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Bupropion Hydrochloride - Sr (Wellbutrin)

Trade Name : WELLBUTRIN

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 150 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 - Sr (Wellbutrin) which is also known as WELLBUTRIN and Manufactured by GlaxoSmithKline LLC. It is available in strength of 150 mg/1 per ml. Read more

Bupropion Hydrochloride - Sr (Wellbutrin) 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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About GNH

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 .
  • 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 .
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased the risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. ()
  • Monitor worsening and emergence of suicidal thoughts and behavior ()
  • WELLBUTRINu00a0SR (bupropion hydrochloride) is 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 WELLBUTRINu00a0SR in maintaining an antidepressant response for up to 44u00a0weeks following 8u00a0weeks of acute treatment was demonstrated in a placebou2011controlled trial .
  • u00a0
  • 1
  • No data
  • 2.1n- 5.3
  • 2.2n- 8.7
  • 2.2n- 8.7
  • 2.3n- 8.6
  • Tablets: 100 mg, 150 mg, 200 mg. ()
  • No data
  • 4n- 5.3
  • 4n- 5.3
  • 4n- 5.3
  • 4n- 7.6
  • 4n- 5.8
  • No data
  • 4n- 5.3n- 7.3
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (incidence u22655% and u22652% 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 GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or .
  • No data
  • 5.3n- 7.3
  • No data
  • No data
  • No data
  • WELLBUTRINu00a0SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reu2011uptake 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. 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:
  • WELLBUTRINu00a0SR is supplied for oral administration as 100u2011mg (blue), 150u2011mg (purple), and 200u2011mg (light pink), filmu2011coated, sustainedu2011release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: carnauba wax, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide and is printed with edible black ink. In addition, the 100u2011mg tablet contains FD&C Blue No.u00a01 Lake, the 150u2011mg tablet contains FD&C Blue No.u00a02 Lake and FD&C Red No.u00a040 Lake, and the 200u2011mg tablet contains FD&C Red No.u00a040 Lake.
  • No data
  • Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150u00a0mg/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 to 300u00a0mg/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 3u00a0times control mutation rate) in 2u00a0of 5u00a0strains in the Ames bacterial mutagenicity assay. Bupropion produced an increase in chromosomal aberrations in 1u00a0of 3u00a0in vivo rat bone marrow cytogenetic studies.
  • There were no effects on male and female fertility when rats were administered oral doses of bupropion up to 300u00a0mg/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 200u00a0mg/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 immediateu2011release formulation of bupropion in the treatment of major depressive disorder was established in two 4u2011week, placebou2011controlled trials in adult inpatients with MDD (Trials 1 and 2 in ) and in one 6u2011week, placebou2011controlled trial in adult outpatients with MDD (Trial 3 in ). In the first trial, the dose range of bupropion was 300 mg to 600u00a0mg/day administered in divided doses; 78% of subjects were treated with doses of 300 mg to 450u00a0mg/day. This trial demonstrated the effectiveness of the immediateu2011release 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 2u00a0doses of the immediateu2011release formulation of bupropion (300 and 450u00a0mg/day) and placebo. This trial demonstrated the effectiveness of the immediateu2011release formulation of bupropion, but only at the 450u2011mg/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 300u00a0mg/day of the immediateu2011release formulation of bupropion. This trial demonstrated the efficacy of the immediateu2011release formulation of bupropion as measured by the HDRS total score, the HDRS Item 1, the Montgomeryu2011Asberg Depression Rating Scale (MADRS), the CGI-S score, and the CGI-Improvement Scale (CGI-I) score.
  • Although there are not as yet independent trials demonstrating the antidepressant effectiveness of the sustainedu2011release formulation of bupropion, trials have demonstrated the bioequivalence of the immediateu2011release and sustainedu2011release forms of bupropion under steadyu2011state conditions, i.e., bupropion sustainedu2011release 150u00a0mg twice daily was shown to be bioequivalent to 100u00a0mg 3u00a0times daily of the immediateu2011release 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 WELLBUTRINu00a0SR (150u00a0mg twice daily) were randomized to continuation of their same dose of WELLBUTRINu00a0SR or placebo for up to 44u00a0weeks 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 3u00a0weeks. Relapse during the double-blind phase was defined as the investigatoru2019s judgment that drug treatment was needed for worsening depressive symptoms. Patients receiving continued treatment with WELLBUTRINu00a0SR experienced significantly lower relapse rates over the subsequent 44u00a0weeks compared with those receiving placebo.
  • WELLBUTRINu00a0SR sustainedu2011release tablets, 100u00a0mg of bupropion hydrochloride, are blue, round, biconvex, filmu2011coated tablets printed with u201cWELLBUTRINu00a0SRu00a0100u201d in bottles of 60 (NDC 0173-0947-55) tablets.
  • WELLBUTRINu00a0SR sustainedu2011release tablets, 150u00a0mg of bupropion hydrochloride, are purple, round, biconvex, filmu2011coated tablets printed with u201cWELLBUTRINu00a0SRu00a0150u201d in bottles of 60 (NDC 0173-0135-55) tablets.
  • WELLBUTRINu00a0SR sustained-release tablets, 200u00a0mg of bupropion hydrochloride, are light pink, round, biconvex, film-coated tablets printed with u201cWELLBUTRIN SR 200u201d in bottles of 60 (NDC 0173-0722-00) tablets.
  • Store at room temperature, 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [see USP Controlled Room Temperature]. Protect from light and moisture.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Suicidal Thoughts and Behaviors
  • Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patientu2019s prescriber or healthcare professional, especially if they are severe, abrupt in onset, or were not part of the patientu2019s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
  • Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment
  • Although WELLBUTRIN SR is not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN which is approved for this use. Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion. Instruct patients to discontinue bupropion and contact a healthcare professional if they experience such symptoms .
  • Severe Allergic Reactions
  • Educate patients on the symptoms of hypersensitivity and to discontinue WELLBUTRIN SR if they have a severe allergic reaction.
  • Seizure
  • Instruct patients to discontinue and not restart WELLBUTRINu00a0SR if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid use of alcohol.
  • As the dose is increased during initial titration to doses above 150u00a0mg/day, instruct patients to take WELLBUTRINu00a0SR in 2u00a0divided doses, preferably with at least 8u00a0hours between successive doses, to minimize the risk of seizures.
  • Angle-Closure Glaucoma
  • Patients should be advised that taking WELLBUTRIN SR can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible n
  • Bupropion-Containing Products
  • Educate patients that WELLBUTRINu00a0SR contains the same active ingredient (bupropion hydrochloride) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that WELLBUTRINu00a0SR should not be used in combination with ZYBAN or any other medications that contain bupropion (such as WELLBUTRIN, the immediate-release formulation and WELLBUTRIN XL or FORFIVO XL, the extended-release formulations, and APLENZIN, the extended-release formulation of bupropion hydrobromide). In addition, there are a number of generic bupropion HCl products for the immediate-, sustained-, and extended-release formulations.
  • Potential for Cognitive and Motor Impairment
  • Advise patients that any CNSu2011active drug like WELLBUTRINu00a0SR may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that WELLBUTRINu00a0SR does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. WELLBUTRIN SR may lead to decreased alcohol tolerance.
  • Concomitant Medications
  • Counsel patients to notify their healthcare provider if they are taking or plan to take any prescription or overu2011theu2011counter drugs because WELLBUTRIN SR sustained-release tablets and other drugs may affect each othersu2019 metabolisms.
  • Pregnancy
  • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with WELLBUTRIN SR. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to WELLBUTRIN SR during pregnancy .
  • Storage Information
  • Instruct patients to store WELLBUTRIN SR at room temperature, between 68u00b0F and 77u00b0F (20u00b0C to 25u00b0C) and keep the tablets dry and out of the light.
  • Administration Information
  • Instruct patients to swallow WELLBUTRINu00a0SR tablets whole so that the release rate is not altered. Do not chew, divide, or crush tablets; they are designed to slowly release drug in the body. When patients take more than 150 mg/day, instruct them to take WELLBUTRIN SR in 2 doses at least 8 hours apart, to minimize the risk of seizures. Instruct patients if they miss a dose, not to take an extra tablet to make up for the missed dose and to take the next tablet at the regular time because of the dose-related risk of seizure. Instruct patients that WELLBUTRIN SR tablets may have an odor. WELLBUTRIN SR can be taken with or without food.
  • WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and ZYBAN are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019 GSK group of companies or its licensor.
  • WLS:18PI
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: 11/2019
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0947-55
  • Wellbutrin SR
  • (bupropion HCl)
  • Sustained-Release Tablets
  • R only
  • Twice-A-Day
  • (After Initial Titration)
  • 100 mg
  • Each sustained-release tablet contains 100 mg bupropion HCl.
  • WARNING: Do not use with other medicines that contain bupropion HCl.
  • Federal Law requires dispensing of Wellbutrin SR with the Medication Guide provided with this bottle.
  • See prescribing information for dosage information.
  • Store at controlled room temperature, 68 to 77F (20 to 25C) [see USP].
  • Keep dry and out of light.
  • 60 Tablets
  • GlaxoSmithKline
  • RTP, NC 27709
  • Made in Spain
  • Trademark owned or licensed by GSK.
  • u00a92019 GSK or licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0135-55
  • Wellbutrin SR
  • (bupropion HCl)
  • Sustained-Release Tablets
  • R only
  • Twice-A-Day
  • (After Initial Titration)
  • 150 mg
  • Each sustained-release tablet contains 150 mg bupropion HCl.
  • WARNING: Do not use with other medicines that contain bupropion HCl.
  • Federal Law requires dispensing of Wellbutrin SR with the Medication Guide provided with this bottle.
  • See prescribing information for dosage information.
  • Store at controlled room temperature, 68 to 77F (20 to 25C) [see USP].
  • Keep dry and out of light.
  • 60 Tablets
  • GlaxoSmithKline
  • RTP, NC 27709
  • Made in Spain
  • Trademark owned or licensed by GSK.
  • u00a92019 GSK or licensor.
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0722-00
  • WellbutrinSR
  • (bupropion HCl)
  • Sustained-Release Tablets
  • R only
  • Twice-A-Day
  • (After Initial Titration)
  • 200 mg
  • Each sustained-release tablet contains 200 mg bupropion HCl.
  • WARNING: Do not use with other medicines that contain bupropion HCl.
  • Federal Law requires dispensing of Wellbutrin SR with the Medication Guide provided with this bottle.
  • See prescribing information for dosage information.
  • Store at controlled room temperature, 68 to 77F (20 to 25C) [see USP].
  • Keep dry and out of light.
  • 60 Tablets
  • GlaxoSmithKline
  • RTP, NC 27709
  • Made in Spain
  • Trademark owned or licensed by GSK.
  • u00a92019 GSK or licensor.

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