What is SPORANOX® (itraconazole)?
SPORANOX® capsules is a prescription medicine used to treat the following fungal infections of the toenails, fingernails and other parts of the body: blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.
SPORANOX® oral solution is a prescription medicine used to treat oropharyngeal and esophageal yeast infections of the mouth, throat and food pipe (esophagus).
It is not known if SPORANOX® is safe and effective in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SPORANOX®?
SPORANOX® can cause serious side effects, including:
Heart failure: Do not take SPORANOX® if you have had heart failure, including congestive heart failure. Stop taking SPORANOX® and call your healthcare provider right away if you have any of these symptoms of congestive heart failure:
Heart problems and other serious medical problems: Serious medical problems that affect the heart and other parts of your body can happen if you take SPORANOX® with certain other medicines.
Do not take SPORANOX® oral solution if you also take levacetylmethadol (levomethadyl).
Do not take SPORANOX® capsules or oral solution if you also take the following medicines:
This is not a complete list of medicines that can interact with SPORANOX®. SPORANOX® may affect the way other medicines work, and other medicines may affect how SPORANOX® works. Ask your pharmacist for a list of medicines that interact with SPORANOX®.
Before you start taking SPORANOX®, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start any new medicine, ask your healthcare provider or pharmacist if it is safe to take it with SPORANOX®.
Liver problems. SPORANOX® can cause serious liver problems which may be severe and lead to death. Stop taking SPORANOX® and call your healthcare provider right away if you have any of these symptoms of liver problems:
For more information about side effects, see “What are the possible side effects of SPORANOX®?”
Do not take SPORANOX® if you:
Before taking SPORANOX®, tell your healthcare provider about all of your medical conditions, including if you have:
Taking SPORANOX® with certain medicines may affect each other. Taking SPORANOX® with other medicines can cause serious side effects.
You should not take SPORANOX® oral solution instead of SPORANOX® capsules, because it will not work the same way.
You should not take SPORANOX® capsules instead of SPORANOX® oral solution, because they will not work the same way.
What should I avoid while taking SPORANOX®?
SPORANOX® can cause dizziness and vision problems. Do not drive or operate machinery until you know how SPORANOX® affects you.
What are the possible side effects of SPORANOX®?
SPORANOX® may cause serious side effects, including:
The most common (≥ 4%) side effects for SPORANOX® capsules include: digestive system problems (such as nausea and vomiting), rash, headache, swelling. Other side effects include constipation, fever, inflammation of the pancreas, menstrual disorder, erectile dysfunction, dizziness, muscle pain, painful joints, unpleasant taste, or hair loss.
The most common (≥ 4%) side effects for SPORANOX® oral solution include: digestive system problems (such as nausea, diarrhea, vomiting), fever, stomach pain, rash, headache, cough.
These are not all the possible side effects of SPORANOX®.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Keep SPORANOX® and all medicines out of the reach of children.
General information about the safe and effective use of SPORANOX®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SPORANOX® for a condition for which it was not prescribed. Do not give SPORANOX® to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your doctor or pharmacist for information about SPORANOX® that is written for health professionals.
Please see full Product Information, including Boxed WARNING, for SPORANOX® capsules.
Please see full Product Information, including Boxed WARNING, for SPORANOX® oral solution.