Nizoral Cream (Ketoconazole)

(℞) Prescription Required

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Nizoral Cream 2%

Product of India
Manufactured by: Janssen-Ortho
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Nizoral Cream 2%
Product of India
Manufactured by Janssen-Ortho
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Nizoral (Ketoconazole) Usage and Side Effects

NIZORAL belongs to a class of drugs called imidazoles. It works by stopping the growth of fungus. It comes in cream and tablet form and is used to treat serious fungal infections when other medicines can't be taken.

Proper Use of this medication

NIZORAL comes as a tablet to take by mouth. It's typically taken once a day at around the same time.

The medicine also comes as a topical cream and shampoo.

The cream is usually applied once a day for two to six weeks.

The prescription shampoo is typically applied as a one-time treatment. The OTC shampoo is usually used every three to four days for up to eight weeks, and as needed after that.

Follow the directions on your prescription label carefully when taking this medicine. Don't take more or less of the drug than is prescribed.

Your doctor may increase your dose if your condition doesn't improve.

NIZORAL Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of NIZORAL

If you miss a dose of NIZORAL, take it as soon as you remember.

However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule.

Don't take extra medicine to make up for a missed dose.

Side Effects

Common Side Effects of NIZORAL

Tell your doctor if any of the following side effects become severe or don't go away:

  • Headache
  • Stomach pain, diarrhea, or constipation
  • Heartburn or gas
  • Change in the ability to taste
  • Change in tongue color
  • Dry mouth
  • Difficulty sleeping
  • Nervousness
  • Numbness, tingling, or burning of the hands or feet
  • Hair loss
  • Flushing
  • Chills
  • Muscle pain
  • Sensitivity to light
  • Nosebleeds
  • Breast enlargement in men
  • Decreased sexual ability

Serious Side Effects of NIZORAL

Tell your doctor immediately if you experience any of the symptoms listed in the Warning section or any of the following serious side effects:

  • Rash, hives, or itching
  • Swelling of the eyes, face, lips, tongue, hands, feet, ankles, or lower legs
  • Hoarseness
  • Extreme tiredness
  • Weakness
  • Difficulty breathing or swallowing

Warnings and Precautions

The FDA requires a black-box warning on NIZORAL because the drug can cause serious liver damage that might result in the need for a liver transplant or death.

Call your doctor immediately if you experience any of the following symptoms of liver problems:

  • Yellowing of the skin or eyes (jaundice)
  • Upper stomach pain
  • Itching
  • Fatigue
  • Nausea
  • Loss of appetite
  • Dark-colored urine
  • Clay-colored stools

Consuming alcohol while taking NIZORAL may increase the risk of liver side effects. Avoid drinking alcohol while taking this medicine.

Tell your doctor if you have or have ever had any liver problems.

NIZORAL may cause an irregular heart rhythm disorder known as QT prolongation. This condition can lead to seizures, loss of consciousness, fainting, or sudden death.

Stop taking NIZORAL and tell your doctor immediately if you experience:

  • A fast, pounding, or irregular heartbeat
  • Fainting
  • Dizziness
  • Lightheadedness
  • Loss of consciousness

Don't take the following medications while using NIZORAL:

  • Disopyramide (Norpace)
  • Dofetilide (Tikosyn)
  • Dronedarone (Multaq)
  • Pimozide (Orap)
  • Quinidine (Quinidex, Quinaglute)
  • Cisapride (Propulsid; no longer available in the US)
  • Methadone (Dolophine, Methadose)
  • Ranolazine (Ranexa)
  • Alprazolam (Niravam, Xanax)
  • Eplerenone (Inspra)
  • Ergot alkaloids such as ergotamine (Ergomar, in Cafergot, in Migergot), dihydroergotamine (D.H.E. 45, Migranal), and methylergonovine (Methergine)
  • Felodipine (Plendil)
  • Irinotecan (Camptosar)
  • Lovastatin (Mevacor)
  • Lurasidone (Latuda)
  • Midazolam (Versed)
  • Nisoldipine (Sular)
  • Simvastatin (Zocor)
  • Tolvaptan (Samsca)
  • Triazolam (Halcion)

When NIZORAL is taken at high doses, it may cause an adrenal gland problem, a decrease in testosterone, and a decrease in sperm production.

Talk to your doctor about these possible risks, especially if you have a history of adrenal gland problems.

Also, tell your doctor if you take antacids, stomach acid reducers, or drugs to treat stomach ulcers or gastroesophageal reflux disease (GERD). These medicines may make it harder for your body to absorb NIZORAL.

NIZORAL shouldn't be used to treat fungal infections in the brain or on the skin and nails.

Tell your doctor or dentist you're taking this medication before having any type of surgery, including a dental procedure.

NIZORAL is sometimes prescribed for treating prostate cancer or Cushing's syndrome, but the drug hasn't been shown to be safe or effective for these uses. Talk to your doctor about using NIZORAL for these conditions.

You might need to take NIZORAL for six months or longer. Don't stop taking this medicine unless your doctor tells you to do so.

If you stop taking NIZORAL too soon, your infection may return after a short period of time.

Keep all doctor and laboratory appointments while taking this drug. Your doctor will likely test your blood often.

Pregnancy and NIZORAL

NIZORAL is in FDA Pregnancy Category C, which means it's not known whether it will harm an unborn baby.

Tell your doctor if you're pregnant or plan to become pregnant while taking this medicine.

This drug can pass into breast milk and may harm a breastfeeding baby. You shouldn't breastfeed while taking NIZORAL.

Interactions with this medication

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking before taking NIZORAL, especially those listed in the Warning section or any of the following:

  • Aliskiren (Tekturna)
  • Anticoagulants (blood thinners) such as dabigatran (Pradaxa), rivaroxaban (Xarelto) and warfarin (Coumadin)
  • Aprepitant (Emend)
  • Aripiprazole (Abilify)
  • Atorvastatin (Lipitor)
  • Bosentan (Tracleer)
  • Budesonide (Uceris)
  • Buspirone (BuSpar)
  • Carbamazepine (Tegretol)
  • Calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, Verelan)
  • Cancer medications such as bortezomib (Velcade), busulfan (Myleran), dasatinib (Sprycel), docetaxel (Taxotere), erlotinib (Tarceva), ixabepilone (Ixempra), lapatinib (Tykerb), nilotinib (Tasigna), paclitaxel (Taxol), trimetrexate (Neutrexin), vincristine (Vincasar), vinblastine, and vinorelbine (Navelbine)
  • Ciclesonide (Alvesco)
  • Cilostazol (Pletal)
  • Cinacalcet (Sensipar)
  • Colchicine (Colcrys, in Col-Probenecid)
  • Dexamethasone
  • Digoxin (Lanoxin)
  • Eletriptan (Relpax)
  • Fentanyl (Abstral, Actiq, Duragesic, Fentora, Lazanda, Onsolis)
  • Fesoterodine (Toviaz)
  • Fluticasone (Flonase, Flovent)
  • Haloperidol (Haldol)
  • HIV medications such as darunavir (Prezista), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), maraviroc (Selzentry), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase, Fortovase)
  • Immunosuppressants such as cyclosporine (Neoral, Sandimmune), everolimus (Afinitor, Zortress), sirolimus (Rapamune), and tacrolimus (Prograf)
  • Imatinib (Gleevec)
  • Medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra)
  • Medications for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec), and ranitidine (Zantac)
  • Medications to treat tuberculosis such as isoniazid (INH, Nydrazid), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane)
  • Methylprednisolone (Medrol)
  • Nadolol (Corgard)
  • Oxycodone (Oxecta, Oxy Contin, in Percocet, others)
  • Phenytoin (Dilantin)
  • Praziquantel (Biltricide)
  • Quetiapine (Seroquel)
  • Ramelteon (Rozerem)
  • Repaglinide (Prandin, in PrandiMet)
  • Risperidone (Risperdal)
  • Salmeterol (Serevent, in Advair)
  • Saxagliptin (Onglyza)
  • Solifenacin (Vesicare)
  • Tamsulosin (Flomax, in Jalyn)
  • Telithromycin (Ketek)
  • Tolterodine (Detrol)

The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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