South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the limitation for diphenoxylate in C5 preparations?

1. 1 mg

2. 2.5 mg

3. 5 mg

4. 10 mg

The correct answer is: 2.5 mg

Diphenoxylate, when included in combination products used for the treatment of diarrhea, is classified as a controlled substance under the Controlled Substances Act. In South Carolina, as in many jurisdictions, there are specific limitations on the amount of diphenoxylate that can be present in these products to prevent misuse and ensure patient safety. The correct limitation for diphenoxylate in Schedule V preparations is indeed 2.5 mg per dosage unit. This regulation is significant as it reflects the need to manage the potential for abuse of medications, even those considered to have a lower risk profile compared to stronger narcotics. This specific limit is set to ensure that the medication maintains its efficacy for treating diarrhea while minimizing the risk of dependency or misuse. The other amounts listed, while they may reflect various dosages found in different formulations or contexts, do not align with the maximum allowable concentration within Schedule V products as defined by regulatory standards. Understanding these limitations is crucial for pharmacists and healthcare providers to ensure compliance with the law and safe dispensing practices.