BUPROPION HYDROCHLORIDE EXTENDED RELEASE SR  - bupropion hydrochloride tablet, film coated, extended release 
Lake Erie Medical DBA Quality Care Products LLC

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Buproprion Hydrochloride Extended Release(SR)150mg

Bupropion hydrochloride extended-release tablets USP (SR), antidepressants 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 (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO•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

CLINICAL PHARMACOLOGY











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During a chronic dosing study with bupropion in 14 depressed patients with left ventricular dysfunction (history of CHF or an enlarged heart on x-ray), no apparent effect on the pharmacokinetics of bupropion or its metabolites was revealed, compared to healthy volunteers.


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The effects of age on the pharmacokinetics of bupropion and its metabolites have not been fully characterized, but an exploration of steady-state bupropion concentrations from several depression efficacy studies involving patients dosed in a range of 300 mg/day to 750 mg/day, on a 3 times daily schedule, revealed no relationship between age (18 to 83 years) and plasma concentration of bupropion. A single-dose pharmacokinetic study demonstrated that the disposition of bupropion and its metabolites in elderly subjects was similar to that of younger subjects. These data suggest there is no prominent effect of age on bupropion concentration; however, another pharmacokinetic study, single and multiple dose, has suggested that the elderly are at increased risk for accumulation of bupropion and its metabolites (see PRECAUTIONS, Geriatric Use).

A single-dose study involving 12 healthy male and 12 healthy female volunteers revealed no sex-related differences in the pharmacokinetic parameters of bupropion.

The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers. Following oral administration of a single 150-mg dose of bupropion, there was no statistically significant difference in Cmax, half-life, Tmax, AUC or clearance of bupropion or its active metabolites between smokers and nonsmokers.

Bupropion hydrochloride extended-release tablets USP (SR) are indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of bupropion hydrochloride extended-release tablets USP (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets USP (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder.

Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients treated with ZYBAN® (bupropion hydrochloride) sustained-release tablets, bupropion hydrochloride tablets (immediate-release formulation), bupropion hydrochloride extended-release tablets (XL) (the extended-release formulation) or any other medications that contain bupropion because the incidence of seizure is dose dependent.

Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion.

Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of bupropion hydrochloride extended-release tablets (SR) and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (SR).

Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (SR).

Patients with major depressive disorder (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, however, 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 (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to 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 patients. 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 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients 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



WARNINGS PRECAUTIONS

ADVERSE REACTIONS Bupropion Hydrochloride Extended-Release Tablets (SR) ADVERSE REACTIONS, Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion













WARNINGS PRECAUTIONS





Bupropion Hydrochloride Extended-Release Tablets (SR) 300 mg/day:

Bupropion Hydrochloride Extended-Release Tablets (SR) 400 mg/day:





WARNINGS PRECAUTIONS

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions of frequency: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1,000 patients, while rare events are those occurring in less than 1/1,000 patients.

Adverse events for which frequencies are not provided occurred in clinical trials or postmarketing experience with bupropion. Only those adverse events not previously listed for extended-release bupropion (SR) are included. The extent to which these events may be associated with bupropion hydrochloride extended-release tablets (SR) are unknown.

Body (General):Infrequent were chills, facial edema, musculoskeletal chest pain and photosensitivity. Rare was malaise. Also observed were arthralgia, myalgia and fever with rash and other symptoms suggestive of delayed hypersensitivity. These symptoms may resemble serum sickness (see PRECAUTIONS).

Cardiovascular:Infrequent were postural hypotension, stroke, tachycardia and vasodilation. Rare was syncope. Also observed were complete atrioventricular block, extrasystoles, hypotension, hypertension (in some cases severe, see PRECAUTIONS), myocardial infarction, phlebitis and pulmonary embolism.

Digestive:Infrequent were abnormal liver function, bruxism, gastric reflux, gingivitis, glossitis, increased salivation, jaundice, mouth ulcers, stomatitis and thirst. Rare was edema of tongue. Also observed were colitis, esophagitis, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, intestinal perforation, liver damage, pancreatitis and stomach ulcer.

Endocrine:Also observed were hyperglycemia, hypoglycemia and syndrome of inappropriate antidiuretic hormone.

Hemic and Lymphatic:Infrequent was ecchymosis. Also observed were anemia, leukocytosis, leukopenia, lymphadenopathy, pancytopenia and thrombocytopenia. Altered PT and/or INR, infrequently associated with hemorrhagic or thrombotic complications, were observed when bupropion was co-administered with warfarin.

Metabolic and Nutritional:Infrequent were edema and peripheral edema. Also observed was glycosuria.

Musculoskeletal:Infrequent were leg cramps. Also observed were muscle rigidity/fever/rhabdomyolysis and muscle weakness.

Nervous System:Infrequent were abnormal coordination, decreased libido, depersonalization, dysphoria, emotional lability, hostility, hyperkinesia, hypertonia, hypesthesia, suicidal ideation and vertigo. Rare were amnesia, ataxia, derealization and hypomania. Also observed were abnormal electroencephalogram (EEG), akinesia, aggression, aphasia, coma, completed suicide, delirium, delusions, dysarthria, dyskinesia, dystonia, euphoria, extrapyramidal syndrome, hallucinations, hypokinesia, increased libido, manic reaction, neuralgia, neuropathy, paranoid ideation, restlessness, suicide attempt and unmasking tardive dyskinesia.

Respiratory:Rare was bronchospasm. Also observed was pneumonia.

Skin:Rare was maculopapular rash. Also observed were alopecia, angioedema, exfoliative dermatitis and hirsutism.

Special Senses:Infrequent were accommodation abnormality and dry eye. Also observed were deafness, diplopia, increased intraocular pressure and mydriasis.

Urogenital:Infrequent were impotence, polyuria and prostate disorder. Also observed were abnormal ejaculation, cystitis, dyspareunia, dysuria, gynecomastia, menopause, painful erection, salpingitis, urinary incontinence, urinary retention and vaginitis.



OVERDOSAGE

Overdoses of up to 30 g or more of bupropion have been reported. Seizure was reported in approximately one-third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia and ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.

Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure and cardiac arrest prior to death were reported in these patients.

Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. EEG monitoring is also recommended for the first 48 hours post-ingestion. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended.

Activated charcoal should be administered. There is no experience with the use of forced diuresis, dialysis, hemoperfusion or exchange transfusion in the management of bupropion overdoses. No specific antidotes for bupropion are known.

Due to the dose-related risk of seizures with bupropion hydrochloride extended-release tablets (SR), hospitalization following suspected overdose should be considered. Based on studies in animals, it is recommended that seizures be treated with intravenous benzodiazepine administration and other supportive measures, as appropriate.

In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference (PDR).


DOSAGE AND ADMINISTRATION

General Dosing Considerations

It is particularly important to administer bupropion hydrochloride extended-release tablets (SR) in a manner most likely to minimize the risk of seizure (see WARNINGS). Gradual escalation in dosage is also important if agitation, motor restlessness and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. Bupropion hydrochloride extended-release tablets (SR) should be swallowed whole and not crushed, divided or chewed, as this may lead to an increased risk of adverse effects including seizures.

Initial Treatment:The usual adult target dose for bupropion hydrochloride extended-release tablets (SR) is 300 mg/day, given as 150 mg twice daily. Dosing with bupropion hydrochloride extended-release tablets (SR) should begin at 150-mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, an increase to the 300-mg/day target dose, given as 150 mg twice daily, may be made as early as day 4 of dosing. There should be an interval of at least 8 hours between successive doses.

Increasing the Dosage Above 300 mg/day:As with other antidepressants, the full antidepressant effect of bupropion hydrochloride extended-release tablets (SR) may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 400 mg/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/day.

Maintenance Treatment:It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In a study in which patients with major depressive disorder, recurrent type, who had responded during 8 weeks of acute treatment with bupropion hydrochloride extended-release tablets (SR) were assigned randomly to placebo or to the same dose of bupropion hydrochloride extended-release tablets (SR) (150 mg twice daily) during 44 weeks of maintenance treatment as they had received during the acute stabilization phase, longer-term efficacy was demonstrated (see CLINICAL TRIALS under CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of bupropion hydrochloride extended-release tablets (SR) needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Dosage Adjustment for Patients with Impaired Hepatic Function:Bupropion hydrochloride extended-release tablets (SR) should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 100 mg every day or 150 mg every other day in these patients. Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with hepatic impairment (including mild-to-moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild-to-moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY, WARNINGSand PRECAUTIONS).

Dosage Adjustment for Patients with Impaired Renal Function: Bupropion hydrochloride extended-release tablets (SR) should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGYand PRECAUTIONS).

HOW SUPPLIED

Bupropion hydrochloride extended-release tablets USP (SR) for oral administration are available as:

100 mg: Aquamarine, round, biconvex, film-coated tablets, debossed “E” over “410” 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

150 mg: Plub, round, biconvex, film-coated tablets, debossed “E” over “415” 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

200 mg: Light pink, round, biconvex, film-coated tablets, debossed “E” on one side and debossed “1111” 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Protect from light.

Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Do not use in combination with ZYBAN® or any other medicines that contain bupropion hydrochloride.

ZYBAN®, Wellbutrin® and Wellbutrin XL® are registered trademarks of GlaxoSmithKline.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNING

Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of bupropion hydrochloride extended-release tablets (SR) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Bupropion hydrochloride extended-release tablets (SR) is not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders , PRECAUTIONS, Information for Patients and PRECAUTIONS, Pediatric Use).

Use in Smoking Cessation Treatment: WELLBUTRIN®, bupropion hydrochloride extended-release tablets (SR) , and WELLBUTRIN XL® are not approved for smoking cessation treatment, but bupropion under the name ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.

All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN in the post-marketing experience. When symptoms were reported, most were during treatment with ZYBAN, but some were following discontinuation of treatment with ZYBAN. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial (see WARNINGS, Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS, Information for Patients).

Medication Guide

Bupropion Hydrochloride Extended-Release Tablets (SR)

Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (SR) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (SR), ask your doctor 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 “What other important information should I know about bupropion hydrochloride extended-release tablets (SR)?”

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. Talk to your, or your family member’s, healthcare provider about:

all risks and benefits of treatment with antidepressant medicines

all treatment choices for depression or other serious mental illness

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 and young adults within the first few months of treatment.
  2. Depression and 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. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or 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 a 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?

Bupropion hydrochloride extended-release tablets (SR) has not been studied in children under the age of 18 and is not approved for use in children and teenagers.

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 ZYBAN® which is used to help patients quit smoking.

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 doctor 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 extended-release tablets (SR)?

Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (SR), especially in people:

The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (SR). For more information, see the sections “Who should not take bupropion hydrochloride extended-release tablets (SR)?” and “What should I tell my doctor before using bupropion hydrochloride extended-release tablets (SR)?” Tell your doctor about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are using bupropion hydrochloride extended-release tablets (SR) unless your doctor has said it is okay to take them.

If you have a seizure while taking bupropion hydrochloride extended-release tablets (SR), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (SR) again if you have a seizure.

What is 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 doctor before using bupropion hydrochloride extended-release tablets (SR)?

Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.”

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. Read this entire Medication Guide for more information about these serious side effects.

The most common side effects of bupropion hydrochloride extended-release tablets (SR) are loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often.

If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.

These are not all the side effects of bupropion hydrochloride extended-release tablets (SR). For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store bupropion hydrochloride extended-release tablets (SR)?

General Information about 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. Keep bupropion hydrochloride extended-release tablets (SR) out of the reach of children.

This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for health professionals.

What are the ingredients in bupropion hydrochloride extended-release tablets (SR)?

Active ingredient: bupropion hydrochloride.


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BUPROPION HYDROCHLORIDE EXTENDED RELEASE SR 
bupropion hydrochloride   tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 49999-381 (0185-0415)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPROPION HYDROCHLORIDE (BUPROPION) BUPROPION HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
HYDROXYPROPYL CELLULOSE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
HYPROMELLOSE  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL  
POLYSORBATE 80  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
Product Characteristics
Color purple (plum) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code E;415
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 49999-381-30 30 BOTTLE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075932 10/04/2010

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical DBA Quality Care Products LLC 831276758 repack
Establishment
Name Address ID/FEI Operations
Epic Pharma LLC 827915443 manufacture
Revised: 10/2010 Lake Erie Medical DBA Quality Care Products LLC