Ketoconazole Topical

Ketoconazole Topical is a prescription medicine used to treat the symptoms of fungal infections such as athlete’s foot, jock itch, ringworm, and seborrhoea (dry, flaking skin or dandruff).

• Ketoconazole Topical is available under the following different brand names: Nizoral Topical, Extina, Ketozole, Xolegel

Adult and pediatric dosage

Cream/Gel/Foam

• 2%

Shampoo

• 1%
• 2%

Seborrheic Dermatitis

Adult dosage

• Foam: Apply to the affected area every 12 hours for 4 weeks
• Cream: Apply every 12 hours for 4 weeks or until clear
• Shampoo: Apply twice weekly for 4 weeks, with at least 3 days between each shampoo
• Gel: Apply to affected area once daily for 2 weeks

Pediatric dosage

• Children below 12 years: Safety and efficacy not established
• Children above 12 years (cream/foam): Apply to the affected area every 12 hours for 4 weeks
• Children above 12 years (gel): Apply to affected area once daily for 2 weeks

Dandruff

Adult and pediatric dosage

Shampoo (1%; OTC label)

• Adults and children above 12 years: Use every 3-4 days for up to 8 weeks; then apply only as needed for dandruff control

Tinea Versicolor

Adult dosage 

Shampoo (2%)

• Apply to the affected area of damp skin, lather, wait 5 min, and rinse (one application usually sufficient)

Cream

• Apply once daily to cover affected and immediate surrounding area for 2 weeks

Tinea Corporis, Tinea Cruris, Tinea Pedis

Adult dosage

• Cream: Apply once daily for 2 weeks (6 weeks for tinea pedis), covering the affected area

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ketoconazole Topical include:

• thinning hair,
• changes in the color or texture of hair,
• dry skin, and
• mild itching.

Serious side effects of Ketoconazole Topical include:

• burning, stinging, or severe irritation,
• redness, pain, or oozing of treated skin,
• shortness of breath, and
• signs of an allergic reaction: hives, difficult breathing, swelling of the face, lips, tongue, or throat.

Rare side effects of Ketoconazole Topical include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ketoconazole Topical has no noted severe interactions with any other drugs.
• Ketoconazole Topical has no noted serious interactions with any other drugs.
• Ketoconazole Topical has no noted moderate interactions with any other drugs.
• Ketoconazole Topical has no noted minor interactions with any other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Scalp that is broken or inflamed (OTC self-medication)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ketoconazole Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ketoconazole Topical?”

Cautions

• Discontinue if irritation occurs
• Angioedema reported
• Foam formulation contains alcohol; do not expose to flames or smoking following application of the product
• The gel formulation is flammable; avoid exposure to fire, flames, or smoking during or immediately after application
• Shampoo may discolor hair and change hair texture
• Some formulations contain sulfites, which could cause allergic-type reactions; may also cause severe life-threatening or less severe asthmatic episodes in some patients
• Avoid contact with eyes and other mucous membranes; not for oral, intravaginal, or ophthalmic use; discontinue use and contact health care professional if condition worsens or does not improve

Pregnancy and Lactation

• There are no available data on use in pregnant women to identify a drug-associated risk of birth defects, miscarriage or adverse maternal or fetal outcomes; no reproductive studies in animals have been performed; in animal reproduction studies with pregnant mice, rats, and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis; assuming equivalent systemic absorption of Topical and oral ketoconazole doses and a maximum recommended human dose (MRHD) of 8 grams (equivalent to 160 mg ketoconazole), embryotoxic effects were observed at 0.8 to 2.4 times the MRHD and developmental effects were observed at 4.8 times the MRHD
• Infertility
  • In animal fertility studies in rats and dogs, administration of oral doses of ketoconazole between 3-day and 3-month periods resulted in infertility that was reversible.
• Lactation
  • There is no information available on the presence of ketoconazole in human milk, or effects on the breastfed child, or effects on milk production after Topical application to women who are breastfeeding; in animal studies, ketoconazole was found in milk following oral administration; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from treatment or underlying maternal condition