Bupropion/Naltrexone

DEA Class;  Rx

Common Brand Names; Contrave

Uncontrolled hypertension

Seizure disorder or a history of seizures

Use of other bupropion-containing products

Bulimia or anorexia nervosa, which may increase risk of seizures

Long-term opioid or opiate agonists use or acute opiate withdrawal

Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs

Within 14 days of monoamine oxidase inhibitor therapy

Hypersensitivity

Pregnancy

• Nausea (32.5%)
• Constipation (19.2%)
• Headache (17.6%)
• Vomiting (10.7%)
• Dizziness (9.9%)
• Insomnia (9.2%)
• Dry mouth (8.1%)
• Diarrhea (7.1%)
• Anxiety (4.2%)
• Hot flash (4.2%)
• Fatigue (4%)
• Tremor (4%)
• Upper abdominal pain (3.5%)
• Viral gastroenteritis (3.5%)
• Influenza (3.4%)
• Tinnitus (3.3%)
• Urinary tract infection (3.3%)
• Hypertension (3.2%)
• Abdominal pain (2.8%)
• Hyperhidrosis (2.6%)
• Irritability (2.6%)
• Increased blood pressure (2.4%)
• Dysgeusia (2.4%)
• Rash (2.4%)
• Muscle strain (2.2%)
• Palpitations (2.1%)
• Tachycardia
• Myocardial infarction
• Vertigo
• Motion sickness
• Lower abdominal pain
• Eructation
• Lip swelling
• Hematochezia
• Hernia
• Feeling jittery
• Thirst
• Feeling hot
• Asthenia
• Cholecystitis
• Pneumonia
• Staphylococcal infection
• Kidney infection
• Increased creatinine clearance
• Increased hepatic enzymes
• Decreased hematocrit

Monitor patients for suicidal ideation or behavior and for unusual changes in behavior (see black box warning)

Discontinue therapy and do not restart if seizure occurs while on therapy; use caution when prescribing to patients with predisposing risk factors for seizures

Not for administration to patients receiving long-term opioids, owing to naltrexone component (opioid antagonist); discontinue therapy if long-term opiate therapy required

Following therapy, patients may be more sensitive to opioids, even at lower doses

A patient should not attempt to overcome naltrexone opioid blockade by administering large amounts of exogenous opioids; may lead to fatal overdose

Opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before therapy is initiated; opioid-free interval of a minimum of 7-10 days is recommended for patients previously dependent on short-acting opioids; patients transitioning from buprenorphine or methadone may need as long as 2 weeks

Blood pressure and pulse should be measured prior to starting therapy and should be monitored at regular intervals, particularly among patients with controlled hypertension prior to treatment

Discontinue therapy if symptoms or signs of acute hepatitis occur

Screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder; therapy was not studied in patients receiving antidepressant medications patients with a history of bipolar disorder or recent hospitalization foor psychiatric illness were excluded from clinical trials

Angle-closure attack may occur in patients with anatomically narrow angles that do not have a patent iridectomy

Measure blood glucose levels prior to and during therapy; patients who develop hypoglycemia after initiating Contrave therapy should adjust antidiabetic drug regimen

Use caution in patients with history of tumor or infection of the brain or spine

Initiation of therapy in patients receiving linezolid or intravenous (IV) methylene blue

Use caution in hepatic impairment

May precipitate a manic, mixed, or hypomanic episode; risk higher in patients with bipolar disorders or have risk factors for bipolar disorder, including family history of bipolar disorder, suicide, or depression; not FDA approved for bipolar depression

Weight loss offers no benefit to a pregnant patient and may cause fetal harm; when a pregnancy is recognized, advise pregnant patient of risk to fetus

Data from published literature report the presence of bupropion and its metabolites in human milk