Unsubscribe
You have now been unsubscribed.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY?
AUVELITY (aw-VEHL-ah-tee) and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children.
You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine.
Call your healthcare provider (HCP) or get emergency help right away if you or your loved one with MDD have any of the following symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- new or worsening depression or anxiety
- agitation or restlessness
- trouble sleeping (insomnia)
- acting aggressive, being angry, or violent
- an extreme increase in activity and talking (mania)
- suicide attempts
- panic attacks
- new or worsening irritability
- acting on dangerous impulses
- other unusual changes in behavior or mood
WHAT IS AUVELITY?
It is a prescription oral medicine used to treat adults with major depressive disorder (MDD) and agitation that may happen with dementia due to Alzheimer’s disease.
AUVELITY should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.
It is not known if AUVELITY is safe and effective in children with MDD.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? (CONT'D)
Do not take AUVELITY if you:
- have or had a seizure disorder.
- have or had an eating disorder like anorexia or bulimia.
- have recently suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and have recently suddenly stopped taking them.
- are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in the last 14 days, or are being treated with the antibiotic linezolid or intravenous methylene blue. Ask your HCP or pharmacist if you are unsure whether you take an MAOI. Do not start taking an MAOI until you have stopped taking AUVELITY for at least 14 days.
- are allergic to dextromethorphan, bupropion, or any other ingredients in AUVELITY.
- greatly increased energy
- racing thoughts
- unusually grand ideas
- talking more or faster than usual
- severe trouble sleeping
- reckless behavior
- excessive happiness or irritability
- agitation
- hallucinations
- confusion
- coma
- fast heartbeat
- blood pressure changes
- dizziness
- sweating
- flushing
- high body temperature (hyperthermia)
- shaking (tremors), stiff muscles, or muscle twitching
- loss of coordination
- seizures
- nausea, vomiting, diarrhea
COMMON SIDE EFFECTS
The most common side effects of AUVELITY when treating MDD include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.The most common side effects of AUVELITY when treating agitation that may happen with dementia due to Alzheimer’s disease include dizziness and stomach upset or pain.
- skin rash
- itching
- hives
- chest pain
- swelling
- shortness of breath
- muscle or joint pain
- fever
BEFORE USING
- Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
-
It is important to tell your HCP if you are taking:
- other medicines containing bupropion or dextromethorphan
- medicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), MAOIs, and tricyclic antidepressants
- theophylline
- corticosteroids
- oral diabetes medicines or use insulin to control your blood sugar
- medicines to control appetite (anorectic)
- nicotine medicines to help you stop smoking
- street (illicit) drugs
- benzodiazepines, sedative-hypnotic (sleep medicines), or opiates
- central nervous system (CNS) stimulants
- digoxin
- levodopa
- amantadine
- have problems with your liver or kidneys.
- have diabetes, heart disease, or high blood pressure.
- have a history of seizure, stroke, heart attack, eating disorder, head injury, or have a tumor in your brain or spinal cord.
- have a history of alcohol or drug abuse.
- have a history of seizure, eating disorder, or abuse alcohol or drugs.
- have low blood sugar or low blood sodium levels.
- have problems walking or a history of falls.
- take certain other medicines that could interact with AUVELITY.
- have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.
- have high pressure in the eye (glaucoma).
- you drink a lot of alcohol.
- you abuse prescription or street drugs.
- you are pregnant or plan to become pregnant.
- you are breastfeeding or plan to breastfeed.
HOW TO TAKE
- Take AUVELITY exactly as instructed by your HCP.
- Your HCP may increase your dose of AUVELITY during treatment. Do not change your dose or stop taking AUVELITY without first talking to your HCP.
- If you take AUVELITY 1 time a day, take your tablet in the morning.
- If your HCP increases your dose to 2 times a day, take AUVELITY tablets at least 8 hours apart.
- Do not take more than 2 AUVELITY tablets in 24 hours.
- If you miss a dose, do not take an extra dose. Wait and take your next dose at the regular time. Do not take more than 1 dose of AUVELITY at a time.
- Swallow AUVELITY tablets whole. Do not crush, chew, or divide the tablets.
- Take AUVELITY with or without food.
- If you take too much AUVELITY call your Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.