Which Schedule V product has a dosage limit of ≤2.5 mg diphenoxylate and ≥25 mcg atropine per dosage unit?

Which Schedule V product has a dosage limit of ≤2.5 mg diphenoxylate and ≥25 mcg atropine per dosage unit?

• A. Lomotil (diphenoxylate/atropine)
• B. Pregabalin
• C. Certain cough preparations
• D. Codeine-containing cough syrups

Answer: (A)

The concept tested is how certain opioid-containing products are classified as Schedule V based on per-dose limits that balance therapeutic use with abuse deterrence. Lomotil fits this exactly because its label sets a maximum of 2.5 mg of diphenoxylate per dosage unit and requires at least 25 mcg of atropine per dosage unit. This combination is designed to be safe for routine use as an anti-diarrheal while making misuse less appealing, which is why it is categorized as Schedule V. Other options don’t meet these specific per-dose criteria. Pregabalin is Schedule V but is not a diphenoxylate/atropine product. Some cough preparations may contain small amounts of codeine, but they are not the diphenoxylate/atropine combination with the exact per-dose limits described, so they don’t fit the scenario.

The concept tested is how certain opioid-containing products are classified as Schedule V based on per-dose limits that balance therapeutic use with abuse deterrence. Lomotil fits this exactly because its label sets a maximum of 2.5 mg of diphenoxylate per dosage unit and requires at least 25 mcg of atropine per dosage unit. This combination is designed to be safe for routine use as an anti-diarrheal while making misuse less appealing, which is why it is categorized as Schedule V.

Other options don’t meet these specific per-dose criteria. Pregabalin is Schedule V but is not a diphenoxylate/atropine product. Some cough preparations may contain small amounts of codeine, but they are not the diphenoxylate/atropine combination with the exact per-dose limits described, so they don’t fit the scenario.