ketoconazole topical (Rx)

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

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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

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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.

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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

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
ketoconazole oral
-
200 mg tablet
ketoconazole oral
-
200 mg tablet
ketoconazole oral
-
200 mg tablet
ketoconazole oral
-
200 mg tablet
Xolegel topical
-
2 % gel
Nizoral A-D topical
-
1 % shampoo
Nizoral A-D topical
-
1 % shampoo
ketoconazole topical
-
2 % foam
ketoconazole topical
-
2 % foam
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % shampoo
ketoconazole topical
-
2 % foam
ketoconazole topical
-
2 % foam
ketoconazole topical
-
2 % shampoo
ketoconazole topical
-
2 % shampoo
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
ketoconazole topical
-
2 % cream
Extina topical
-
2 % foam
Extina topical
-
2 % foam
Ketodan topical
-
2 % foam

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
ketoconazole topical

KETOCONAZOLE CREAM - TOPICAL

(kee-toe-CON-uh-zole)

COMMON BRAND NAME(S): Nizoral

USES: Ketoconazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and certain kinds of dandruff. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Ketoconazole is an azole antifungal that works by preventing the growth of fungus.

HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually once or twice a day or as directed by your doctor. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.Apply enough medication to cover the affected skin and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor.Do not apply this medication in the eyes, nose, mouth, or vagina. If this medication gets in the eyes (for example, when used to treat dandruff), rinse thoroughly with water.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting ketoconazole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.Inform your doctor if your condition persists after the prescribed amount of treatment or worsens at any time.

SIDE EFFECTS: Stinging, swelling, irritation, or redness of the treated skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: blistering, open sores.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or miconazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (such as your doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.When treating pityriasis, this medication may not cause an immediate return to normal skin color. It may take several months after treatment is completed for your natural skin color to return.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from heat and light. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
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Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.