Uses

This medication is used to treat a severe intestinal condition (C. difficile-associated diarrhea) due to a certain type of bacteria. This condition may rarely occur after taking antibiotics. Symptoms include diarrhea that doesn't stop, stomach/abdominal pain or cramping, and blood/mucus in your stool. Fidaxomicin is known as a macrolide antibiotic. It works by stopping the growth of this bacteria.

This antibiotic works in the intestines and is not absorbed by your body. It should only be used to treat this type of intestinal bacterial infection. It will not work for other types of infections, including viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking fidaxomicin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily (every 12 hours). For children, the dosage is based on their weight.

If you are using the liquid form of this medication, remove the bottle from the refrigerator 15 minutes before taking the medication. Shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Nausea, vomiting, or stomach/abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• black/tarry/bloody stools
• vomit that looks like coffee grounds
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• unusual tiredness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking fidaxomicin, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (such as azithromycin, clarithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Fidaxomicin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using fidaxomicin before having any immunizations/vaccinations.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Lab and/or medical tests (such as stool sample tests) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store the tablets at room temperature away from light and moisture. Do not store in the bathroom. Store the liquid medication in the original bottle in the refrigerator. Discard the liquid medication after 12 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.