Dextromethorphan and bupropion (Oral route)

Pronunciation:

dex-troe-meth-OR-fan hye-droe-BROE-mide, bue-PROE-pee-on hye-droe-KLOR-ide

Brand Names:

Auvelity

Dosage Forms:

Tablet, Extended Release

Warnings:

Oral route(Tablet, Extended Release)

Warning: Suicidal Thoughts and BehaviorsAntidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors. Dextromethorphan hydrobromide/buPROPion hydrochloride is not approved for use in pediatric patients .

Classifications:

Therapeutic—

Antidepressant

Chemical—

Bupropion

Uses of This Medicine:

Dextromethorphan and bupropion combination is used to treat major depressive disorder (MDD).

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dextromethorphan and bupropion combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dextromethorphan and bupropion combination in the elderly.

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.

Other 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
Clorgyline
Eliglustat
Furazolidone
Iproniazid
Isocarboxazid
Linezolid
Methylene Blue
Moclobemide
Nialamide
Ozanimod
Pargyline
Phenelzine
Procarbazine
Rasagiline
Safinamide
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.

Acetophenazine
Aclidinium
Acrivastine
Acyclovir
Adagrasib
Alcaftadine
Alfentanil
Almotriptan
Amantadine
Ambenonium
Amdinocillin
Amdinocillin Pivoxil
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
Brexpiprazole
Bromodiphenhydramine
Bromperidol
Brompheniramine
Buclizine
Budesonide
Bupivacaine
Buprenorphine
Bupropion
Buspirone
Busulfan
Butorphanol
Butriptyline
Butylscopolamine
Carbamazepine
Carbenicillin
Carbimazole
Carbinoxamine
Carvedilol
Celecoxib
Chlorambucil
Chloroquine
Chlorotrianisene
Chlorpheniramine
Chlorphenoxamine
Chlorpromazine
Chlorprothixene
Cimetidine
Cimetropium
Cinnarizine
Ciprofloxacin
Citalopram
Clemastine
Clemizole
Clidinium
Clobetasone
Clomipramine
Clopidogrel
Clothiapine
Clovoxamine
Cloxacillin
Clozapine
Cocaine
Codeine
Conjugated Estrogens
Corticotropin
Cortisone
Cosyntropin
Cyclacillin
Cyclizine
Cyclobenzaprine
Cyclopentolate
Cyclosporine
Cyproheptadine
Dabrafenib
Dalfampridine
Danazol
Darifenacin
Deflazacort
Delavirdine
Demecarium
Desipramine
Desonide
Desvenlafaxine
Deutetrabenazine
Dexamethasone
Dexbrompheniramine
Dexchlorpheniramine
Dextroamphetamine
Dextromethorphan
Dibenzepin
Dicloxacillin
Dicyclomine
Dienestrol
Diethylstilbestrol
Difenoxin
Dihydroartemisinin
Dihydrocodeine
Dimenhydrinate
Dimethindene
Diphenhydramine
Diphenoxylate
Diphenylpyraline
Distigmine
Dixyrazine
Dolasetron
Donepezil
Dopamine
Dothiepin
Doxepin
Doxofylline
Doxorubicin
Doxorubicin Hydrochloride Liposome
Doxylamine
Droperidol
Duloxetine
Ebastine
Echothiophate
Edrophonium
Efavirenz
Eletriptan
Emedastine
Enflurane
Enoxacin
Epinastine
Escitalopram
Esterified Estrogens
Estradiol
Estramustine
Estriol
Estrone
Estropipate
Ethinyl Estradiol
Ethopropazine
Ethylmorphine
Etomidate
Famotidine
Fedratinib
Femoxetine
Fenfluramine
Fentanyl
Fesoterodine
Fexinidazole
Flavoxate
Flecainide
Floxacillin
Fludrocortisone
Flumequine
Flunarizine
Flunisolide
Fluoxetine
Fluphenazine
Fluticasone
Fluvoxamine
Foscarnet
Fosphenytoin
Frovatriptan
Galantamine
Ganciclovir
Gatifloxacin
Gepirone
Givosiran
Glycopyrrolate
Granisetron
Guanidine
Halofantrine
Haloperidol
Hetacillin
Homatropine
Hydrocodone
Hydrocortisone
Hydromorphone
Hydroxyamphetamine
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ifosfamide
Imipenem
Imipramine
Indalpine
Iobenguane I 123
Iobenguane I 131
Iprindole
Isoflurane
Isoflurophate
Isoniazid
Isopropamide
Ketamine
Ketobemidone
Ketotifen
Lasmiditan
Lemborexant
Levocabastine
Levodopa
Levofloxacin
Levomilnacipran
Levorphanol
Lidocaine
Lindane
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lomefloxacin
Lopinavir
Lorcaserin
Loxapine
Maprotiline
Mebeverine
Mebhydrolin
Meclizine
Mefenamic Acid
Mefloquine
Melitracen
Melperone
Memantine
Mepenzolate
Meperidine
Meropenem
Mesoridazine
Mestranol
Metaxalone
Metformin
Methadone
Methamphetamine
Methantheline
Methdilazine
Methenolone
Methicillin
Methimazole
Methixene
Methotrimeprazine
Methylene Blue
Methylphenidate
Methylprednisolone
Methyltestosterone
Metoclopramide
Metopimazine
Metronidazole
Mexiletine
Mezlocillin
Midostaurin
Milnacipran
Mirtazapine
Mizolastine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nadifloxacin
Nafcillin
Nalbuphine
Nalidixic Acid
Nandrolone
Naratriptan
Nebivolol
Nefazodone
Neostigmine
Nevirapine
Niaprazine
Nicomorphine
Norfloxacin
Nortriptyline
Ofloxacin
Olanzapine
Oliceridine
Olopatadine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Oxacillin
Oxaliplatin
Oxandrolone
Oxatomide
Oxybutynin
Oxycodone
Oxymetholone
Oxymorphone
Palonosetron
Panobinostat
Papaveretum
Paramethasone
Paregoric
Paroxetine
Pazufloxacin
Pefloxacin
Penicillin G
Penicillin V
Pentazocine
Perazine
Periciazine
Perphenazine
Phenindamine
Pheniramine
Phenobarbital
Phenylpropanolamine
Phenyltoloxamine
Phenytoin
Physostigmine
Pimozide
Pinaverium
Pindolol
Pipamperone
Piperacillin
Piperaquine
Pipotiazine
Pirenzepine
Piritramide
Pitolisant
Pivampicillin
Pizotyline
Polyestradiol Phosphate
Prednisolone
Prednisone
Procainamide
Procaine
Prochlorperazine
Proguanil
Promazine
Promestriene
Promethazine
Propafenone
Propantheline
Propicillin
Propiverine
Propizepine
Propofol
Propoxyphene
Propranolol
Protriptyline
Prulifloxacin
Pyrilamine
Quetiapine
Quinacrine
Quinestrol
Ranitidine
Remifentanil
Rifampin
Rimexolone
Risperidone
Ritonavir
Rivastigmine
Rizatriptan
Rolapitant
Rufloxacin
Safinamide
Scopolamine
Sertraline
Sevoflurane
Sibutramine
Solifenacin
Sparfloxacin
Sparsentan
Stanozolol
St John's Wort
Sufentanil
Sulbenicillin
Sultamicillin
Sumatriptan
Tacrine
Tapentadol
Temocillin
Terfenadine
Testosterone
Theophylline
Thiethylperazine
Thiopropazate
Thioproperazine
Thioridazine
Thiotepa
Thiothixene
Thonzylamine
Tianeptine
Tibolone
Ticarcillin
Ticlopidine
Tilidine
Timiperone
Timolol
Tolterodine
Tramadol
Trazodone
Trifluoperazine
Triflupromazine
Trimeprazine
Trimipramine
Tripelennamine
Triprolidine
Tropicamide
Trospium
Tryptophan
Umeclidinium
Valbenazine
Valethamate
Varenicline
Venlafaxine
Vilazodone
Vortioxetine
Zidovudine
Ziprasidone
Zuclopenthixol

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.

Abiraterone Acetate
Aripiprazole Lauroxil
Digoxin
Haloperidol
Isavuconazonium Sulfate
Lofexidine
Metoprolol
Nirmatrelvir
Quinidine
St John's Wort
Terbinafine
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 or
Seizure medicine use, if stopped suddenly, or
Sleeping or anxiety medicine use, if stopped suddenly—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 or
Stroke, severe—May increase risk for seizures.

Bipolar disorder (mood disorder with mania and depression), or risk of or
Falls, history of or
Glaucoma, angle closure or
Heart attack or
Heart problems or
High blood pressure or
Kidney disease, moderate or
Mania or hypomania, history of or
Problems with movement or walking or
Psychosis—Use with caution. May make these conditions worse.

Kidney disease, severe or
Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

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. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

You may take this medicine with or without food.

Swallow the extended-release tablet whole. Do not crush, divide, or chew it.

Do not drink alcohol while you are using this medicine. Talk with your doctor before suddenly stopping drinking alcohol.

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—At first, one tablet once a day in the morning for 3 days. Your doctor may increase your dose to one tablet 2 times a day at least 8 hours apart. However, the dose is usually not more than 2 tablets per day. Each tablet contains 45 milligrams (mg) dextromethorphan and 105 mg bupropion.
  - 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.

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 This Medicine:

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. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause some teenagers and young adults 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. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness. These may be symptoms of seizures.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

This medicine may make you dizzy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

This medicine may cause a condition called serotonin syndrome when used together with certain MAO inhibitors (eg, phenelzine, rasagiline, tranylcypromine) and medicines to treat depression (eg, amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft®). Check with your doctor right away if you have anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there.

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 of This Medicine:

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:

Less common: Fear, nervousness

Incidence not known: Absence of or decrease in body movement; attack, assault, force; bigger, dilated, or enlarged pupils (black part of the eye); bleeding gums; blistering, peeling, or loosening of the skin; bloating; bloody, black, tarry stools; bloody or cloudy urine; bluish color; blurred vision; burning, tingling, numbness or pain in the hands, arms, feet, or legs; change in vision; changes in patterns and rhythms of speech; changes in skin color; chest pain or tightness; chills; cold sweats; coma; confusion; confusion as to time, place, or person; cool, pale skin; cough; cracks in the skin; dark urine; deafness; decrease in frequency of urination; decreased urine output; depression; diarrhea; difficult, burning, or painful urination; difficulty in passing urine (dribbling); difficulty in swallowing; dizziness; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; drowsiness; dry mouth; extra heartbeats; eye pain; fainting; false or unusual sense of well-being; feeling, seeing, or hearing things that are not there; feeling that others can hear your thoughts; feeling that others are watching you or controlling your behavior; fever; flushed, dry skin; frequent urge to urinate; fruit-like breath odor; hallucinations; headache; heartburn; holding false beliefs that cannot be changed by fact; inability to move the eyes; increased blinking or spasms of the eyelid; increased hunger; increased in sexual ability, desire, drive, or performance; increased interest in sexual intercourse; increased sensitivity of the eyes to light; increased thirst; increased urination; indigestion; irritability; itching; itching of the vagina or genital area; joint or muscle pain; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; lip smacking or puckering; loss of appetite; loss of bladder control; loss of heat from the body; loss of vision; muscle cramps, spasms, pain, stiffness, tightness, or weakness; nausea; nerve pain; nightmares; pain during sexual intercourse; pain or burning in the throat; pains in the stomach, side, or abdomen, possibly radiating to the back; pounding, slow heartbeat; pounding in the ears; problems with speech or speaking; puffing of cheeks; rapid or worm-like movements of tongue; red, swollen, or scaly skin; red irritated eyes; red skin lesions, often with a purple center; restlessness; seizures; sensation of pins and needles; severe mood or mental changes; shakiness; slurred speech; sore throat; sores, ulcers, or white spots on the lips or tongue or inside the mouth; stabbing pain; sticking out of the tongue; stomach cramps, tenderness, pain, or burning; sugar in the urine; sweating; swelling of the breasts or breast soreness in both females and males; swelling of the face, ankles, or hands; swelling of the foot or leg; swollen, painful, or tender lymph glands in the neck, armpit, or groin; swollen glands; tenderness; tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area; thick, white vaginal discharge with no odor or with a mild odor; thoughts of killing oneself changes in behavior; trouble breathing; trouble sleeping; trouble speaking; twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs; uncontrolled chewing movements; uncontrolled twisting movements of the neck, trunk, arms, or legs; unexplained weight loss; unusual behavior; unusual bleeding or bruising; unusual excitement, nervousness, or restlessness; unusual facial expressions; unusual tiredness or weakness; upper right abdominal or stomach pain; vomiting; vomiting of blood or material that looks like coffee grounds; watery or bloody diarrhea; yellow eyes and skin

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

Symptoms of overdose: Agitation; blurred vision; coma; confusion; dark-colored urine; decreased awareness or responsiveness; diarrhea; difficult or trouble breathing; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fast, pounding, or irregular heartbeat or pulse; fever; hyperexcitability; inability to move the eyes; increased blinking or spasms of the eyelid; irregular, fast or slow, or shallow breathing; loss of consciousness; mental depression or anxiety; muscle cramps, spasms, pain, stiffness, or tightness; nausea; nightmares or unusually vivid dreams; overactive reflexes; pale or blue lips, fingernails, or skin; poor coordination; seeing, hearing, or feeling things that are not there; seizures; severe sleepiness; shakiness and unsteady walk; shivering; sticking out of the tongue; sweating; talking or acting with excitement you cannot control; trembling or shaking; twitching; uncontrolled twisting movements of the neck, trunk, arms, or legs; unsteadiness, trembling, or other problems with muscle control or coordination; unusual facial expressions; 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: Increased sweating

Less common: Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; constipation

Incidence not known: Feeling of discomfort; inflammation of the joints; loss or thinning of the hair; muscle aches

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.

Last Updated: 4/24/2024

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