fidaxomicin

What is the most important information I should know about fidaxomicin?

What is 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.

What should I discuss with my healthcare provider before taking fidaxomicin?

Tell your doctor if you are pregnant or breastfeeding.

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

How should I take fidaxomicin?

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.

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 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.

Throw away any unused liquid after 12 days.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking fidaxomicin?

What are the possible side effects of fidaxomicin?

• 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 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.

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.

Where can I get more information?

Your pharmacist can provide more information about fidaxomicin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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