Nizoral

You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion).

Before taking ketoconazole, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, decreased stomach acid (achlorhydria), or a history of "Long QT syndrome."

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ketoconazole will not treat a viral infection such as the common cold or flu.

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking ketoconazole.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For fungal infections:
    • Adults—At first, 200 milligrams (mg) once a day. Your doctor may increase your dose as needed.
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 3.3 to 6.6 milligrams (mg) per kilogram (kg) of body weight per day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Serious side effects have been reported with Nizoral. See the “Nizoral Precautions” section.

Common side effects include:

• rash
• worsening of dandruff

This is not a complete list of Nizoral side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine, sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan, delavirdine, and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin, St John's wort, and nimodipine (Nimotop)
• methylprednisolone (Medrol)
• midazolam (Versed)
• triazolam (Halcion)
• digoxin (Lanoxin)
• warfarin (Coumadin, Jantoven)
• phenytoin (Dilantin)
• rifampin
• alcohol

This is not a complete list of Nizoral drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nizoral falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with Nizoral, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take Nizoral exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Nizoral dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your liver function
• your kidney function
• your age

The recommended dose of the over-the-counter form of Nizoral shampoo for the treatment of dandruff is the application of shampoo to wet hair; lather, rinse, and repeat. Use the shampoo every 3 to 4 days for up to 8 weeks, or as directed by a doctor.

The recommended dose of the prescription form of Nizoral shampoo for the treatment of dandruff is one application onto damp skin. Leave shampoo in place for 5 minutes, then rinse with water.

You should not use ketoconazole if you are allergic to it, or if you have liver disease.

Some medicines can interact with ketoconazole and should not be used at the same time. Certain drug interactions can cause life-threatening irregular heartbeats. Your doctor may need to change your treatment plan if you use any of the following drugs:

• alprazolam, midazolam, or triazolam;

• cisapride or pimozide;

• dihydroergotamine or ergotamine;

• disopyramide, dofetilide, dronedarone, eplerenone, nisoldipine, quinidine, or ranolazine;

• lovastatin or simvastatin; or

• methadone.

To make sure ketoconazole is safe for you, tell your doctor if you have:

• any history of liver problems;

• problems with your adrenal gland;

• personal or family history of long QT syndrome; or

• if you also use certain antibiotics, heart rhythm medication, migraine headache medicine, anti-malaria medication, or medicine to treat depression or mental illness.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

Ketoconazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

Avoid taking antacids, stomach acid reducers, or medicines to treat stomach ulcer or gastroesophageal reflux disease (Axid, Nexium, Pepcid, Prevacid Prilosec, sucralfate, Tagamet, Zantac, and others). These medications can make it harder for your body to absorb ketoconazole.

Avoid drinking alcohol. It may increase your risk of liver damage while you are taking ketoconazole.

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve, or if they become worse, check with your doctor. You may need to take this medicine for several months before your infection gets better.

Do not use this medicine together with alprazolam, cisapride, colchicine, disopyramide, dofetilide, dronedarone, eplerenone, felodipine, irinotecan, lovastatin, lurasidone, methadone, nisoldipine, oral midazolam, pimozide, quinidine, ranolazine, simvastatin, terfenadine, tolvaptan, triazolam, or ergot medicines (such as dihydroergotamine, ergometrine, ergotamine, methylergometrine). Using these medicines together may cause serious unwanted effects.

Liver problems may occur while you are taking this medicine. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Avoid drinking alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in color vision
• change in the ability to see colors, especially blue or yellow
• chest pain
• chills
• confusion
• cough
• dark urine
• difficulty seeing at night
• difficulty swallowing
• dizziness
• fast heartbeat
• fever
• general body swelling
• headache
• hoarseness
• increased sensitivity of the eyes to sunlight
• irritation
• joint pain, stiffness, or swelling
• light-colored stools
• loss of appetite
• mood or mental changes
• nausea or vomiting, severe
• nosebleeds
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• skin rash, hives, itching
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the eyelids, face, lips, hands, or feet
• swollen glands
• tightness in the chest
• trouble sleeping
• troubled breathing or swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change in number of sperm and their ability to move
• decreased interest in sexual intercourse
• diarrhea
• hair loss or thinning of the hair
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• sleepiness or unusual drowsiness
• swelling of the breasts or breast soreness for both female and male

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.

Adults

The recommended starting dose of Nizoral® (ketoconazole) Tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of Nizoral® Tablets may be increased to 400 mg (two tablets) once daily.

Children

In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Nizoral® Tablets have not been studied in children under 2 years of age.

Nizoral should be used only when you cannot use other antifungal medications. Nizoral can cause serious harm to your liver that may result in liver transplant or cause death.

Call your doctor at once if you have any signs of liver damage, such as nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Some medicines can interact with Nizoral and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs: alprazolam, cisapride, dihydroergotamine, disopyramide, dofetilide, dronedarone, eplerenone, ergotamine, lovastatin, methadone, midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, or triazolam.. Certain drug interactions can cause life-threatening irregular heartbeats.

Call your doctor right away if you have a headache with chest pain and severe dizziness, and fast or pounding heartbeats.

Get emergency medical help if you have any signs of an allergic reaction to Nizoral: hives; fever; difficulty breathing, chest pain; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• unusual weakness or tired feeling, nausea and vomiting; or

• liver problems--upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Common Nizoral side effects may include:

• mild nausea or stomach pain;

• diarrhea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.