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Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

Amneal Pharmaceuticals of New York LLC

TABLET, FILM COATED, EXTENDED RELEASE

Strength 200 mg/1

BUPROPION HYDROCHLORIDE Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Bupropion Hydrochloride (Bupropion Hydrochloride) which is also known as Bupropion Hydrochloride and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 200 mg/1 per ml. Read more

Bupropion Hydrochloride (Bupropion Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Arrayn- SUICIDALITY AND ANTIDEPRESSANT DRUGS
  • 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 .
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. ()
  • Monitor for worsening and emergence of suicidal thoughts and behaviors. ()
  • 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 tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial .
  • Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ()
  • No data
  • Starting dose: 150 mg/day. ()
  • General: Increase dose gradually to reduce seizure risk. (, )
  • After 3 days, may increase the dose to 300 mg/day, given as 150 mg twice daily at an interval of at least 8 hours. ()
  • Usual target dose: 300 mg/day as 150 mg twice daily. ()
  • Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients not responding to 300 mg/day. ()
  • Periodically reassess the dose and need for maintenance treatment. ()
  • Moderate to severe hepatic impairment: 100 mg daily or 150 mg every other day. (, )
  • Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. (, )
  • Renal impairment: Consider reducing the dose and/or frequency. (, )
  • Bupropion hydrochloride extended-release tablets (SR), 200 mg are pale orange, film-coated, round, convex extended-release tablets debossed with u201c555u201d on one side and plain on the other side
  • Tablets: 200 mg. ()
  • No data
  • 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). (, )
  • No data
  • Neuropsychiatric adverse events during smoking cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion for the occurrence of such symptoms and instruct them to discontinue bupropion and contact a healthcare provider if they experience such adverse events. ()
  • Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if seizure occurs. (, , )
  • Hypertension: Bupropion hydrochloride extended-release tablets (SR) can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ()
  • Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms. ()
  • Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. ()
  • Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ()
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (incidence u2265 5% and u2265 2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • CYP2B6 inducers: Dose increase may be necessary if co-administered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical response, but should not exceed the maximum recommended dose. ()
  • 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. ()
  • Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels. ()
  • Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (SR) with caution. (, )
  • Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR). ()
  • MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR). ()
  • Drug-laboratory test interactions: Bupropion hydrochloride extended-release tablets (SR) can cause false-positive urine test results for amphetamines. ()
  • No data
  • No data
  • No data
  • Bupropion hydrochloride, 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 (u00b1)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is CHClNOu2022HCl. The structural formula is:
  • 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.
  • Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 200 mg, film-coated, extended-release tablets. Each tablet contains 200 mg of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The film-coating material contains FD&C Yellow No. 6, hypromellose type 2910/ 3cP, 6cP and 50cP, polyethylene glycol, polydextrose, titanium dioxide, and triacetin.
  • This product meets USP Dissolution Test #3.
  • No data
  • Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 mg/kg/day and 150 mg/kg/day, respectively. These doses are approximately 7 and 2 times the MRHD, respectively, on a mg/m basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 mg/kg/day to 300 mg/kg/day (approximately 2 to 7 times the MRHD on a mg/m basis); lower doses were not tested. The question of whether or not such lesions may be precursors of neoplasms of the liver is currently unresolved. Similar liver lesions were not seen in the mouse study, and no increase in malignant tumors of the liver and other organs was seen in either study.
  • Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in the Ames bacterial mutagenicity assay. Bupropion produced an increase in chromosomal aberrations in 1 of 3 rat bone marrow cytogenetic studies.
  • There were no effects on male and female fertility when rats were administered oral doses of bupropion up to 300 mg/kg/day (approximately 7 times the MRHD on a mg/m basis) to females prior to mating and either through Day 13 of gestation or through lactation, and to males for 60 days prior to and through mating. However, doses of 200 mg/kg/day (approximately 5 times the MRHD on a mg/m basis) or greater, caused transient ataxia or behavioral changes in adult female rats. There were also no adverse effects on fertility, reproduction, or growth and development of male or female offspring.
  • The efficacy of the immediate-release formulation of bupropion in the treatment of major depressive disorder was established in two 4-week, placebo-controlled trials in adult inpatients with MDD (Trials 1 and 2 in Table 6) and in one 6-week, placebo-controlled trial in adult outpatients with MDD (Trial 3 in Table 6). In the first trial, the dose range of bupropion was 300 mg/day to 600 mg/day administered in divided doses; 78% of subjects were treated with doses of 300 mg/day to 450 mg/day. This trial demonstrated the effectiveness of the immediate-release formulation of bupropion by the Hamilton Depression Rating Scale (HDRS) total score, the HDRS depressed mood item (Item 1), and the Clinical Global Impressions severity score (CGI-S). The second trial included 2 doses of the immediate-release formulation of bupropion (300 mg/day and 450 mg/day) and placebo. This trial demonstrated the effectiveness of the immediate-release formulation of bupropion, but only at the 450-mg/day dose. The efficacy results were significant for the HDRS total score and the CGI-S score, but not for HDRS Item 1. In the third trial, outpatients were treated with 300 mg/day of the immediate-release formulation of bupropion. This trial demonstrated the efficacy of the immediate-release formulation of bupropion as measured by the HDRS total score, the HDRS Item 1, the Montgomery-Asberg Depression Rating Scale (MADRS), the CGI-S score, and the CGI-Improvement Scale (CGI-I) score.
  • Table 6. Efficacy of Immediate-Release Bupropion for the Treatment of Major Depressive Disorder
  • Although there are not as yet independent trials demonstrating the antidepressant effectiveness of the sustained-release formulation of bupropion, trials have demonstrated the bioequivalence of the immediate-release and sustained-release forms of bupropion under steady-state conditions, i.e., bupropion sustained-release 150 mg twice daily was shown to be bioequivalent to 100 mg 3 times daily of the immediate-release formulation of bupropion, with regard to both rate and extent of absorption, for parent drug and metabolites.
  • In a longer-term trial, outpatients meeting DSM-IV criteria for major depressive disorder, recurrent type, who had responded during an 8-week open trial on bupropion hydrochloride extended-release tablets (SR) (150 mg twice daily) were randomized to continuation of their same dose of bupropion hydrochloride extended-release tablets (SR) or placebo for up to 44 weeks of observation for relapse. Response during the open phase was defined as CGI Improvement score of 1 (very much improved) or 2 (much improved) for each of the final 3 weeks. Relapse during the double-blind phase was defined as the investigator's judgment that drug treatment was needed for worsening depressive symptoms. Patients receiving continued treatment with bupropion hydrochloride extended-release tablets (SR) experienced significantly lower relapse rates over the subsequent 44 weeks compared with those receiving placebo.
  • Bupropion Hydrochloride Extended-Release Tablets (SR), are pale orange, film-coated, round, convex tablets debossed with u201c555u201d on one side and plain on the other side.They are available as:
  • Bottles of 60: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0115-5445-13Bottles of 180: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0115-5445-19
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from light and moisture.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Trademarks listed are the property of their respective owners.
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 12-2019-01
  • No data
  • Arrayn- Array

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