Brand Name

    US Brand Name

    Aplenzin

    Budeprion SR

    Budeprion XL

    Buproban

    Forfivo XL

    Wellbutrin

    Wellbutrin SR

    Wellbutrin XL

    Zyban


    Description

    Bupropion is used to treat major depressive disorder (MDD) and to prevent seasonal affective disorder (SAD), which is sometimes called autumn-winter seasonal depression. It is also used as part of a support program to help people stop smoking.

    Bupropion is sold under different brand names. If you are already taking medicine for 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 at a time for bupropion.

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

    This product is available in the following dosage forms:

    • Tablet, Extended Release, 24 HR
    • Tablet, Extended Release, 12 HR
    • Tablet
    • Tablet, Extended Release

    Before Using

    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. Safety and efficacy have not been established.

    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 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.

    Breastfeeding

    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.

    Drug Interactions

    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.

    • Bromopride
    • Isocarboxazid
    • Linezolid
    • Methylene Blue
    • Ozanimod
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Safinamide
    • Selegiline
    • 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.

    • Acetophenazine
    • Aclidinium
    • Acrivastine
    • Acyclovir
    • Alcaftadine
    • Alfentanil
    • Amantadine
    • Ambenonium
    • Amdinocillin
    • Amiloride
    • Amineptine
    • Aminophylline
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amphetamine
    • Amphotericin B
    • Ampicillin
    • Anisotropine
    • Antazoline
    • Aripiprazole
    • Astemizole
    • Atomoxetine
    • Atovaquone
    • Atropine
    • Azatadine
    • Azelastine
    • Azlocillin
    • Aztreonam
    • Bacampicillin
    • Baclofen
    • Balofloxacin
    • Belladonna Alkaloids
    • Benperidol
    • Benzhydrocodone
    • Benzphetamine
    • Bepotastine
    • Besifloxacin
    • Betamethasone
    • Bornaprine

    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.

    • Aripiprazole Lauroxil
    • Isavuconazonium Sulfate
    • Lofexidine
    • Metoprolol
    • Nirmatrelvir
    • St John's Wort
    • Tipranavir

    Other Interactions

    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 (eg, anorexia, bulimia), history of or
    • Seizures, history of or
    • Seizure medicine use, if stopped suddenly (eg, carbamazepine (Tegretol®), phenobarbital, phenytoin (Dilantin®)), or
    • Sleeping or anxiety medicine use, if stopped suddenly (eg, benzodiazepine)—Should not be used in patients with these conditions.
    • Arteriovenous malformation (circulation problem) or
    • Brain tumor or infection or
    • Diabetes or
    • Drug or alcohol use disorder, history of or
    • Head injury, severe or
    • Hypoglycemia (low blood sugar) or
    • Hyponatremia (low sodium in the blood) or
    • Hypoxia (low oxygen in the blood) or
    • Liver disease, severe or
    • Stroke, history of—May increase the risk of seizures.
    • Bipolar disorder (type of depression), or risk of or
    • Glaucoma, angle closure or
    • Hypertension (high blood pressure) or
    • Mania or hypomania (type of mental disease), history of or
    • Psychosis (type of mental disease) or
    • Schizophrenia (type of mental disease)—Use with caution. May make these conditions worse.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    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 extended-release tablet, sustained-release tablet, and tablet whole. Do not cut, crush, or chew it.

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

    A part of the extended-release tablet may pass into your stool. This is normal and is nothing to worry about.

    Use of Zyban® tablets:

    • You may continue to smoke for about 1 week after you start the medicine.
    • Set a target date to quit smoking during your second week of treatment.
    • If you are still having trouble with quitting after using the medicine for at least 7 weeks, talk to your doctor.
    • If you use a nicotine product (eg, patch) together with Zyban®, do not smoke. Smoking may increase the chance for serious side effects.

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

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

    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 adjust your dose as needed. 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 adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • For seasonal affective disorder:
        • Adults—
          • Aplenzin®: At first, 174 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 522 mg per day.
          • Wellbutrin XL®: At first, 150 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg once a day.
        • 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) 2 times a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg 2 times per day, taken at least 8 hours apart.
        • Children—Use and dose must be determined by your doctor.
      • To quit smoking:
        • Adults—At first, 150 milligrams (mg) once a day for the first 3 days. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
        • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • For depression:
        • Adults—At first, 100 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg 3 times per day, taken at least 6 hours apart.
        • 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 Wellbutrin XL® extended-release tablet 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

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

    Do not take bupropion with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking bupropion during the 2 weeks after you stop a MAO inhibitor. Wait for 2 weeks after stopping bupropion before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may have confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

    Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with bupropion may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

    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 your 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.

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

    This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain.

    Serious skin reactions (eg, Stevens-Johnson syndrome) 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 a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

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

    This medicine may cause some people to have a false sense of wellbeing, 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 drowsy, dizzy, or less alert.

    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 certain side effects when you stop the medicine, such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headaches, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness.

    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.

    Check with your doctor right away if blurred vision, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

    This medicine may cause a change in your appetite or weight. Your doctor may need to check your weight on a regular basis.

    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.


    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
    • body aches or pain
    • chills
    • cough
    • dry mouth
    • ear congestion
    • fever
    • hyperventilation
    • irregular heartbeats
    • irritability
    • loss of voice
    • restlessness
    • shaking
    • sneezing
    • sore throat
    • stuffy or runny nose
    • trouble breathing
    • trouble sleeping
    • unusual tiredness or weakness

    Less common

    • Bladder pain
    • bloody or cloudy urine
    • blurred vision
    • buzzing or ringing in the ears
    • difficult, burning, or painful urination
    • dizziness
    • frequent urge to urinate
    • headache (severe)
    • lower back or side pain
    • nervousness
    • pounding in the ears
    • skin rash, hives, or itching
    • slow or fast heartbeat

    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
    • trouble concentrating

    Incidence not known

    • Actions that are out of control
    • anger
    • assaulting or attacking others
    • being aggressive or impulsive
    • bigger, dilated, or enlarged pupils
    • black, tarry stools
    • bleeding gums
    • blistering, peeling, or loosening of the skin
    • bloating or swelling of the face, arms, hands, lower legs, or feet
    • bluish color
    • change in vision
    • changes in skin color
    • chest pain or discomfort
    • coma
    • constipation
    • cool, pale skin
    • dark urine
    • diarrhea
    • fast or pounding heartbeat
    • force
    • inability to sit still
    • increased hunger
    • increased sensitivity of the eyes to light
    • indigestion
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • light-colored stools
    • loss of appetite
    • nausea
    • need to keep moving
    • nightmares
    • pain or discomfort in the arms, jaw, back, or neck
    • pains in stomach, side, or abdomen, possibly radiating to the back
    • pinpoint red spots on the skin
    • rapid weight gain
    • red irritated eyes
    • red skin lesions, often with a purple center
    • shakiness
    • slurred speech
    • sores, ulcers, or white spots in the mouth or on the lips
    • sweating
    • swelling of the foot or leg
    • swollen glands
    • talking, feeling, or acting with excitement
    • tingling of the hands or feet
    • unusual bleeding or bruising
    • unusual weight gain or loss
    • upper right abdominal or stomach pain
    • vomiting
    • vomiting of blood or material that looks like coffee grounds
    • yellow eyes or skin

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

    Symptoms of overdose

    • Blue lips, fingernails, or skin
    • change in or loss of consciousness
    • confusion
    • decreased awareness or responsiveness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • muscle cramps or spasms
    • severe sleepiness

    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

    • Decrease in appetite
    • stomach pain
    • trembling

    Less common

    • Change in sense of taste
    • drowsiness
    • unusual feeling of well-being

    Incidence not known

    • Changes in menstrual flow or amount
    • deafness
    • decreased interest in sexual intercourse
    • hot flashes
    • increased hair growth, especially on the face
    • inability to have or keep an erection
    • irritation in the mouth
    • loss in sexual ability, desire, drive, or performance
    • loss or thinning of the hair
    • mouth ulcers
    • night sweats
    • swelling of the breasts or breast soreness in both females and males
    • swelling or inflammation of the mouth

    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.






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