Fidaxomicin (fye-dax-oh-MYE-sin)

Treats Clostridium difficile-associated diarrhea (CDAD). This medicine is a macrolide antibiotic.

Brand Name(s):

Dificid

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease or liver disease.
• Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
• If your symptoms do not improve or if they get worse, call your doctor.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Use this medicine only to treat the infection your doctor has prescribed it for. Do not use this medicine for any infection or condition that has not been checked by a doctor. This medicine will not treat the flu or the common cold.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools.
• Bloody vomit or material that looks like coffee grounds.
• Fever, chills, cough, sore throat, and body aches.
• Severe constipation, nausea, vomiting, or stomach pain.
• Unusual bleeding, bruising, or weakness.

If you notice these less serious side effects, talk with your doctor:

• Mild nausea, vomiting, gas, or stomach upset.
• Rash or itching skin.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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