Do not take Aplenzin if you:
- have or had a seizure disorder or epilepsy.
- drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
- have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI).
- have or had an eating disorder such as anorexia nervosa or bulimia.
- are allergic to the active ingredient in Aplenzin, bupropion hydrobromide, or to any of the inactive ingredients.
Aplenzin can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Aplenzin affects you. Do not drink alcohol while using Aplenzin.
- Store Aplenzin at room temperature between 59°F and 86°F (15°C to 30°C).
- Keep Aplenzin away from direct sunlight.
- Keep Aplenzin bottle closed tightly.
Keep Aplenzin and all medicines out of the reach of children.
Before starting Aplenzin, tell your healthcare provider if you:
- have ever had depression, suicidal thoughts or actions, or other mental health problems.
Tell your healthcare provider about your medical conditions. Tell your healthcare provider if you:
- are pregnant or plan to become pregnant. It is not known if Aplenzin can harm your unborn baby.
- are breastfeeding. Aplenzin passes through your milk. It is not known if Aplenzin can harm your baby.
- have liver problems, especially cirrhosis of the liver.
- have kidney problems.
- have an eating disorder such as anorexia nervosa or bulimia.
- have had a head injury.
- have had a seizure (convulsion, fit).
- have a tumor in your nervous system (brain or spine).
- have had a heart attack, heart problems, or high blood pressure.
- are a diabetic taking insulin or other medicines to control your blood sugar.
- drink a lot of alcohol.
- abuse prescription medicines or street drugs.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Aplenzin and some medicines may interact with each other, may not work as well, may increase your chances of having seizures or cause other serious side effects.
Aplenzin may cause serious side effects. See “Drug Precautions”.
Common possible side effects in people who take Aplenzin include:
- weight loss
- loss of appetite
- stomach pain
- nausea. If you have nausea take your medicine with food.
- feeling anxious or trouble sleeping. If you have trouble sleeping, do not take your medicine too close to bedtime.
- dry mouth
- skin rash
- sweating
- ringing in the ears
- shakiness
- agitation
- dizziness
- muscle pain
- fast heartbeat
- urinating more often
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Aplenzin. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Aplenzin passes through your milk. It is not known if Aplenzin can harm your baby.
Aplenzin is a prescription medicine used to treat adults with:
- a certain type of depression called major depressive disorder (MDD)
- seasonal depression (seasonal affective disorder)
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Aplenzin will harm your unborn baby.
Active ingredient: bupropion hydrobromide
Inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths. The tablets are printed with edible black ink.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Aplenzin and some medicines may interact with each other, may not work as well, may increase your chances of having seizures or cause other serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take Aplenzin with your other medicines. Do not start or stop any medicine while taking Aplenzin without first talking to your healthcare provider.
If you take Aplenzin, you should not take any other medicines that contain (bupropion) including: (i.e., ZYBAN, WELLBUTRIN Tablets, WELLBUTRIN SR Sustained-Release Tablets, or WELLBUTRIN XL Extended-Release Tablets. Bupropion is the same active ingredient that is in Aplenzin.
- Take Aplenzin exactly as prescribed by your healthcare provider. Your healthcare provider may need to change the dose of Aplenzin until it is the right dose for you.
- Do not chew, cut, or crush Aplenzin tablets. You must swallow the tablets whole. Tell your healthcare provider if you cannot swallow medicine tablets.
- Take Aplenzin at the same time each day.
- Take your doses of Aplenzin at least 24 hours apart.
- Aplenzin may be taken with or without food.
- If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time. This is very important. Too much Aplenzin can increase your chance of having a seizure.
- If you take too much Aplenzin, or overdose, call your local emergency room or poison control center right away.
- The Aplenzin tablet is covered by a shell that slowly releases the medicine inside your body. You may notice something in your stool that looks like a tablet. This is normal. This is the empty shell passing from your body.
- Do not take any other medicines while using Aplenzin unless your healthcare provider has told you it is okay.
- If you are taking Aplenzin for the treatment of major depressive disorder, it may take several weeks for you to feel that Aplenzin is working. Once you feel better, it is important to keep taking Aplenzin exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel Aplenzin is working for you.
- Do not change your dose or stop taking Aplenzin without first talking with your healthcare provider.
Aplenzin (generic: bupropion) is a prescription medication used to treat depression in adults. Aplenzin is a once-daily, long-acting version of bupropion.
Aplenzin, an antidepressant, belongs to a group of drugs called norepinephrine and dopamine reuptake inhibitors, or NDRIs. These medications are thought to improve mood by balancing certain natural chemicals in the brain.
This medication comes in tablet form and is taken once a day, with or without food.
Some of the common side effects of Aplenzin include dry mouth, nausea and trouble sleeping. Do not take Aplenzin with alcohol. Aplenzin may cause dizziness and can impair your ability to drive.
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Use in treating Psychiatric Disorders: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Aplenzin™ or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Aplenzin is not approved for use in pediatric patients.
Use in Smoking Cessation Treatment: Aplenzin is not approved for smoking cessation treatment, but bupropion under the name Zyban is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.
All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking Zyban in the post-marketing experience. When symptoms were reported, most were during treatment with Zyban, but some were following discontinuation of treatment with Zyban. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of Zyban.
Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of Zyban was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.
The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. Zyban has been demonstrated to increase the likelihood of abstinence from smoking for as long as six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial.
If you take too much Aplenzin, or overdose, call your local emergency room or poison control center right away.