Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. WELLBUTRIN bupropion hydrochloridean 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. The molecular weight is 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:. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: Increases in dose should not exceed mg per day in a 3-day period. The recommended starting dose is mg per day, given as mg twice daily. After 3 days of dosing, the dose may be increased to mg per day, given as mg 3 times daily, with at least wellbutrin and cocaine addiction hours between successive doses.
Dosing above mg per day may be accomplished using the or mg tablets. A maximum of mg per day, given in divided doses of not more than mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at mg per day.
Administer the mg tablet 4 times daily to not exceed the limit of mg in a single dose. 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.
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: Drug interactions can increase the risk of hypertensive reactions. 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 linezolid 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. The risk of administering methylene blue by non-intravenous routes such as oral wellbutrin and cocaine addiction or by local injection or in intravenous doses much lower than 1 mg per kg with WELLBUTRIN is unclear.
Protect from light and moisture. The following adverse reactions are discussed in greater detail in other sections of the labeling:, wellbutrin and cocaine addiction. 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 rates in the clinical trials of another drug and may not reflect the rates wellbutrin and cocaine addiction in clinical practice.
The more common events causing discontinuation include neuropsychiatric disturbances 3. It is important to note, wellbutrin and cocaine addiction, however, that many of these events occurred at doses that exceed the recommended daily dose. During this experience, wellbutrin and cocaine addiction, 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: Infrequent was gynecomastia ; rare was glycosuria. Frequent was nocturia ; infrequent were vaginal irritation, testicular swelling, urinary tract infectionpainful erection, and retarded ejaculation ; rare were enuresisand urinary incontinence.
Frequent was stomatitis; infrequent were weed and hair lossbruxismgum irritation, and oral edema.
Infrequent was visual disturbance; rare was wellbutrin and cocaine addiction. Frequent were flu-like symptoms; infrequent was nonspecific pain; rare was overdose.
This incidence is approximately double that seen in comparable subjects treated with tricyclics or placebo. Because these reactions are reported voluntarily from a population of uncertain size, it is wellbutrin and cocaine addiction always wellbutrin and cocaine addiction to reliably estimate their frequency or establish a causal relationship to drug exposure. Arthralgiawellbutrin and cocaine addiction, myalgiaand fever with rash and other symptoms suggestive of delayed hypersensitivity.
Hypertension in some cases severeorthostatic hypotensionthird degree heart block. Syndrome of inappropriate antidiuretic hormone secretion, hyperglycemiahypoglycemia. Ecchymosisleukocytosisleukopeniathrombocytopenia, wellbutrin and cocaine addiction. Aggression, coma, completed suicide, deliriumdream abnormalities, paranoid ideation, paresthesiaparkinsonismrestlessness, suicide attempt, unmasking of tardive dyskinesia.
Stevens-Johnson syndromeangioedemaexfoliative dermatitisurticaria. Tinnitusincreased intraocular pressure. Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Concomitant treatment with these drugs can increase bupropion exposure but decrease hydroxybupropion exposure.
Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded. Bupropion and its metabolites erythrohydrobupropion, wellbutrin and cocaine addiction, threohydrobupropion, hydroxybupropion are CYP2D6 inhibitors.
Such drugs include certain antidepressants e. Drugs that require metabolic activation by CYP2D6 to be effective e. Bupropion, levodopa, and amantadine have dopamine agonist effects. CNS toxicity has been reported when bupropion was coadministered with levodopa or amantadine. Adverse reactions have included restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness. It is presumed that the toxicity results from cumulative dopamine agonist effects. In postmarketing experience, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients who were drinking alcohol during treatment with Wellbutrin and cocaine addiction. Bupropion inhibits the reuptake of dopamine and norepinephrine.
Concomitant use of MAOIs and bupropion is contraindicated because there is an increased risk of hypertensive reactions if bupropion is used concomitantly with MAOIs. Studies in animals demonstrate that the acute toxicity of bupropion is enhanced by the MAO inhibitor phenelzine. False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion.
This is due to lack of specificity of some screening tests. Falsepositive test results may result even following discontinuation of bupropion therapy. In a population of individuals experienced with drugs of abuse, a single oral dose of mg of bupropion produced mild amphetamine -like activity as compared with placebo on the Morphine -Benzedrine Subscale of the Addiction Research Center Inventories ARCI and a score greater than placebo but less than 15 mg of the Schedule II stimulant dextroamphetamine on the Liking Scale of the ARCI.
These scales measure general feelings of euphoria and drug liking which are often associated with abuse potential. Findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs.
Nonetheless, evidence from single-dose trials does suggest that the recommended daily dosage of bupropion when administered orally in divided doses is not likely to be significantly reinforcing to amphetamine or CNS stimulant abusers. However, higher doses which could not be tested because of the risk of seizure might be modestly attractive to those who abuse CNS stimulant drugs, wellbutrin and cocaine addiction.
The inhalation of crushed tablets or injection of dissolved bupropion has been reported, wellbutrin and cocaine addiction. Studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. In rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavior response, and increase rates of responding in several schedule-controlled behavior paradigms. In primate models assessing the positive-reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously.
In rats, bupropion produced amphetamine-like and cocaine -like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs. 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.
Pooled analyses of short-term placebo-controlled trials of antidepressant drugs selective serotonin reuptake inhibitors [SSRIs] and others show that these drugs increase the risk of suicidal thinking and behavior suicidality in children, wellbutrin and cocaine addiction, and young adults ages 18 to 24 with MDD and other psychiatric disorders. Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo vinager as antibacterial adults beyond age 24; there was a reduction with antidepressants compared with placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder OCDor other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4, subjects.
The pooled analyses of placebo-controlled trials in adults with MDD wellbutrin and cocaine addiction other psychiatric disorders included a total of short-term trials median duration vitamins and urine increased 2 months of 11 antidepressant drugs in over 77, subjects. There was considerable variation in anti psychotic geodon 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, wellbutrin and cocaine addiction, 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 BOX WARNING ].
The following symptoms, anxiety, agitation, panic attacks, wellbutrin and cocaine addiction, irritability, hostility, aggressiveness, impulsivityakathisia psychomotor restlessnesshypomaniaand maniahave 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.
Families and caregivers wellbutrin and cocaine addiction 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. Such monitoring should include daily observation by families and caregivers.
Serious neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation. These postmarketing reports have included changes in mood including depression and maniapsychosishallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide [see ADVERSE REACTIONS ], wellbutrin and cocaine addiction.
Some patients who stopped smoking may have been experiencing symptoms of nicotine withdrawal, including depressed mood. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessations attempt without medication. However, some of these adverse events occurred in patients taking bupropion who continued to smoke.
Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses.
Observe patients for the occurrence of neuropsychiatric adverse events, wellbutrin and cocaine addiction. Advise patients and caregivers that the patient should stop taking WELLBUTRIN 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, wellbutrin and cocaine addiction.