Aplenzin (Bupropion) - Oral

Warning:

The United States Food and Drug Administration (FDA) has issued a boxed warning for Aplenzin. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks. Review these warnings and discuss your concerns with your healthcare provider before starting treatment.

The boxed warning: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. Anyone considering using Aplenzin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. People of all ages who are on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers must keep a close observation and communication with the prescriber. Aplenzin is not approved for use in pediatric individuals.

What Is Aplenzin?

Aplenzin (bupropion) is an orally administered medication used to treat major depressive disorder (MDD) and seasonal affective disorder (SAD) in adults 18 and older. Aplenzin is in a class of antidepressant drugs called norepinephrine and dopamine reuptake inhibitors (NDRIs), which are drugs used primarily to treat depression.

Aplenzin has a novel antidepressant mechanism that works by dual inhibition of norepinephrine and dopamine reuptake, restoring their natural balance in the brain.

It's important to recognize that while similar brands exist containing bupropion as their primary ingredient, only Aplenzin possesses the specific bupropion hydrobromide ingredient. Comparatively, brands such as Forfivo XL and Wellbutrin XL contain bupropion hydrochloride—an ingredient that is not interchangeable with bupropion hydrobromide on a milligram-to-milligram basis.

Aplenzin is a prescription-only medicine available in the form of an extended-release (long-acting) tablet to consume orally.

Drug Facts

Generic Name: Bupropion

Brand Name(s): Aplenzin, Forfivo XL (bupropion hydrochloride), Wellbutrin XL (bupropion hydrochloride)

Drug Availability: Prescription

Administration Route: Oral

Therapeutic Classification: Antidepressant

Available Generically: Yes

Controlled Substance: N/A

Active Ingredient: Bupropion hydrobromide

Dosage Form(s): Extended-release tablet

What Is Aplenzin Used For?

The Food and Drug Administration (FDA) has approved Aplenzin for the treatment of major depressive disorder (MDD) in addition to other major depressive disorders such as seasonal affective disorder (SAD).

MDD is a common and serious mood disorder that impacts the way an individual feels, thinks, and acts on a daily basis. It also goes by the name of clinical depression.

There are several types of depressive disorders that include:

  • Psychotic depression: A form of depression with psychosis, such as delusions and/or hallucinations (hearing or seeing things that are not there).
  • Melancholic depression: A severe form of depression where people experience a complete loss of pleasure in nearly all activities.
  • Postpartum depression: Affects people after having a baby. It causes intense, long-lasting feelings of anxiety, sadness, and fatigue, making it difficult for the person to care for themselves and/or their babies and handle daily responsibilities. Postpartum depression can start anywhere from weeks to months after childbirth. However, According to the Diagnostic and Statistical Manual (DSM) of Mental Disorders criteria and the American College of Obstetricians and Gynecologists (ACOG), postpartum depression can present during pregnancy and not only after the baby is born, despite what the name implies. The DSM and American Psychiatric Association (APA) specify that it is a major depressive episode with peripartum onset and no later than four weeks after delivery. However, not every resource agrees with this timeframe, and some (such as the American Academy of Pediatrics [AAP] and ACOG) suggest that it can present up to a year after childbirth.

Additionally, SAD refers to mood changes and symptoms similar to depression. The symptoms usually occur during the fall and winter months when there is less sunlight and usually improve with the arrival of spring.

The most challenging months for people with SAD in the United States (U.S.) tend to be January and February. However, while rarer, some people do experience SAD in the summer.

Aplenzin is also used to treat episodes of depression in people with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) and to treat attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age).

Talk to your healthcare provider about the possible risks of using this medication for your condition.

How to Take Aplenzin

Read the prescription label carefully before you start using Aplenzin and get a refill each time. If you have any questions or don't understand anything, ask your healthcare provider. Take Aplenzin by mouth with or without food as directed, usually once daily in the morning.

If you have a stomach upset, take this medication with or after a meal or snack. Taking Aplenzin later in the day may cause insomnia.

Aplenzin is an extended-release tablet, so do not crush or chew the drug. If done, it can release all of the drugs at once, increasing the risk of side effects. Swallow the whole or split tablet if they have a score line, and your healthcare provider directs you to do so. Do not stop taking medicine without asking your healthcare provider. Your dose may need to be gradually decreased.

Storage

Store this medicine in a well-closed container at room temperature. Keep the medicine away from direct light, heat, and moisture. Do not store it in the bathroom. Keep all the medication locked out of the sight and reach of children.

Do not keep expired or unwanted medicines. Discard the products when expired or are no longer needed. Do not discard unwanted medications into a drain, flush down the toilet, or throw them away in the waste bin. 

The best way is to return the unwanted medicine through a medicine take-back program. Ask your pharmacist or contact the local waste disposal company about the medicine take-back program.

Off-Label Uses

Aplenzin may be indicated off-label for disorders including:

How Long Does Aplenzin Take to Work?

Aplenzin may take four weeks or longer to show the full benefits. Contact your healthcare provider if your condition does not improve or if it worsens.

What Are The Side Effects of Aplenzin?

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

As with all medications, Aplenzin can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

Common Side Effects

Some common side effects of Aplenzin include:

Severe Side Effects

The FDA has issued a boxed warning for Aplenzin. Boxed warnings are the agency’s strongest warnings for serious and potentially life-threatening risks. Review these warnings and discuss your concerns with your healthcare provider before starting treatment.

The boxed warning: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults. Anyone considering using Aplenzin or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. People of all ages who are on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers must keep a close observation and communication with the prescriber. Aplenzin is not approved for use in pediatric individuals.

Some side effects can be severe. If you notice any of the following symptoms or warning sections, call your healthcare provider right away or get emergency medical treatment.

Potential serious side effects include:

  • Seizures
  • Confusion
  • Hallucinations (seeing or hearing something that does not exist)
  • Irrational fears
  • Muscular or joint pain
  • Heart palpitations (rapid, irregular, or pounding heartbeat

If you experience any allergy symptoms, such as fever, rash, itching, hives, or swelling of the face, throat, tongue, lips, eyes, hands, hoarseness, or difficulty breathing or swallowing, stop taking medicine and seek emergency medical help.

Report Side Effects

Aplenzin may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Aplenzin Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For depression:
      • Adults—
        • Aplenzin®: At first, 174 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 522 mg per day.
        • Forfivo XL®: 450 mg once a day.
        • Wellbutrin XL®: At first, 150 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 450 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For seasonal affective disorder:
      • Adults—
        • Aplenzin®: At first, 174 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 522 mg per day.
        • Wellbutrin XL®: At first, 150 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg once a day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (sustained-release tablets):
    • For depression:
      • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg two times per day, taken at least 8 hours apart.
      • Children—Use and dose must be determined by your doctor.
    • To quit smoking:
      • Adults—At first, 150 milligrams (mg) once a day for the first 3 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For depression:
      • Adults—At first, 100 milligrams (mg) two times per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg three times per day, taken at least 6 hours apart.
      • Children—Use and dose must be determined by your doctor.

Modifications

Users should be aware of the following before beginning Aplenzin:

Pregnancy: Data from studies of pregnant people exposed to Aplenzin in the first trimester have not identified an increased risk of negative adverse reactions to the fetus. However, there is a pregnancy exposure registry that monitors pregnancy outcomes in people exposed to antidepressants during pregnancy.

As a result, the estimated background risk for major birth defects and miscarriage is unknown for the indicated population. Healthcare providers are encouraged to register people by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185.

Therefore, make your healthcare provider aware if you intend to become pregnant or are pregnant while taking Aplenzin.

Breastfeeding: Data shows the presence of Aplenzin and its metabolites in human milk. However, there are no data on the effects of Aplenzin or its metabolites on milk production. Moreover, limited data from reports have not identified a clear association between adverse reactions in the breastfed infant.

As a result, be sure to make your healthcare provider aware if you intend to, or are currently breastfeeding while taking Aplenzin.

Older adults: Aplenzin is extensively metabolized in the liver to active metabolites, metabolized and excreted by the kidneys. Therefore, adverse reactions may be greater in people with impaired kidney function. Because older adults are more likely to have decreased kidney function, it may be necessary to consider this factor in dose selection.

Pediatric use: The safety and effectiveness in the pediatric population have not been established. It's important to remember that Aplenzin is prescribed traditionally for adults over the age of 18.

Missed Dose

If you missed a dose of Aplenzin, take it as soon as you remember. Skip the missed dose if it's nearly time for the next dose. Don't take a double dose to make up for the missed one.

Overdose: What Happens If I Take Too Much Aplenzin?

If someone has overdosed, call the Poison Control Center right away. If the person has severe symptoms such as passing out or trouble breathing, call 911.

Symptoms of overdose may include:

What Happens If I Overdose on Aplenzin?

If you think you or someone else may have overdosed on Aplenzin, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Tylenol, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

Do not take bupropion with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking bupropion during the 2 weeks after you stop a MAO inhibitor. Wait for 2 weeks after stopping bupropion before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may have confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with bupropion may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Bupropion may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies, or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Drinking alcoholic beverages should be limited or avoided, if possible, with bupropion. This will help prevent seizures.

This medicine may cause some people to have a false sense of wellbeing, or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy, dizzy, or less alert.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having certain side effects when you stop the medicine, such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headaches, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause a change in your appetite or weight. Your doctor may need to check your weight on a regular basis.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn't Take Aplenzin?

Aplenzin is not recommended in the following:

  • Individuals with a seizure disorder.
  • People with an existing or previous diagnosis of bulimia (an eating disorder) or anorexia nervosa (an eating disorder and severe mental health condition). A higher chance of having seizures was observed in such people when treated with Aplenzin.
  • People who are undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and anti-epileptic drugs.
  • Individuals using or have used monoamine oxidase inhibitors (MAOIs; a class of antidepressant medications) in the last 14 days. Use of MAO with or within 14 days of discontinuing treatment with Aplenzin is not recommended. 
  • People who are hypersensitive to bupropion or other ingredients of Aplenzin tablet.
  • Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported in some people.

What Other Medications May Interact With Aplenzin?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter (OTC) medicines, and vitamins or supplements. 

Taking MAO inhibitors with bupropion may cause a fatal drug interaction. Tell your healthcare provider if you are taking or if you have stopped taking a monoamine oxidase (MAO) inhibitor in the past 14 days. These drugs include:

  • Marplan (isocarboxazid)
  • Nardil (phenelzine)
  • Zyvox (linezolid)
  • Provayblue (methylene blue)
  • Emsam (selegiline)

Some other drugs that may interact with Aplenzin are:

Additionally, Aplenzin may interfere with certain medical/laboratory tests, brain scans for Parkinson's disease, and urine screening for amphetamines, possibly causing incorrect results. Therefore, tell laboratory personnel and all your medics if you use this drug.

What Medications Are Similar?

Aplenzin is distinct from other antidepressants SSRIs, such as:

SSRIs inhibit serotonin reuptake and help increase active serotonin levels in the brain, improving mood and anxiety. For clarification, serotonin is a neurotransmitter that affects emotions and moods.

Comparatively, Aplenzin is thought to act by controlling levels of the neurotransmitters norepinephrine and dopamine. These brain chemicals are involved in mood regulation and other mental functions.

Frequently Asked Questions

  • What is Aplenzin used for?

    Aplenzin is prescribed to treat major depressive disorder (MDD) and prevent seasonal affective disorder (SAD). The drug is used to improve a person's mood and feelings of well-being.

  • How does Aplenzin work?

    Aplenzin may work by restoring the balance of certain neurotransmitters such as dopamine and norepinephrine in the brain.

  • How long does it take for Aplenzin to work?

    Aplenzin may take four weeks or longer to show the complete benefit of the drug.

How Can I Stay Healthy While Taking Aplenzin?

Treatment of depression is usually a long-term process and has emotional side effects. Therefore, it is necessary to consider potentially significant drug interactions with antidepressants to effectively prevent or manage damaging events.

In contrast, optimizing a person's response to treatment, helping emotionally, and closely monitoring the person to avoid suicidal thoughts by professionals and close family and friends help achieve therapeutic goals.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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