Fidaxomicin

Generic name: Fidaxomicin
Brand names: Dificid
Drug class: Macrolides

Usage of 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 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 side effects

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.

Before taking Fidaxomicin

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.

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How to use Fidaxomicin

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

Warnings

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.

What other drugs will affect Fidaxomicin

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.

Disclaimer

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