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Bupropion hydrochloride XL

Class
Antidepressants
Subclass
Norepinephrine-dopamine reuptake inhibitors
Substance name
buPROPion XL
Brand names
Forfivo XL®, Wellbutrin XL®
Common formulations
Film-coated tablet, Tablet
See also
Bupropion hydrochloride
Bupropion hydrochloride SR (Wellbutrin SR®, Zyban®)
Bupropion hydrobromide ER (Aplenzin®)
Contained in
Naltrexone / bupropion XR (Contrave ER®)
Dosage and administration
Adults patients
Major depressive disorder
•
Start at: 150 mg PO qAM for 4 days
•
Maintenance: 300 mg PO qAM
Seasonal affective disorder
•
Start at: 150 mg PO qAM for 7 days
•
Maintenance: 300 mg PO qAM
Individualize treatment duration based on the patient's historical pattern of seasonal MDD episodes. Reduce to 150 mg daily when discontinuing.
ADHD • Off-label
•
Start at: 150 mg PO qAM for > 1 week
•
Maintenance: 300 mg PO qAM for 3 weeks
•
Maximum: 450 mg per day
Other off-label uses
•
Treatment of anxiety
Indications for use
Labeled indications
Adults
•
Treatment of major depressive disorder
•
Treatment of seasonal affective disorder
Off-label indications
Adults
•
Treatment of anxiety
•
Treatment of ADHD
Safety risks
Boxed warnings
Suicidal ideation
•
Use extreme caution in patients with major depressive disorder or other psychiatric disorders, particularly in children and young adults. Monitor closely for suicidality and unusual changes in behavior.
Contraindications
Hypersensitivity to bupropion or its components
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
Concomitant use of MAOIs
•
Do not use bupropion with or within 14 days of stopping MAOIs, including reversible MAOIs, such as linezolid and methylene blue.
Warnings and precautions
Acute angle-closure glaucoma
•
Use caution in patients with untreated anatomically narrow angles.
Hypertension
•
Maintain a high level of suspicion, as bupropion has been associated with an increased risk of hypertension, especially when used with drugs increasing dopaminergic or noradrenergic activity. Assess BP before initiating treatment and monitor periodically during treatment.
Manic or mixed episodes
•
Use caution in patients with bipolar disorder or risk factors for bipolar disorder, such as family history of bipolar disorder, depression, or suicidal thoughts. Screen patients for a personal or family history of bipolar disorder, mania, or hypomania before initiating bupropion.
Psychosis, neuropsychiatric adverse events
•
Maintain a high level of suspicion, as bupropion has been associated with an increased risk of neuropsychiatric adverse events, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion.
Seizure
•
Use extreme caution in patients with metabolic disorders or using illicit drugs, misusing prescription medications, or receiving medications lowering the seizure threshold, as well as conditions that increasing the risk of seizure, such as severe head injury, AVM, CNS tumor or infection, or severe stroke. Discontinue if seizures occur.
Specific populations
Renal impairment
GFR 0-90 mL/min
•
Reduce dose. Can also consider reducing dose frequency. Maximum dose of 150 mg/day.
Renal replacement therapy
Intermittent hemodialysis
•
Use with caution. Reduce dose. Maximal dose of 150 mg. Maximal frequency of daily. Titrate slowly.
Peritoneal dialysis
•
Use with caution. Reduce dose. Maximal dose of 150 mg. Maximal frequency of daily. Titrate slowly.
Hepatic impairment
Child-Pugh A (mild)
•
Reduce dose. Monitor serum aminotransferases.
Child-Pugh B (moderate)
•
Reduce dose. Monitor serum aminotransferases. Maximum dose of 150 mg every other day.
Child-Pugh C (severe)
•
Reduce dose. Maximal dose of 150 mg every other day. Monitor serum aminotransferases.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B2
•
Use only if benefits outweigh potential risks. Consider safer alternatives. Evidence of fetal harm in animals. Enroll patients in a dedicated pregnancy outcome monitoring registry. A pregnancy exposure registry is available. Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization. Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g.,. respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).
Breastfeeding
Consider alternative agents that may be safer.
•
Use with caution during breastfeeding. A decision should be made to discontinue nursing or discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother.
Very low levels in breastfed infants (< 5%).
May potentially cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Agitation, hyperhidrosis, lethargy, migraine, pharyngitis, anorexia, blurred vision, constipation, dry mouth, headache, insomnia, nausea, vomiting, weight gain, weight loss, rhinitis, tachycardia, tremor
Common 1-10%
•
Acne vulgaris, ataxia, drug-induced parkinsonism, dysarthria, dystonia, ecchymosis, gingivitis, glossitis, gynecomastia, hyperkinesia, hypertension, hypertonia, hypotension, ↑ liver enzymes, influenza, jaundice, myoclonus, nasopharyngitis, oral ulcers, orthostatic hypotension, peripheral edema, photosensitivity of skin, psychosis, abdominal pain, acid reflux, akathisia, anejaculation, anxiety, arthralgia, asthenia, back pain, bruxism, chest pain, chills, confusion, cough, dental pain, diarrhea, diplopia, dizziness, dysgeusia, dysmenorrhea, dyspareunia, dyspepsia, dysphagia, dyspnea, emotional lability, euphoria, fatigue, fever, flatulence, hair loss, hallucinations, hostility, hot flashes, hypersalivation, impotence, ↑ appetite, ↑ libido, irritability, itching, mania, memory impairment, menstrual irregularity, muscle cramps, myalgia, nasal congestion, nightmares, nocturia, nosebleed, palpitations, paranoid ideation, paresthesia, polydipsia, polyuria, restlessness, skin flushing, skin rash, somnolence, suicidal ideation, syncope, tinnitus, urinary retention, urinary urgency, vaginal bleeding, vaginal irritation, vertigo, sinusitis, skin dryness, stomatitis, testicular swelling, urticaria, xerophthalmia
Uncommon < 1%
•
Acute cystitis, aphasia, bronchospasm, coma, gastrointestinal perforation, hirsutism, maculopapular rash, myocardial infarction, neuropathic pain, pallor, phlebitis, body odor, hair discoloration, malaise, memory impairment, seizure, stroke
Unknown frequency
•
AV block, acute generalized exanthematous pustulosis, acute pancreatitis, anaphylactoid reactions, anaphylaxis, angioedema, DRESS syndrome, ↓ blood glucose, ↓ platelet count, ↓ serum sodium, erythema multiforme, esophagitis, exfoliative dermatitis, gastrointestinal bleeding, hearing loss, ↑ WBC count, ↑ blood glucose, ↑ intraocular pressure, ↑ urine glucose, lymphadenopathy, myasthenia gravis, mydriasis, pulmonary embolism, pancytopenia, akinesia, depression, urinary incontinence, rhabdomyolysis, syndrome of inappropriate antidiuretic hormone secretion, serum sickness, Stevens-Johnson syndrome, tardive dyskinesia
Interactions
Drug(s)
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