Fidaxomicin

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 who are at least 6 months old.

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

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

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.

Fidaxomicin should not be used to treat infections that are not caused by Clostridium difficile. fidaxomicin is only for treating diarrhea that results from an infection with Clostridium difficile.

Call your doctor right away if you experience a serious side effect like 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.

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 caused by Clostridium difficile. This medicine is only for treating diarrhea caused by an infection with Clostridium difficile. Fidaxomicin will not treat a viral infection like 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.

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

Fidaxomicin may cause serious side effects. Call your doctor right away 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 faint;
• 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.

Usual Adult Dose for Clostridial Infection:

200 mg orally twice a day for 10 daysUse: 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 dayTablets:-Weight at least 12.5 kg: 200 mg orally twice a dayDuration of therapy: 10 daysUse: For the treatment of CDAD

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

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.