Dificid 200mg Tablets
It is used to treat diarrhea caused by a bacterial infection called C diff.
Drug Class
Antibiotic, Macrolide-like
Pharmacologic Class
Macrocyclic antibiotic; RNA polymerase inhibitor
Pregnancy Category
Not available
FDA Approved
Jan 2011
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fidaxomicin (Dificid) is an antibiotic used to treat diarrhea caused by a specific type of bacteria called Clostridioides difficile (C. diff). It works mainly in your gut to kill the C. diff bacteria and is not absorbed much into your body.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if your symptoms improve.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep it in its original container and out of reach of children and pets. Ensure all medications are stored safely.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if your symptoms improve.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep it in its original container and out of reach of children and pets. Ensure all medications are stored safely.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take the medication exactly as prescribed, even if you start feeling better.
- Stay well-hydrated, especially if you have severe diarrhea.
- Practice good hand hygiene (wash hands thoroughly with soap and water) to prevent the spread of C. diff.
- Avoid alcohol during treatment as it can worsen gastrointestinal upset.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
200 mg orally twice daily for 10 days
Dose Range:
200 - 200 mg
Condition-Specific Dosing:
Clostridioides difficile-associated diarrhea (CDAD):
200 mg orally twice daily for 10 days
Pediatric Dosing
Neonatal:
Not established
Infant:
6 months to < 18 years: 200 mg orally twice daily for 10 days (using tablets or oral suspension)
Child:
6 months to < 18 years: 200 mg orally twice daily for 10 days (using tablets or oral suspension)
Adolescent:
6 months to < 18 years: 200 mg orally twice daily for 10 days (using tablets or oral suspension)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; minimal systemic absorption
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Fidaxomicin is a macrocyclic antibacterial drug that acts locally in the gastrointestinal tract. It exerts its bactericidal activity by inhibiting bacterial RNA polymerase, leading to inhibition of protein synthesis and cell death in Clostridioides difficile. It is minimally absorbed systemically.
Pharmacokinetics
Absorption:
Bioavailability:
<1%
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Food does not significantly affect the systemic exposure of fidaxomicin or its active metabolite OP-1118.
Distribution:
Vd:
Not applicable (primarily local GI action)
ProteinBinding:
91-92% (fidaxomicin), 90-93% (OP-1118)
CnssPenetration:
No
Elimination:
HalfLife:
11.7 hours (fidaxomicin), 9.9 hours (OP-1118) - systemic, but primarily eliminated via feces
Clearance:
Not applicable (primarily fecal excretion)
ExcretionRoute:
Fecal (primarily as unchanged drug and OP-1118)
Unchanged:
>92% (feces)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-3 days
PeakEffect:
Not applicable (local action)
DurationOfAction:
Maintains therapeutic concentrations in the colon for the duration of treatment
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Feeling extremely tired or weak
Fever or chills
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
For all patients taking this medication:
+ Stomach pain
+ Upset stomach or vomiting
For children:
+ Diarrhea
+ Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Feeling extremely tired or weak
Fever or chills
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
For all patients taking this medication:
+ Stomach pain
+ Upset stomach or vomiting
For children:
+ Diarrhea
+ Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening or persistent diarrhea
- Severe abdominal pain or cramping
- Fever
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- New or unusual symptoms
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Due to minimal systemic absorption, overdose is unlikely to cause systemic toxicity. Gastrointestinal upset (nausea, vomiting, diarrhea) might be exacerbated.
What to Do:
Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is supportive.
Drug Interactions
Moderate Interactions
- P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, ketoconazole, verapamil, amiodarone, quinidine): May increase systemic exposure of fidaxomicin and its metabolite OP-1118, but clinical significance is minimal due to low systemic absorption.
Monitoring
Routine Monitoring
Resolution of diarrhea
Frequency: Daily during treatment and post-treatment
Target: Return to normal bowel habits
Action Threshold: Persistent or worsening diarrhea, fever, abdominal pain may indicate treatment failure or recurrence.
Signs of C. difficile infection recurrence
Frequency: Monitor for several weeks post-treatment
Target: Absence of symptoms
Action Threshold: New onset of diarrhea, fever, abdominal pain after initial resolution.
Symptom Monitoring
- Diarrhea frequency and consistency
- Abdominal pain or cramping
- Fever
- Nausea
- Vomiting
- Signs of dehydration
Special Patient Groups
Pregnancy
Available data from published studies and postmarketing experience are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal reproduction studies did not show adverse developmental effects at exposures up to 1.5 times the human exposure at the maximum recommended human dose (MRHD). Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Insufficient data; animal studies show no adverse effects.
Second Trimester:
Insufficient data; animal studies show no adverse effects.
Third Trimester:
Insufficient data; animal studies show no adverse effects.
Lactation
There are no data on the presence of fidaxomicin in human milk, the effects on the breastfed infant, or the effects on milk production. Due to very low systemic absorption, it is not expected to be present in human milk or to harm a breastfed infant. Consider the benefits of breastfeeding and the potential risks.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Approved for pediatric patients 6 months and older. Dosing is 200 mg twice daily for 10 days for patients 6 months to <18 years. Safety and effectiveness in pediatric patients younger than 6 months of age have not been established.
Geriatric Use
No dosage adjustment is necessary based on age. Clinical studies included sufficient numbers of subjects aged 65 and over to determine that efficacy and safety profiles are similar to younger adults. Elderly patients may be more susceptible to C. difficile infection and its complications.
Clinical Information
Clinical Pearls
- Fidaxomicin is a highly effective, locally acting antibiotic specifically for C. difficile infection, with minimal systemic absorption, leading to a low risk of systemic side effects and drug interactions.
- It is often preferred for recurrent C. difficile infection or in patients who have failed other therapies like vancomycin.
- Ensure patients complete the full 10-day course, even if symptoms improve, to minimize recurrence risk.
- The high cost of fidaxomicin often necessitates prior authorization from insurance companies.
Alternative Therapies
- Vancomycin (oral) for C. difficile infection
- Metronidazole (oral) for mild C. difficile infection (less effective for severe or recurrent cases)
- Bezlotoxumab (adjunctive therapy to prevent C. difficile recurrence)
Cost & Coverage
Average Cost:
$4,000 - $6,000+ per 20 tablets (10-day course)
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.