Aplenzin (Bupropion Hydrobromide Tablet) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 24, 2012

Aplenzin

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A depressive disorder is a syndrome (group of symptoms) that reflects a sad, blue mood exceeding normal sadness or grief.
Depressive disorders are characterized not only by negative thoughts, moods, and behaviors but also by specific changes in bodily functions (for example, eating, sleeping, and sexual activity).
One in 10 people will have a depressive disorder in their lifetime, and in one of 10 cases, the depression is a fatal disease as a result of suicide.
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There can be some differences in symptoms of depression depending on age, gender, and ethnicity.
Depression is diagnosed only clinicall...

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Aplenzin
(bupropion hydrobromide) Tablet, Film Coated, Extended Release for Oral use

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior

(suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Aplenzin (bupropion hydrobromide tablet) ™ or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.

Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aplenzin (bupropion hydrobromide tablet) is not approved for use in pediatric patients. [See WARNINGS AND PRECAUTIONS: Clinical Worsening and Suicide Risk and Use In Specific Populations: Pediatric Use]

DRUG DESCRIPTION

Aplenzin (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-butylamino)-3'-chloropropiophenone hydrobromide. The molecular weight is 320.6. The molecular formula is C₁₃H₁₈ClNO•HBr.

Bupropion hydrobromide powder is white or almost white, crystalline, and soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:

Aplenzin (bupropion hydrobromide) Structural Formula Illustration

Aplenzin (bupropion hydrobromide tablet) Tablets are supplied for oral administration as 174 mg, 348 mg, and 522 mg white to off white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrobromide and the inactive ingredients: ethylcellulose aqueous dispersion, 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.

The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.

What are the precautions when taking bupropion hydrobromide tablet (Aplenzin)?

See also How to Use and Warning Sections

Before taking bupropion, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: seizures, eating disorders (e.g., bulimia, anorexia nervosa).

This medication should not be used if you are suddenly stopping regular use of sedatives (e.g., benzodiazepines such as lorazepam) or alcohol, which can cause a higher risk of seizures.

Before using this medication, tell your doctor or pharmacist your...

Read All Potential Precautions of Aplenzin »

Last reviewed on RxList: 5/20/2010
This monograph has been modified to include the generic and brand name in many instances.