Ketoconazole

Do not take Nizoral if you are taking astemizole (Hismanal), cisapride (Propulsid), triazolam (Halcion) or midazolam (Versed). Combined with these drugs, Nizoral could cause serious, even fatal, side effects.

In rare cases, Nizoral has caused severe liver damage, sometimes resulting in death. Notify your doctor immediately if you develop nausea, vomiting, abdominal pain, unusual fatigue, loss of appetite, yellow skin or eyes, itching, dark urine or clay colored stools. These symptoms may be early signs of liver damage.

Take all of the Nizoral that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Nizoral is an antifungal medication. It is like an antibiotic but is used to treat fungal infections.

Nizoral is used to treat yeast infections of the mouth, throat and esophagus; fungal infections throughout the whole body; and serious fungal infections of the skin and nails.

Nizoral may also be used for purposes other than those listed in this medication guide.

Do not take Nizoral if you are taking any of the following drugs:

cisapride (Propulsid),

astemizole (Hismanal) or

triazolam (Halcion) or midazolam (Versed).

Dangerous or life-threatening events may occur if Nizoral is taken with any of the medicines listed above.

Before taking Nizoral, tell your doctor if you have

liver disease; or

achlorhydria (decreased stomach acid production) or if you take antacids, stomach acid reducers or stomach ulcer medicines.

You may not be able to take Nizoral or you may require a dosage adjustment, special monitoring or special directions for use during your treatment.

Do not take this medication without talking to your doctor first if you are pregnant or could become pregnant during treatment. Nizoral is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby.

Do not take this medication without talking to your doctor first if you are breast-feeding a baby. Nizoral passes into breast milk and may be harmful to a nursing baby. For this reason, Nizoral should not be taken by nursing mothers.

Take Nizoral exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse or doctor to explain them to you.

Each dose should be taken with a full glass of water.

Nizoral is usually taken once a day. Follow your doctor’s instructions.

If you have a condition that decreases the amount of acid produced by the stomach, you may require a special mixture of this medication. Drink this solution through a straw far back in the mouth away from the teeth and follow each dose with a swish and swallow of water to prevent damage to the teeth.

It is important to take Nizoral regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with Nizoral to monitor progress and side effects.

Store this medication at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

Seek emergency medical attention if an overdose is suspected.

Symptoms of a Nizoral overdose are not well known but might include dizziness, ringing in the ears, headache, nausea, vomiting, diarrhea and abdominal pain.

Alcohol should be used with moderation while taking Nizoral. Alcohol and Nizoral can both affect the liver. Rarely, flushing, nausea, vomiting, headache, swelling and rashes have occurred when alcohol has been used during Nizoral therapy.

Use caution when driving or performing other hazardous activities. Nizoral may cause dizziness. If you experience dizziness, avoid these activities.

If you experience any of the following serious side effects, stop taking Nizoral and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue or face; or hives); or

liver damage (pale stools, yellowish skin or eyes, abdominal pain, unusual fatigue or dark urine).

Other, less serious side effects may be more likely to occur. If you experience any of the following side effects, continue to take Nizoral and talk to your doctor:

nausea, vomiting or abdominal pain;

diarrhea;

headache;

dizziness;

fatigue; or

itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not take Nizoral if you are taking any of the following drugs:

astemizole (Hismanal),

cisapride (Propulsid) or

triazolam (Halcion) or midazolam (Versed).

Dangerous or life-threatening events may occur if Nizoral is taken with any of the medicines listed above.

Before taking Nizoral, tell your doctor if you are taking any other medicines, especially any of the following:

cyclosporine (Sandimmune, Neoral);

antacids;

methylprednisolone (Medrol, others);

tacrolimus ((Prograf);

cimetidine (Tagamet, Tagamet HB), nizatidine (Axid, Axid AR), famotidine (Pepcid, Pepcid AC) or ranitidine (Zantac, Zantac 75);

omeprazole (Prilosec), lansoprazole (Prevacid), or rabeprazole (Aciphex);

digoxin (Lanoxin, Lanoxicaps);

warfarin (Coumadin);

phenytoin (Dilantin, others);

rifampin (Rifadin, Rimactane); or

an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), tolbutamide (Orinase), tolazamide (Tolinase), chlorpropamide (Diabinese) and others.

You may not be able to take Nizoral, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with Nizoral or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals and herbal products.