Aplenzin

Generic Name: bupropion (Oral route)

bue-PROE-pee-on

Oral route(Tablet;Tablet, Extended Release;Tablet, Extended Release, 12 HR;Tablet, Extended Release, 24 HR)

Wellbutrin(R) formulations and Forfivo XL: Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients. Zyban(R): Serious neuropsychiatric events, including depression, suicidal ideation, suicide attempt, and completed suicide, have been reported in patients with and without preexisting psychiatric disease who were taking bupropion for smoking cessation; some experienced worsening of their psychiatric illnesses. All patients should be observed for changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. The patient should stop taking bupropion and contact a healthcare provider immediately if any neuropsychiatric behavior that is not typical for the patient is observed, or if the patient develops suicidal ideation or suicidal behavior. This risk should be weighed against the benefits of its use .

Oral route(Tablet, Extended Release)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Aplenzin


• Budeprion SR


• Budeprion XL


• Buproban


• Wellbutrin


• Wellbutrin SR


• Wellbutrin XL


• Zyban

Available Dosage Forms:

• Tablet, Extended Release, 24 HR


• Tablet, Extended Release, 12 HR


• Tablet


• Tablet, Extended Release

Therapeutic Class: Antidepressant

Chemical Class: Aminoketone

Uses For Aplenzin

Bupropion is used to treat mental depression. It is also used as part of a support program to help people stop smoking. This medicine may also be used to prevent depression in patients with seasonal affective disorder, which is sometimes called winter depression.

Bupropion is sold under different brand names for different uses. If you are already taking medicine for mental depression or to help you stop smoking, discuss this with your doctor before taking bupropion. It is very important that you receive only one prescription for bupropion at a time.

This medicine is available only with your doctor's prescription.

Before Using Aplenzin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bupropion in the pediatric population. Studies with other medicines used for depression have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking these medicines. Because of this toxicity, use in children is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bupropion in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving bupropion.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Methylene Blue


• Metoclopramide


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betamethasone


• Budesonide


• Carbimazole


• Clobetasone


• Corticotropin


• Cortisone


• Cosyntropin


• Danazol


• Deflazacort


• Desonide


• Dexamethasone


• Fludrocortisone


• Flunisolide


• Fluticasone


• Hydrocortisone


• Linezolid


• Methenolone


• Methylprednisolone


• Methyltestosterone


• Nandrolone


• Oxandrolone


• Oxymetholone


• Paramethasone


• Prednisolone


• Prednisone


• Rimexolone


• Stanozolol


• Testosterone


• Theophylline

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine


• Citalopram


• Desipramine


• Efavirenz


• Flecainide


• Fluoxetine


• Haloperidol


• Levodopa


• Lopinavir


• Metoprolol


• Nortriptyline


• Paroxetine


• Propafenone


• Risperidone


• Ritonavir


• Sertraline


• St John's Wort


• Thioridazine


• Tipranavir


• Zolpidem

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol use, if stopped suddenly, or


• Eating disorders (e.g., anorexia nervosa, bulimia nervosa), history of or


• Sedative (sleeping medicine) use, if stopped suddenly (e.g., alprazolam [Xanax®], diazepam [Valium®], triazolam [Restoril®]), or


• Seizures or epilepsy, history of—Should not be used in patients with these conditions.

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Depression, history of or


• Hypertension (high blood pressure) or


• Psychosis (mental disease that affects emotions and behaviors) or


• Schizophrenia (mental illness)—Use with caution. May make these conditions worse.

• Brain or spine tumor or


• Diabetes or


• Drug or alcohol abuse (e.g., opiates, cocaine, stimulants) or


• Head injury, history of or


• Liver disease (including cirrhosis), severe—The risk of seizures may be increased when bupropion is taken by patients with these conditions.

• Heart attack, recent or


• Heart disease, unstable—The effects of bupropion in patients with these conditions are not known.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Mania or hypomania, history of—Use of bupropion may activate these conditions.

Proper Use of bupropion

This section provides information on the proper use of a number of products that contain bupropion. It may not be specific to Aplenzin. Please read with care.

Use bupropion only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so, may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Swallow the sustained-release tablets whole. Do not break, crush, divide, or chew it.

You may take this medicine with or without food. But, if you have nausea, take this medicine with food.

To lessen stomach upset, this medicine may be taken with food, unless your doctor has told you to take it on an empty stomach.

If you are taking Zyban® tablets to help you stop smoking, you may continue to smoke for about 1 week after you start using this medicine. Then, you should set a target date to quit smoking during your second week of Zyban® treatment. Talk to your doctor if you are having trouble to stop smoking after you have used this medicine for at least 7 weeks.

Do not smoke if you are using a nicotine patch or any other medicine containing nicotine together with Zyban® tablets. To do so, may increase risk for more serious side effects.

This medicine must be taken for several weeks, usually 4 weeks, before you start to feel better. You will probably need to keep taking bupropion for several months to help prevent the return of your depression. Your doctor will check your progress at regular visits, especially during the first few weeks that you take this medicine.

If you have trouble with sleeping (insomnia), do not take this medicine too close to bedtime.

For patients taking the extended-release tablet form of this medicine:

• Take doses at least 24 hours apart to decrease the chance of seizures.


• Swallow the tablets whole. Do not crush, break, or chew them.


• While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.


• If you use this medicine to prevent depression in seasonal affective disorder, take it during the autumn season before your symptoms start. Continue using this medicine through the winter season and until early spring.

To help you remember to use your medicine, take it at the same time each day.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  
  • For depression:
    
    • Adults—
      
      • Aplenzin™: At first, 174 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 522 mg per day.
      
      
      • Forfivo XL®: 450 mg once a day.
      
      
      • Wellbutrin XL®: At first, 150 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 450 mg once a day.
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For seasonal affective disorder:
    
    • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 300 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (tablets):
  
  • For depression:
    
    • Adults—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg three times a day. Take doses at least 4 hours apart to decrease the chance of seizures.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (sustained-release tablets):
  
  • For depression:
    
    • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 200 mg two times a day. Take doses at least 8 hours apart to decrease the chance of seizures.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To help you stop smoking:
    
    • Adults—At first, 150 milligrams (mg) once a day for the first 3 days. Then, your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day. Take doses at least 8 hours apart to decrease the chance of seizures.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you are taking the extended-release tablets and you miss a dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Aplenzin

Your doctor will check your progress at regular visits, especially during the first few months that you take this medicine. The amount of bupropion you take may have to be adjusted to meet the needs of your condition and to help avoid unwanted effects.

Do not take bupropion with or within 14 days of taking a drug with monoamine oxidase inhibitor (MAOI) activity (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking bupropion. If you do, you might have convulsions (seizures).

Your blood pressure might get too high while you are using this medicine. This may cause headaches, blurred vision, and other symptoms. You might need to measure your blood pressure at home. If you think your blood pressure is getting too high, call your doctor right away.

Bupropion may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you take this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Drinking alcoholic beverages should be limited or avoided, if possible, while taking bupropion. This will help prevent seizures.

This medicine may cause some people to have a false sense of well-being, or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause changes in your appetite or weight. Your doctor may need to check your weight regularly during treatment with this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Aplenzin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety


• dry mouth


• hyperventilation


• irregular heartbeats


• irritability


• nervousness


• restlessness


• shaking


• shortness of breath


• trouble with sleeping

Less common

• Buzzing or ringing in the ears


• headache (severe)


• skin rash, hives, or itching

Rare

• Confusion


• fainting


• false beliefs that cannot be changed by facts


• having extreme distrust of people


• seeing, hearing, or feeling things that are not there


• seizures (convulsions)


• trouble with concentrating

Incidence not known

• Actions that are out of control


• anger


• assaulting others


• attacking others


• being aggressive


• being impulsive


• chest pain or discomfort


• fast or pounding heartbeat


• force


• inability to sit still


• need to keep moving


• sweating


• talking, feeling, or acting with excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blue lips, fingernails, or skin


• blurred vision


• change in consciousness


• dark-colored urine


• decreased awareness or responsiveness


• difficult or troubled breathing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fever


• irregular, fast or slow, or shallow breathing


• loss of consciousness


• muscle cramps, pain, or spasms


• muscle stiffness or tightness


• nausea


• severe sleepiness


• unusual tiredness or weakness


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• constipation


• decrease in appetite


• dizziness


• increased sweating


• trembling


• weight loss (unusual)

Less common

• Blurred vision


• change in sense of taste


• drowsiness


• frequent need to urinate


• sore throat


• unusual feeling of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Aplenzin side effects (in more detail)

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More Aplenzin resources

• Aplenzin Side Effects (in more detail)
• Aplenzin Use in Pregnancy & Breastfeeding
• Aplenzin Drug Interactions
• Aplenzin Support Group
• 7 Reviews for Aplenzin - Add your own review/rating

• Aplenzin Prescribing Information (FDA)


• Aplenzin Consumer Overview


• Aplenzin Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Budeprion XL Prescribing Information (FDA)


• Bupropion Professional Patient Advice (Wolters Kluwer)


• Bupropion MedFacts Consumer Leaflet (Wolters Kluwer)


• Bupropion Prescribing Information (FDA)


• Bupropion Hydrochloride Monograph (AHFS DI)


• Wellbutrin Prescribing Information (FDA)


• Wellbutrin Consumer Overview


• Wellbutrin SR Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Wellbutrin SR Prescribing Information (FDA)


• Wellbutrin XL Prescribing Information (FDA)


• Wellbutrin XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Zyban Prescribing Information (FDA)


• Zyban Consumer Overview


• Zyban Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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