Aplenzin Er
Loading...Aplenzin Er Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Aplenzin™ (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder.
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) [see CLINICAL STUDIES (14)].
A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion [see CLINICAL STUDIES (14)]. Nevertheless, the physician who elects to use Aplenzin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
History
There is currently no drug history available for this drug.
Other Information
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 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.
Sources
Aplenzin Er Manufacturers
-
Stat Rx Usa Llc
![Aplenzin Er (Bupropion Hydrobromide ) Tablet, Extended Release [Stat Rx Usa Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Aplenzin Er | Stat Rx Usa Llc
2.1 General Dosing ConsiderationsIt is particularly important to administer Aplenzin Tablets in a manner most likely to minimize the risk of seizure [see WARNINGS AND PRECAUTIONS: Seizures (5.4)]. Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. Aplenzin should be swallowed whole and not crushed, divided, or chewed. Aplenzin may be taken without regard to meals.
2.2 Initial TreatmentThe usual adult target dose for Aplenzin Tablets is 348 mg/day (equivalent to 300 mg/day bupropion HCl), given once daily in the morning. Dosing with Aplenzin Tablets should begin at 174 mg/day (equivalent to 150 mg/day bupropion HCl) given as a single daily dose in the morning. If the 174 mg initial dose is adequately tolerated, an increase to the 348 mg/day target dose, given as once daily, may be made as early as day 4 of dosing. There should be an interval of at least 24 hours between successive doses.
Increasing the Dosage Above 348 mg/day: As with other antidepressants, the full antidepressant effect of Aplenzin Tablets may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 522 mg/day, given as a single dose, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 348 mg/day.
2.3 Maintenance TreatmentIt is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. It is unknown whether or not the dose of Aplenzin needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
2.4 Switching Patients from WELLBUTRIN, WELLBUTRIN SR or WELLBUTRIN XLWhen switching patients from WELLBUTRIN®, WELLBUTRIN SR® or WELLBUTRIN XL® Tablets to Aplenzin, give the equivalent total daily dose when possible (522 mg bupropion HBr are equivalent to 450 mg bupropion HCl; 348 mg bupropion HBr are equivalent to 300 mg bupropion HCl; 174 mg bupropion HBr are equivalent to 150 mg bupropion HCl). Patients who are currently being treated with WELLBUTRIN Tablets at 300 mg/day (for example, 100 mg 3 times a day) may be switched to Aplenzin 348 mg once daily. Patients who are currently being treated with WELLBUTRIN SR Sustained-Release Tablets at 300 mg/day (for example, 150 mg twice daily) may be switched to Aplenzin 348 mg once daily.
2.5 Dosage Adjustment for Patients With Impaired Hepatic FunctionAplenzin should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 174 mg every other day in these patients. Aplenzin should be used with caution in patients with hepatic impairment (including mild to moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild to moderate hepatic cirrhosis [see WARNINGS AND PRECAUTIONS: Hepatic Impairment (5.5), USE IN SPECIFIC POPULATIONS: Hepatic Impairment (8.7) and CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3)].
2.6 Dosage Adjustment for Patients With Impaired Renal FunctionAplenzin should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered [see USE IN SPECIFIC POPULATIONS: Renal Impairment (8.6) and CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3)].
Login To Your Free Account