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Comprehensive Patient Information Guide

Dificid is a prescription antibiotic medication used to treat Clostridioides difficile-associated diarrhea (CDAD) in adults and children 6 months and older. It’s a narrow-spectrum antibiotic that targets C. diff bacteria while preserving beneficial gut bacteria.

General Information

Dificid (fidaxomicin) is a prescription antibiotic specifically designed to treat Clostridioides difficile-associated diarrhea (CDAD), also known as C. diff colitis. It’s a narrow-spectrum antibiotic that targets C. diff bacteria while preserving the normal, beneficial bacteria in your gut.

Dificid works by inhibiting bacterial RNA synthesis in C. difficile bacteria, effectively stopping their growth and reproduction. Unlike broad-spectrum antibiotics, fidaxomicin has minimal activity against most normal gut bacteria, which helps preserve your natural intestinal microbiome during treatment.

Clostridioides difficile (C. diff) is a bacteria that can cause severe diarrhea and colitis. It often occurs after taking antibiotics that disrupt normal gut bacteria, allowing C. diff to multiply and produce toxins. C. diff infections can range from mild diarrhea to life-threatening conditions like toxic megacolon or perforation of the colon.

Dificid was first approved by the FDA in May 2011 for treating C. difficile-associated diarrhea in adults. In 2020, it was also approved for use in children 6 months and older. It’s specifically indicated for CDAD and should not be used for other types of infections.

Dosage and Administration

For adults, the standard dosage is 200 mg twice daily for 10 days. Each tablet contains 200 mg of fidaxomicin. The medication should be taken approximately every 12 hours, with or without food.

For children 6 months to less than 18 years, Dificid is dosed based on body weight. The oral suspension (40 mg/mL) is typically used for pediatric patients. Your child’s doctor will calculate the exact dose based on their weight and provide specific instructions for preparation and administration.

Take Dificid exactly as prescribed by your doctor. Swallow the tablets whole with water. You can take it with or without food. Take doses approximately 12 hours apart and try to take them at the same times each day. Complete the full 10-day course even if you start feeling better.

If you miss a dose, take it as soon as you remember. However, if it’s almost time for your next dose (within 6 hours), skip the missed dose and continue with your regular schedule. Never take two doses at the same time to make up for a missed dose.

Side Effects and Safety

The most common side effects include:

Most Common (2% or more of patients):

• Nausea
• Vomiting
• Abdominal pain
• Diarrhea (may be ongoing from C. diff infection)

Less Common:

• Headache
• Dizziness
• Rash
• Constipation (after diarrhea resolves)

Most side effects are mild and resolve after completing treatment.

WARNING: Seek immediate medical attention if you experience:

• Severe allergic reactions: Rash, hives, swelling of face/lips/tongue, difficulty breathing
• Severe abdominal pain or cramping
• Blood in stool or black, tarry stools
• High fever (especially if accompanied by severe abdominal pain)
• Signs of dehydration: Dizziness, dry mouth, decreased urination

Yes, although allergic reactions to Dificid are uncommon. Signs of an allergic reaction may include rash, hives, itching, swelling (especially of face, lips, tongue, or throat), or difficulty breathing. If you experience any signs of an allergic reaction, stop taking Dificid and seek immediate medical attention.

Dificid should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. Limited data is available about fidaxomicin use during pregnancy. It’s unknown whether fidaxomicin passes into breast milk. Discuss with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding.

Drug Interactions and Precautions

Dificid has minimal systemic absorption, which reduces the likelihood of drug interactions. However, you should still inform your healthcare provider about all medications you’re taking, including prescription drugs, over-the-counter medications, and supplements. This is especially important if you’re taking other antibiotics or medications that affect gut bacteria.

While Dificid preserves more beneficial gut bacteria than other antibiotics, you should consult your healthcare provider before taking probiotics during treatment. They may recommend waiting until after you complete the full course of Dificid, or they may suggest specific timing to avoid any potential interference with the medication’s effectiveness.

Generally, you should not take other antibiotics while being treated with Dificid for C. diff infection, as other antibiotics can worsen C. diff infections or interfere with treatment. However, in some specific medical situations, your doctor may prescribe additional antibiotics. Always follow your healthcare provider’s instructions and inform them of all medications you’re taking.

Because Dificid has minimal systemic absorption (most of the drug stays in the intestines), kidney or liver impairment typically doesn’t require dose adjustments. However, you should still inform your healthcare provider about any kidney or liver problems, as they may want to monitor you more closely during treatment.

Effectiveness and Treatment

Clinical studies show that Dificid is highly effective for treating C. difficile infections. In clinical trials, 87-92% of patients achieved clinical cure with Dificid treatment. Additionally, Dificid has been shown to have lower recurrence rates compared to vancomycin, with recurrence rates of approximately 15-25% versus 25-35% with vancomycin.

Many patients begin to notice improvement in their symptoms within 2-4 days of starting Dificid treatment. Diarrhea frequency often decreases, and abdominal pain may improve. However, it’s crucial to complete the full 10-day course even if you feel better, as stopping early can lead to treatment failure or recurrence of infection.

Yes, Dificid can be used to treat recurrent C. difficile infections. In fact, studies suggest that Dificid may be particularly beneficial for patients with recurrent infections, as it has been associated with lower rates of subsequent recurrence compared to other treatments. Your doctor will determine if Dificid is appropriate for your specific situation.

Dificid can be used for severe C. difficile infections, though the choice of treatment depends on various factors including the severity of illness and patient-specific considerations. For very severe or complicated cases, your doctor may recommend combination therapy or other treatment approaches. Always follow your healthcare provider’s specific recommendations for your situation.

Prevention and Recovery

To reduce the risk of C. diff reinfection:

• Complete your full treatment course – don’t stop early
• Practice good hand hygiene – wash hands frequently with soap and water
• Avoid unnecessary antibiotics in the future
• Clean surfaces with bleach-based disinfectants
• Don’t share personal items like towels or utensils
• Follow healthcare provider instructions for any future antibiotic use

During treatment and recovery:

• Stay hydrated – drink plenty of fluids to replace losses from diarrhea
• Eat bland, easy-to-digest foods – toast, rice, bananas, applesauce
• Avoid dairy products temporarily if they worsen symptoms
• Limit high-fiber foods until diarrhea resolves
• Avoid alcohol during treatment
• Consider electrolyte replacement if recommended by your doctor

C. diff infections can be contagious, and you may remain contagious until your symptoms resolve and you complete treatment. Practice strict hygiene measures, including frequent handwashing with soap and water (alcohol-based sanitizers are less effective against C. diff spores). Follow your healthcare provider’s guidance about when it’s safe to return to work or normal activities.

Routine follow-up testing is generally not recommended if your symptoms have resolved and you’ve completed the full treatment course. However, your healthcare provider may recommend follow-up if you have ongoing symptoms, severe infection, or other complications. Contact your doctor if symptoms return or worsen after completing treatment.

Storage, Cost and Access

Store Dificid tablets at room temperature between 68-77°F (20-25°C). Keep them in the original container, away from moisture, heat, and direct light. For the oral suspension (pediatric formulation), follow specific storage instructions provided by your pharmacist. Keep all medications out of reach of children and pets.

Dificid can be expensive, with costs varying significantly based on insurance coverage, pharmacy, and location. The brand-name medication typically costs several thousand dollars for a 10-day course without insurance. Many insurance plans cover Dificid for C. diff infections, though prior authorization may be required. Contact your insurance provider or pharmacist about coverage and potential assistance programs.

As of now, there is no generic version of fidaxomicin available in the United States. Dificid remains under patent protection. When generic versions become available in the future, they may offer more affordable treatment options for C. difficile infections.

Yes, the manufacturer may offer patient assistance programs for eligible patients. These programs can help reduce out-of-pocket costs for qualifying individuals. Additionally, some pharmacy discount programs and patient advocacy organizations may provide assistance. Contact your healthcare provider, pharmacist, or the manufacturer directly to learn about available programs and eligibility requirements.

This FAQ is for educational purposes only and does not replace professional medical advice. Always consult with your healthcare provider before starting, stopping, or changing any medication regimen.

For medical emergencies, call 911 immediately. For medication questions, contact your pharmacist or healthcare provider.