PTCB PTCE Question Answer
Which of the following drugs must be dispensed with a patient package insert?
Sulfamethoxazole/Trimethoprim
Norethindrone/Ethinyl Estradiol
Triamterene/HCTZ
Emtricitabine/Tenofovir Disoproxil
Comprehensive and Detailed Step-by-Step Explanation:
The FDA requires patient package inserts (PPIs) for certain medications, including oral contraceptives like norethindrone/ethinyl estradiol.
????Explanation of Answer Choices:
✅B. Norethindrone/Ethinyl Estradiol → Correct. Oral contraceptives must include a PPI with risk information.
❌A. Sulfamethoxazole/Trimethoprim → Incorrect. Does not require a package insert.
❌C. Triamterene/HCTZ → Incorrect. A diuretic, no required PPI.
❌D. Emtricitabine/Tenofovir Disoproxil → Incorrect. A PPI is required only for certain formulations.
????Reference:
FDA Patient Information Leaflet Requirements
TESTED 06 Aug 2025
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