DrugindexOnline^{2nd edition}

Generic name: Ketoconazole
Brand names: Nizoral

Why is Ketoconazole prescribed?

Nizoral, a broad-spectrum antifungal drug available in tablet form, may be given to treat several fungal infections within the body, including oral thrush and candidiasis.

It may also be given to treat severe, hard-to-treat fungal skin infections that have not cleared up after treatment with creams or ointments, or the oral drug griseofulvin (Fulvicin, Grisactin).

Most important fact about Ketoconazole

In some people, Nizoral may cause serious or even fatal damage to the liver. Before starting to take Nizoral, and at frequent intervals while you are taking it, you should have blood tests to evaluate your liver function. Tell your doctor immediately if you experience any signs or symptoms that could mean liver damage: these include unusual fatigue, loss of appetite, nausea or vomiting, jaundice, dark urine, or pale stools.

How should you take Ketoconazole?

Take Nizoral exactly as prescribed.

You should keep taking the drug until tests show that your fungal infection has subsided. If you stop too soon, the infection might return.

You may want to take Nizoral Tablets with meals to avoid stomach upset.

Avoid alcohol and do not take with antacids. If antacids are necessary, you should wait 2 to 3 hours before taking them.

--If you miss a dose...

Take the forgotten dose as soon as you remember. This will help to keep the proper amount of medicine in the body. However, if it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take double doses.

--Storage instructions...

Nizoral should be stored at room temperature.

What side effects may occur?

Side effects from Nizoral cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Nizoral.

• More common side effects may include:
  Nausea, vomiting

Why should Ketoconazole not be prescribed?

Do not take Nizoral if you are sensitive to it or have ever had an allergic reaction to it. Never take Nizoral together with Seldane, Hismanal, Halcion, or Propulsid. Rare, but sometimes fatal reactions have been reported when these drugs are combined.

Special warnings about Ketoconazole

In rare cases, people have had anaphylaxis (a life-threatening allergic reaction) after taking their first dose of Nizoral.

Observe caution when driving or performing other tasks requiring alertness, due to potential side effects of headache, dizziness, and drowsiness.

Possible food and drug interactions when taking Ketoconazole

If Nizoral is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Nizoral with the following:

Alcoholic beverages
Antacids such as Di-Gel, Maalox, Mylanta, and others
Anticoagulants such as Coumadin, Dicumarol, and others
Anti-ulcer medications such as Axid, Pepcid, Tagamet, and Zantac
Astemizole (Hismanal)
Cisapride (Propulsid)
Cyclosporine (Sandimmune, Neoral)
Digoxin (Lanoxin)
Drugs that relieve spasms, such as Donnatal
Isoniazid (Nydrazid)
Methylprednisolone (Medrol)
Midazolam (Versed)
Oral diabetes drugs such as Diabinese and Micronase
Phenytoin (Dilantin)
Rifampin (Rifadin, Rifamate, and Rimactane)
Tacrolimus (Prograf)
Terfenadine (Seldane)
Theophyllines (Slo-Phyllin, Theo-Dur, others)
Triazolam (Halcion)

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, inform your doctor immediately. Nizoral should be taken during pregnancy only if the benefit outweighs the possible harm to your unborn child.

Since Nizoral can probably make its way into breast milk, it should not be taken during breastfeeding. If you are a new mother, check with your doctor. You may need to stop breastfeeding while you are taking Nizoral.

Recommended dosage

ADULTS

The recommended starting dose of Nizoral is a single daily dose of 200 milligrams (1 tablet).

In very serious infections, or if the problem does not clear up within the expected time, the dose of Nizoral may be increased to 400 milligrams (2 tablets) once daily. Treatment lasts at least 1 to 2 weeks, and for some infections much longer.

CHILDREN

In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 milligrams per 2.2 pounds of body weight has been used.

Nizoral has not been studied in children under 2 years of age.

Overdosage

Although no specific information is available, any medication taken in excess can have serious consequences. If you suspect an overdose of Nizoral, seek medical attention immediately.