U.S. Brand Names

Extina®; Kuric™; Nizoral®; Nizoral® A-D [OTC]; Xolegel™

Canadian Brand Names

Apo-Ketoconazole®; Ketoderm®; Novo-Ketoconazole; Xolegel™

Mexican Brand Names

Akorazol; Conazol; Fungoral; Konaturil; Nastil; Nizoral; Tiniazol

Pharmacologic Category

Antifungal Agent, Oral; Antifungal Agent, Topical

What key warnings should I know about before taking this medicine?

This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with healthcare provider. This medicine may rarely cause severe liver damage.

Reasons not to take this medicine

• If you have an allergy to ketoconazole or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

• If you have a yeast infection of the brain.

• If you are taking any of these medicines: Bromocriptine, cabergoline, cisapride, dihydroergotamine, ergoloid mesylate, ergonovine, ergotamine, methylergonovine, methysergide, or pergolide.

What is this medicine used for?

• This medicine is used to prevent or treat a variety of yeast infections.

• This medicine is used to treat dandruff.

• This medicine is used to treat prostate cancer.

How does it work?

• Ketoconazole works to injure the yeast and fight the infection.

• It may decrease testosterone levels.

How is it best taken?

Oral:

• To gain the most benefit, do not miss doses.

• Use prescription as directed, even if feeling better.

• Take this medicine at a similar time of day.

• Take this medicine with food.

• A liquid (suspension) is available if you cannot swallow pills. Shake well before use.

Skin, cream, foam, and gel:

• Do not take this medicine by mouth. For skin only. Keep out of mouth, nose, and eyes (may burn).

• Wash hands before and after use.

• Clean affected area before use. Make sure to dry well.

• Apply a thin layer to the affected skin and rub in gently.

• Do not place foam or gel directly in hands.

• Avoid fire, flames, or smoking until the foam or gel has dried.

Skin, shampoo:

• Keep out of mouth, nose, and eyes (may burn).

• Wet hair and scalp.

• Apply enough shampoo to lather.

• Lather well and leave on for 1 minute.

• Rinse and reapply, lather, and leave on for 3 minutes.

• Rinse and dry hair.

• Shampoo twice a week with 3 days between shampooing.

What do I do if I miss a dose? (does not apply to patients in the hospital)

• Take a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your regular schedule.

• Do not take a double dose or extra doses.

• Do not change dose or stop medicine. Talk with healthcare provider.

What are the precautions when taking this medicine?

All forms:

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

• Tell healthcare provider if you are breast-feeding.

Oral:

• If you have liver disease, talk with healthcare provider.

• Avoid grapefruit and grapefruit juice.

• Do not take antacids or sucralfate within 2 hours of this medicine.

• Avoid alcohol (includes wine, beer, and liquor).

What are some possible side effects of this medicine?

Oral:

• Belly pain.

• Nausea or vomiting. Small frequent meals, frequent mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help.

• Diarrhea.

• Liver damage can rarely occur.

Shampoo:

• Scalp irritation.

• Removal of curl from hair.

• Hair loss. Hair usually grows back when medicine is stopped.

Cream, foam, and gel:

• Skin irritation.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?

Reasons to call healthcare provider immediately

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• Signs of a life-threatening reaction. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; or swelling of face, lips, tongue, or throat.

• Severe belly pain.

• Severe nausea or vomiting.

• Severe diarrhea.

• Not hungry.

• Dark urine or yellow skin or eyes.

• Feeling extremely tired or weak.

• Severe skin irritation.

• Any rash.

• No improvement in condition or feeling worse.

How should I store this medicine?

• Store cream, foam, gel, shampoo, and tablets at room temperature.

• Protect foam and shampoo from light.

• Protect foam from heat.

• Protect tablets from moisture. Do not store in a bathroom or kitchen.

• Store liquid (suspension) at room temperature. Throw away any unused portion after 2 months.

General statements

• If you have a life-threatening allergy, wear allergy identification at all times.

• Do not share your medicine with others and do not take anyone else's medicine.

• Keep all medicine out of the reach of children and pets.

• Keep a list of all your medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Talk with healthcare provider before starting any new medicine, including over-the-counter, natural products, or vitamins.

Created: 2006-10-13 13:25:13.0

Modified: 2008-04-30 11:12:31.0

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