Aplenzin

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 »


Aplenzin Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, joint aches, dizziness, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, fainting, fast/pounding heartbeat, irregular heartbeat, mental/mood changes (e.g., agitation, anxiety, confusion, hallucinations, nervousness, restlessness), muscle aches, ringing in the ears, severe headache, uncontrolled movements (tremor), unusual weight loss or gain.

Tell your doctor immediately if any of these rare but very serious side effects occur: muscle pain/tenderness/weakness, change in the amount of urine.

This drug may rarely cause seizures. Seek immediate medical attention if you experience a seizure. If you have a seizure while taking bupropion, you should not take this drug again.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

An empty tablet shell may appear in your stool. This is harmless.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 medical history, especially of: alcohol/drug dependence, brain tumor, diabetes, head injury, heart disease, high blood pressure, personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, kidney problems, liver problems, intention to quit smoking.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

Limit or avoid consumption of alcoholic beverages. Alcohol can increase your risk of seizures and dizziness.

Do not take this medicine with any other product containing bupropion (e.g., drugs to help quit smoking) since large doses of bupropion are more likely to cause seizures.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug and to side effects.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infrequently, newborns whose mothers have used certain newer antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Promptly report any such symptoms to the doctor. However, do not stop taking this medication unless your doctor directs you to do so.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.



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