ketoconazole topical (Rx)

Brand and Other Names:Nizoral Topical, Extina, more...Ketozole, Xolegel
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream/gel/foam

  • 2%

shampoo

  • 1%
  • 2%

Seborrheic Dermatitis

Foam: Apply to affected area q12hr for 4 weeks

Cream: Apply q12hr 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

Dandruff

Shampoo (1%; OTC label)

  • Apply to wet hair, lather, and rinse thoroughly; repeat
  • Use every 3-4 days for up to 8 weeks; then apply only as needed for dandruff control

Tinea Versicolor

Shampoo (2%)

  • Apply to 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

Cream: Apply qDay for 2 weeks (6 weeks for tinea pedis), covering affected area

Dosage Forms & Strengths

cream/gel/foam

  • 2%

shampoo

  • 1%
  • 2%

Seborrheic Dermatitis

<12 years: Safety and efficacy not established

≥12 years (cream/foam): Apply to affected area q12hr for 4 weeks

≥12 years (gel): Apply to affected area once daily for 2 weeks

Dandruff

Shampoo (1%; OTC label)

  • ≥12 years: Apply to wet hair, lather, and rinse thoroughly; repeat
  • Use every 3-4 days for up to 8 weeks; then apply only as needed for dandruff control
Next:

Adverse Effects

1-10%

Irritation, severe

Pruritus

Stinging

Frequency Not Defined

Shampoo

  • Hair loss/alopecia
  • Irritation
  • Abnormal hair texture
  • Scalp pustules
  • Dry skin
  • Pruritus
  • Oiliness/dryness of hair and scalp

Postmarketing Reports

Burning sensation

Pain

Skin irritation

Erythema

Previous
Next:

Warnings

Contraindications

Hypersensitivity

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

Cautions

Discontinue if irritation occurs

Angioedema reported

Foam formulation contains alcohol; do not expose to flames or smoking following application of the product

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

Previous
Next:

Pregnancy & Lactation

Pregnancy

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 presence of ketoconazole in human milk, or effects on 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 breastfed infant from treatment or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

Fungistatic in action, but may be fungicidal at high concentrations after prolonged incubation or against very susceptible organisms

Alters cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition

Absorption

Minimal

Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.