Medically reviewed on April 2, Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in wellbutrin and food trials. Wellbutrin and food 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 [see Warnings and Precautions 5.
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 [see Warnings and Precautions 5. Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see Warnings and Precautions 5. 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. Instruct the patient to contact a healthcare provider if such reactions occur [see Warnings and Precautions 5, wellbutrin and food. The efficacy of Wellbutrin in the treatment of a major depressive episode was established in two wellbutrin and food controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies 14 ]. To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions 5.
Wellbutrin Tablets should be swallowed whole and not crushed, divided, or chewed. Wellbutrin may be taken with or without food. Dosing above mg per day may be accomplished using the wellbutrin and food mg tablets.
It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of Wellbutrin needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment. In patients with moderate to severe hepatic impairment Child-Pugh score: In patients with mild hepatic impairment Child-Pugh score: At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with Wellbutrin.
Conversely, at least 14 days should be allowed after stopping Wellbutrin before starting an MAOI antidepressant [see Contraindications 4Drug Interactions 7.
Do not start Wellbutrin in a patient who is being treated wellbutrin and food a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, wellbutrin and food, including hospitalization, should be considered [see Contraindications 4Drug Interactions 7.
In some cases, a patient already receiving therapy with Wellbutrin may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, Wellbutrin should be stopped promptly, and wellbutrin and food or intravenous methylene blue can be administered.
The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Wellbutrin may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
The clinician should, nevertheless, wellbutrin and food, be aware of the possibility of a drug interaction wellbutrin and food such use [see Contraindications 4Drug Interactions 7.
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 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. Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with placebo in adults aged 65 and older.
There was considerable variation wellbutrin and food risk of suicidality among drugs, but a tendency toward an increase in the younger subjects 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. These risk differences drug-placebo difference in the number of cases of suicidality per 1, subjects 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. 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 [see Boxed Warning].
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, wellbutrin and food, impulsivity, akathisia psychomotor restlessnesshypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder wellbutrin and food well as for other indications, both psychiatric and nonpsychiatric.
Families and caregivers of patients being treated with antidepressants for MDD 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, wellbutrin and food.
Such monitoring should include daily observation by families and caregivers. Prescriptions for Wellbutrin should be written for the smallest quantity of tablets wellbutrin and food with good patient management, in order to reduce the risk of overdose. Wellbutrin is not approved for smoking cessation treatment; however, bupropion HCl sustained-release is approved for this use, wellbutrin and food.
Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation, wellbutrin and food. These have included changes in mood including depression and maniapsychosis, hallucinations, paranoia, delusions, wellbutrin and food, homicidal wellbutrin and food, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide [see Boxed Warning, Adverse Reactions 6.
Observe patients for wellbutrin and food occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur. In many of these cases, a causal relationship to bupropion treatment is not certain, because depressed mood can be a symptom of nicotine withdrawal. Wellbutrin can cause seizure. The risk of seizure is dose-related. The dose should not exceed mg per weight loss online charts and support. Increase the dose gradually.
Discontinue Wellbutrin and do not restart treatment if the patient experiences a seizure. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold. Consider these risks before initiating treatment with Wellbutrin. Wellbutrin is contraindicated in patients with a seizure disorder, current or prior diagnosis of anorexia nervosa or bulimia, or undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Contraindications 4Drug Interactions 7.
The following conditions can also increase the risk of seizure: Incidence of Seizure with Bupropion Use: Bupropion is associated with seizures in approximately 0.
Treatment with Wellbutrin can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with Wellbutrin, wellbutrin and food, and monitor periodically during treatment. The risk of hypertension is increased if Wellbutrin is used concomitantly with Wellbutrin and food or other drugs that increase dopaminergic or noradrenergic activity [see Contraindications 4 ], wellbutrin and food.
Data from a comparative trial of the sustained-release formulation of bupropion HCl, nicotine transdermal system NTSwellbutrin and food, the combination of sustained-release bupropion plus NTS, and placebo as an aid to smoking cessation suggest a higher incidence of treatment-emergent hypertension in wellbutrin and food treated with the combination of sustained-release bupropion and NTS.
In this trial, 6. The majority of these subjects had evidence of pre-existing hypertension. Monitoring of blood pressure is recommended in tegretol and leg pain who receive the combination of bupropion and nicotine replacement.
There are no controlled trials assessing the safety of bupropion in patients with a recent history of myocardial infarction or unstable cardiac disease. Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder.
Prior to initiating Wellbutrin, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder e. Wellbutrin is not approved for use in treating bipolar depression. Depressed patients treated with Wellbutrin have had a variety of neuropsychiatric signs and wellbutrin and food, including delusions, hallucinations, wellbutrin and food, concentration disturbance, paranoia, and confusion.
Some of these patients had a diagnosis of bipolar disorder. The pupillary dilation vdt and cancer occurs following use of many antidepressant drugs including Wellbutrin may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Reactions have been characterized by pruritus, wellbutrin and food, urticaria, angioedema, and dyspnea requiring medical treatment. There are reports of arthralgia, wellbutrin and food, myalgia, fever with rash and other serum sickness-like symptoms suggestive of delayed hypersensitivity.
The following adverse reactions are discussed in greater detail in other sections of the labeling:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with wellbutrin and food in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The more common events causing discontinuation include neuropsychiatric disturbances 3. It is important to note, however, that many of these events occurred at doses that exceed the recommended daily dose. The conditions and duration of exposure to Wellbutrin varied greatly, and a substantial proportion of the experience was gained in open and uncontrolled clinical settings. During this experience, numerous adverse events were reported; however, without appropriate controls, it is impossible to determine with certainty which events were or were not caused by Wellbutrin.
The following enumeration is organized by organ system and describes events in terms of their relative frequency of reporting in the database. The following definitions of frequency are used: Frequent was nocturia; infrequent were vaginal irritation, testicular swelling, urinary tract infection, painful erection, and retarded ejaculation; rare were enuresis, and urinary incontinence. Frequent was stomatitis; infrequent were toothache, bruxism, gum irritation, and oral edema.
Infrequent was visual disturbance; rare was diplopia. This incidence is approximately double that seen in comparable subjects treated with tricyclics or placebo.
The following adverse reactions have been identified during post-approval use of Wellbutrin and are not described elsewhere in the label. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Arthralgia, myalgia, and fever with rash and other symptoms suggestive of delayed hypersensitivity.
These symptoms may sore throat and arthritis serum sickness wellbutrin and food Warnings and Precautions 5. Ecchymosis, leukocytosis, leukopenia, thrombocytopenia, wellbutrin and food.
Aggression, coma, completed suicide, delirium, dream abnormalities, paranoid ideation, wellbutrin and food, parkinsonism, restlessness, suicide attempt, unmasking of tardive dyskinesia. Bupropion is primarily metabolized to hydroxybupropion by CYP2B6.