Fidaxomicin is a macrolide antibiotic that fights bacteria.

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

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

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

Fidaxomicin may also be used for purposes not listed in this medication guide.

Fidaxomicin should not be used to treat infections that are not related to Clostridium difficile. fidaxomicin 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take fidaxomicin 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.

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

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

Store fidaxomicin liquid 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 this medicine if you are allergic to fidaxomicin or other macrolide antibiotics, such as azithromycin, clarithromycin, erythromycin, or telithromycin.

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

Tell your doctor if you are pregnant or breastfeeding.

Fidaxomicin 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep the suspension in the refrigerator, tightly closed, and dispose of any unused suspension after 12 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

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

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

Fidaxomicin may cause serious side effects. 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 side effects of fidaxomicin 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 affect 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.

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.