Dificid is a macrolide antibiotic that works by killing sensitive bacteria.

Dificid is used to treat diarrhea caused by infection with Clostridium difficile.

Fidaxomicin works differently from other medicines because it passes into your stomach and intestines without being absorbed into your bloodstream.

Dificid is for use in adults and children at least 6 months old.

Dificid should not be used to treat infections that are not related to Clostridium difficile. This medicine is for use only to treat diarrhea caused by infection with Clostridium difficile.

Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, mouth sores, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, mouth sores, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Before taking this medicine

You should not use Dificid if you are allergic to fidaxomicin or other macrolide antibiotics, such as azithromycin, clarithromycin, erythromycin, or telithromycin.

Fidaxomicin will not treat a viral infection such as the common cold or flu.

Tell your doctor if you are pregnant or breastfeeding.

Dificid is not approved for use by anyone younger than 6 months old.

Take Dificid exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take this medicine with or without food.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Carefully follow directions when measuring the dose for a child. Fidaxomicin doses are based on weight in children.

Dificid is usually taken for 10 days. Follow your doctor's dosing instructions very carefully.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Fidaxomicin will not treat a viral infection such as the flu or a common cold.

Store the tablets in the original bottle at room temperature away from moisture and heat.

Store the liquid medicine in the refrigerator, do not freeze. Take the medicine out of the refrigerator 15 minutes before giving each dose. Do not leave the medicine out for longer than 15 minutes.

Throw away any unused liquid after 12 days.

Usual Adult Dose for Clostridial Infection:

200 mg orally twice a day for 10 days

Use: For the treatment of Clostridioides difficile-associated diarrhea (CDAD)

Usual Pediatric Dose for Clostridial Infection:

6 Months to Less Than 18 Years:
Oral suspension:
-Weight 4 to less than 7 kg: 80 mg orally twice a day
-Weight 7 to less than 9 kg: 120 mg orally twice a day
-Weight 9 to less than 12.5 kg: 160 mg orally twice a day
-Weight at least 12.5 kg: 200 mg orally twice a day

Tablets:
-Weight at least 12.5 kg: 200 mg orally twice a day

Duration of therapy: 10 days

Use: For the treatment of CDAD

You should not use Dificid if you are allergic to fidaxomicin or other macrolide antibiotics, such as azithromycin, clarithromycin, erythromycin, or telithromycin.

Fidaxomicin will not treat a viral infection such as the common cold or flu.

Tell your doctor if you are pregnant or breastfeeding.

Dificid is not approved for use by anyone younger than 6 months old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use fidaxomicin to treat any condition that has not been checked by your doctor.

Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Dificid: hives, rash, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• inflammation in your colon - stomach pain and bloating, painful or bloody stools, fast heartbeats, cool or clammy skin, feeling like you might pass out;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Dificid side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea, constipation;

• stomach bleeding;

• fever;

• low blood cell counts;

• abnormal liver function tests; or

• rash.

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.

Other drugs may interact with fidaxomicin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.