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Which of the following would be the MOST APPROPRIATE auxiliary label for cyclobenzaprine?

A. "Take with food or milk."

B. "Shake well before use."

C. "Avoid sun exposure."

D. "May cause drowsiness."

E. "Take on empty stomach."

D. "May cause drowsiness"

Cyclobenzaprine (Amrix®, Flexeril®, Fexmid®, FusePaq Tabradol®, and more) is a skeletal muscle relaxant agent that possesses analgesic properties as well as anti-cholinergic actions. Therefore, this drug may cause drowsiness. The following types of medications can cause drowsiness alone or with alcohol and should bear an auxiliary label that reads "May cause drowsiness":

  • Schedule II through V controlled substances (narcotics and anti-depressants)

  • Antihistamines/Anticholinergics

  • Anti-depressant/Antipsychotics

  • Disulfiram

  • Nitrates

  • Monoamine oxidase inhibitors (MAOIs)

Which of the following medications should bear an auxiliary label that reads "Caution: federal law prohibits transferring of this drug to any person other than the patient for whom it was prescribed?"

A. Nandrolone

B. Augmentin

C. Prednisolone

D. Flagyl

E. Genvoya

A. Nandrolone

Nandrolone (Deca-Durabolin®, Hybolin Decanoate®) is an injected anabolic-androgenic steroid (AAS), a C-III controlled substance. All controlled substances must bear an auxiliary label required by federal law that should read, "Caution: federal law prohibits transferring of this drug to any person other than the patient for whom it was prescribed."

B. Augmentin (amoxicillin/clavulanate is an antibiotic)

C. Prednisolone (steroid)

D. Flagyl (metronidazole is an antibiotic)

E. Genvoya (combination HIV drug, emtricitabine/tenofovir alafenamide/elvitegravir/cobicistat)

Which of the following rating code for generic substitution would indicate that the generic product has NOT shown therapeutic equivalence?

A. AB-rated

B. AN-rated

C. BA-rated

D. AP-rated

E. AT-rated

C. BA-rated

The Orange Book rates each generic with a code with two letters, starting with an "A" or a "B" (i.e. AB-rated, BN-rated, etc.). The first letter "A" indicates therapeutic equivalence whereas letter "B" indicates products that have not demonstrated therapeutic equivalence. The following are second letters of the codes, which designate different routes of administration:

  • A = oral dosage form

  • N = aerosolization

  • P = ...

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