Aplenzin (bupropion)

FDA warning: Suicidal thoughts and behaviors

This
drug has a boxed warning. This is the most serious
warning from the Food and Drug Administration (FDA). A boxed warning alerts
doctors and patients about drug effects that may be dangerous.

Taking
Aplenzin may cause you to have suicidal thoughts and behaviors. Your doctor will
monitor you for signs of these during your Aplenzin treatment. But if you or a
loved one notices that you’re thinking about or trying to harm yourself, your
doctor should be told right away.

What is Aplenzin?

Aplenzin is a brand-name prescription medication. It’s used
in adults to:

• Treat major depressive disorder (MDD), a type of depression that can include long-term and very regular feelings of intense sadness.
• Prevent episodes of depression in people with seasonal affective disorder (SAD), which is a form of MDD. SAD occurs only in certain seasons or times of the year, usually in the winter.

Aplenzin contains the drug bupropion hydrobromide. Aplenzin is a type of medication called an antidepressant and belongs to the aminoketone drug class. A class of drugs is a group of medications that work in a similar way.

Aplenzin comes as an extended-release tablet that you
swallow. “Extended-release” means the drug is released more slowly and works
longer in the body compared to an immediate-release form.

Effectiveness

There are no clinical trials that have tested the
effectiveness of Aplenzin. However, researchers have studied another form of
the drug called bupropion hydrochloride. The FDA approved bupropion hydrobromide
(Aplenzin) based on these studies because it works in a very similar way to
bupropion hydrochloride.

Studies of MDD

In clinical studies of people with MDD, bupropion (the drug in Aplenzin) was found to
be more effective than a placebo (no treatment).

A study of MDD looked at people who had taken bupropion hydrochloride sustained-release
tablets for 8 weeks. (Sustained-release tablets slowly release the same amount
of medication in the body over a period of time.)

The people either continued taking bupropion or stopped
taking the drug for up to 44 weeks. The group of people who continued taking
bupropion didn’t have worsening depression, while those who stopped taking
bupropion did. These results were based on whether people needed additional
drug treatment due to worsening depression symptoms.

For more information about how effective Aplenzin is in
helping treat MDD, see the “Aplenzin uses” section below.

Studies of SAD

In clinical studies of SAD, bupropion hydrochloride extended-release tablets were found
to be more effective than a placebo. (With extended-release tablets, the amount
of drug released in the body isn’t always the same over time.) People who usually
had SAD in the winter started taking bupropion in the fall (September to
November). They took the drug for about 4 to 6 months. Their dose was lowered
until they stopped treatment in early spring (the end of March).

Based on three combined trials, 84.3% of people who took bupropion didn’t develop
depression compared to 72% of people who took a placebo. These results were
based on whether people developed depression symptoms or needed treatment for
depression. A depression rating score was used as well.

For more information about how effective Aplenzin is in
helping treat SAD, see the “Aplenzin uses” section below.

Aplenzin generic

Aplenzin is available only as a brand-name medication. It’s
not currently available in generic form.

Aplenzin contains one active drug ingredient: bupropion hydrobromide. But immediate-release and extended-release forms of
bupropion hydrochloride are available as generics. Studies have shown that Aplenzin is bioequivalent (clinically similar and works the same) to the generic extended-release bupropion hydrochloride. So if you’re
interested in a generic, talk with your doctor.

Aplenzin side effects

Aplenzin can cause mild or serious side effects. The
following lists contain some of the key side effects that may occur while
taking Aplenzin. These lists don’t include all possible side effects.

For more information on the possible side effects of
Aplenzin, talk with your doctor or pharmacist. They can give you tips on how to
deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Aplenzin can include:

If they’re severe or don’t go away, talk with your doctor or
pharmacist.

Serious side effects

Serious side effects from Aplenzin aren’t common, but they
can occur. Call your doctor right away if you have serious side effects. Call
911 if your symptoms feel life-threatening or if you think you’re having a
medical emergency.

Serious side effects and their symptoms can include the
following:

• Suicidal thoughts and behaviors.* Symptoms can include:
  • thinking about or trying to harm yourself or others
  • sudden changes in mood, thoughts, behaviors ,or feelings
  • new or worsening depression
  • feeling anxious, irritated, or restless
  • acting angry or violent
  • mania (feeling very energetic or unbeatable)
  • insomnia (trouble sleeping)
  • panic attacks
• Unusual thoughts or behaviors. Symptoms can include:
  • delusions (believing or thinking you’re someone you’re not)
  • hallucinations and psychosis (seeing or hearing things that are not there)
  • paranoia (thinking something is going to get you or someone wants to harm you)
  • feeling confused
  • inability to concentrate
• Seizures. Symptoms can include:
  • jerky body movements that you can’t control
  • not being aware of your surroundings
  • loss of consciousness
• High blood pressure. Symptoms can include:
  • feeling a pounding in your chest
• Narrow-angle glaucoma (also known as angle-closure glaucoma). Symptoms can include:
  • increased eye pressure

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with
this drug. Here’s some detail on several
of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic
reaction after taking Aplenzin. It’s not known how often allergic reactions
happen in people using this drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Some
people have reported having severe allergic and anaphylactic reactions while taking Aplenzin. However, there aren’t any clinical studies that found whether Aplenzin causes allergic
reactions. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your
  eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have a severe allergic
reaction to Aplenzin. Call 911 if your symptoms feel life-threatening or if you
think you’re having a medical emergency.

Weight loss

Aplenzin may cause a loss of appetite, which can lead to
weight loss.

There aren’t any studies of Aplenzin that looked at weight
loss. However, researchers have studied bupropion hydrochloride. This
drug and bupropion hydrobromide, the main drug in Aplenzin, are
bioequivalent (clinically similar and work the same way).

In clinical trials of major depressive disorder (MDD), people took 300-mg or 400-mg
bupropion hydrochloride sustained-release tablets each day. (Sustained-release
tablets slowly release the same amount of medication in the body over a period
of time.) In the 300-mg group, 14% of people lost more than 5 pounds. In the
400-mg group, 19% of people lost more than 5 pounds. This was compared to 6% of
people who took a placebo (sugar pill or no active drug in the pill).

In clinical trials for seasonal affective disorder (SAD), people took 150-mg to 300-mg bupropion
hydrochloride extended-release tablets each day. (With extended-release
tablets, the amount of drug released in the body isn’t always the same over
time.) In this group, 23% of people lost more than 5 pounds. This was compared
to 11% of people who took a placebo.

If you’re taking Aplenzin and you lose your appetite for
multiple days in a row or lose weight, tell your doctor. They may monitor your
weight, have you stop taking Aplenzin, or switch you to another medication.

Insomnia

A type of sleep disorder called insomnia can occur when
taking Aplenzin.

There aren’t any studies of Aplenzin that looked at insomnia.
However, researchers have studied bupropion hydrochloride. This drug and
bupropion hydrobromide, the main drug in Aplenzin, work in similar ways.

In clinical trials of major depressive disorder (MDD), people took 300-mg or 400-mg
bupropion hydrochloride sustained-release tablets each day. In the 300-mg
group, 11% of people developed insomnia. In the 400-mg group, 16% of people
developed insomnia. This was compared to 6% of people who took a placebo (no
treatment).

In clinical trials for seasonal affective disorder (SAD), people took 150-mg to 300-mg bupropion
hydrochloride extended-release tablets each day. In this group, 20% of people
developed insomnia. This was compared to 13% of people who took a placebo.

If you have trouble sleeping for multiple days in a row, talk
with your doctor. Your doctor may monitor your sleeping patterns, have you stop
taking Aplenzin, or switch you to another medication.

Dry mouth

Dry mouth, a condition in which your mouth feels dry, can
occur with Aplenzin.

There aren’t any studies of Aplenzin that looked at dry
mouth. However, researchers have studied bupropion hydrochloride. This
drug and bupropion hydrobromide, the main drug in Aplenzin, work in
similar ways.

In clinical trials of people with MDD, people took 300-mg or 400-mg bupropion
hydrochloride sustained-release tablets each day. In the 300-mg group, 17% of
people had dry mouth. In the 400-mg group, 24% of people had dry mouth. This
was compared to 7% of people who took a placebo.

In clinical trials of people with SAD, people took 150-mg to 300-mg bupropion
hydrochloride extended-release tablets each day. In this group, 26% of people had
dry mouth, compared to 15% of people who took a placebo.

If you have dry mouth for multiple days in a row, talk with
your doctor. They may monitor your symptoms, have you stop taking Aplenzin, or
switch you to another medication.

Nausea

Nausea can occur when taking Aplenzin.

There aren’t any studies of Aplenzin that looked at nausea.
However, researchers have studied bupropion hydrochloride. This drug and
bupropion hydrobromide, the main drug in Aplenzin, work in similar ways.

In clinical trials of MDD, people took 300-mg or 400-mg bupropion hydrochloride
sustained-release tablets each day. In the 300-mg group, 13% of people had
nausea. In the 400-mg group, 18% of people had nausea. This was compared to 8%
of people who took a placebo. Also, 0.8% of people in the 300-mg group and 1.8%
in the 400-mg group stopped taking the drug due to nausea. This was compared to
0.3% of people who took a placebo.

In clinical trials of SAD, people took 150-mg to 300-mg bupropion hydrochloride
extended-release tablets each day. In this group, 13% of people had nausea, compared
to 8% of people who took a placebo.

If you have nausea or have been vomiting for multiple days
in a row, talk with your doctor. They may monitor your symptoms, have you stop taking
Aplenzin, or switch you to another medication.

Suicidal thoughts and behaviors

Taking Aplenzin may worsen and increase the risk of suicidal
thoughts and behaviors.* This risk is highest during the first few months of
treatment. An increase in suicidal thoughts or actions is a known risk of depression and other serious
psychiatric disorders. This can happen whether or not you are taking an
antidepressant medication.

In short-term clinical trials, people with depression and other serious psychiatric disorders took
various antidepressants, including bupropion (the main drug in Aplenzin) or a placebo.

The risk of suicidal thoughts and behaviors was highest for
people ages 24 years and younger. Out of 1,000 people, compared to those who
took a placebo, 14 more people younger than age 18 years and 5 more people
between ages 18 and 24 years who took an antidepressant thought of or attempted
suicide.

For people ages 25 to 64 years, there was no risk of suicide
while taking a placebo.

And finally, there were six fewer cases of suicidal thoughts
or suicide attempts in adults ages 65 and older who took an antidepressant.
This was compared to people in the same age group who took a placebo.

Your doctor
will monitor you for signs of suicidal thoughts and behaviors during your
Aplenzin treatment. But if you or a loved one notices that you’re thinking
about or trying to harm yourself, your doctor should be told right away.

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Alternatives to Aplenzin

Other drugs are available that can treat major depressive
disorder (MDD) and seasonal affective disorder (SAD). Some may be better suited for you than others. If
you’re interested in finding an alternative to Aplenzin, talk with your doctor.
They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label
to treat these specific conditions. Off-label use is when a drug that’s
approved to treat one condition is used to treat a different condition.

Alternatives for major depressive disorder (MDD)

Examples of other drugs that may be used to treat major
depressive disorder (MDD) include:

• selective serotonin reuptake inhibitors (SSRIs),
  such as fluoxetine (Prozac)
• serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine (Effexor XR)
• alpha-2 antagonists, such as mirtazapine (Remeron)
• tricyclic antidepressants (TCAs), such as
  nortriptyline (Pamelor)

Monoamine oxidase inhibitors (MAOIs) aren’t specifically approved for MDD or
SAD, but they can be used to treat depression. Keep in mind that taking Aplenzin with an MAOI can increase your risk for high blood pressure. (To learn more, see the “Aplenzin interactions”
section below.)

Alternatives for seasonal affective disorder (SAD)

SAD is a form of MDD, so the same medications can be used to
treat both conditions. Please see “Alternatives for major depressive disorder
(MDD)” above.

SAD also has some alternative nondrug treatments such as
light therapy (for example, special light therapy to use during the winter
months to prevent SAD).

Aplenzin vs. Wellbutrin XL

You may wonder how Aplenzin compares to other medications
that are prescribed for similar uses. Here we look at how Aplenzin and Wellbutrin
XL are alike and different.

Uses

The Food and Drug Administration (FDA) has approved both Aplenzin
and Wellbutrin XL to treat major depressive disorder (MDD) and prevent episodes
of depression in people who have seasonal affective disorder (SAD). MDD is a type of depression that includes long-term
and very regular feelings of intense sadness. SAD is a form of MDD, but SAD
occurs only in certain seasons or times of the year (usually in the winter).

Drug forms and administration

Both Aplenzin and Wellbutrin XL contain the active drug bupropion. Aplenzin contains bupropion hydrobromide, and Wellbutrin XL contains bupropion hydrochloride. Clinical studies have showed that both forms of bupropion are very similar.

Aplenzin and Wellbutrin XL both come as extended-release
tablets that you swallow. “Extended-release” means the drug is released more
slowly and works longer in the body compared to an immediate-release form.

Aplenzin is available in three strengths: 174 mg, 348 mg,
and 522 mg. Wellbutrin XL is available in two strengths: 150 mg and 300 mg.
Both medications are taken once a day in the morning, with or without food.

Side effects and risks

Aplenzin and Wellbutrin XL both contain the drug bupropion.
Therefore, both medications can cause very similar side effects. Below are examples
of these side effects.

More common side effects

This list contains examples of more common side effects that
can occur with Aplenzin or Wellbutrin XL (when taken individually):

Serious side effects

This list contains examples of serious side effects that can
occur with Aplenzin or Wellbutrin XL (when taken individually):

• worsening mental health, such
  as mood changes or thinking of or trying to harm yourself or others*
• seizures
• high blood pressure
• narrow-angle glaucoma (also
  known as angle-closure glaucoma)
• allergic reactions

* Aplenzin and Wellbutrin XL have a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Effectiveness

The only conditions both Aplenzin and Wellbutrin XL are used
to treat are MDD and SAD.

In clinical studies, Aplenzin (bupropion hydrobromide extended-release) has been
shown to be very clinically similar to Wellbutrin XL (bupropion hydrochloride
extended-release).

Costs

Aplenzin and Wellbutrin XL are both brand-name drugs. Wellbutrin
XL has a generic form, but Aplenzin does not. Brand-name medications usually
cost more than generics.

According to estimates on GoodRx.com,
Aplenzin is more expensive than Wellbutrin XL and the generic form of Wellbutrin
XL. The actual price you’ll pay depends on your insurance plan, your location,
and the pharmacy you use.

Aplenzin vs. Effexor XR

You may wonder how Aplenzin compares to other medications
that are prescribed for similar uses. Here we look at how Aplenzin and Effexor
XR are alike and different.

Uses

The Food and Drug Administration (FDA) has approved both Aplenzin
and Effexor XR to treat major depressive disorder (MDD). MDD is a type of depression that includes long-term and very regular feelings of intense sadness.

Aplenzin is also approved to prevent depression in people
who have seasonal
affective disorder (SAD). SAD is a form of MDD, but SAD occurs only in
certain seasons or times of the year (usually in the winter). Effexor XR is
also approved to treat certain types of anxiety including generalized anxiety
disorder, social anxiety disorder (also called social phobia), and panic
disorder.

Drug forms and administration

Aplenzin contains the active drug bupropion hydrobromide. Effexor XR contains the active drug venlafaxine.

Aplenzin comes as a tablet that you swallow. You take it
once a day in the morning with or without food. Effexor XR comes as a capsule
that you can either swallow or open and pour on a spoonful of applesauce. After
swallowing the applesauce, you should drink a glass of water. You take Effexor
XR once a day (in the morning or evening) with food.

Both Aplenzin and Effexor XR are extended-release. “Extended-release”
means the drug is released more slowly and works longer in the body compared to
an immediate-release form.

Aplenzin is available in three strengths: 174 mg, 348 mg,
and 522 mg. Effexor XR is also available in three strengths: 37.5 mg, 75 mg,
and 150 mg.

Side effects and risks

Aplenzin and Effexor XR both contain antidepressant medications. Therefore, both medications can cause very similar side effects.
Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects
that can occur with Aplenzin, with Effexor XR, or with both drugs (when taken
individually).

• Can occur with Aplenzin:
• Can occur with Effexor XR:
• Can occur with both Aplenzin and Effexor XR:
  • dry mouth
  • nausea
  • decreased appetite
  • weight loss
  • feeling nervous, anxious, or sweaty

Serious side effects

These lists contain examples of serious side effects that
can occur with Aplenzin, with Effexor XR, or with both drugs (when taken
individually).

• Can occur with Aplenzin:
  • few unique serious side effects
• Can occur with Effexor XR:
• Can occur with both Aplenzin and Effexor XR:
  • worsening mental health, such as mood changes or thinking of or trying to harm yourself or others*
  • high blood pressure
  • narrow-angle glaucoma (also known as angle-closure glaucoma)
  • seizures
  • allergic reactions

* Aplenzin and Effexor XR have a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Effectiveness

The only condition both Aplenzin and Effexor XR are used to
treat is MDD.

These drugs haven’t been directly compared in clinical
studies, but studies have found both Aplenzin and Effexor XR to be effective for treating MDD.

Costs

Aplenzin and Effexor XR are both brand-name drugs. Effexor
XR has a generic form, but Aplenzin does not. Brand-name medications usually
cost more than generics.

According to estimates on GoodRx.com, Aplenzin is more expensive than Effexor XR and the generic form of Effexor XR.
The actual price you’ll pay depends on your insurance plan, your location, and
the pharmacy you use.

Aplenzin dosage

The Aplenzin dosage your doctor prescribes will depend on
several factors. These include:

• the type and severity of the condition you’re
  using Aplenzin to treat
• other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then
they’ll slowly adjust it over time to reach the amount that’s right for you. Your
doctor will ultimately prescribe the smallest dosage that provides the desired
effect.

The following information describes dosages that are
commonly used or recommended. However,
be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best
dosage to suit your needs.

Drug forms and strengths

Aplenzin comes as an extended-release tablet that you
swallow. “Extended-release” means the drug is released more slowly and works
longer in the body compared to an immediate-release form. Aplenzin is available
in the following strengths: 174 mg, 348 mg, and 522 mg.

Dosage for major depressive disorder

For major depressive disorder (MDD), your doctor will likely
start you on the lowest Aplenzin dose needed. The usual starting dose is 174 mg,
once a day in the morning. After taking Aplenzin for 4 days, your doctor will see
if your dose needs to be increased. They may slowly increase your dose to 348 mg,
once a day. The slow increase is meant to help prevent seizures. (For a list of
seizure symptoms, see the “Aplenzin side effects” section above.)

Dosage for seasonal affective disorder

Because seasonal affective disorder (SAD) usually occurs in the winter season, your doctor will probably
start your treatment in the fall. This may help prevent episodes of SAD in winter.
You’ll start taking the lowest dose of Aplenzin needed.

The usual starting dose is 174 mg, once a day. After taking
Aplenzin for 1 week, your doctor will see if your dose needs to be increased. They
may slowly increase your dose to 348 mg, once a day. The slow increase is meant
to help prevent seizures. (For a list of seizure symptoms, see the “Aplenzin
side effects” section above.) You’ll likely continue treatment through the
winter season. Then your doctor will probably start lowering your dose until
you stop treatment in early spring.

What if I miss a dose?

If you miss a dose of Aplenzin, wait until it’s time for
your next scheduled dose. Then keep taking the drug as usual. Don’t try to make
up the missed dose because taking too much Aplenzin may increase your risk for
seizures. (For a list of seizure symptoms, see the “Aplenzin side effects”
section above.)

To help make sure that you don’t miss a dose, set a reminder
on your phone. You can also try using a medication timer.

Will I need to use this drug long term?

Aplenzin is meant to be used as a long-term treatment. If
you and your doctor determine that Aplenzin is safe and effective for you,
you’ll likely take it long term. Your doctor will likely monitor your use of
Aplenzin. They may adjust your dose or have you stop treatment if needed.

If you’re using Aplenzin for SAD, you may start treatment
right before the season you need it for. Then you’ll taper off shortly after
the season ends.

Aplenzin and alcohol

It’s best to avoid drinking alcohol or limit alcoholic
drinks while taking Aplenzin because of an increased risk of seizures. In rare cases, Aplenzin strengthened the effect of alcohol, making people more drowsy, and worsened mental health.* Aplenzin shouldn’t be used in people who suddenly stop drinking
alcohol because this can also increase the risk of seizures.

If you drink alcohol, talk with your doctor before you start
taking Aplenzin.

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Aplenzin interactions

Aplenzin can interact with several other medications. It can
also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For
instance, some interactions can interfere with how well a drug works. Other
interactions can increase the number side effects or make them more severe.

Aplenzin and other medications

Below is a list of medications that can interact with
Aplenzin. This list doesn’t contain all drugs that may interact with Aplenzin.

Before taking Aplenzin, talk with your doctor and pharmacist.
Tell them about all prescription, over-the-counter, and other drugs you take.
Also tell them about any vitamins, herbs, and supplements you use. Sharing this
information can help you avoid potential interactions.

If you have questions about drug interactions that may
affect you, ask your doctor or pharmacist.

Aplenzin and CYP2B6 inducers

Taking Aplenzin with certain drugs called CYP2B6 inducers
can decrease the level of Aplenzin in your body.

Examples of CYP2B6 inducers include:

• HIV drugs such as ritonavir (Norvir), lopinavir/ritonavir (Kaletra), and efavirenz (Sustiva)
• seizure drugs such as carbamazepine (Tegretol), phenytoin
  (Dilantin), and phenobarbital

Before you take Aplenzin, tell your doctor if you’re using
any of these drugs. They may monitor you during your Aplenzin treatment or increase
your Aplenzin dose, if you’re not already taking the maximum dose each day. Or
your doctor may switch you to a different medication.

Aplenzin and CYP2B6 inhibitors

Taking Aplenzin with certain drugs called CYP2B6 inhibitors
can increase the level of Aplenzin in your body.

Examples of CYP2B6 inhibitors include:

• blood-thinning drugs such as ticlopidine (Ticlid),
  clopidogrel (Plavix),
  and prasugrel (Effient)

Before you take Aplenzin, tell your doctor if you’re using
any of these drugs. They may monitor you during your Aplenzin treatment or adjust
your Aplenzin dose. Or your doctor may switch you to a different medication.

Aplenzin and drugs broken down by the CYP2D6 enzyme

Aplenzin blocks an enzyme called CYP2D6. (An enzyme is a
type of protein.) This enzyme breaks down certain drugs in your body. Taking
Aplenzin with drugs that CYP2D6 breaks down can increase the levels of those
drugs in your body.

Examples of these drugs include:

Before you take Aplenzin, tell your doctor if you’re using
any of these drugs. They may monitor you during your Aplenzin treatment, lower
the dose of your other medication, or switch you to a different medication.

Aplenzin and drugs that can increase your risk of seizures

Taking Aplenzin may increase your risk for seizures. Other
drugs may also increase your risk for seizures. So taking Aplenzin with these
drugs may increase your seizure risk even more.

Examples of drugs that can increase your risk for seizures:

• other drugs that contain bupropion (the active drug in Aplenzin), such as Wellbutrin XL or Wellbutrin SR

Before you take Aplenzin, tell your doctor if you’re using a
drug that raises your risk of seizures. They may monitor you during your
Aplenzin treatment, keep you on a lower dose of Aplenzin, or switch you to a
different medication.

Aplenzin and dopaminergic drugs

Drugs called dopaminergics affect a chemical in your body
called dopamine. Taking Aplenzin with dopaminergic drugs can cause dopamine to
build up to dangerous levels. This can affect your central nervous system, which includes your brain and spinal cord. You may feel dizzy,
shaky, nervous, or have trouble walking.

Examples of dopaminergic drugs are those for Parkinson’s disease such as levodopa (Inbrija) and amantadine (Gocovri, Osmolex ER).

Before you take Aplenzin, tell your doctor if you’re using
any of these drugs. They may monitor you during your Aplenzin treatment, change
your dose, or switch you to a different medication.

Aplenzin and drugs that can increase blood pressure

Taking Aplenzin can increase your blood pressure. Other
drugs can also increase your blood pressure. So taking Aplenzin with these
drugs can increase your risk for high blood pressure.

Examples of drugs that can increase your blood pressure
include:

• monoamine oxidase inhibitors (MAOIs) such as phenelzine
  (Nardil), which treat depression
• linezolid (Zyvox), an antibiotic
• methylene blue (ProvayBlue), a drug that’s used treat
  a blood disorder called methemoglobinemia

Your doctor will likely have you stop taking the MAOI at
least 14 days before you start using Aplenzin. In some situations, they may want
you to take an MAOI while you’re taking Aplenzin. If this is the case, your
doctor will have you stop using Aplenzin 14 days before you start taking an MAOI.
You shouldn’t use Aplenzin if you’re taking linezolid or methylene blue.

Aplenzin and certain laboratory tests

Aplenzin may cause a false positive result in urine tests
for amphetamines, even if you’ve stopped taking Aplenzin. (Amphetamines are a type of medication
that’s often used to treat attention deficit hyperactivity disorder [ADHD].) Your doctor may order a different test to
check for amphetamine use.

Aplenzin and herbs and supplements

There aren’t any herbs or supplements that have been
specifically reported to interact with Aplenzin. However, you should still
check with your doctor or pharmacist before using any of these products while
taking Aplenzin. It’s possible that some herbs or supplements can increase your
risk of seizures while you’re taking Aplenzin.

Aplenzin uses

The Food and Drug Administration (FDA) approves prescription
drugs such as Aplenzin to treat certain conditions. Aplenzin may also be used off-label
for other conditions. Off-label use is when a drug that’s approved to treat one
condition is used to treat a different condition.

Aplenzin for major depressive disorder

Aplenzin is used to treat major depressive disorder (MDD).
MDD is a type of depression that includes long-term and very regular feelings of intense sadness. Someone
with MDD may feel hopeless, lose interest in activities they once enjoyed, or
feel as though life isn’t worth living. These feelings last over a long period
of time.

Effectiveness

Aplenzin is an extended-release drug that contains bupropion hydrobromide. There are no clinical trials that tested the effectiveness of Aplenzin. However, researchers have studied another form of the drug called
bupropion hydrochloride. The FDA approved bupropion hydrobromide based
on these studies because it works in a very similar way to bupropion
hydrochloride.

In clinical studies of MDD, the immediate-release form of bupropion hydrochloride was
found to be more effective than a placebo (no treatment).

In three
short-term studies that lasted 4 to 6 weeks, people took bupropion
hydrochloride immediate-release tablets or a placebo. Based on different depression
rating scales, bupropion was more effective at treating MDD compared to the
placebo. Depending on the study, these scales included the:

• Hamilton Depression Rating Scale
• Clinical Global Impressions-Severity Scale
• Montgomery-Asberg Depression Rating Scale

A longer study of MDD looked at people who had taken bupropion hydrochloride sustained-release
tablets for 8 weeks. (Sustained-release tablets slowly release a steady amount
of medication in the body over a long period of time.) The people either
continued taking bupropion or stopped taking the drug for up to 44 weeks. The
group of people who continued taking bupropion didn’t have worsening depression,
while those who stopped taking bupropion did. These results were based whether
people needed additional drug treatment due to worsening depression symptoms.

Aplenzin for seasonal affective disorder

Aplenzin is used to prevent episodes of depression in people
who have seasonal affective disorder (SAD). SAD is a form of MDD but happens only in certain seasons
or times of the year (usually in the winter).

Effectiveness

Aplenzin is an extended-release drug that contains bupropion
hydrobromide. There are no clinical trials that tested the effectiveness
of Aplenzin. However, researchers have studied another form of the drug called
bupropion hydrochloride. Bupropion hydrochloride comes in immediate-,
sustained-, and extended-release versions. All these versions and Aplenzin work
in a similar way in the body.

In clinical studies of SAD, bupropion hydrochloride extended-release tablets were found
to be more effective than a placebo (no treatment). People with SAD in the
winter started taking bupropion in the fall (September to November). They took
the drug for about 4 to 6 months and started to lower their dose until they
stopped treatment in early spring (the end of March).

Based on three combined trials, 84.3% of people who took bupropion didn’t develop
depression compared to 72% of people who took a placebo. These results were
based on whether people developed depression symptoms or needed treatment for
depression, and a depression rating score. The score was determined by the Structured
Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective
Disorders.

Off-label uses for Aplenzin

In addition to the uses listed above, Aplenzin may be used
off-label. Off-label drug use is when a drug that’s approved for one use is
used for a different one that’s not approved.

Aplenzin for ADHD

Aplenzin isn’t FDA-approved to treat the mental health condition called attention deficit hyperactivity disorder (ADHD). However, Aplenzin may be prescribed
off-label to treat ADHD.

A review of six clinical studies found that bupropion (the active drug in Aplenzin) helped decrease
ADHD symptoms in adults more than a placebo (no treatment).

Aplenzin for sexual dysfunction

Aplenzin isn’t FDA-approved to treat sexual dysfunction,
which includes trouble getting an erection or achieving orgasm.

However, American Psychiatric Association guidelines recommend using bupropion (the active drug in Aplenzin) off-label to treat sexual dysfunction when it’s a side effect
of a selective serotonin reuptake inhibitor (SSRI) medication. (SSRIs are a
type of antidepressant that can cause sexual dysfunction.) The guidelines specify Aplenzin’s use for
people with MDD who are taking SSRIs such as sertraline (Zoloft).

Aplenzin for children

Aplenzin is approved for use in adults only. Aplenzin hasn’t
been proven to be safe and effective in children.

In short-term clinical trials, people took various antidepressants, including bupropion (the main
drug in Aplenzin). The risk of suicidal thoughts and behaviors* was highest for people ages 24 years and younger. Out
of 1,000 people, compared to those who took a placebo, 14 more people younger
than age 18 years and 5 more people between ages 18 and 24 years who took an
antidepressant thought of or attempted suicide.

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see “FDA warning” at the beginning of this article.

Aplenzin cost

As with all medications, the cost of Aplenzin can vary. To
find current prices for Aplenzin in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without
insurance. The actual price you’ll pay depends on your insurance plan, your location,
and the pharmacy you use.

Financial assistance

If you need financial support to pay for Aplenzin, help is
available. Valeant Pharmaceuticals North America LLC, the manufacturer of Aplenzin,
offers a Copay Savings Program. For more information and to find out if you’re
eligible for support, call 844-556-3476 or visit the program website.

How to take Aplenzin

You should take Aplenzin according to your doctor or
healthcare provider’s instructions.

When to take

Aplenzin comes as a tablet that you take once a day by swallowing
it. You can take the medication with or without food in the morning. Make sure
the doses are at least 8 hours apart.

If you miss an Aplenzin dose, wait until it’s time for your
next scheduled dose. Then keep taking the drug as usual. Don’t try to make up
the missed dose because taking too much Aplenzin may increase your risk for seizures.
(For a list of seizure symptoms, see the “Aplenzin side effects” section
above.)

To help make sure that you don’t miss a dose, set a reminder
on your phone. You can also try using a medication timer.

Taking Aplenzin with food

You can take Aplenzin with or without food because food
doesn’t affect how well the medication works.

Can Aplenzin be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Aplenzin. Doing so can
cause your body to absorb the drug too quickly and lead to side effects. (See
the “Aplenzin side effects” section above.) Be sure to swallow the Aplenzin tablet
whole with a liquid such as water.

How Aplenzin works

A possible cause of depression, such as MDD and SAD, is a chemical imbalance in the brain. Some chemicals in
the brain that impact mood are dopamine and norepinephrine.

Aplenzin belongs to a drug class called antidepressants. (A class of drugs is a group of medications that work in a similar way.) The
way that Aplenzin works isn’t completely understood. But it’s thought that the
drug blocks neurons (nerve cells) from absorbing chemicals called dopamine and
norepinephrine. As a result, there are more of these chemicals in the brain, so
this helps correct the chemical imbalance.

How long does it take to work?

Aplenzin should start working about a week after you start
taking it. It takes 8 days to reach a stable level in your body.

Aplenzin and pregnancy

There isn’t enough data to know if it’s safe to take
Aplenzin while pregnant. In clinical studies, pregnant mothers took bupropion,
the active drug in Aplenzin, in the first 3 months of pregnancy. Bupropion
didn’t increase the risk of birth defects such as heart problems. However, more
data is needed to confirm whether or not Aplenzin is safe to take during
pregnancy.

Some animal studies found that bupropion given to pregnant mothers didn’t harm the
babies. But other animal studies found that the drug did harm the babies. Keep in mind that animal
studies don’t always predict what will happen in humans.

If you’re pregnant or are planning to become pregnant, talk
with your doctor. They can tell you about the pros and cons of using Aplenzin
while pregnant compared to the risks of untreated depression.

Aplenzin and birth control

It’s not known if Aplenzin is safe to take during pregnancy.
If you or your sexual partner can become pregnant, talk with your doctor about
your birth control needs while you’re using Aplenzin.

Aplenzin and breastfeeding

There isn’t enough data to know if it’s safe to take
Aplenzin while breastfeeding. However, in clinical studies, Aplenzin did pass into breast milk.

If you’re breastfeeding or are planning to breastfeed, talk
with your doctor. They can tell you about the pros and cons of using Aplenzin
while breastfeeding compared to the risks of untreated depression.

Common questions about Aplenzin

Here are answers to some frequently asked questions about Aplenzin.

Can Aplenzin make me gain weight?

Taking Aplenzin shouldn’t make you gain weight. In fact, the
drug may actually cause you to lose weight. (For more on Aplenzin and weight
loss, see “Weight loss” in the “Side effect details” section above.)

There aren’t any studies of Aplenzin that looked at weight
gain. However, researchers have studied bupropion hydrochloride. This
drug and bupropion hydrobromide, the main drug in Aplenzin, work in
similar ways.

In clinical trials of major depressive disorder (MDD), people took 300-mg or 400-mg bupropion
hydrochloride sustained-release tablets each day. (Sustained-release tablets
slowly release the same amount of medication in the body over a period of
time.) In the 300-mg group, 3% of people gained more than 5 pounds. In the
400-mg group, 2% of people gained more than 5 pounds. This was compared to 4%
of people who took a placebo (no treatment).

In clinical trials of seasonal affective disorder (SAD), people took 150-mg to 300-mg bupropion
hydrochloride extended-release tablets each day. (With extended-release
tablets, the amount of drug released in the body isn’t always the same over
time.) In this group, 11% of people gained more than 5 pounds. This was
compared to 21% of people who took a placebo.

If you’re concerned about weight gain, talk with your doctor.
They can review your diet and exercise routine.

Can Aplenzin cause sexual problems?

Aplenzin hasn’t been shown to cause sexual problems. However,
other antidepressants
such as sertraline
(Zoloft) may
cause sexual problems such as trouble getting an erection, difficulty achieving
orgasm, or a lower sex drive.

If you’re concerned about sexual problems, talk with your
doctor.

Can I take Aplenzin if I have an eating disorder?

No. You shouldn’t take Aplenzin if you have or have had an eating
disorder such as anorexia
or bulimia. This
is because Aplenzin can make these disorders worse and increase your risk for seizures.
(For a list of seizure symptoms, see the “Aplenzin side effects” section above.)

If you have a history of eating disorders, talk with your
doctor. They may be able to suggest a depression treatment other than Aplenzin.

I’ve noticed what looks like a pill in my stool.
Does this mean I didn’t get my full dose of Aplenzin?

You received your proper dose. After taking Aplenzin, only a
very small amount (0.5%) of the drug may be left in your stool. Your body
absorbs the rest of the medication to help treat MDD or SAD.

Aplenzin precautions

This drug comes with several precautions.

FDA warning: Suicidal thoughts and behaviors

This drug has a boxed warning. This is the
most serious warning from the Food and Drug Administration (FDA). A boxed
warning alerts doctors and patients about drug effects that may be dangerous.

Taking Aplenzin may cause you to have suicidal thoughts and behaviors. Your doctor will monitor you for signs of these
during your Aplenzin treatment. But if you or a loved one notices that you’re
thinking about or trying to harm yourself, your doctor should be told right
away.

Other precautions

Before taking Aplenzin, talk with your doctor about your
health history. Aplenzin may not be right for you if you have certain medical
conditions or other factors affecting your health. These include:

• Allergic
  reactions. If you’ve had an allergic reaction to bupropion
  or any other ingredients in Aplenzin, your doctor may switch you to another
  medication. Or they may monitor your Aplenzin treatment, depending on how
  severe the allergic reaction was.
• Alcohol use. Drinking alcohol or suddenly
  stopping drinking alcohol while taking Aplenzin may increase your risk for
  seizures. To learn more, please see the “Aplenzin and alcohol” section above.
• Seizures. If you have seizures or had
  them in the past, you shouldn’t take Aplenzin. The medication may increase your
  risk for seizures. Ask your doctor what other depression
  treatments may better suited for you.
• High
  blood pressure. If you have high blood pressure,
  taking Aplenzin may make it even higher. (Please see the “Aplenzin interactions”
  section above.) Your doctor will likely monitor your blood pressure while
  you’re taking Aplenzin.
• Bipolar disorder. Taking Aplenzin when
  you have a mental illness called bipolar disorder can lead to mania
  (feeling very energetic or unbeatable). While you take Aplenzin, your doctor
  may monitor you for symptoms of bipolar disorder or switch you to another
  medication.
• Psychosis
  and worsening mental health. Aplenzin
  may cause symptoms of psychosis such seeing or thinking about things that aren’t there. This includes having hallucinations,
  delusions, or paranoia. If you have worsening mental health
  while taking Aplenzin, tell your doctor. They may lower your dose or switch you
  to a different medication.
• Anorexia or bulimia. If you have or have
  had an eating disorder such anorexia or bulimia, you
  shouldn’t take Aplenzin. This is because the drug can cause more weight loss
  and increase your risk for seizures. Ask your doctor what other depression
  treatments may be better suited for you.
• Narrow-angle
  glaucoma. Aplenzin may increase pressure in your eyes, which can lead to new
  or worsening narrow-angle glaucoma. This
  kind of glaucoma is also known as angle-closure glaucoma. If you have this form of glaucoma, your doctor will monitor you
  while you take Aplenzin.
• Pregnancy
  and breastfeeding. It’s not known if Aplenzin is harmful during pregnancy
  and breastfeeding. Your doctor can advise you on the risks of taking Aplenzin
  compared to the risks of untreated depression. For more information, please see
  the “Aplenzin and pregnancy” and “Aplenzin and breastfeeding” sections above.

Note: For more
information about the potential negative effects of Aplenzin, see the “Aplenzin
side effects” section above.

Aplenzin overdose

Taking more than the recommended dose of Aplenzin can lead
to serious side effects, including increasing your risk for seizures. When you
have a seizure, the electrical activity in your brain changes. You may have jerky
body movements that you can’t control, not be aware of your surroundings, or
lose consciousness. Seizures have been reported
in one-third of overdose cases.

Overdose symptoms

Symptoms of an overdose can include:

• seizures
• hallucinations (seeing things that aren’t really
  there)
• feeling fast, uneven, or skipped heartbeats
• low blood pressure, which may make you feel
  lightheaded or dizzy
• fever
• stiffness or pain in your muscles
• coma or your
  body shuts down (for example, you stop breathing)

What to do in case of overdose

If you think you’ve taken too much of this drug, call your
doctor. You can also call the American Association of Poison Control Centers at
800-222-1222 or use their online tool. But if your symptoms are severe, call 911
or go to the nearest emergency room right away.

Aplenzin expiration, storage, and disposal

When you get Aplenzin from the pharmacy, the pharmacist will
add an expiration date to the label on the bottle. This date is typically 1
year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the
medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using
expired medications. If you have unused medication that has gone past the
expiration date, talk to your pharmacist about whether you might still be able
to use it.

Storage

How long a medication remains good can depend on many
factors, including how and where you store the medication.

Store Aplenzin tablets at room temperature (77°F/25°C) in a
tightly sealed container away from light. Avoid storing this medication in
areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Aplenzin and have leftover
medication, it’s important to dispose of it safely. This helps prevent others,
including children and pets, from taking the drug by accident. It also helps
keep the drug from harming the environment.

The FDA website provides several useful tips on medication
disposal. You can also ask your pharmacist for information on how to dispose of
your medication.

Professional information for Aplenzin

The following information is provided for clinicians and
other healthcare professionals.

Indications

Aplenzin (bupropion
hydrobromide extended-release) is used to treat adults with major depressive
disorder (MDD) and used to prevent depression
in adults who have seasonal
affective disorder (SAD).

Mechanism of action

Aplenzin is an antidepressant
that belongs to the aminoketone drug class. The mechanism of action is unknown,
but the drug is thought to block neurons from absorbing dopamine and norepinephrine.

Pharmacokinetics and metabolism

Aplenzin 348 mg given once daily should reach steady-state
within 8 days. The half-life of bupropion is 21.3 hours.

After taking Aplenzin, it takes 6 hours for the active
metabolites of bupropion (hydroxybupropion, erythrohydrobupropion, and
threohydrobupropion) to reach peak plasma levels. The half-life of
hydroxybupropion is 24.3 hours, the half-life of erythrohydrobupropion is 31.1
hours, and the half-life of threohydrobupropion is 50.8 hours.

While there are no direct trials with Aplenzin
(extended-release version), immediate-release, sustained-release, and
extended-release forms of bupropion have similar bioavailability. Also,
Aplenzin (bupropion hydrobromide extended-release) is bioequivalent to
bupropion hydrochloride extended-release.

Contraindications

Aplenzin is contraindicated in patients who:

• have a seizure history
• have anorexia or bulimia either
  currently or had it in the past
• have suddenly stopped drinking alcohol or taking
  benzodiazepines,
  antiepileptics, or barbiturates
• are taking or have taken monoamine oxidase
  inhibitors (MAOIs) in the past 14 days or are taking linezolid (Zyvox) or
  methylene blue (ProvayBlue)
• have experienced hypersensitivity reactions to
  bupropion or any other ingredients in Aplenzin

Misuse and dependence

In human
and animal studies, bupropion immediate-release showed some mild effects
similar to amphetamines
compared to placebo. Bupropion immediate-release was not tested at higher doses
due to risk of seizures. There have been reports
of seizures and death when crushed bupropion tablets were used parenterally or
intranasally. However, there isn’t enough evidence to know the abuse potential
of Aplenzin or bupropion.

Storage

Aplenzin should be stored at 77°F (25°C), but excursions from
59°F to 86°F (15°C to 30°C) are acceptable.

Disclaimer: Medical
News Today has made every effort to make certain that all information is
factually correct, comprehensive, and up-to-date. However, this article should
not be used as a substitute for the knowledge and expertise of a licensed
healthcare professional. You should always consult your doctor or other
healthcare professional before taking any medication. The drug information
contained herein is subject to change and is not intended to cover all possible
uses, directions, precautions, warnings, drug interactions, allergic reactions,
or adverse effects. The absence of warnings or other information for a given
drug does not indicate that the drug or drug combination is safe, effective, or
appropriate for all patients or all specific uses.