From the Guidelines
Dificid (fidaxomicin) typically expires 3 years from the date of manufacture when stored properly, as indicated by the expiration date printed on the medication packaging. The storage conditions for Dificid tablets, as recommended, are at room temperature (68-77°F or 20-25°C) in the original container to protect them from moisture 1. It is crucial to adhere to the expiration date because, after this period, the medication may lose its potency and effectiveness, potentially leading to treatment failure for Clostridioides difficile infections. Although the provided guideline evidence focuses on the clinical practice for managing Clostridioides difficile infection, including the use of fidaxomicin versus vancomycin 1, it does not directly address the expiration of Dificid. However, based on general pharmaceutical principles, the chemical stability of fidaxomicin, like other medications, gradually decreases over time, which is why pharmaceutical companies establish expiration dates based on stability testing.
Key Points to Consider:
- The expiration date of Dificid is determined by the manufacturer based on stability testing.
- Proper storage conditions are essential to maintain the medication's potency.
- Using expired Dificid may not provide the intended therapeutic effect and could potentially be harmful.
- If Dificid has expired, it should be disposed of properly, and a healthcare provider should be consulted for a new prescription if needed. Given the information available and prioritizing patient safety and treatment efficacy, it is essential to follow the expiration date on the packaging and store Dificid under the recommended conditions to ensure its effectiveness against Clostridioides difficile infections, as suggested by guidelines such as those from the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) 1.
From the FDA Drug Label
16 HOW SUPPLIED/STORAGE AND HANDLING
... Once reconstituted, store DIFICID oral suspension refrigerated at 2°C-8°C (36°F-46°F) for up to 12 days. ... Discard unused suspension after 12 days.
The expiration of Dificid (Fidaxomicin) is not explicitly stated in the provided text, but it does mention that unused suspension should be discarded after 12 days of reconstitution. However, this does not directly answer the question of when the product expires. The FDA drug label does not answer the question.
From the Research
Dificid (Fidaxomicin) Expiration
- There are no research papers to assist in answering this question, as the provided studies focus on the efficacy, safety, and stability of fidaxomicin in treating Clostridium difficile infection, but do not mention the expiration date of Dificid (Fidaxomicin) 2, 3, 4, 5, 6.
- The studies discuss the stability of fidaxomicin in various conditions, such as when crushed and dispersed in water, applesauce, or Ensure brand liquid nutritional supplement 5, but do not provide information on the expiration date.