Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

In what context is diphenoxylate significant within Schedule V classification?

1. It is prohibited.

2. It requires co-administration with atropine sulfate.

3. It is only available in compounding.

4. It has no maximum dosage limitation.

The correct answer is: It requires co-administration with atropine sulfate.

Diphenoxylate is significant within Schedule V classification primarily because it is often combined with atropine sulfate to deter potential abuse. This combination works to minimize the addictive potential of diphenoxylate, which is an opioid used primarily as an antidiarrheal agent. The inclusion of atropine serves to produce unpleasant side effects if the medication is misused, thereby discouraging individuals from taking it in higher than prescribed doses for the euphoric effects that opioids can produce. This combined formulation is pivotal because it aligns with federal regulations that aim to mitigate the risks associated with opioid misuse while still allowing for therapeutic use in patients who require it for legitimate medical reasons. The Schedule V classification itself indicates that while diphenoxylate is available for medical use, it is recognized for its potential for dependence, hence the necessity of the addition of atropine as a safeguard. In contrast, being prohibited or having no maximum dosage limitation does not accurately reflect the guidelines set forth for this substance, as there are regulations regarding its use. Similarly, its inclusion in compounding does not capture its primary significance in the context of Schedule V classification.