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Furthermore, lower doses place less of a burden on liver enzymes during hepatic metabolism. Upon ingestion of a high dose, the efficiency of hepatic CYP2B6 enzymes may decrease, distribution of the drug may increase throughout the body, and renal clearance rate may also drop slightly. Therefore, expect the elimination half-life of bupropion to be slightly longer if you discontinued from a high dose. If you are taking WELLBUTRIN SR for the treatment of major depressive disorder, it may take several weeks for you to feel that WELLBUTRIN SR is working. Once you feel better, it is important to keep taking WELLBUTRIN SR exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel WELLBUTRIN SR is working for you.
Starting WELLBUTRIN SR in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated . Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk ofcongenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. WELLBUTRIN SR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Instruct patients to discontinue and not restart WELLBUTRIN SR if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Depressed patients treated with WELLBUTRIN SR have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Adverse reactions reported in placebo-controlled trials are presented in Table 3. Reported adverse reactions were classified using a COSTART-based Dictionary. Bupropion is one of the norepinephrine-dopamine reuptake inhibitor 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 [see Warnings and Precautions (5.1)]. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older. They occur in up to one-third of overdose exposures, though usually more in the range of 10% to 15%.
A maximum of 400 mg per 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 per day. To avoid high peak concentrations of bupropion and/or its metabolites, do not exceed 200 mg in any single dose. In clinical trials conducted with the immediate-release formulation of bupropion, 35% of subjects receiving tricyclic antidepressants gained weight, compared with 9% of subjects treated with the immediate-release formulation of bupropion. If weight loss is a major presenting sign of a patient’s depressive illness, the anorectic and/or weight-reducing potential of bupropion hydrochloride extended-release tablets should be considered. 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. In the first trial, the dose range of bupropion was 300 mg to 600 mg per day administered in divided doses; 78% of subjects were treated with doses of 300 mg to 450 mg per day.
Do not start bupropion hydrochloride extended-release tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. Do not take an MAOI within 2 weeks of stopping bupropion hydrochloride extended-release tablets unless directed to do so by your healthcare provider. Are taking any other medicines that contain bupropion, ZYBAN# APLENZIN®#, FORFIVO XL™#, WELLBUTRIN®#, or WELLBUTRIN XL®#.
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