Drug Class: Miscellaneous antidepressants
Usual Adult Dose for Major Depressive Disorder
Initial dose: 1 tablet orally once a day in the morning for 3 days
Maintenance dose: 1 tablet orally twice a day
Comments:
- Maintenance doses should be administered at least 8 hours apart.
- The maintenance dose should not be exceeded.
Use: For the treatment of major depressive disorder
Renal Dose Adjustments
Moderate renal dysfunction (estimated GFR 30 to 59 mL/min/1.73 m2): 1 tablet orally once a day in the morning
Severe renal dysfunction (estimated GFR 15 to 29 mL/min/1.73 m2): Not recommended
Comments:
- The pharmacokinetics have not been evaluated in patients with severe renal dysfunction.
Liver Dose Adjustments
Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended
Severe liver dysfunction (Child-Pugh C): Not recommended
Comments:
- The pharmacokinetics have not been evaluated in patients with severe liver dysfunction.
Dose Adjustments
Coadministration with strong CYP450 2D6 inhibitors: 1 tablet orally once a day in the morning
Known CYP450 2D6 poor metabolizers: 1 tablet orally once a day in the morning
Switching to or from a monoamine oxidase inhibitor (MAOI) antidepressant:
- At least 14 days must elapse between discontinuing an MAOI intended to treat depression and starting this drug.
- At least 14 days must be allowed after stopping this drug before starting an MAOI antidepressant.
Precautions
US BOXED WARNING:
- SUICIDAL THOUGHTS AND BEHAVIORS: In short-term studies, antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients; all antidepressant-treated patients should be closely monitored for clinical worsening and emergence of suicidal thoughts and behaviors. This drug is not approved for use in pediatric patients.
CONTRAINDICATIONS:
- Seizure disorder
- Current/prior diagnosis of bulimia or anorexia nervosa (a higher incidence of seizure was seen in such patients treated with immediate-release bupropion)
- Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
- Taking, or within 14 days of stopping, MAOIs (due to risk of serious and possibly fatal drug interactions [including hypertensive crisis, serotonin syndrome])
- Starting this drug in a patient treated with reversible MAOIs (e.g., linezolid, IV methylene blue)
- Known hypersensitivity to either active component or to any of the ingredients
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Before and during therapy:
- assess blood pressure and monitor periodically during therapy.
- screen patients for personal/family history of bipolar disorder, mania, or hypomania.
- screen patients to determine if they are receiving any other agents that contain bupropion or dextromethorphan.
- Do not exceed 2 doses within the same day.
- Administer orally with or without food.
- Swallow tablets whole; do not crush, divide, or chew.
Storage requirements:
- Store in original bottle at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
General:
- Each extended-release tablet contains bupropion hydrochloride 105 mg and dextromethorphan hydrobromide 45 mg.
- Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported with bupropion; arthralgia, myalgia, fever with rash, and other serum sickness-like symptoms suggestive of delayed hypersensitivity have also been reported with bupropion.
Monitoring:
- Cardiovascular: Blood pressure (before and periodically during therapy)
- Psychiatric: For clinical worsening and emergence of suicidal thoughts and behaviors in all patients; for changes in behavior; for neuropsychiatric reactions
Patient advice:
- Read the US FDA-approved patient labeling (Medication Guide).
- Watch for the emergence of suicidal ideation and behavior, especially early during therapy and when the dose is adjusted up or down; report these symptoms to the health care provider.
- Seek immediate medical attention if symptoms suggestive of hypersensitivity (e.g., skin rash, pruritus, hives, chest pain, edema, shortness of breath, arthralgia, myalgia, fever) occur after taking this drug.
- Minimize or avoid use of alcohol during therapy.
- Use this drug as directed and discontinue (and do not restart) this drug if a seizure occurs during therapy.
- Watch for signs of activation of mania/hypomania; report these symptoms to the health care provider.
- Notify health care provider if changes in mood including delusions, hallucinations, psychosis, concentration disturbances, paranoia, and confusion occur.
- This drug may cause dizziness; take precautions to reduce the risk of falls, especially if you have motor impairment affecting gait or history of falls. Use caution operating hazardous machinery (including motor vehicles) until you know how you will be affected by this drug.
- Contact health care provider or report to the emergency room if you have signs/symptoms of serotonin syndrome.
- Notify health care provider if you become pregnant or intend to become pregnant during therapy; there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to this drug during pregnancy.
- Do not breastfeed during therapy and for 5 days after the last dose.
- Do not take more than 2 tablets in the same day and allow at least 8 hours between doses.
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