BUPROPION HYDROCHLORIDE (SR)

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Overview

What is BUPROPION HYDROCHLORIDE (SR)?

Bupropion hydrochloride USP is 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 (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C H ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:

Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 100-mg (blue), 150-mg (purple), and 200-mg (pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, hydroxy propyl methyl cellulose, diluted hydrochloric acid, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, the 100 mg-tablet contains FD&C Blue No. 1 Aluminum lake, the 150 mg- tablet contains FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake and the 200 mg-tablet contains FD&C Red No. 40 Aluminum lake.

USP Dissolution Test Pending

What does BUPROPION HYDROCHLORIDE (SR) look like?

What are the available doses of BUPROPION HYDROCHLORIDE (SR)?

What should I talk to my health care provider before I take BUPROPION HYDROCHLORIDE (SR)?

How should I use BUPROPION HYDROCHLORIDE (SR)?

Bupropion hydrochloride extended-release tablets, (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD .

The efficacy of bupropion hydrochloride extended-release tablet (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial .

To minimize the risk of seizure, increase the dose gradually . Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (SR) may be taken with or without food.

The usual adult target dose for bupropion hydrochloride extended-release tablet (SR) is 300 mg per day, given as 150 mg twice daily. Initiate dosing with 150 mg per day given as a single daily dose in the morning. After 3 days of dosing, the dose may be increased to the 300-mg-per-day target dose, given as 150 mg twice daily. There should be an interval of at least 8 hours between successive doses. A maximum of 400 mg per day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg per day. To avoid high peak concentrations of bupropion and/or its metabolites, do not exceed 200 mg in any single dose.

It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of bupropion hydrochloride extended-release tablets (SR) needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.

What interacts with BUPROPION HYDROCHLORIDE (SR)?

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What are the warnings of BUPROPION HYDROCHLORIDE (SR)?

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What are the precautions of BUPROPION HYDROCHLORIDE (SR)?

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What are the side effects of BUPROPION HYDROCHLORIDE (SR)?

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What should I look out for while using BUPROPION HYDROCHLORIDE (SR)?

Seizure disorder. ( , )

Current or prior diagnosis of bulimia or anorexia nervosa. ( , )

Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( , )

Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrochloride extended-release tablets (SR) or within 14 days of stopping treatment with bupropion hydrochloride extended-release tablets (SR). Do not use bupropion hydrochloride extended-release tablets (SR) within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride extended-release tablets (SR) in a patient who is being treated with linezolid or intravenous methylene blue. ( , )

Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (SR). ( , )

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber .

What might happen if I take too much BUPROPION HYDROCHLORIDE (SR)?

How should I store and handle BUPROPION HYDROCHLORIDE (SR)?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDCBupropion hydrochloride extended-release tablets, USP (SR), 100 mg, are blue, round, biconvex, film-coated tablets debossed with on one side and on other side in bottles of 30 ( 69097-877-02), 60 ( 69097-877-03), 100 ( 69097-877-07) and 500 ( 69097-877-12). “IG”“485”NDCNDCNDCNDC“IG”“486”NDCNDCNDCNDC

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Clinical Information

Chemical Structure

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Clinical Pharmacology

The exact mechanism of the antidepressant action of bupropion is not known, but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine, and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.

Non-Clinical Toxicology

Seizure disorder. ( , )

Current or prior diagnosis of bulimia or anorexia nervosa. ( , )

Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. ( , )

Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrochloride extended-release tablets (SR) or within 14 days of stopping treatment with bupropion hydrochloride extended-release tablets (SR). Do not use bupropion hydrochloride extended-release tablets (SR) within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride extended-release tablets (SR) in a patient who is being treated with linezolid or intravenous methylene blue. ( , )

Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride extended-release tablets (SR). ( , )

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber .

Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.

Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism , particularly when bactericidal activity is desired, this drug combination should be avoided.

In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

Patients with 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 MDD and other psychiatric disorders. Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with 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 4,400 subjects. 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 subjects. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger subjects 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 1,000 subjects 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 MDD 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 bupropion hydrochloride extended-release tablets (SR) 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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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).

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