Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Bupropion is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders under Cautions.)
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving bupropion for smoking cessation. (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment under Cautions.)
Symptoms have occurred in patients with and without preexisting psychiatric disease; some patients experienced worsening of their psychiatric illness.
Depressed mood may be a symptom of nicotine withdrawal; however, some symptoms occurred in bupropion-treated patients who continued to smoke.
Most symptoms occurred during bupropion therapy, but some were reported following discontinuance of drug.
Monitor all patients receiving bupropion for smoking cessation for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).
Patients should discontinue bupropion and immediately contact their clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.
Symptoms resolved upon drug discontinuance in many cases, but persisted in a few cases. Provide ongoing monitoring and supportive care until symptoms resolve.
Weigh risks of bupropion for smoking cessation against benefits. Bupropion shown to increase likelihood of abstinence from smoking for up to 6 months compared with placebo. Health benefits of quitting smoking are immediate and substantial.
REMS:
FDA approved a REMS for bupropion to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of bupropion and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. If you take this medicine more than once a day, take your second dose at least 8 hours after you take your first dose. To limit difficulty in sleeping, avoid taking this medicine at bedtime. Do not take your medicine more often than directed. If you have been taking this medicine for some time, do not suddenly stop taking it. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, skip the missed dose and take your next tablet at the regular time. There should be at least 8 hours between doses. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You may have to take this medicine for several days before you start to feel better.
Patients and their families should watch out for depression or thoughts of suicide that get worse. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your doctor.
Alcohol may increase dizziness or drowsiness. Avoid alcoholic drinks while taking this medicine. Drinking excessive alcoholic beverages, using sleeping or anxiety medicines, or quickly stopping the use of these agents while taking this medicine may increase your risk for a seizure.
You may get dizzy or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional. Also do not take any herbal or non-prescription medicines for weight loss without the advice of your doctor or health care professional. Some ingredients may increase possible side effects.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F), away from direct sunlight and moisture. Keep tightly closed. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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