Description
Fidaxomicin is used to treat Clostridium difficile-associated diarrhea (CDAD).
Fidaxomicin belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Powder for Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fidaxomicin in children 6 months and older. However, safety and efficacy have not been established in children younger than 6 months old.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fidaxomicin in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Cholera Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin), history of—Allergic reactions are more likely to occur.
- Infection (systemic)—Should not be used to treat systemic infections.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine usually comes with patient information leaflet. Read the instructions carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.
You may take this medicine with or without food.
Swallow the tablet whole. Do not crush, break, or chew it.
If you are using the oral suspension: Remove the bottle of mixed suspension from the refrigerator 15 minutes before using it and shake it well. Use a dosing syringe to measure the right amount of medicine.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop using this medicine too soon, your infection may return.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (oral suspension or tablets):
- For Clostridium difficile-associated diarrhea (CDAD):
- Adults—200 milligrams (mg) two times a day for 10 days.
- Children 6 months and older and weighing at least 12.5 kilograms (kg) and can swallow tablets—Dose is based on body weight and must be determined by your doctor. The dose is usually 200 mg two times a day for 10 days.
- Children 6 months and older and weighing at least 12.5 kg and cannot swallow tablets—Dose is based on body weight and must be determined by your doctor. An oral suspension is recommended. The dose is usually 2 to 5 milliliters (mL) two times a day for 10 days.
- Children younger than 6 months old—Use and dose must be determined by your doctor.
- For Clostridium difficile-associated diarrhea (CDAD):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the mixed suspension in the refrigerator for up to 12 days. Throw away any unused medicine after 12 days.
Precautions
It is very important that your doctor check your progress after you finish taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
If your symptoms do not improve within a few days after you start this medicine or if they become worse, check with your doctor.
This medicine may cause serious allergic reactions, including angioedema. Angioedema can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Abdominal or stomach pain
- bloating
- bloody or black, tarry stools
- chills
- confusion
- cough
- drowsiness
- fever
- loss of appetite
- lower back or side pain
- muscle tremors
- nausea
- painful or difficult urination
- pale skin
- rapid, deep breathing
- restlessness
- severe constipation
- shortness of breath
- sore throat
- stomach cramps
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of blood or material that looks like coffee grounds
Incidence not known
- Difficult or labored breathing
- itching skin or rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- tightness in the chest
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Abdominal or stomach distension or tenderness
- acid or sour stomach
- belching
- blurred vision
- difficulty with swallowing
- dry mouth
- excess air or gas in the stomach or intestines
- flushed, dry skin
- fruit-like breath odor
- full feeling
- heartburn
- increased hunger
- increased thirst
- increased urination
- indigestion
- passing gas
- stomach discomfort or upset
- sweating
- troubled breathing
- unexplained weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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