Auvelity (Dextromethorphan/Buproprion)
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Fact Table
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| Formula | Dextromethorphan hydrobromide / Bupropion hydrochloride |
| License | FDA approved (August?2022) for major depressive disorder (MDD) in adults |
| Bioavailability | Dextromethorphan ~ high when CYP2D6 inhibited; bupropion not fully specified |
| Legal status | Prescription only (Rx) |
| Chemical Name | (Dextromethorphan) morphinan,?3-methoxy-17-methyl-, hydrobromide monohydrate; (Bupropion) (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride |
| Elimination half-life | Approximately 22?hours for dextromethorphan when combined; ~15?hours for bupropion base |
| Dosage (Strength) | Each tablet: 45?mg dextromethorphan hydrobromide (˜?32.98?mg base) + 105?mg bupropion hydrochloride (˜?91.14?mg base); initial dosing once daily for 3?days then twice daily. |
| Pregnancy | Use only if clearly needed; limited data available |
| Brands | Auvelity® (by Axsome Therapeutics) |
| Protein binding | Not fully specified for combination form |
| PubChem CID | Dextromethorphan base: 5360696; Bupropion base: 444 |
| MedlinePlus | a622070 |
| ChEBI | Dextromethorphan:?4470; Bupropion:?3219 |
| ATC code | N06AX62 (combination) |
| DrugBank | Not separately listed for comb.; Bupropion: DB01156 |
| KEGG | D12493 (combination) |
| Routes of administration | By mouth (oral extended-release tablet) |
Auvelity is an oral, extended-release prescription medication that combines dextromethorphan hydrobromide and bupropion hydrochloride for the treatment of major depressive disorder (MDD) in adults. It is the first and only FDA-approved rapid-acting oral antidepressant that targets the glutamatergic system via NMDA receptor antagonism, offering a novel mechanism compared to traditional monoaminergic antidepressants.
Dextromethorphan acts as an NMDA receptor antagonist and sigma-1 receptor agonist, while bupropion serves both as a norepinephrine-dopamine reuptake inhibitor (NDRI) and a metabolic inhibitor that increases the bioavailability of dextromethorphan. The dual mechanism aims to provide faster symptom relief and address treatment-resistant depression in appropriate patients.
Directions
Auvelity is administered orally, once daily for the first three days, followed by twice-daily dosing thereafter. The typical titration schedule begins with one tablet in the morning on Days 1 to 3, then increased to one tablet in the morning and one in the evening starting on Day 4.
Tablets should be swallowed whole and not crushed, chewed, or divided. Auvelity can be taken with or without food. Dose modifications may be required for patients who are CYP2D6 poor metabolizers or those taking strong CYP2D6 inhibitors. The use of monoamine oxidase inhibitors (MAOIs) must be avoided, and at least 14 days should elapse between stopping an MAOI and starting Auvelity.
Ingredients
Each Auvelity extended-release tablet contains 45 mg of dextromethorphan hydrobromide and 105 mg of bupropion hydrochloride as active ingredients. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, hypromellose, magnesium stearate, and other pharmaceutical excipients required for extended-release functionality and tablet integrity.
Cautions
Caution is advised when prescribing Auvelity to individuals with underlying psychiatric conditions, cardiovascular disease, hepatic impairment, or a history of substance abuse. As bupropion lowers the seizure threshold, care must be taken in dose selection and patient screening. The drug carries a boxed warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults; although Auvelity is not approved for use in pediatric populations, monitoring is essential in all treated individuals.
Drug interactions involving CYP2D6 substrates and inhibitors should be evaluated before initiating therapy. Patients should be counseled regarding the risk of hypertension, insomnia, and neuropsychiatric symptoms.
Contraindications
Auvelity is contraindicated in patients with a seizure disorder, current or prior diagnosis of bulimia or anorexia nervosa, or those undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs. It must not be used concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation. Additionally, it is contraindicated in patients with known hypersensitivity to bupropion, dextromethorphan, or any of the product's components.
Side Effects
Common and serious side effects associated with Auvelity include:
- Dizziness
- Headache
- Diarrhea
- Somnolence
- Dry mouth
- Sexual dysfunction
- Increased blood pressure
- Anxiety
- Insomnia
- Nausea
Rare but serious adverse effects may include seizures, hypertensive crisis, and serotonin syndrome when combined with other serotonergic agents.
Frequently Asked Questions about Auvelity (Dextromethorphan-Bupropion)
What is Auvelity used for?
Auvelity is a prescription medication used to treat major depressive disorder (MDD) in adults. It is the first oral antidepressant with a rapid-acting effect approved by the FDA that works on both NMDA and monoamine pathways.
How does Auvelity work?
Auvelity combines dextromethorphan, which modulates glutamate activity through NMDA receptor antagonism, with bupropion, which enhances norepinephrine and dopamine activity and slows dextromethorphan metabolism to maintain its levels in the brain.
How is Auvelity taken?
Auvelity is taken orally, typically once daily for the first 3 days, then increased to twice daily thereafter. It should be swallowed whole with or without food and should not be crushed, chewed, or divided.
How quickly does Auvelity start working?
Some patients report improvement in depressive symptoms within one week, although full therapeutic effects may take several weeks. It may act faster than traditional antidepressants due to its dual mechanism.
What are common side effects of Auvelity?
Common side effects include dizziness, headache, dry mouth, insomnia, anxiety, and increased blood pressure. Some people may also experience gastrointestinal upset or restlessness.
Can Auvelity cause serious side effects?
Yes, serious risks include seizures (especially at higher doses), increased risk of suicidal thoughts or behaviors, and potential for elevated blood pressure. It may also cause manic episodes in people with bipolar disorder.
Who should not take Auvelity?
Auvelity is not recommended for people with seizure disorders, a history of eating disorders, uncontrolled hypertension, or those taking monoamine oxidase inhibitors (MAOIs) or other medications containing bupropion.
Are there any drug interactions with Auvelity?
Yes, Auvelity can interact with MAOIs, SSRIs, antipsychotics, and drugs that lower seizure threshold. It also interacts with alcohol and medications affecting CYP2D6 metabolism. Inform your doctor of all medications you take.
What should I do if I miss a dose of Auvelity?
If you miss a dose, skip it and take your next dose at the regular time. Do not take two doses at once to make up for the missed dose, as this may increase the risk of seizures or side effects.
Is Auvelity addictive or a controlled substance?
Auvelity is not classified as a controlled substance and is not considered habit-forming. However, it should be used only as prescribed and monitored for any signs of misuse, especially due to its dextromethorphan component.
