Wellbutrin Information
Wellbutrin (Colesevelam hydrochloride) Warning
®
Use in Smoking Cessation Treatment:
All patients 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.
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 six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. (See
Wellbutrin (Colesevelam hydrochloride)
Wellbutrin (Colesevelam hydrochloride) Clinical Pharmacology
Pharmacodynamics:
Pharmacokinetics:
In a study comparing 14-day dosing with Wellbutrin (Colesevelam hydrochloride) XL 300 mg once daily to the immediate-release formulation of bupropion at 100 mg 3 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion). Additionally, in a study comparing 14-day dosing with Wellbutrin (Colesevelam hydrochloride) XL 300 mg once daily to the sustained-release formulation of bupropion at 150 mg 2 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites.
Population Subgroups:
Wellbutrin (Colesevelam hydrochloride) Clinical Trials
Major Depressive Disorder:
In a longer-term study, outpatients meeting DSM-IV criteria for major depressive disorder, recurrent type, who had responded during an 8-week open trial on bupropion (150 mg twice daily of the sustained-release formulation) were randomized to continuation of their same dose of bupropion or placebo, for up to 44 weeks of observation for relapse. Response during the open phase was defined as CGI Improvement score of 1 (very much improved) or 2 (much improved) for each of the final 3 weeks. Relapse during the double-blind phase was defined as the investigator's judgment that drug treatment was needed for worsening depressive symptoms. Patients receiving continued bupropion treatment experienced significantly lower relapse rates over the subsequent 44 weeks compared to those receiving placebo.
Although there are no independent trials demonstrating the antidepressant effectiveness of Wellbutrin (Colesevelam hydrochloride) XL, studies have demonstrated similar bioavailability of Wellbutrin (Colesevelam hydrochloride) XL to both the immediate-release formulation and to the sustained-release formulation of bupropion under steady-state conditions, i.e., Wellbutrin (Colesevelam hydrochloride) XL 300 mg once daily was shown to have bioavailability that was similar to that of 100 mg 3 times daily of the immediate-release formulation of bupropion and to that of 150 mg 2 times daily of the sustained-release formulation of bupropion, with regard to both peak plasma concentration and extent of absorption, for parent drug and metabolites.
Seasonal Affective Disorder:
In these 3 trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for Wellbutrin (Colesevelam hydrochloride) XL than for placebo: 81.4% vs 69.7%, 87.2% vs 78.7%, and 84.0% vs 69.0% for Study 1, 2 and 3, respectively; with a depression-free rate for the 3 studies combined of 84.3% vs 72.0%.
Wellbutrin (Colesevelam hydrochloride) Indications And Usage
Major Depressive Disorder:
The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see ).
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 in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see ). Nevertheless, the physician who elects to use Wellbutrin (Colesevelam hydrochloride) XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Seasonal Affective Disorder:
The efficacy of Wellbutrin (Colesevelam hydrochloride) XL for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see ).
Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.
Wellbutrin (Colesevelam hydrochloride) Contraindications
Wellbutrin (Colesevelam hydrochloride) XL is contraindicated in patients with a seizure disorder.
Wellbutrin (Colesevelam hydrochloride) XL is contraindicated in patients treated with ZYBAN (bupropion hydrochloride) Sustained-Release Tablets; Wellbutrin (Colesevelam hydrochloride) (bupropion hydrochloride), the immediate-release formulation; Wellbutrin (Colesevelam hydrochloride) SR, (bupropion hydrochloride), the sustained-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent.
Wellbutrin (Colesevelam hydrochloride) XL is 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.
Wellbutrin (Colesevelam hydrochloride) XL is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
The concurrent administration of Wellbutrin (Colesevelam hydrochloride) XL 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 Wellbutrin (Colesevelam hydrochloride) XL.
Wellbutrin (Colesevelam hydrochloride) XL is contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up Wellbutrin (Colesevelam hydrochloride) XL.
Wellbutrin (Colesevelam hydrochloride) Warnings
Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders
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. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.
These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. All patients being treated with bupropion as part of smoking cessation treatment should be observed for neuropsychiatric symptoms or worsening of pre-existing psychiatric illness.
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, depressed mood, or changes in behavior or thinking 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 six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial.
Screening Patients for Bipolar Disorder:
Seizures: Bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with Wellbutrin (Colesevelam hydrochloride) XL. Wellbutrin (Colesevelam hydrochloride) XL should be discontinued and not restarted in patients who experience a seizure while on treatment.
As Wellbutrin (Colesevelam hydrochloride) XL is bioequivalent to both the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion, the seizure incidence with Wellbutrin (Colesevelam hydrochloride) XL, while not formally evaluated in clinical trials, may be similar to that presented below for the immediate-release and sustained-release formulations of bupropion.
Data for the immediate-release formulation of bupropion revealed a seizure incidence of approximately 0.4% (i.e., 13 of 3,200 patients followed prospectively) in patients treated at doses in a range of 300 to 450 mg/day. This seizure incidence (0.4%) may exceed that of some other marketed antidepressants.
Additional data accumulated for the immediate-release formulation of bupropion suggested that the estimated seizure incidence increases almost tenfold between 450 and 600 mg/day. The 600 mg dose is twice the usual adult dose and one and one-third the maximum recommended daily dose (450 mg) of Wellbutrin (Colesevelam hydrochloride) XL. This disproportionate increase in seizure incidence with dose incrementation calls for caution in dosing.
Hepatic Impairment: Wellbutrin (Colesevelam hydrochloride) XL should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced frequency and/or dose is required as peak bupropion as well as AUC levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 150 mg every other day in these patients (see , , and ).
Potential for Hepatotoxicity:
Wellbutrin (Colesevelam hydrochloride) Precautions
Information for Patients:
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Wellbutrin (Colesevelam hydrochloride) XL.
Laboratory Tests:
Drug Interactions:
Because bupropion is extensively metabolized, the coadministration of other drugs may affect its clinical activity. studies indicate that bupropion is primarily metabolized to hydroxybupropion by the CYP2B6 isoenzyme. Therefore, the potential exists for a drug interaction between Wellbutrin (Colesevelam hydrochloride) XL and drugs that are substrates of or inhibitors /inducers of the CYP2B6 isoenzyme (e.g., orphenadrine, thiotepa, cyclophosphamide, ticlopidine, and clopidogrel). In addition, studies suggest that paroxetine, sertraline, norfluoxetine, and fluvoxamine as well as nelfinavir and efavirenz inhibit the hydroxylation of bupropion. No clinical studies have been performed to evaluate this finding. The threohydrobupropion metabolite of bupropion does not appear to be produced by the cytochrome P450 isoenzymes. The effects of concomitant administration of cimetidine on the pharmacokinetics of bupropion and its active metabolites were studied in 24 healthy young male volunteers. Following oral administration of two 150-mg tablets of the sustained-release formulation of bupropion with and without 800 mg of cimetidine, the pharmacokinetics of bupropion and hydroxybupropion were unaffected. However, there were 16% and 32% increases in the AUC and C, respectively, of the combined moieties of threohydrobupropion and erythrohydrobupropion.
In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir (KALETRA) 400 mg twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by approximately 20% to 80%. This effect is thought to be due to the induction of bupropion metabolism. Patients receiving ritonavir may need increased doses of bupropion, but the maximum recommended dose of bupropion should not be exceeded (see ).
While not systematically studied, certain drugs may induce the metabolism of bupropion (e.g., carbamazepine, phenobarbital, phenytoin).
Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 healthy volunteers.
Animal data indicated that bupropion may be an inducer of drug-metabolizing enzymes in humans. In one study, following chronic administration of bupropion, 100 mg 3 times daily to 8 healthy male volunteers for 14 days, there was no evidence of induction of its own metabolism. Nevertheless, there may be the potential for clinically important alterations of blood levels of coadministered drugs.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Bupropion produced a positive response (2 to 3 times control mutation rate) in 2 of 5 strains in the Ames bacterial mutagenicity test and an increase in chromosomal aberrations in 1 of 3 rat bone marrow cytogenetic studies.
A fertility study in rats at doses up to 300 mg/kg/day revealed no evidence of impaired fertility.
Labor and Delivery:
Nursing Mothers:
Pediatric Use:
Geriatric Use:
A single-dose pharmacokinetic study demonstrated that the disposition of bupropion and its metabolites in elderly subjects was similar to that of younger subjects; 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 ).
Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of toxic reaction to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see and ).
Wellbutrin (Colesevelam hydrochloride)
Wellbutrin (Colesevelam hydrochloride) Drug Abuse And Dependence
Controlled Substance Class:
Humans:
In a population of individuals experienced with drugs of abuse, a single dose of 400 mg of bupropion produced mild amphetamine-like activity as compared to placebo on the Morphine-Benzedrine Subscale of the Addiction Research Center Inventories (ARCI), and a score intermediate between placebo and amphetamine on the Liking Scale of the ARCI. These scales measure general feelings of euphoria and drug desirability.
Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. Nonetheless, evidence from single-dose studies does suggest that the recommended daily dosage of bupropion when administered in divided doses is not likely to be especially reinforcing to amphetamine or stimulant abusers. However, higher doses that could not be tested because of the risk of seizure might be modestly attractive to those who abuse stimulant drugs.
Animals:
Wellbutrin (Colesevelam hydrochloride) Overdosage
Human Overdose Experience:
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.
Overdosage Management:
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 Wellbutrin (Colesevelam hydrochloride) XL, 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 (PDR).
Wellbutrin (Colesevelam hydrochloride) Dosage And Administration
General Dosing Considerations:
Major Depressive Disorder:
I
:
Maintenance Treatment:
Seasonal Affective Disorder:
Dosing with Wellbutrin (Colesevelam hydrochloride) XL should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, the dose of Wellbutrin (Colesevelam hydrochloride) XL should be increased to the 300-mg/day dose after 1 week. If the 300-mg dose is not adequately tolerated, the dose can be reduced to 150 mg/day. The usual adult target dose for Wellbutrin (Colesevelam hydrochloride) XL is 300 mg/day, given once daily in the morning.
For patients taking 300 mg/day during the autumn-winter season, the dose should be tapered to 150 mg/day for 2 weeks prior to discontinuation.
Doses of Wellbutrin (Colesevelam hydrochloride) XL above 300 mg/day have not been studied for the prevention of seasonal major depressive episodes.
Switching Patients from Wellbutrin (Colesevelam hydrochloride) Tablets or from Wellbutrin (Colesevelam hydrochloride) SR Sustained-Release Tablets:
Dosage Adjustment for Patients With Impaired Hepatic Function:
Dosage Adjustment for Patients With Impaired Renal Function:
Wellbutrin (Colesevelam hydrochloride) How Supplied
Wellbutrin (Colesevelam hydrochloride) XL Extended-Release Tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with "Wellbutrin (Colesevelam hydrochloride) XL 150" in bottles of 30 (NDC 54868-5010-0) and 60 (NDC 54868-5010-1).
Wellbutrin (Colesevelam hydrochloride) XL Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with "Wellbutrin (Colesevelam hydrochloride) XL 300" in bottles of 30 (NDC 54868-4935-0).
Wellbutrin (Colesevelam hydrochloride) Medication Guide
Read this Medication Guide carefully before you start using Wellbutrin (Colesevelam hydrochloride) XL 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 Wellbutrin (Colesevelam hydrochloride) XL, ask your doctor or pharmacist.
This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.
Wellbutrin (Colesevelam hydrochloride) XL has not been studied in children under the age of 18 and is not approved for use in children and teenagers.
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 Wellbutrin (Colesevelam hydrochloride) XL is 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.
The chance of having seizures increases with higher doses of Wellbutrin (Colesevelam hydrochloride) XL. For more information, see the sections "" and "" Tell your doctor about all of your medical conditions and all the medicines you take.
Wellbutrin (Colesevelam hydrochloride) XL is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for prevention of autumn-winter seasonal depression (seasonal affective disorder).
Wellbutrin (Colesevelam hydrochloride) XL can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.
Common side effects reported in studies of major depressive disorder include weight loss, 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. In studies of seasonal affective disorder, common side effects included weight loss, constipation, and gas.
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 Wellbutrin (Colesevelam hydrochloride) XL. 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 or BTA Pharmaceuticals at 866-246-8245 (opt. 3).
This Medication Guide summarizes important information about Wellbutrin (Colesevelam hydrochloride) XL. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about Wellbutrin (Colesevelam hydrochloride) XL that is written for health professionals or call 866-246-8245 (opt. 3).
Active ingredient: bupropion hydrochloride.
Inactive ingredients: ethylcellulose aqueous dispersion, glyceryl behenate, methacrylic acid copolymer dispersion, polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide, and triethyl citrate. The tablets are printed with edible black ink.
*The following are registered trademarks of their respective manufacturers: Wellbutrin (Colesevelam hydrochloride) and Wellbutrin (Colesevelam hydrochloride) XL/GlaxoSmithKline; ZYBAN /GlaxoSmithKline; PARNATE / GlaxoSmithKline; NARDIL/Warner Lambert Company; MARPLAN/ Validus Pharmaceuticals LLC; KALETRA /Abbott Laboratories.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:Biovail CorporationMississauga, ON L5N 8M5, Canada
For:BTA Pharmaceuticals, Inc. (subsidiary of Biovail Corporation)Bridgewater, NJ 08807
Rev. 02/10 LB0033-09
Wellbutrin (Colesevelam hydrochloride) Principal Display Panel - Mg Tablets
Wellbutrin (Colesevelam hydrochloride) Principal Display Panel - Mg Tablets
