Aplenzin 522 mg/1
bupropion hydrobromide · TABLET, EXTENDED RELEASE · Bausch Health US, LLC
Aplenzin is a tablet, extended release containing bupropion hydrobromide at 522 mg/1, taken oral. Manufactured by Bausch Health US, LLC.
Key Facts
- Brand Name
- Aplenzin
- Generic Name
- bupropion hydrobromide
- NDC Code (Product)
0187-5812- Manufacturer
- Bausch Health US, LLC
- Strength
- 522 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA022108
- Marketing Start
- 04/23/2008
Recall History
Valeant Pharmaceuticals North America LLC
Labeling: Incorrect or Missing Package Insert
Valeant Pharmaceuticals North America LLC
Labeling: Incorrect or Missing Package Insert
Valeant Pharmaceuticals North America LLC
Labeling: Incorrect or Missing Package Insert
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE APLENZIN is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder APLENZIN ® (bupropion hydrobromide) extended-release tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ]. 1.2 Seasonal Affective Disorder APLENZIN is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the preven…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION General • Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Major Depressive Disorder • 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). ( 2.3 ) • After 4 days, may increase the dose to 348 mg once daily. ( 2.3 ) Seasonal Affective Disorder • Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.4 ) • 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). ( 2.4 ) • After one week, may increase the dose to 348 mg once daily. ( 2.4 ) • Continue treatment through the winter season. ( 2.4 ) Hepatic Impairment • Moderate to severe hepatic impairment: Maximum dose 174 mg every other day ( 2.6 ) • Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.2 , 2.6 , 8.7 ) Renal Impairment • Consider reducing the dose and/or frequency of dosing. ( 2.2 , 2.7 , 8.6 ) 2.1 General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3) ]. APLENZIN should …
Contraindications
4 CONTRAINDICATIONS • APLENZIN is contraindicated in patients with a seizure disorder. • APLENZIN is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with APLENZIN [see Warnings and Precautions (5.3) ]. • APLENZIN is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3) ]. • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with APLENZIN or within 14 days of discontinuing treatment with APLENZIN is contraindicated. There is an increased risk of hypertensive reactions when APLENZIN is used concomitantly with MAOIs. The use of APLENZIN within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting APLENZIN in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.5 , 2.6 , 2.9 ), Warnings and Precautions (5.4) , and Drug Interactions (7.6) ]. • APLENZIN is contraindicated in patients with known hyper…
Drug Interactions
7 DRUG INTERACTIONS • CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin) based on clinical exposure, but should not exceed the maximum dose. ( 7.1 ) • Drugs metabolized by CYP2D6: 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. ( 7.2 ) • Drugs that lower seizure threshold: Dose APLENZIN with caution. ( 5.3 , 7.3 ) • Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with APLENZIN. ( 7.4 ) • MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with APLENZIN. ( 7.6 ) • Drug-laboratory test interactions: APLENZIN can cause false-positive urine test results for amphetamines. ( 7.7 ) 7.1 Potential for Other Drugs to Affect APLENZIN Bupropion is primarily metabolized to hyd…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions (5.1) ] • Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions (5.2) ] • Seizure [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Activation of mania or hypomania [see Warnings and Precautions (5.5 )] • Psychosis and other neuropsychiatric events [see Warnings and Precautions (5.6) ] • Angle-closure glaucoma [see Warnings and Precautions (5.7) ] • Hypersensitivity reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions are (incidence ≥5%; ≥2× placebo rate): dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted u…
Frequently Asked Questions
What is Aplenzin used for?
Aplenzin contains bupropion hydrobromide. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Aplenzin a controlled substance?
Aplenzin is not classified as a controlled substance by the DEA.
What is the generic name for Aplenzin?
The generic name for Aplenzin is bupropion hydrobromide. There are no other listed brand versions of bupropion hydrobromide.
What is the NDC code for Aplenzin 522 mg/1?
The NDC (National Drug Code) for Aplenzin 522 mg/1 is 0187-5812, listed by Bausch Health US, LLC.
Other Aplenzin Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)