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Aplenzin (bupropion hydrobromide) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating adults with major depressive disorder.
Aplenzin is a type of antidepressant that works by changing norepinephrine and dopamine, two brain chemicals linked to mood. The exact way it works is not fully known. In major depressive disorder, this helps reduce symptoms such as low mood and loss of interest.
Doctors prescribe Aplenzin when an adult needs treatment for major depressive disorder. Aplenzin is given as an extended-release tablet by mouth, typically once daily in the morning. It may be taken with or without food.
The recommended starting dose of Aplenzin for major depressive disorder is 174 milligrams once daily in the morning.
For people who respond to treatment, the recommended maintenance dose is 348 milligrams once daily in the morning.
After four days of dosing, a doctor may increase the dose to 348 milligrams once daily in the morning. Doctors may also periodically reassess the need for ongoing treatment and the right dose. This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of adults taking bupropion HCl sustained-release for major depressive disorder, certain side effects were reported more often than with a placebo (inactive treatment). Side effects can vary based on dose.
It is expected that Aplenzin will have side effects similar to bupropion HCl sustained-release. The side effects that occurred in more than 5 percent of individuals, and more often than placebo, were:
Aplenzin can cause serious side effects that require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Bausch Health, the manufacturer of Aplenzin, offers the Aplenzin Savings & Access Program. Eligible commercially insured people may pay as little as $0 for Aplenzin. This offer is not valid for people covered by Medicare, Medicaid, Tricare, Veterans Administration or Department of Defense health coverage, or other federal or state healthcare programs.
The Aplenzin Savings & Access Program also offers free delivery of Aplenzin through PhilRx, including help applying the lowest available out-of-pocket cost, scheduling refills, and troubleshooting insurance.
Tell your doctor if you have any allergies to bupropion hydrobromide or any ingredients in Aplenzin.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements.
Do not take Aplenzin if you:
If you miss a dose, do not take an extra tablet to make up for the missed dose.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Aplenzin, talk with your doctor about the risks and benefits. A pregnancy exposure registry is available: National Pregnancy Registry for Antidepressants, 844-405-6185.
These answers are fact-checked by our editorial staff.
How effective is Aplenzin?
In studies of adults with major depressive disorder, bupropion HCl showed benefit in two four-week placebo-controlled inpatient trials and one six-week placebo-controlled outpatient trial. In a longer-term maintenance study, people who responded during an eight-week acute treatment phase and then stayed on bupropion HCl had significantly lower relapse rates over the next 44 weeks than those who switched to a placebo. Aplenzin is bioequivalent to extended-release bupropion HCl, meaning it delivers the same active medicine exposure as that form.
How long does Aplenzin take to work for major depressive disorder?
The studies that established benefit in major depressive disorder lasted four weeks, six weeks, and, for maintenance treatment, up to 44 weeks after an initial eight-week response phase. An exact time for when symptoms start to improve is not given.
What tests or monitoring are needed with Aplenzin for major depressive disorder?
Blood pressure should be checked before starting Aplenzin and monitored from time to time during treatment because it can raise blood pressure. People of all ages should also be watched closely for worsening depression, suicidal thoughts or behaviors, and unusual changes in behavior, especially when starting treatment or when the dose changes. In older adults, it may also be useful to monitor kidney function.
What should I do if I miss a dose of Aplenzin for major depressive disorder?
If you miss a dose, do not take an extra tablet to make up for it. Aplenzin should be swallowed whole and is usually taken once daily in the morning.
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