Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

NuCare Pharmaceuticals, Inc.

TABLET, FILM COATED

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 NuCare Pharmaceuticals, 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 n n n .n n 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 n n n .n n n
Arrayn- NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation n n n n The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although bupropion hydrochloride tablets are not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur n n n n .n n n
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
See full prescribing information for complete boxed warning.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. (n n n )n n n
Monitor for worsening and emergence of suicidal thoughts and behaviors. (n n n )n n n
Serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation. (n n n )n n n

Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSMn n n .n nn
The efficacy of bupropion hydrochloride tablets 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 n n n n .n nn
Bupropion hydrochloride is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). (n n n )n nn

No data

Starting dose: 200 mg per day given as 100 mg twice daily (n n n )n n n
General: Increase dose gradually to reduce seizure risk. (n n n , n n n )n n n
After 3 days, may increase the dose to 300 mg per day, given as 100 mg 3 times daily at an interval of at least 6 hours between doses. (n n n )n n n
Usual target dose: 300 mg per day as 100 mg 3 times daily. (n n n )n n n
Maximum dose: 450 mg per day given as 150 mg 3 times daily. (n n n )n n n
Periodically reassess the dose and need for maintenance treatment. (n n n )n n n
Moderate to severe hepatic impairment: 75 mg once daily. (n n n , n n n )n n n
Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. (n n n , n n n )n n n
Renal impairment: Consider reducing the dose and/or frequency. (n n n , n n n )n n n

Tablets: 75 mg and 100 mg. (n n n )n nn

No data

Seizure disorder. (n n n , n n n )n n n
Current or prior diagnosis of bulimia or anorexia nervosa. (n n n , n n n )n n n
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. (n n n , n n n )n n n
Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrochloride tablets or within 14 days of stopping treatment with bupropion hydrochloride tablets. Do not use bupropion hydrochloride tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrochloride tablets in a patient who is being treated with linezolid or intravenous methylene blue. (n n n , n n n )n n n
Known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride tablets. (n n n , n n n )n n n

No data

Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 450 mg. Discontinue if seizure occurs. (n n n , n n n , n n n )n n n
Hypertension: Bupropion hydrochloride tablets can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. (n n n )n n n
Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms. (n n n )n n n
Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. (n n n )n n n
Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (n n n )n n n

The following adverse reactions are discussed in greater detail in other sections of the labeling:
Most common adverse reactions (incidence u22655% and u22651% more than placebo rate) are: agitation, dry mouth, constipation, headache/migraine, nausea/vomiting, dizziness, excessive sweating, tremor, insomnia, blurred vision, tachycardia, confusion, rash, hostility, cardiac arrhythmias, and auditory disturbance. (n n n )n nn

No data

CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical response, but should not exceed the maximum recommended dose. (n n n )n n n
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. (n n n )n n n
Drugs that lower seizure threshold: Dose bupropion hydrochloride tablets with caution. (n n n , n n n )n n n
Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrochloride tablets. (n n n )n n n
MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride tablets. (n n n )n n n
Drug-laboratory test interactions: bupropion hydrochloride tablets can cause false- positive urine test results for amphetamines. (n n n )n n n

No data

Pregnancy: Use only if benefit outweighs potential risk to the fetus. (n n n )n n n

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 Cn n n Hn n n ClNOu2022HCl. 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:n nn
Bupropion hydrochloride tablets, USP are supplied for oral administration as 75-mg and 100-mg lavender film-coated tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate.

No data

Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg per kg per day, respectively. These doses are approximately 7 and 2 times the MRHD, respectively, on a mg per mn n n basis. In the rat study there was an increase in nodular proliferative lesions of the liver at doses of 100 to 300 mg per kg per day (approximately 2 to 7 times the MRHD on a mg per mn n n 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.n nn
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 in vivo rat bone marrow cytogenetic studies.
A fertility study in rats at doses up to 300 mg per kg per day revealed no evidence of impaired fertility.

The efficacy of bupropion hydrochloride tablets 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 4) and in one 6-week, placebo-controlled trial in adult outpatients with MDD (Trial 3 in Table 4). In the first trial, the dose range of bupropion hydrochloride tablets was 300 mg to 600 mg per day administered in 3 divided doses; 78% of subjects were treated with doses of 300 mg to 450 mg per day. The trial demonstrated the efficacy of bupropion hydrochloride tablets as measured 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 bupropion hydrochloride tablets (300 and 450 mg per day) and placebo. This trial demonstrated the effectiveness of bupropion hydrochloride tablets for only the 450-mg-per-day dose. The efficacy results were statistically 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 per day of bupropion hydrochloride tablets. This trial demonstrated the efficacy of bupropion hydrochloride tablets 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. Effectiveness of bupropion hydrochloride tablets in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.

Bupropion hydrochloride tablets, USP, 100 mg of bupropion hydrochloride, are lavender, round, film-coated tablets, debossed GG 930 on one side and plain on the reverse side.
NDC 66267-614-60 in bottles of 60 tablets
Store at 20u00baC to 25u00baC (68u00baF to 77u00baF) [see USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with bupropion hydrochloride tablets and counsel them in its appropriate use.
A patient Medication Guide about u201cAntidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions,u201d u201cQuitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions,u201d and u201cWhat Other Important Information Should I Know About bupropion hydrochloride tablets?u201d is available for bupropion hydrochloride tablets. Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Advise patients regarding the following issues and to alert their prescriber if these occur while taking bupropion hydrochloride tablets.
Suicidal Thoughts and Behaviors:
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment:
Severe Allergic Reactions:
Seizure:
Angle-Closure Glaucoma:n- [see Warnings and Precautions (n n n )]n n n
Bupropion-Containing Products:
Potential for Cognitive and Motor Impairment:
Concomitant Medications:
Pregnancy:
Precautions for Nursing Mothers:
Storage Information:
Administration Information:
Brands listed are trademarks of their respective owners.

Bupropion Hydrochloride Tablets, USP
(bue proe' pee on)
Read this Medication Guide carefully before you start taking bupropion hydrochloride tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about bupropion hydrochloride tablets, ask your healthcare provider or pharmacist.
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 Tablets?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 n n n :n nn
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
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 tablets 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 tablets are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBANn n n which is used to help patients quit smoking.n nn
Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion.
If you, your family member, or your caregiver notice agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking bupropion and call your healthcare provider right away:
When you try to quit smoking, with or without bupropion, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. 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.
Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illnesses. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion.
What Other Important Information Should I Know About Bupropion Hydrochloride Tablets?
The chance of having seizures increases with higher doses of bupropion hydrochloride tablets. For more information, see the sections u201cWho should not take bupropion hydrochloride tablets?u201d and u201cWhat should I tell my healthcare provider before taking bupropion hydrochloride tablets?u201d Tell your healthcare provider about all of your medical conditions and all the medicines you take. n n n n n
If you have a seizure while taking bupropion hydrochloride tablets, stop taking the tablets and call your healthcare provider right away.
If you have any of the above symptoms of mania, call your healthcare provider.
What are bupropion hydrochloride tablets?
Bupropion hydrochloride tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.
Who should not take bupropion hydrochloride tablets?
Do not take bupropion hydrochloride tablets if you
What should I tell my healthcare provider before taking bupropion hydrochloride tablets?
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 your other medical conditions including if you:
Tell your healthcare provider about all the medicines you take
How should I take bupropion hydrochloride tablets?
What should I avoid while taking bupropion hydrochloride tablets?
What are possible side effects of bupropion hydrochloride tablets?
See n n n n
Bupropion hydrochloride tablets can cause serious side effects.
The most common side effects of bupropion hydrochloride tablets 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 tablets. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider 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 tablets?
Keep bupropion hydrochloride tablets and all medicines out of the reach of children.
General Information about bupropion hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride tablets for a condition for which it was not prescribed. Do not give bupropion hydrochloride tablets 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 tablets 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 tablets, they can do a more specific drug screening test that should not have this problem.
This Medication Guide summarizes important information about bupropion hydrochloride tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bupropion hydrochloride tablets that is written for healthcare professionals.
For more information about bupropion hydrochloride tablets, call Sandoz Inc. at 1-800-525-8747.
What are the ingredients in bupropion hydrochloride tablets?
Active ingredient: bupropion hydrochloride, USP.
Inactive ingredients: FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, hypromellose, microcrystalline cellulose, potassium chloride, pregelatinized starch, stearic acid, titanium dioxide, and triethyl citrate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Brands listed are trademarks of their respective owners.
For Medication Guides, please call 1-800-507-2130.
05-2016M
7334
Sandoz Inc.
Princeton, NJ 08540

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Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

TABLET, FILM COATED

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

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Bupropion Hydrochloride (Bupropion Hydrochloride)

Trade Name : Bupropion Hydrochloride

TABLET, FILM COATED

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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