Aplenzin Extended-Release TabletsGeneric Name: Bupropion Hydrobromide
Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Aplenzin Extended-Release Tablets outweigh the risks.
Family and caregivers must closely watch patients who take Aplenzin Extended-Release Tablets. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.
Aplenzin Extended-Release Tablets are used for:
Treating depression. It may also be used for other conditions as determined by your doctor.
Aplenzin Extended-Release Tablets are an antidepressant. It works in the brain to treat depression. Exactly how it works is not known.
Do NOT use Aplenzin Extended-Release Tablets if:
- you are allergic to any ingredient in Aplenzin Extended-Release Tablets
- you are taking any other medicine that contains bupropion
- you have a history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)
- you are suddenly stopping the use of alcohol or sedatives (eg, benzodiazepines) after long-term use
- you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Aplenzin Extended-Release Tablets:
Some medical conditions may interact with Aplenzin Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse
- if you have diabetes, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), or a recent heart attack
- if you have a history of seizure, head injury, tumor in the brain or spinal cord, or liver problems (eg, cirrhosis)
Some MEDICINES MAY INTERACT with Aplenzin Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amantadine, antipsychotics (eg, haloperidol, risperidone), corticosteroids (eg, prednisone), cyclophosphamide, efavirenz, HIV protease inhibitors (eg, nelfinavir, ritonavir), insulin, levodopa, MAOIs (eg, phenelzine), nicotine patches, oral hypoglycemics (eg, glipizide), orphenadrine, other antidepressants (eg, fluoxetine, amitriptyline), sympathomimetics (eg, pseudoephedrine), theophylline, thiotepa, or tiagabine because they may increase the risk of Aplenzin Extended-Release Tablets's side effects
- Carbamazepine, phenobarbital, phenytoin, or rifampin because they may decrease Aplenzin Extended-Release Tablets's effectiveness
- Antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine), or tricyclic antidepressants (eg, nortriptyline) because the risk of their side effects may be increased by Aplenzin Extended-Release Tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Aplenzin Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Aplenzin Extended-Release Tablets:
Use Aplenzin Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Aplenzin Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aplenzin Extended-Release Tablets refilled.
- Take Aplenzin Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow Aplenzin Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
- Several weeks may pass before your symptoms improve. Do not stop taking Aplenzin Extended-Release Tablets without checking with your doctor.
- Take your doses at the same time each day at least 24 hours apart. This may help to decrease the risk of seizures with Aplenzin Extended-Release Tablets.
- Continue to take Aplenzin Extended-Release Tablets even if you feel well. Do not miss any doses.
- If you miss a dose of Aplenzin Extended-Release Tablets, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose within 24 hours. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Aplenzin Extended-Release Tablets.
Important safety information:
- Aplenzin Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Aplenzin Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Aplenzin Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Aplenzin Extended-Release Tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you drink large amounts of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Aplenzin Extended-Release Tablets.
- If you already drink alcohol or use sedatives, do not suddenly stop them without first checking with your doctor. Suddenly stopping them may increase your seizure risk.
- Do not take decongestants (eg, pseudoephedrine), stimulants, or diet pills while you are taking Aplenzin Extended-Release Tablets without first checking with your doctor. They may increase your risk of seizures.
- The risk of seizures may be greater if you take Aplenzin Extended-Release Tablets in high doses or for a long time. Do NOT take more than the recommended dose, change your dose, or use Aplenzin Extended-Release Tablets for longer than prescribed without checking with your doctor.
- Children, teenagers, and young adults who take Aplenzin Extended-Release Tablets may be at increased risk for suicidal thoughts or actions. Watch all patients who take Aplenzin Extended-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- You may notice the tablet shell in your stool. This is normal and not a cause for concern.
- If you have trouble sleeping, you may be taking your dose too close to bedtime. Talk with your doctor about changing your dosing schedule.
- Aplenzin Extended-Release Tablets contains the same ingredients as Zyban, a medicine used to help stop smoking, and Wellbutrin, another medicine used to treat depression. Do not take Aplenzin Extended-Release Tablets if you are also taking Zyban or Wellbutrin. Discuss any questions or concerns with your doctor.
- Use Aplenzin Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
- Aplenzin Extended-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aplenzin Extended-Release Tablets while you are pregnant. Aplenzin Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Aplenzin Extended-Release Tablets.
Possible side effects of Aplenzin Extended-Release Tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dizziness; drowsiness; dry mouth; flushing; gas; headache; increased sweating; increased urination; loss of appetite; muscle pain; nausea; nervousness; restlessness; ringing in the ears; stomach pain; taste changes; trouble sleeping; vomiting; weakness; weight changes.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; painful sores in the mouth or around the eyes; tightness in the chest; swollen lymph nodes; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; delusions; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; hearing problems; menstrual changes; new or worsening mental or mood changes (eg, concentration problems, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being or inability to sit still); red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent joint or muscle pain; severe or persistent nausea, vomiting, or stomach pain; severe or persistent nervousness, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor; unusual swelling; vision changes; worsening depression; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fast, slow, or irregular heartbeat; fever; hallucinations; loss of consciousness; rigid or painful muscles; seizures; severe dizziness; slow or difficult breathing.Proper storage of Aplenzin Extended-Release Tablets:
Store Aplenzin Extended-Release Tablets at 77 degrees F (25 degrees C) in a tight, light-resistant container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aplenzin Extended-Release Tablets out of the reach of children and away from pets.
- If you have any questions about Aplenzin Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
- Aplenzin Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Aplenzin Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Aplenzin Prescribing Information (FDA)
- Aplenzin Consumer Overview
- Aplenzin Advanced Consumer (Micromedex) - Includes Dosage Information
- Bupropion Prescribing Information (FDA)
- Bupropion Professional Patient Advice (Wolters Kluwer)
- Wellbutrin Prescribing Information (FDA)
- Wellbutrin Consumer Overview
- Wellbutrin Detailed Consumer Information (PDR)
- Wellbutrin SR Prescribing Information (FDA)
- Wellbutrin XL Prescribing Information (FDA)
- Zyban Prescribing Information (FDA)
- Zyban Detailed Consumer Information (PDR)
- Zyban Consumer Overview