Wellbutrin XL

Name: Wellbutrin XL

Other uses for this medicine

Bupropion is also sometimes used to treat episodes of depression in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) and to treat attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

  • ADHD Medication for Children
  • ADHD Medications for Adults
  • Depression
  • Oral Cancer
  • Prescription Anxiety Medications
  • Smoking (How to Quit Smoking)

Inform MD

Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems.

Tell your doctor about your other medical conditions including if you:

  • are pregnant or plan to become pregnant. It is not known if bupropion can harm your unborn baby.
  • are breastfeeding. Bupropion passes through your milk. It is not known if bupropion 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 doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are using bupropion.

Forms of Medication

 Buproprion is available in three different types of tablets.

  1. Buproprion tablet which is available in both 75mg and 150mg strengths.  This tablet may be taken every eight hours or up to three times a day.
  2. Buproprion SR (Sustained Release) is available as a 100mg, 150mg, and 200mg tablet. The Sustained Release coating allows for this medication to be taken every twelve hours or twice a day.
  3. Buproprion XL (Extended Release) is available as a 150mg, 300mg, and 450mg tablet. The Extended Release coating on allows for this medication to taken once every twenty four hours or once a day. The 450mg is available only as a brand name medication called Forfivo XL.

Before Using Wellbutrin XL

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. However, children are more sensitive to the effects of this medicine than adults when used for treating depression. Use of bupropion to treat depression in children is not recommended. Safety and efficacy of bupropion to help stop smoking have not been established in children.

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.

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.

  • Bromopride
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • 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
  • Alcaftadine
  • Amantadine
  • Ambenonium
  • Amdinocillin
  • Amdinocillin Pivoxil
  • Amiloride
  • Amineptine
  • Aminophylline
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amphetamine
  • Ampicillin
  • Anisotropine
  • Antazoline
  • Aripiprazole
  • Astemizole
  • Atomoxetine
  • Atropine
  • Azatadine
  • Azelastine
  • Azlocillin
  • Bacampicillin
  • Belladonna Alkaloids
  • Benperidol
  • Benzphetamine
  • Bepotastine
  • Betamethasone
  • Brexpiprazole
  • Bromodiphenhydramine
  • Bromperidol
  • Brompheniramine
  • Buclizine
  • Budesonide
  • Bupivacaine
  • Butriptyline
  • Butylscopolamine
  • Carbamazepine
  • Carbenicillin
  • Carbimazole
  • Carbinoxamine
  • Carvedilol
  • Chlorambucil
  • Chlorotrianisene
  • Chlorpheniramine
  • Chlorphenoxamine
  • Cimetidine
  • Cimetropium
  • Cinnarizine
  • Citalopram
  • Clemastine
  • Clemizole
  • Clidinium
  • Clobetasone
  • Clomipramine
  • Clopidogrel
  • Cloxacillin
  • Clozapine
  • Codeine
  • Conjugated Estrogens
  • Corticotropin
  • Cortisone
  • Cosyntropin
  • Cyclacillin
  • Cyclizine
  • Cyclosporine
  • Cyproheptadine
  • Danazol
  • Darifenacin
  • Deflazacort
  • Delavirdine
  • Demecarium
  • Desipramine
  • Desonide
  • Desvenlafaxine
  • Deutetrabenazine
  • Dexamethasone
  • Dexbrompheniramine
  • Dexchlorpheniramine
  • Dextroamphetamine
  • Dextromethorphan
  • Dibenzepin
  • Dicloxacillin
  • Dicyclomine
  • Dienestrol
  • Diethylstilbestrol
  • Dimenhydrinate
  • Diphenhydramine
  • Diphenylpyraline
  • Distigmine
  • Donepezil
  • Dopamine
  • Dothiepin
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Doxylamine
  • Droperidol
  • Duloxetine
  • Ebastine
  • Echothiophate
  • Edrophonium
  • Efavirenz
  • Eliglustat
  • Emedastine
  • Enflurane
  • Epinastine
  • Escitalopram
  • Esterified Estrogens
  • Estradiol
  • Estramustine
  • Estriol
  • Estrone
  • Estropipate
  • Ethinyl Estradiol
  • Famotidine
  • Fesoterodine
  • Flavoxate
  • Flecainide
  • Floxacillin
  • Fludrocortisone
  • Flunarizine
  • Flunisolide
  • Fluoxetine
  • Fluticasone
  • Fluvoxamine
  • Fosphenytoin
  • Galantamine
  • Glycopyrrolate
  • Guanidine
  • Haloperidol
  • Hetacillin
  • Homatropine
  • Hydrocortisone
  • Hydroxyzine
  • Hyoscyamine
  • Imipramine
  • Indalpine
  • Iobenguane I 123
  • Isoflurophate
  • Isoniazid
  • Isopropamide
  • Ketamine
  • Ketotifen
  • Levocabastine
  • Levodopa
  • Levomilnacipran
  • Lidocaine
  • Lindane
  • Lisdexamfetamine
  • Lofepramine
  • Lopinavir
  • Loxapine
  • Mebeverine
  • Mebhydrolin
  • Meclizine
  • Memantine
  • Mepenzolate
  • Mestranol
  • Metformin
  • Methamphetamine
  • Methantheline
  • Methdilazine
  • Methenolone
  • Methicillin
  • Methimazole
  • Methixene
  • Methylphenidate
  • Methylprednisolone
  • Methyltestosterone
  • Metronidazole
  • Mexiletine
  • Mezlocillin
  • Milnacipran
  • Mizolastine
  • Nafcillin
  • Nalidixic Acid
  • Nandrolone
  • Nebivolol
  • Nefazodone
  • Neostigmine
  • Niaprazine
  • Nortriptyline
  • Olopatadine
  • Ondansetron
  • Opipramol
  • Ospemifene
  • Oxacillin
  • Oxaliplatin
  • Oxandrolone
  • Oxatomide
  • Oxybutynin
  • Oxymetholone
  • Paramethasone
  • Paroxetine
  • Penicillin G
  • Penicillin V
  • Phenindamine
  • Pheniramine
  • Phenobarbital
  • Phenyltoloxamine
  • Phenytoin
  • Physostigmine
  • Pimozide
  • Pinaverium
  • Pindolol
  • Piperacillin
  • Pirenzepine
  • Pivampicillin
  • Pizotyline
  • Polyestradiol Phosphate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Procainamide
  • Procaine
  • Promestriene
  • Promethazine
  • Propafenone
  • Propantheline
  • Propicillin
  • Propiverine
  • Propizepine
  • Propranolol
  • Protriptyline
  • Pyrilamine
  • Quinestrol
  • Ranitidine
  • Regorafenib
  • Rimexolone
  • Risperidone
  • Ritonavir
  • Rivastigmine
  • Scopolamine
  • Sertraline
  • Sibutramine
  • Solifenacin
  • Sorafenib
  • Stanozolol
  • Sultamicillin
  • Tacrine
  • Terfenadine
  • Testosterone
  • Theophylline
  • Thioridazine
  • Thiotepa
  • Thonzylamine
  • Tibolone
  • Ticarcillin
  • Ticlopidine
  • Timiperone
  • Tiotropium
  • Tolterodine
  • Tramadol
  • Trimeprazine
  • Trimipramine
  • Tripelennamine
  • Triprolidine
  • Tropicamide
  • Trospium
  • Umeclidinium
  • Valbenazine
  • Valethamate
  • Varenicline
  • Venlafaxine
  • Vortioxetine

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
  • Digoxin
  • Isavuconazonium Sulfate
  • St John's Wort
  • 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 (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, alprazolam (Xanax®), lorazepam (Ativan®), temazepam (Restoril®), triazolam (Halcion®))—Should not be used in patients with these conditions.
  • Arteriovenous malformation (circulation problem) or
  • Brain tumor or infection or
  • Diabetes or
  • Drug or alcohol abuse 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
  • 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.

What do I need to tell my doctor BEFORE I take Wellbutrin XL?

  • If you have an allergy to bupropion or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have ever had seizures.
  • If you drink a lot of alcohol and you stop drinking all of a sudden.
  • If you use certain other drugs like drugs for seizures or anxiety and you stop using them all of a sudden.
  • If you have ever had an eating problem like anorexia or bulimia.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Wellbutrin XL within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Wellbutrin XL with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for Wellbutrin XL

Major Depressive Disorder

Wellbutrin XL® (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)].

Seasonal Affective Disorder

Wellbutrin XL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).

The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2)].

Dosage Forms and Strengths

Wellbutrin XL Extended-Release Tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with "Wellbutrin XL 150".

Wellbutrin XL Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with "Wellbutrin XL 300".

Contraindications

• Wellbutrin XL is contraindicated in patients with seizure disorder. • Wellbutrin XL is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with Wellbutrin XL [see Warnings and Precautions (5.3)]. • Wellbutrin XL is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3)]. • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with Wellbutrin XL or within 14 days of discontinuing treatment with Wellbutrin XL is contraindicated. There is an increased risk of hypertensive reactions when Wellbutrin XL is used concomitantly with MAOIs. The use of Wellbutrin XL within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting Wellbutrin XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration (2.9), Warnings and Precautions (5.4) and Drug Interactions (7.6)]. • Wellbutrin XL is contraindicated in patients with known hypersensitivity to bupropion or other ingredients of Wellbutrin XL. Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions (5.8)].
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