Dosing & Uses
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
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
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
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.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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| 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 % shampoo |  | |
| ketoconazole topical - | 2 % cream |  | |
| ketoconazole topical - | 2 % cream |  | |
| ketoconazole topical - | 2 % cream |  | |
| ketoconazole topical - | 2 % cream |  | |
| ketoconazole topical - | 2 % cream |  | |
| ketoconazole topical - | 2 % foam |  | |
| ketoconazole topical - | 2 % foam |  | |
| 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 % cream |  | |
| ketoconazole oral - | 200 mg tablet |  | |
| ketoconazole oral - | 200 mg tablet |  | |
| ketoconazole oral - | 200 mg tablet |  | |
| Nizoral A-D topical - | 1 % shampoo |  | |
| Xolegel topical - | 2 % gel |  | |
| Ketodan topical - | 2 % foam |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ketoconazole oral
KETOCONAZOLE - ORAL
(kee-toe-CON-uh-zole)
COMMON BRAND NAME(S): Nizoral
WARNING: Ketoconazole can cause serious (possibly fatal) side effects and drug interactions. It should only be used when other treatments have not worked, are not available, or cannot be taken by you. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for fungal infections, with your doctor.Ketoconazole has rarely caused very serious (possibly fatal) liver problems. Get medical help right away if you develop symptoms of liver problems, including nausea/vomiting that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin, loss of appetite, or light colored stools. To reduce your risk for liver problems, your doctor should obtain liver function tests every week while you are taking this medication. Do not drink alcoholic beverages while taking ketoconazole because alcohol increases the risk of serious liver problems. See also Notes section.Ketoconazole must not be used with certain other medications because a serious, possibly fatal, drug interaction may occur. Ketoconazole interacts with drugs such as disopyramide, dofetilide, dronedarone, methadone, pimozide, quinidine, ranolazine, among others. These interactions may increase the risk of a certain condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. Tell your doctor and pharmacist about all the medications and products you may be taking before you start ketoconazole treatment. See also Precautions section.
USES: See also Warning section.Ketoconazole is used to treat certain serious fungal infections in the body. Ketoconazole belongs to the class of drugs called azole antifungals. It works by stopping the growth of the fungus.Ketoconazole should not be used to treat fungal infections on the skin and nails due to the risk of serious side effects and drug interactions. Talk to your doctor about other medications you can use to treat these types of infection.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ketoconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once a day. This medication may be taken with or without food, but taking it with food helps to reduce stomach upset.If you are taking an antacid, take ketoconazole at least 2 hours before or 1 hour after taking the antacid, otherwise ketoconazole may not be absorbed into the body. See also Drug Interactions for more information.The dosage and length of treatment is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). In children, the dosage is also based on weight. It may take from several days to several months to complete treatment.This medication works best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: See also Warning section.Nausea and vomiting may occur. If any of these effects last or get worse, tell 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 you have any serious side effects, including: headache, vision changes, mental/mood changes (such as depression, thoughts of suicide).Although unlikely, when ketoconazole is used at high doses, it may cause an adrenal gland problem (adrenal insufficiency), a decrease in testosterone levels, and a decrease in sperm production. Ketoconazole can also worsen existing adrenal gland function problems (See also Precautions section). The adrenal gland problem may make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication. Your doctor may order a blood test to monitor your adrenal gland function while you are taking ketoconazole. These effects usually go away after ketoconazole treatment is stopped. Tell your doctor right away if you have any serious side effects, including: unusual tiredness, weakness, dizziness upon standing, diarrhea, weight loss, menstrual period changes, decreased sexual interest or ability, enlarged/tender breasts in men.Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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: See also Side Effects section.Before taking ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to levoketoconazole; or to other azole antifungal drugs (such as fluconazole, itraconazole); 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, especially of: liver problems, alcohol use, low testosterone levels, decreased adrenal gland function problems (such as low cortisol levels, Addison's disease, adrenal insufficiency), little or no stomach acid production (achlorhydria).Ketoconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ketoconazole, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ketoconazole safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not drink alcoholic beverages while taking this medication because alcohol increases the risk of serious liver problems. Avoiding alcoholic beverages will also decrease the risk of a rare reaction with ketoconazole that may result in flushing, headache, and nausea.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also Warning and How to Use sections.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Ketoconazole interacts with many prescription and nonprescription drugs. While you are taking ketoconazole, it is very important to tell your doctor or pharmacist of any changes in medications that you are taking.Some products that may interact with this drug include: other drugs that can cause liver problems (such as acetaminophen).Other medications can affect the removal of ketoconazole from your body, which may affect how ketoconazole works. Examples include isoniazid, nevirapine, rifamycins (such as rifabutin, rifampin), St. John's wort, among others.This medication can slow down the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include some benzodiazepines (such as alprazolam, midazolam, triazolam), domperidone, eletriptan, eplerenone, ergot drugs (such as ergotamine), nisoldipine, drugs used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), some drugs used to treat seizures (such as phenytoin), some statin drugs (such as lovastatin, simvastatin), among others.Ketoconazole requires acid in the stomach to be well absorbed. If you are taking drugs that decrease the amount of stomach acid including antacids, heartburn/ulcer drugs (H2 blockers such as cimetidine, famotidine, ranitidine), sucralfate, or if you are taking drugs that slow down gut movement (anticholinergics such as dicyclomine, propantheline), take ketoconazole at least 2 hours before any of these drugs. If you are taking proton pump inhibitors (PPIs such as lansoprazole, omeprazole), ask your doctor or pharmacist for advice on how to reduce or avoid this interaction.Ketoconazole is very similar to levoketoconazole. Do not use medications containing levoketoconazole while using ketoconazole.
OVERDOSE: 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.Lab and/or medical tests (such as liver function, INR) must be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.
Information last revised December 2022. Copyright(c) 2023 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.
Formulary
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