.

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

Ketoconazole Shampoo

Ketoconazole 1% shampoo for scalp flaking, scaling, and itching associated with dandruff.

• Wet hair and apply shampoo, generously lather, then rinse thoroughly and repeat.
• Use every 3 or 4 days for up to 8 weeks or as directed by your doctor. Then use only as needed to control dandruff.

Ketoconazole 2% shampoo for Tinea versicolor:

• 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.

Tinea versicolor (pityriasis) 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 will not immediately normalize the pigment in the affected sites. Fading of patches following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Tinea versicolor may recur because the organism that causes the disease is part of the normal skin flora.

Store at room temperature away from moisture, heat, and light.

Do not share this medicine with another person, even if they have the same symptoms you have.

Ketoconazole Foam for Seborrheic Dermatitis: Apply ketoconazole foam to the affected area twice daily for 4 weeks. Dispense the foam directly into the cap or onto a cool surface. Do not dispense it directly onto your hands, because the foam will begin to melt on contact with warm skin. Apply to the affected areas using your fingertips and wash your hands after application.

Store the foam at room temperature. Do not refrigerate or freeze. Keep away from heat and do not store at temperatures above 120°F (49°C). Do not puncture the can or throw it into a fire, even if empty.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

For tablets, or if the topical medicine is swallowed, seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ketoconazole could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Ketoconazole foam is flammable. Avoid fire, flames, or smoking during and right after you apply the foam to your skin.