Fidaxomicin

Fidaxomicin is used to treat diarrhea caused by Clostridium difficile (C. difficile; a type of bacteria that may cause severe or life-threatening diarrhea) in adults and children 6 months of age and older. Fidaxomicin is in a class of medications called macrolide antibiotics. It works by killing bacteria in the intestines.

Fidaxomicin will not treat infections in any other part of the body. Antibiotics such as fidaxomicin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Fidaxomicin comes as a tablet and as an suspension (liquid) to take by mouth. It is usually taken with or without food two times a day (approximately 12 hours apart) for 10 days. Take fidaxomicin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fidaxomicin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take the suspension bottle out of the refrigerator 15 minutes before preparing your dose. Shake the suspension well before each use to mix the medication evenly. Use an oral syringe to measure the correct amount of medication. Do not use a household spoon to measure your dose.

You should begin to feel better during the first few days of treatment with fidaxomicin. If your symptoms do not improve or get worse, call your doctor.

Take fidaxomicin until you finish the prescription, even if you feel better. If you stop taking fidaxomicin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking fidaxomicin,

• tell your doctor and pharmacist if you are allergic to fidaxomicin, azithromycin (Zithromax), clarithromycin (Biaxin, in Prevpac), erythromycin (E.E.S., ERY-C, Erythrocin), telithromycin (Ketek; not available in the U.S.), any other medications, or any of the ingredients in fidaxomicin tablets or suspension. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical condition.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking fidaxomicin, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Fidaxomicin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• stomach pain
• constipation

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• itching
• swelling of the face, throat, tongue, lips, and eyes
• shortness of breath
• difficulty breathing or swallowing
• weakness
• fatigue
• dizziness
• headache
• chest pain
• fast, pounding heartbeat
• pale skin
• cold hands and feet
• stomach cramps
• bright red blood in vomit
• vomit that looks like coffee-grounds
• black, tarry stools
• bright red blood in stools
• fever, sore throat, chills, or other signs of infection

Fidaxomicin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Keep the suspension in the refrigerator, tightly closed, and dispose of any unused suspension after 12 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the fidaxomicin, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Dificid^®