FIDAXOMICIN

(fye DAX oh MYE sin) Brand: Dificid

What is the most significant information I must know about fidaxomicin?

• You must not use fidaxomicin if you are allergic to it.

• Take this medicine for the full predesigned length of time. Your symptoms may improve till the infection is completely cleared. Skipping doses may also magnify your risk of further infection that is resistant to antibiotics.

• Fidaxomicin must 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 general cool or flu.

• 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 course, trouble concentrating, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What is fidaxomicin?

• Fidaxomicin is an antibiotic that fights bacteria.

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

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

What must I discuss with my healthcare provider till taking fidaxomicin?

• You must not use fidaxomicin if you are allergic to it.

• FDA pregnancy category B. Fidaxomicin is not expected to harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant during treatment.

• It is not known whether fidaxomicin passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

• Do not give this medicine to anyone under 18 years old without medical advice.

How must I take fidaxomicin?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Fidaxomicin is generally taken 2 times every day for 10 days. Follow your doctor's instructions.

• You may take fidaxomicin with or without food.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking fidaxomicin?

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of fidaxomicin?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have a serious side effect such as:

· fever, chills, body aches, flu symptoms, sores in your mouth and throat;

· pale skin, feeling light-headed or short of breath, rapid heart course, trouble concentrating;

· black, bloody, or tarry stools; or

· coughing up blood or vomit that looks like coffee grounds.

• Smaller serious side effects may include:

· nausea, vomiting, stomach pain;

· bloating or gas; or

· mild rash or itching.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect fidaxomicin?

• There may be another drugs that can interact with fidaxomicin. Speak your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start using a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fidaxomicin.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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