Aplenzin extended-release tablets

Generic Name: bupropion hydrobromide (bue-PROE-pee-on HYE-droe-BROE-mide)
Brand Name: Aplenzin

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.

Although Aplenzin extended-release tablets is not used to help patients stop smoking, another brand of medicine that contains bupropion is approved for this use. Serious mental or mood problems, including depression, and suicidal thoughts or actions have been reported in some patients using bupropion to help them stop smoking.

Family and caregivers must closely watch all patients who take Aplenzin extended-release tablets. It is important to keep in close contact with the patient's doctor. Contact the doctor at once if new, worsened, or sudden symptoms, such as agitation, hostility, depressed mood, or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. Discuss any questions with the patient's doctor.

Aplenzin extended-release tablets is not approved for use in children. Talk with the doctor.


Aplenzin extended-release tablets is used for:

Treating depression. It is also used to prevent autumn-winter seasonal depression in patients with seasonal affective disorder (SAD). It may also be used for other conditions as determined by your doctor.

Aplenzin extended-release tablets is 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 seizures (eg, epilepsy) or have a condition that increases the risk of seizures (eg, certain blood vessel problems in the brain, severe head injury, a tumor or infection in the brain or spinal cord, stroke)
  • you have a history of an eating disorder (eg, anorexia, bulimia)
  • you are suddenly stopping the use of alcohol, barbiturates (eg, phenobarbital), benzodiazepines (eg, alprazolam), sedatives (medicines that make you sleepy), or seizure medicines after long-term use
  • you are taking linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken one of these medicines within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: 10 Common Symptoms That Should Never Be Ignored

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 or dependence
  • if you have diabetes, low blood sugar levels, low blood sodium levels, low blood oxygen levels, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), or increased eye pressure or glaucoma, or have had a recent heart attack
  • if you have a history of a head injury, a tumor or infection in the brain or spinal cord, blood vessel problems, stroke, or liver problems (eg, cirrhosis)
  • if you drink alcohol
  • if you are taking weight loss medicines or stimulants
  • if you are taking a medicine that contains methylene blue

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:

  • Antipsychotics (eg, haloperidol, risperidone), corticosteroids (eg, prednisone), insulin or oral medicines to treat diabetes (eg, glipizide), theophylline, tiagabine, tricyclic antidepressants (eg, amitriptyline), or other medicine that contains bupropion because the risk of seizures may be increased
  • Nicotine replacement therapy (eg, nicotine patches) because the risk of high blood pressure may be increased
  • Amantadine, clopidogrel, fluvoxamine, levodopa, linezolid, MAOIs (eg, phenelzine), nelfinavir, or ticlopidine because they may increase the risk of Aplenzin extended-release tablets's side effects
  • Carbamazepine, efavirenz, lopinavir, phenobarbital, phenytoin, rifamycins (eg, rifampin), or ritonavir because they may decrease Aplenzin extended-release tablets's effectiveness
  • Antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), tricyclic antidepressants (eg, nortriptyline), or venlafaxine because the risk of their side effects may be increased by Aplenzin extended-release tablets
  • Tamoxifen because its effectiveness may be decreased by Aplenzin extended-release tablets, which may lead to an increased risk of breast cancer recurrence in women with a history of breast cancer

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, divide, or chew before swallowing. If you cannot swallow Aplenzin extended-release tablets whole, contact your doctor.
  • Several weeks may pass before your symptoms get better. Do not stop taking Aplenzin extended-release tablets without checking with your doctor.
  • Take your doses at the same time each day, about 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 have SAD and you are taking Aplenzin extended-release tablets to prevent episodes of seasonal depression, it is important to keep taking Aplenzin extended-release tablets through the autumn-winter season, unless your doctor tells you otherwise.
  • 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.
  • Do not drink alcohol while you are taking Aplenzin extended-release tablets.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using 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 use a lot 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 take barbiturates (eg, phenobarbital), benzodiazepines (eg, alprazolam), sedatives (medicines that make you sleepy), or seizure medicines, 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.
  • Some people may be at risk for eye problems from Aplenzin extended-release tablets. Your doctor may want you to have an eye exam to see if you are at risk for these eye problems. Call your doctor right away if you have eye pain, vision changes, or swelling or redness in or around the eye.
  • Aplenzin extended-release tablets may increase blood pressure. Your doctor will monitor your blood pressure while you are taking Aplenzin extended-release tablets.
  • You may notice the tablet shell in your stool. This is normal and not a cause for concern.
  • Other brands of medicine that contain the same ingredient as Aplenzin extended-release tablets (bupropion) are available. These other brands may be used to help stop smoking or to treat depression. Do not take Aplenzin extended-release tablets if you are taking any other medicine that contains bupropion. Discuss any questions or concerns with your doctor.
  • Aplenzin extended-release tablets may interfere with certain lab tests, including urine screenings for amphetamines. Be sure your doctor and lab personnel know you are taking Aplenzin extended-release tablets.
  • 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 is 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:

Changes in appetite; constipation; dizziness; drowsiness; dry mouth; flushing; gas; headache; increased sweating; increased urination; mild sore throat; mild stomach pain; muscle pain; nausea; nervousness; ringing in the ears; 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; unusual hoarseness); chest pain; confusion; dark urine; delusions; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; hearing problems; menstrual changes; new or worsening mental, mood, or behavior changes (eg, depression, concentration problems, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being or inability to sit still); pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent 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; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Proper storage of Aplenzin extended-release tablets:

Store Aplenzin extended-release tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tight, light-resistant container. 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.

General information:

  • 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 is 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Aplenzin extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aplenzin extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aplenzin extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Aplenzin extended-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web1)