Fidaxomicin

Fidaxomicin is used to treat diarrhea caused by Clostridium difficile (C. difficile; a type of bacteria that my cause severe or life-threatening diarrhea.) Fidaxomicin is in a class of medications called macrolide antibiotics. It works by killing bacteria in the intestines. Fidaxomicin will not treat infections in any other part of the body. Antibiotics will not work for colds, flu, or other viral infections.

Fidaxomicin comes as a tablet to take by mouth. It is usually taken with or without food two times a day for 10 days. Take fidaxomicin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fidaxomicin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with fidaxomicin. If your symptoms do not improve or get worse, call your doctor.

Take fidaxomicin until you finish the prescription, even if you feel better. If you stop taking fidaxomicin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking fidaxomicin,

• tell your doctor and pharmacist if you are allergic to fidaxomicin, any other medications, or any of the ingredients in fidaxomicin tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fidaxomicin, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Fidaxomicin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea

• vomiting

• stomach pain

• rash

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• weakness

• fatigue

• dizziness

• headache

• shortness of breath

• chest pain

• fast, pounding heartbeat

• pale skin

• cold hands and feet

• stomach cramps

• bright red blood in vomit

• vomit that looks like coffee-grounds

• black, tarry stools

• bright red blood in stools

• fever, sore throat, chills, and other signs of infection

Fidaxomicin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the fidaxomicin, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Last Revised - 04/15/2012