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Ketoconazole is both an over-the-counter and a prescription medication. The over-the-counter form is used to treat dandruff. The prescription form is used to treat serious fungal infections that can spread to different parts of the body.
Ketoconazole belongs to a class of drugs called antifungals, which work by slowing the growth of fungi that cause infection.
This medication comes in tablet form and is taken once daily, with or without food. It is also available as a topical gel, cream, and foam and as a shampoo. A form of the shampoo is available without a prescription.
Common side effects of ketoconazole tablets include nausea, vomiting, stomach pain, and diarrhea. Ketoconazole tablets can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how it affects you.
Ketoconazole is a prescription medication used to treat fungal infections, including the following: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis for patients in which other treatments have failed or who are intolerant to other therapies.
Ketoconazole tablets are not for people with fungal nail infections.
Ketoconazole is also available in topical forms – a gel, cream, foam, and shampoo – to treat forms of dermatitis and fungal infections of the skin. A form of the shampoo is available without a prescription for the treatment of dandruff.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Ketoconazole may be found in some form under the following brand names:
Ketoconazole is part of the drug class:
Serious side effects have been reported. See the “Ketoconazole Precautions” section.
Common side effects of ketoconazole tablets include:
Common side effects of ketoconazole shampoo include:
Common side effects of ketoconazole gel, cream, and foam include:
This is not a complete list of ketoconazole side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
This is not a complete list of ketoconazole drug interactions. Ask your doctor or pharmacist for more information.
Serious side effects have been reported with ketoconazole including the following:
Ketoconazole can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how ketoconazole affects you.
Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ketoconazole, there are no specific foods that you must exclude from your diet when receiving this medication.
Before taking ketoconazole, tell your doctor about all of your medical conditions. Especially tell your doctor if you:
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories – A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Ketoconazole falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with ketoconazole, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known if ketoconazole crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using ketoconazole.
Take ketoconazole exactly as prescribed.
This medication comes in tablet form and is taken once daily, with or without food.
Ketoconazole tablets should only be used in children if prescribed by the healthcare provider who has determined that the benefits outweigh the risks.
This medication is also available as a shampoo to treat dandruff and flaking scalp.
This medication is also available a topical gel, cream, and foam to treat seborrheic dermatitis and fungal infections of the skin.
Alcohol may intensify some of the side effects of this medication.
If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ketoconazole at the same time.
Take ketoconazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The ketoconazole dose your doctor recommends will be based on the following:
The recommended dose for ketoconazole is 200 mg (one tablet) one daily. In very serious infections or if responsiveness is insufficient within the expected time, the dose of ketoconazole may be increased to 400 mg (two tablets) once daily.
In a small number of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. ketoconazole have not been studied in children under 2 years of age.
The recommended dose of the over-the-counter form of ketoconazole shampoo for the treatment of dandruff is the application of shampoo to wet hair; lather, rinse, and repeat. Use the shampoo every 3 to 4 days for up to 8 weeks, or as directed by a doctor.
The recommended dose of the prescription form of ketoconazole shampoo for the treatment of dandruff is one application onto damp skin. Leave shampoo in place for 5 minutes, then rinse with water.
The recommended dose of the topical gel and foam is application to the affected area twice daily. The recommended dose of the topical cream is application to the affected area once daily.
If you take too much ketoconazole, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.
When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored.
Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and tordades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets.
Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated.
Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride.
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