Digicid Suspension

Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile . ( 1.2 ) 1.1 Clostridioides difficile -Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile - associated diarrhea (CDAD). …

• Fidaxomicin tablets are administered orally with or without food. • Adults One 200 mg tablet orally twice daily for 10 days; Important Administration Instructions Fidaxomicin tablets are available for oral administration as 200 mg tablets
• Fidaxomicin tablets are administered orally with or without food
• Adult Patients The recommended dosage for adults is one 200 mg fidaxomicin tablet orally twice daily for 10 days
• Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets
• However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information

Fidaxomicin tablets 200 mg white to off-white film-coated, oblong tablets; each tablet is debossed with "200" on one side and plain on the other side. Film-coated tablets: 200 mg ( 3 )

• The safety and effectiveness of fidaxomicin have not been established
• In pediatric patients younger than 6 months of age
• Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets
• However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information

Of the total number of patients in controlled trials of fidaxomicin, 50% were 65 years of age and over, while 31% were 75 and over. No overall differences in safety or effectiveness of fidaxomicin compared to vancomycin were observed between these subjects and younger subjects. In controlled trials, elderly patients (≥65 years of age) had higher plasma concentrations of fidaxomicin and its main metabolite, OP-1118, versus non-elderly patients (

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Administration with Food Inform patients and caregivers that fidaxomicin tablets may be taken with or without food
• Antibacterial Resistance Patients should be counseled that antibacterial drugs, including fidaxomicin tablets, should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold)
• When fidaxomicin tablets are prescribed to treat a C. difficile infection, patients should be told that, although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. …

• Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets [see Warnings and Precautions ]
• Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets

Fidaxomicin and its main metabolite, OP-1118, are substrates of the efflux transporter, P-glycoprotein (P-gp), which is expressed in the gastrointestinal tract. 7.1 Cyclosporine Cyclosporine is an inhibitor of multiple transporters, including P-gp. When cyclosporine was co-administered with fidaxomicin, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range [see Clinical Pharmacology ( 12.3 )] . …

• Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue fidaxomicin tablets. ( 5.1 ) • Fidaxomicin tablets are not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. Fidaxomicin tablets should only be used for the treatment of C. difficile-associated diarrhea. ( 5.2 ) • Development of drug-resistant bacteria: Only use fidaxomicin for infection proven or strongly suspected to be caused by C. difficile. …

The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary The limited available data on use of fidaxomicin in pregnant women are insufficient to inform any drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Embryo-fetal reproduction studies in rats and rabbits dosed intravenously during organogenesis revealed no evidence of harm to the fetus at fidaxomicin and OP-1118 (its main metabolite) exposures 65-fold or higher than the clini …

No cases of acute overdose have been reported in humans. No drug-related adverse effects were seen in dogs dosed with fidaxomicin tablets at 9600 mg/day (over 100 times the human dose, scaled by weight) for 3 months.

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