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New FDA Approved Drugs & Vaccines
The mechanism of action of zuranolone in the treat- ment of PPD is not fully understood but is thought to be related to its positive allosteric modulation of gamma-aminobutyric acid (GABA) A receptors. Administration: The standard dose of zuranolone is 50 mg by mouth every evening for 14 days, with fat-containing food. The dose may be reduced to 40 mg if CNS depression occurs. The dose may be further reduced to 30 mg once daily in women with severe hepatic impairment, moderate to severe renal impairment, or concomitant use with a strong CYP3A4 inhibitor. Concomitant use with a CYP3A4 inducer should be avoided. It can be used alone or as an adjunct to other antidepressant therapy. If the evening dose is missed, take the next dose at the regular time the following evening. Do not take extra capsules on the same day to make up for the missed dose. Continue taking for the full 14 days. Safety: The most common side effects are drows- iness, somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. Zuranolone carries a boxed warning for driving impairment due to CNS depression; patients should
be advised to avoid driving or engaging in other potentially hazardous activities for at least 12 hours after administration. They should also be counseled to avoid other agents that cause CNS depression, such as alco- hol, opioids, and benzodiazepines which can compound this effect. Like with other antidepres- sants, patients should be counseled on the potential for suicidal thoughts and behavior; the dose may need to be decreased or discontinued if this occurs. Additionally, zuranolone may cause fetal harm, so birth control should be used during treatment and for at least one week after the last dose. How Supplied : Zuranolone is available as 20 mg, 25 mg, and 30 mg capsules in bottles of 14 (the 25 mg strength is also available in a 28-count blister pack. Store at controlled room temperature. Additional Notes: Zuranolone is a sched- ule IV-controlled substance per the Controlled Substances Act. Due to its effect on GABA, zurano- lone has abuse potential with associated risks of misuse, abuse, and substance use disorder includ- ing addiction. Zuranolone may produce physical dependence.
CONCLUSION
2023 was a busy and exciting year in regard to new drug approvals; we saw new therapies for dis- eases that have not previously had viable treatment options in the field of women's health (i.e., post- partum depression and menopausal vasomotor symptoms), neurology (i.e., Alzheimer’s disease), and ophthalmology (i.e., dry eye disease). 2023 also brought about the approval of new vac- cines for the prevention of complications associated with RSV infection, which took over 60 years to develop. We also now have options in previously approved drug classes that may allow for a more individualized treatment approach (e.g., a nasal spray for acute migraine treatment, a more afford- able oral tablet for type II DM, and an add-on
therapy for resistant hypertension). The drugs and the therapeutic areas discussed in this article are only a fraction of the medications approved by the FDA in 2023 and 2024. It is important that pharmacy technicians remain up to date on all drugs that they dispense in their applicable area(s) of practice. The full list of 2023 new drug approvals can be found in the Center for Drug Evaluation and Research (CDER) Annual Report published in January 2024. A list of 2024 new drug approvals can be found on the FDA’s website at < https://www.fda.gov/drugs/ novel-drug-approvals-fda/novel-drug-approv- als-2024>, which is updated in real-time.
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