Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

Eon Labs, Inc.

TABLET, EXTENDED RELEASE

Strength 100 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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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 Eon Labs, Inc.. It is available in strength of 100 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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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 n
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 .n
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.

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 n
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 .

u2022
1

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2.1n- 5.3
2.2n- 8.7
2.2n- 8.7
2.3n- 8.6

Tablets: 100 mg, 150 mg, 200 mg. ()

Seizure disorder. (, )

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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n

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5.3n- 7.3

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Bupropion hydrochloride extended-release tablets, USP (SR), an antidepressant of the aminoketone class, are 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. 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 (aquamarine), 150 mg (plum), and 200 mg (light pink), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: carnauba wax, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, hypromellose, titanium dioxide, polyethylene glycol and polysorbate. In addition, the 100 mg tablet contains FD&C blue No. 1 lake and 150 mg tablet contains FD&C red No. 40 lake and FD&C blue No. 2 lake and the 200 mg tablet contains FD&C red No. 40 lake and FD&C yellow No. 6 lake.
This product meets USP Drug Release Test #2.

No data

Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 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 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/mbasis) 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/mbasis) 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 ) and in one 6-week, placebo-controlled trial in adult outpatients with MDD (Trial 3 in ). In the first trial, the dose range of bupropion was 300 mg to 600 mg/day administered in divided doses; 78% of subjects were treated with doses of 300 mg 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 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.
n: sample size; SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval included for doses that were demonstrated to be effective; NA: not available.
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 investigatoru2019s 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, USP (SR), for oral administration, are available as
Arrayn- 100 mg
Aquamarine, round, biconvex, film-coated tablets, debossed u201cu201d over u201c410u201d on one side and plain on the other side and supplied as:
NDC 0185-0410-60 bottles of 60
NDC 0185-0410-01 bottles of 100
NDC 0185-0410-52 bottles of 250
NDC 0185-0410-05 bottles of 500
Arrayn- 150 mg
Plum, round, biconvex, film-coated tablets, debossed u201cu201d over u201c415u201d on one side and plain on the other side and supplied as:
NDC 0185-0415-60 bottles of 60
NDC 0185-0415-01 bottles of 100
NDC 0185-0415-52 bottles of 250
NDC 0185-0415-05 bottles of 500
Arrayn- 200 mg
Light pink, round, biconvex, film-coated tablets, debossed u201cu201d on one side and debossed u201c1111u201d on the other side and supplied as:
NDC 0185-1111-60 bottles of 60
NDC 0185-1111-01 bottles of 100
NDC 0185-1111-52 bottles of 250
NDC 0185-1111-05 bottles of 500
NDC 0185-1111-10 bottles of 1000
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
Protect from light and moisture. Keep tightly closed.
KEEP OUT OF THE REACH OF CHILDREN.

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 bupropion hydrochloride extended-release tablets (SR) are 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 ()n ().
Severe Allergic Reactions
Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (SR) if they have a severe allergic reaction.
Seizure
Instruct patients to discontinue and not restart bupropion hydrochloride extended-release tablets (SR) 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 150 mg/day, instruct patients to take bupropion hydrochloride extended-release tablets (SR) in 2 divided doses, preferably with at least 8 hours between successive doses, to minimize the risk of seizures.
Angle-Closure Glaucoma
Patients should be advised that taking bupropion hydrochloride extended-release tablets (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 ().
Bupropion-Containing Products
Educate patients that bupropion hydrochloride extended-release tablets (SR) contain the same active ingredient (bupropion hydrochloride) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (SR) should not be used in combination with ZYBAN or any other medications that contain bupropion (such as WELLBUTRIN, the immediate-release formulation and WELLBUTRIN XLor 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 CNS-active drug like bupropion hydrochloride extended-release tablets (SR) may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that bupropion hydrochloride extended-release tablets (SR) does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride extended-release tablets (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 over-the-counter drugs because bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (SR). Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to bupropion hydrochloride extended-release tablets (SR) during pregnancy n .
Storage Information
Instruct patients to store bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (SR) 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 bupropion hydrochloride extended-release tablets (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 bupropion hydrochloride extended-release tablets (SR) may have an odor. Bupropion hydrochloride extended-release tablets (SR) can be taken with or without food.
The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

BuPROPion Hydrochloride Extended-Release Tablets, USP (SR)
(byoo-PROE-pee-on)
IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled u201cWhat Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?u201d
Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions
This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.n
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
What else do I need to know about antidepressant medicines?
It is not known if bupropion hydrochloride extended-release tablets (SR) are safe and effective in children under the age of 18.
Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions
This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Although bupropion hydrochloride extended-release tablets (SR) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBANwhich is used to help patients quit smoking.
Talk to your healthcare provider or your family memberu2019s healthcare provider about:
When you try to quit smoking, with or without bupropion you may have symptoms that may be due to nicotine withdrawal, including:
Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression.
Some people have had serious side effects while taking bupropion to help them quit smoking, including:
New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions.
Stop taking bupropion hydrochloride extended-release tablets (SR) and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride extended-release tablets (SR). In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (SR), but in some people, symptoms continued after stopping bupropion hydrochloride extended-release tablets (SR). It is important for you to follow-up with your healthcare provider until your symptoms go away.
Before taking bupropion hydrochloride extended-release tablets (SR)
What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?
If you have any of the above symptoms of mania, call your healthcare provider.
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
What are bupropion hydrochloride extended-release tablets (SR)?
Bupropion hydrochloride extended-release tablets (SR) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.
Who should not take bupropion hydrochloride extended-release tablets (SR)? Do not take bupropion hydrochloride extended-release tablets (SR) if you
What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets (SR)?
Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See u201cAntidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.u201d
Tell your healthcare provider about all the medicines you take
How should I take bupropion hydrochloride extended-release tablets (SR)?
What should I avoid while taking bupropion hydrochloride extended-release tablets (SR)?
What are possible side effects of bupropion hydrochloride extended-release tablets (SR)?
Bupropion hydrochloride extended-release tablets (SR) can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of bupropion hydrochloride extended-release tablets (SR).
The most common side effects of bupropion hydrochloride extended-release tablets (SR) include:
If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.
Tell your healthcare provider right away about any side effects that bother you.
These are not all the possible side effects of bupropion hydrochloride extended-release tablets (SR). For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Sandoz Inc. at 1-800-525-8747.
How should I store bupropion hydrochloride extended-release tablets (SR)?
Keep out of the reach of children.
General Information about the safe and effective use of bupropion hydrochloride extended-release tablets (SR).
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (SR) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (SR) to other people, even if they have the same symptoms you have. It may harm them.
If you take a urine drug screening test, bupropion hydrochloride extended-release tablets (SR) may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking bupropion hydrochloride extended-release tablets (SR), they can do a more specific drug screening test that should not have this problem.
This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for healthcare professionals.
For more information about bupropion hydrochloride extended-release tablets (SR), go to www.us.sandoz.com.
What are the ingredients in bupropion hydrochloride extended-release tablets (SR)?
Active ingredient:
Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
Manufactured for
Sandoz Inc.
Princeton, NJ 08540
Manufactured by
Epic Pharma, LLC
Laurelton, NY 11413
OS8674
Rev. December 2019
MF0410REV12/19

NDC
BuPROPion Hydrochloride Extended-Release Tablets, USP (SR)
100 mg
Twice-A-Day
(After Initial Titration)
WARNING: Do not use in combination with ZYBANu00ae or any other medicines that contain bupropion hydrochloride.
PHARMACIST: Dispense with attached Medication Guide.
Rx only
60 Tablets
Sandoz

NDC
BuPROPion Hydrochloride Extended-Release Tablets, USP (SR)
150 mg
Twice-A-Day
(After Initial Titration)
WARNING: Do not use in combination with ZYBANu00ae or any other medicines that contain bupropion hydrochloride.
PHARMACIST: Dispense with attached Medication Guide.
Rx only
60 Tablets
Sandoz

NDC
BuPROPion Hydrochloride Extended-Release Tablets, USP (SR)
200 mg
Twice-A-Day
(After Initial Titration)
WARNING: Do not use in combination with ZYBANu00ae or any other medicines that contain bupropion hydrochloride.
PHARMACIST: Dispense with attached Medication Guide.
Rx only
60 Tablets
Sandoz

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Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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