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Aplenzin

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Overview

What is Aplenzin?

APLENZIN (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake 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 CHClNO•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, 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 does Aplenzin look like?



What are the available doses of Aplenzin?

APLENZIN Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "174".

APLENZIN Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "348".

APLENZIN Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "522".

What should I talk to my health care provider before I take Aplenzin?

How should I use Aplenzin?

APLENZIN (bupropion hydrobromide extended-release tablets) is 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

To minimize the risk of seizure, increase the dose gradually

APLENZIN should be swallowed whole and not crushed, divided, or chewed. APLENZIN should be administered in the morning and may be taken with or without regard to meals.


What interacts with Aplenzin?

Sorry No Records found


What are the warnings of Aplenzin?

Sorry No Records found


What are the precautions of Aplenzin?

Sorry No Records found


What are the side effects of Aplenzin?

Sorry No records found


What should I look out for while using Aplenzin?












What might happen if I take too much Aplenzin?


How should I store and handle Aplenzin?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].APLENZIN Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "174" in bottles of 30 tablets (NDC 0187-5810-30).APLENZIN Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "348" in bottles of 30 tablets (NDC 0187-5811-30).APLENZIN Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "522" in bottles of 30 tablets (NDC 0187-5812-30).APLENZIN Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "174" in bottles of 30 tablets (NDC 0187-5810-30).APLENZIN Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "348" in bottles of 30 tablets (NDC 0187-5811-30).APLENZIN Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "522" in bottles of 30 tablets (NDC 0187-5812-30).APLENZIN Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "174" in bottles of 30 tablets (NDC 0187-5810-30).APLENZIN Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "348" in bottles of 30 tablets (NDC 0187-5811-30).APLENZIN Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "522" in bottles of 30 tablets (NDC 0187-5812-30).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

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.

Non-Clinical Toxicology










Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem (see ).

Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.

Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (Selective Serotonin Reuptake Inhibitors [SSRIs] and others) show that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for APLENZIN should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).