Bupropion hydrobromide

What is Bupropion hydrobromide?

• Bupropion hydrobromide (Aplenzin) is an aminoketone antidepressant used for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD).

Bupropion

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What are the uses of this medicine?

• Bupropion hydrobromide (Aplenzin) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

How does this medicine work?

• The mechanism of action of bupropion is unknown, as is the case with other antidepressants.
• However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms.
• Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have or had a seizure disorder or epilepsy.
• have or had an eating disorder such as anorexia nervosa or bulimia.
• are taking any other medicines that contain bupropion, including WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, ZYBAN, or FORFIVO XL. Bupropion is the same active ingredient that is in Aplenzin.
• drink a lot of alcohol and abruptly stop drinking, or take medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop taking them all of a sudden.
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• do not take an MAOI within 2 weeks of stopping Aplenzin unless directed to do so by your healthcare provider.
• do not start Aplenzin if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
• are allergic to the active ingredient in Aplenzin, bupropion, or to any of the inactive ingredients.

What drug interactions can this medicine cause?

• Dose increase of Aplenzin may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, and efavirenz, carbamazepine, phenobarbital, phenytoin) based on clinical exposure, but should not exceed the maximum dose.
• Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Consider dose reduction when using with bupropion.
• Use extreme caution when coadministering Aplenzin with other drugs that lower the seizure threshold (e.g., other bupropion products, antipsychotics, antidepressants, theophylline, or systemic corticosteroids). Use low initial doses of Aplenzin and increase the dose gradually.
• Use caution when administering Aplenzin concomitantly with Bupropion, levodopa, and amantadine.
• The consumption of alcohol during treatment with Aplenzin should be minimized or avoided.
• Concomitant use of MAOIs and bupropion is contraindicated because there is an increased risk of hypertensive reactions if bupropion is used concomitantly with MAOIs.
• False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish bupropion from amphetamines.

Is this medicine FDA approved?

* It was first approved for medical use in the United States in 1985.

How should this medicine be used?

Recommended dosage: Dosage for Major Depressive Disorder (MDD):

• Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl).
• Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl).
• After 4 days, may increase the dose to 348 mg once daily.

Dosage for Seasonal Affective Disorder (SAD):

• Initiate treatment in the autumn prior to onset of seasonal depressive symptoms.
• Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl).
• After one week, may increase the dose to 348 mg once daily.
• Continue treatment through the winter season.

Hepatic Impairment:

• Moderate to severe hepatic impairment: Maximum dose 174 mg every other day.
• Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing.

Renal Impairment:

• Consider reducing the dose and/or frequency of dosing.

Administration:

• Swallow Aplenzin tablets whole. Do not chew, cut, or crush Aplenzin tablets. If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. Tell your healthcare provider if you cannot swallow tablets.
• Aplenzin tablets may have an odor. This is normal.
• Take your doses of Aplenzin at least 24 hours apart.
• You may take Aplenzin with or without food.
• If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time. This is very important. Too much Aplenzin can increase your chance of having a seizure.
• If you take too much Aplenzin, or overdose, call your local emergency room or poison control center right away.
• Do not take any other medicines while taking Aplenzin unless your healthcare provider has told you it is okay.
• If you are taking Aplenzin for the treatment of major depressive disorder, it may take several weeks for you to feel that Aplenzin is working. Once you feel better, it is important to keep taking Aplenzin exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel Aplenzin is working for you.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 174 mg, 348 mg, 522 mg

This medicine is available in fallowing brand namesː

• Aplenzin

What side effects can this medication cause?

The most common side effects of this medicine include:

• trouble sleeping
• stuffy nose
• dry mouth
• dizziness
• feeling anxious
• nausea
• constipation
• joint aches

Aplenzin can cause serious side effects which may include:

• Seizures
• High blood pressure (hypertension)
• Manic episodes
• Unusual thoughts or behaviors
• Visual problems
• Severe allergic reactions

What special precautions should I follow?

• Limit or avoid using alcohol during treatment with Aplenzin. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
• Do not drive a car or use heavy machinery until you know how Aplenzin affects you. Aplenzin can affect your ability to do these things safely.
• Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with Aplenzin for the occurrence of such symptoms and instruct them to discontinue Aplenzin and contact a healthcare provider if they experience such adverse events.
• Aplenzin can cause seizure. The risk of seizure is dose-related. Can minimize risk by limiting daily dose to 522 mg and gradually increasing the dose. Discontinue if seizure occurs.
• Aplenzin can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment.
• Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. Screen patients for bipolar disorder and monitor for these symptoms.
• Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Instruct patients to contact a healthcare professional if such reactions occur.
• Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
• Anaphylactoid/anaphylactic reactions have occurred during clinical trials with bupropion. Instruct patients to discontinue Aplenzin and consult a healthcare provider if they develop an allergic or anaphylactoid/anaphylactic reaction (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) during treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Seizures
• hallucinations
• loss of consciousness
• mental status changes
• sinus tachycardia, ECG changes such as conduction disturbances or arrhythmias clonus, myoclonus, and hyperreflexia
• Fever
• muscle rigidity
• rhabdomyolysis
• hypotension
• stupor
• coma
• respiratory failure
• death due to uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest

Management of overdosage:

• Consult a Certified Poison Control Center for up-to-date guidance and advice.
• Call 1-800-222-1222 or refer to www.poison.org.
• There are no known antidotes for bupropion.
• In case of an overdose, provide supportive care, including close medical supervision and monitoring.
• Consider the possibility of multiple drug overdose.

Can this medicine be used in pregnancy?

• Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185.

Can this medicine be used in children?

• Safety and effectiveness in the pediatric population have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: bupropion hydrobromide

• Inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths. The tablets are printed with edible black ink.

Who manufactures and distributes this medicine?

Distributed by:

• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• Bausch Health Companies Inc.
• Steinbach, MB, Canada

• Aplenzin is a trademark of Bausch Health Companies Inc. or its affiliates.

What should I know about storage and disposal of this medication?

• Store Aplenzin at 77°F (25°C).

• Dailymed label info on Bupropion hydrobromide
• FDA Bupropion hydrobromide

Bupropion hydrobromide Resources
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The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone