Reported anaphylactoid/anaphylactic reactions (eg, pruritus, urticaria, angioedema & dyspnea); arthralgia, myalgia, fever w/ rash & other symptoms suggestive of delayed hypersensitivity. May experience worsening of depression &/or emergence of suicidal ideation & behavior or unusual behavioral changes in adult & ped patients w/ major depressive disorder; appropriately monitor & closely observe especially during initial few mth of therapy or at times of dose changes. Consider changing therapeutic regimen including possible discontinuation in patients whose depression is persistently worse, experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these are severe, abrupt in onset, or not part of patient's presenting symptoms. Alert families & caregivers to monitor for emergence of anxiety, agitation, irritability, unusual changes in behavior & other symptoms; suicidality. Not approved for smoking cessation treatment; & for use in treating bipolar depression. Neuropsychiatric adverse events in patients w/ & w/o pre-existing psychiatric disease; worsening of psychiatric illnesses. Observe occurrence of neuropsychiatric adverse events; immediately discontinue use if agitation, depressed mood, or changes in behavior or thinking that are not typical for patient are observed, or suicidal ideation/behavior develops. Discontinue use & do not restart in patients who experience seizures during treatment. Patients w/ predisposing factors that may increase risk of seizure including history of head trauma or prior seizure, severe stroke, arteriovenous malformation, CNS tumor or infection, or metabolic disorders (eg, hypoglycemia, hyponatremia, severe hepatic impairment & hypoxia); excessive alcohol or sedatives use, addiction to cocaine or stimulants, or sedative w/drawal; those w/ diabetes treated w/ insulin &/or oral diabetic medications (eg, sulfonylureas & meglitinides) that may cause hypoglycemia; concomitant administration w/ medications that may lower seizure threshold including other bupropion products, antipsychotics, TCAs, theophylline, systemic steroids. Not to be administered to patients currently dependent on opioids including opioid-containing medication or patients treated w/ opioid agonists used in opioid dependence (eg, methadone, buprenorphine) or patients in acute opioid w/drawal. Observed serious life-threatening reactions (eg, seizure & serotonin syndrome); reported insufficient intra-/post-op opioid analgesia during treatment. Discontinue Contrave for min of 3 days before & do not increase opioid dose above standard dose in patients requiring intermittent treatment w/ opioids (eg, due to surgical procedure). Opioid-free interval of min 7-10 days is recommended for patients previously dependent on short-acting opioids, & those transitioning from buprenorphine or methadone may need as long as 2 wk. Reported HTN; measure BP & pulse prior to starting therapy & monitor at regular intervals consistent w/ usual clinical practice, particularly among patients w/ controlled HTN prior to treatment. Discontinue treatment if patient experiences clinically relevant & sustained BP & pulse rate increases. Reported severe cutaneous adverse reactions (eg, SJS & acute generalised exanthematous pustulosis); closely monitor for skin reactions; immediately w/draw & consider alternative treatment if signs & symptoms suggestive of these reactions appear. Discontinue use in the event of symptoms &/or signs of acute hepatitis. Reported serotonin syndrome when co-administered w/ serotonergic agent (eg, SSRIs or SNRIs) & opioids (eg, tramadol, methadone); carefully observe patient during treatment initiation & dose increases. Consider discontinuation of therapy if serotonin syndrome is suspected. Screen patients for history of bipolar disorder & presence of bipolar disorder risk factors (eg, family history of bipolar disorder, suicide or depression). Patients w/ history of psychiatric disorders. Angle-closure glaucoma. Measure blood glucose levels prior to starting & during treatment in patients w/ type 2 diabetes. Consider decreasing antidiabetic medication doses which are non-glucose-dependent; change antidiabetic drug regimen if hypoglycemia develops after starting Contrave. May unmask Brugada syndrome; patients w/ Brugada syndrome or family history of cardiac arrest or sudden death. Cases of hepatitis & clinically significant liver dysfunction; transient, asymptomatic hepatic transaminase elevations. Not recommended in patients w/ ESRD & moderate hepatic impairment. Not to be used during pregnancy or in women currently attempting to become pregnant. Lactation. Not recommended in ped patients <18 yr. Elderly >65 yr.
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