Fidaxomicin 200 mg/1
Fidaxomicin · TABLET, FILM COATED · Torrent Pharmaceuticals Limited
Fidaxomicin is a tablet, film coated containing fidaxomicin at 200 mg/1, taken oral. Manufactured by Torrent Pharmaceuticals Limited.
Key Facts
- Brand Name
- Fidaxomicin
- Generic Name
- Fidaxomicin
- NDC Code (Product)
13668-745- Manufacturer
- Torrent Pharmaceuticals Limited
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA220374
- Drug Class
- Macrolide Antibacterial [EPC]
- Marketing Start
- 01/27/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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). 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. Pediatric use information is approved for Cubist Pharmaceu…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Fidaxomicin tablets are administered orally with or without food. ( 2.1 ) Adults One 200 mg tablet orally twice daily for 10 days. ( 2.2 ) 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) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.
Contraindications
4 CONTRAINDICATIONS Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets [see Warnings and Precautions ( 5.1 )]. Fidaxomicin tablets are contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in fidaxomicin tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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 [see Clinical Pharmacology ( 12.3 )]. Concentrations of fidaxomicin and OP-1118 may also be decreased at the site of action (i.e., gastrointestinal tract) via P-gp inhibition; however, concomitant P-gp inhibitor use had no attributable effect on safety or treatment outcome of fidaxomicin-treated adult patients in controlled clinical trials. Based on these results, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended.
Adverse Reactions
6 ADVERSE REACTIONS 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 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 drug and may not reflect the rates observed in practice. Adults The safety of fidaxomicin 200 mg tablets taken twice a day for 10 days was evaluated in 564 adult patients with CDAD in two active-controlled trials with 86.7% of patients receiving a full course of treatment. Thirty-three adult patients receiving fidaxomicin tablets (5.9%) withdrew from trials as a result of adverse reactions (AR). The types of AR resulting in withdrawal from the study varied considerably. Vomiting was the primary adverse reaction leading to discontinuation of dosing; this occurred at an incidence of 0.5% in both the fidaxomicin tablets and vancomycin patients in Ph…
Frequently Asked Questions
What is Fidaxomicin used for?
Fidaxomicin contains Fidaxomicin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Fidaxomicin a controlled substance?
Fidaxomicin is not classified as a controlled substance by the DEA.
What is the generic name for Fidaxomicin?
The generic name for Fidaxomicin is Fidaxomicin. There are 2 other brand versions of Fidaxomicin.
What is the NDC code for Fidaxomicin 200 mg/1?
The NDC (National Drug Code) for Fidaxomicin 200 mg/1 is 13668-745, listed by Torrent Pharmaceuticals Limited.