General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Auvelity
DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE
1 INDICATIONS AND USAGE AUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated wit...
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Brand names:AUVELITY
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE
- Medicine class
- General Medicine
- Brand names
- AUVELITY
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of dextromethorphan was increased approximately 3-fold to 22 hours, as compared to dextrom
- FDA approved
- Yes
What Is Auvelity?
1 INDICATIONS AND USAGE AUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated wit...
Auvelity (DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Auvelity. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Auvelity with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Auvelity is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE AUVELITY is a combination of dextromethorphan, an uncompetitive N -methyl D -aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, and bupropion, an aminoketone and CYP450 2D6 inhibitor, indicated for the treatment of major depressive disorder (MDD) in adults ( 1.1 ) the treatment of agitation associated with dementia due to Alzheimer’s disease ( 1.2 ) Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease (1.2).
1.1 Major Depressive Disorder AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.
1.2 Agitation Associated with Dementia Due to Alzheimer’s Disease AUVELITY is indicated for the treatment of agitation associated with dementia due to Alzheimer’s disease.
Limitations of Use: AUVELITY is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease [see Clinical Studies Section 14.2 ].
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with AUVELITY: assess blood pressure; screen patients for history of bipolar disorder, mania, or hypomania; and determine if patients are receiving any other medications that contain bupropion or dextromethorphan. ( 2.1 ) For MDD, the starting dosage is AUVELITY 45 mg/105 mg once daily in the morning. On day 4, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours. Do not exceed two doses within the same day. ( 2.2 ) For agitation associated with dementia due to Alzheimer’s disease, the starting dosage is AUVELITY 30 mg/105 mg once daily in the morning. On day 8, increase to AUVELITY 30 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. On day 15, increase to the maximum recommended dosage of AUVELITY 45 mg/105 mg twice daily, separated by at least 8 hours, based on tolerability. Do not exceed two doses within the same day. ( 2.3 ) Swallow tablets
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )] Seizure [see Warnings and Precautions ( 5.2 )] Increased Blood Pressure and Hypertension [see Warnings and Precautions ( 5.3 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )] Psychosis and Other Neuropsychiatric Reactions [see Warnings and Precautions ( 5.5 )] Angle-closure Glaucoma [see Warnings and Precautions ( 5.6 )] Dizziness [see Warnings and Precautions ( 5.7 )] Serotonin Syndrome [see Warnings and Precautions ( 5.8 )] Embryo-fetal Toxicity [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] MDD: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, and hyperhidrosis.
- (6.1) Agitation associated with dementia due to Alzheimer’s disease: Most common adverse reactions (≥5% and more than twice as frequently as placebo): dizziness and dyspepsia.
- (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
- AUVELITY has been evaluated for safety in 2,550 adult patients who participated in multiple-dose clinical trials for major depressive disorder, agitation associated with dementia due to Alzheimers disease, or another indication.
- Among them, 918 patients were treated with AUVELITY for at least 6 months, and 251 patients were treated with AUVELITY for at least 1 year.
- Major Depressive Disorder The data below are based on the 6-week, placebo-controlled study in which either AUVELITY (n=162) or placebo (n=164) was administered twice daily to patients with MDD (Study 1).
Serious
- 5 WARNINGS AND PRECAUTIONS Seizure: Risk is dose-related.
- Discontinue if seizure occurs.
- ( 4 , 5.2 ) Increased Blood Pressure and Hypertension: AUVELITY can increase blood pressure and cause hypertension.
- Assess blood pressure before initiating treatment and monitor periodically during treatment.
- ( 5.3 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS Seizure: Risk is dose-related. Discontinue if seizure occurs. ( 4 , 5.2 ) Increased Blood Pressure and Hypertension: AUVELITY can increase blood pressure and cause hypertension. Assess blood pressure before initiating treatment and monitor periodically during treatment. ( 5.3 ) Activation of Mania or Hypomania: Screen patients for bipolar disorder. ( 5.4 ) Psychosis and
How Auvelity Works
12.1 Mechanism of Action Dextromethorphan is an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of dextromethorphan in the treatment of MDD and agitation associated with dementia due to Alzheimer’s disease is unclear. Bupropion increases plasma levels of dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for dextromethorphan. The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.
Pharmacokinetics
Absorption
Absorption The median T max of dextromethorphan and bupropion when given as AUVELITY was 3 hours and 2 hours, respectively
Half-Life
half-life of dextromethorphan was increased approximately 3-fold to 22 hours, as compared to dextrom
Metabolism
metabolism of dextromethorphan via CYP2D6
Excretion
Excretion In CYP2D6 extensive metabolizers, approximately 37-52% of the orally administered dose of dextromethorphan is recovered in the urine
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Auvelitywhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Adult, pediatric, renal, and hepatic dosing for Auvelity
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Auvelity side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Auvelity
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.