WHAT IS Nizoral/Ketoconazole?

• Nizoral/Ketoconazole 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/Ketoconazole is an antifungal medication. It is like an antibiotic but is used to treat fungal infections.
• Nizoral/Ketoconazole may also be used for purposes other than those listed in this medication guide.

WHAT HAPPENS IF I MISS A DOSE?

• 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.

WHAT DRUG(S) MAY INTERACT WITH Nizoral/Ketoconazole?

• paricalcitol
• certain medicines for anxiety or difficulty sleeping
• doxercalciferol
• tolbutamide
• astemizole
• hormones such as Meticorten/prednisone or cortisone
• bosentan
• pimozide
• Sandimmune/cyclosporine
• Actos/pioglitazone
• rifampin
• Cafergot/ergotamine, dihydroergotamine or methysergide
• cisapride
• medicines for stomach ulcers and other stomach problems
• terfenadine
• medicines for lowering cholesterol (such as Lipitor/atorvastatin, Mevacor/lovastatin, Zocor/simvastatin)
• medicines for movement abnormalities as in Parkinson's disease, or for gastrointestinal problems
• isoniazid
• Coumadin/warfarin
• Videx/didanosine (ddI)
• dofetilide
• alcohol
• antacids
• Dilantin er/phenytoin
• quinidine
• other medicines for fungal or yeast infections

WHAT SHOULD I DISCUSS WITH MY DOCTOR BEFORE TAKING Nizoral/Ketoconazole?

• You may not be able to take Nizoral/ketoconazole, or you may require a dosage adjustment, special monitoring, or special directions for use during your treatment.
• Dangerous or life-threatening events may occur if Nizoral/ketoconazole is taken with any of the medicines listed above.
• Nizoral/Ketoconazole 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 first talking to your doctor if you are pregnant or could become pregnant during treatment.
• Before taking Nizoral/ketoconazole, tell your doctor if you have
  • achlorhydria (decreased stomach acid production) or if you take antacids, stomach acid reducers, or stomach ulcer medicines.
  • liver disease; or
• Do not take Nizoral/ketoconazole if you are taking any of the following drugs:
  • astemizole (Hismanal),
  • cisapride (Propulsid), or
  • triazolam (Halcion) or midazolam (Versed).
• Nizoral/Ketoconazole passes into breast milk and may be harmful to a nursing baby. For this reason, Nizoral/ketoconazole should not be taken by nursing mothers. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

WHAT SHOULD I AVOID WHILE TAKING Nizoral/Ketoconazole?

• Use caution when driving or performing other hazardous activities. Nizoral/Ketoconazole may cause dizziness. If you experience dizziness, avoid these activities.
• Alcohol should be used with moderation while taking Nizoral/ketoconazole. Alcohol and Nizoral/ketoconazole can both affect the liver. Rarely, flushing, nausea, vomiting, headache, swelling, and rashes have occurred when alcohol has been used during Nizoral/ketoconazole therapy.

WHAT HAPPENS IF I OVERDOSE?

• Symptoms of a Nizoral/ketoconazole overdose are not well known but might include dizziness, ringing in the ears, headache, nausea, vomiting, diarrhea, and abdominal pain.
• Seek emergency medical attention if an overdose is suspected.

HOW SHOULD I TAKE Nizoral/Ketoconazole?

• Take Nizoral/ketoconazole exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Nizoral/Ketoconazole is usually taken once a day. Follow your doctor's instructions.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Nizoral/ketoconazole to monitor progress and side effects.
• Store this medication at room temperature away from moisture and heat.
• Take each dose with a full glass of water.
• 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/ketoconazole regularly to get the most benefit.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF Nizoral/Ketoconazole?

• If you experience any of the following serious side effects, stop taking Nizoral/ketoconazole and seek emergency medical attention or contact your doctor immediately:
  • liver damage (pale stools, yellowish skin or eyes, abdominal pain, unusual fatigue, or dark urine).
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or
• Other, less serious side effects may be more likely to occur. If you experience any of the following side effects, continue to take Nizoral/ketoconazole and talk to your doctor:
  • nausea, vomiting, or abdominal pain;
  • itching.
  • fatigue; or
  • dizziness;
  • headache;
  • diarrhea;
• 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.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.