MedCallyLooking up the FDA label…
Looking up the FDA label…
Macrolide Antibacterial
Also sold as Dificid
Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. 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. 1.1 Clostridioides difficile -Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile-associated diarrhea (CDAD). 1.2 Usage 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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. …
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 is 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. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by fidaxomicin tablets or other antibacterial drugs in the future. Rx only APOTEX INC FIDAXOMICIN TABLETS 200 mg Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 Rev. 3
The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp., at 1-800-706-5575 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 d…
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Ask a doctor — $19.99Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets. Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets.
Fidaxomicin tablets are administered orally with or without food. Adults One 200 mg tablet orally twice daily for 10 days. 2.1 Important Administration Instructions Fidaxomicin tablets are available for oral administration as 200 mg tablets. Fidaxomicin tablets are administered orally with or without food. 2.2 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)…
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 tablets, plasma concentrations of fidaxomicin and OP-1118 were significantly increased but remained in the ng/mL range. Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gas…
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Works in a similar way — antibiotics
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.