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

• Do not take ketoconazole 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 ketoconazole is taken with any of the medicines listed above.
• Before taking ketoconazole, 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 ketoconazole, or you may require a dosage adjustment, special monitoring, or special directions for use during your treatment.
• 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.
• Ketoconazole passes into breast milk and may be harmful to a nursing baby. For this reason, 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.

• Take 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.
• Take each dose with a full glass of water.
• Ketoconazole 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 ketoconazole regularly to get the most benefit.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with ketoconazole 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 ketoconazole 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 ketoconazole. Alcohol and ketoconazole can both affect the liver. Rarely, flushing, nausea, vomiting, headache, swelling, and rashes have occurred when alcohol has been used during ketoconazole therapy.
• Use caution when driving or performing other hazardous activities. Ketoconazole may cause dizziness. If you experience dizziness, avoid these activities.

• If you experience any of the following serious side effects, stop taking ketoconazole 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 ketoconazole 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.

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

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.
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