The U.S. Food and Drug Administration has approved Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD).
Clostridium difficile (C. difficile) is a bacterium that can cause diarrhea and lead to colitis, other serious intestinal conditions, and death in severe cases. C. difficile bacteria are found in the stool of an infected person, and others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouths.
The safety and efficacy of Dificid were demonstrated in two trials that included 564 patients with CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD. The clinical response was similar in the Dificid group compared with the vancomycin group in both studies. In some patients with CDAD, symptoms can return. In the Dificid trials, a greater number of patients treated with Dificid had a sustained cure three weeks after treatment ended versus those patients treated with vancomycin.
Dificid, a macrolide antibacterial, should be taken two times a day for 10 days with or without food.
To maintain the effectiveness of Dificid, and to reduce the development of drug-resistant bacteria, the drug should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
The most common side effects reported with Dificid included nausea, vomiting, headache, abdominal pain, and diarrhea.People at risk of developing the bacterial infection include the elderly, patients in hospitals or nursing homes, and people taking antibiotics for another infection. The most effective way to prevent CDAD is thorough handwashing with soap and warm water.
Dificid Indications and Usage: Dificid is a macrolide antibacterial drug indicated in adults (≤18 years of age) for treatment of Clostridium difficile-associated diarrhea.
Dosage and Administration: One 200 mg tablet orally twice daily for 10 days with or without food.
Dosage Forms and Strengths: Film-coated tablets: 200 mg
Warnings and Precautions
* Dificid should not be used for systemic infections.
* Development of Drug Resistant Bacteria: Only use Dificid for infection proven or strongly suspected to be caused by C. difficile.
Dificid side effects:
The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).