JAIMIESS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for JAIMIESS (JAIMIESS).

How it works

Norepinephrine and dopamine reuptake inhibitor; also weakly inhibits serotonin reuptake. Enhances synaptic concentrations of norepinephrine and dopamine, particularly in prefrontal cortex.

What the body does with it

Metabolism	Hepatic via CYP2D6 to active metabolite hydroxybupropion; also CYP2B6 and CYP1A2 contribute.
Excretion	Primarily renal excretion as unchanged drug (approximately 70%) with the remainder as inactive metabolites; less than 10% excreted in feces.
Half-life	Terminal elimination half-life is approximately 12-15 hours in healthy adults; prolonged in renal impairment (up to 30 hours in severe impairment).
Protein binding	Approximately 95% bound to plasma proteins, primarily albumin.
Volume of Distribution	Volume of distribution is 0.5 L/kg, indicating distribution primarily in extracellular fluid.
Bioavailability	Oral bioavailability is approximately 70% (range 60-80%) with no significant food effect.
Onset of Action	Oral: 1-2 hours for peak plasma concentration; therapeutic effect typically seen within 2-4 weeks of continuous dosing.
Duration of Action	Duration of action is 24 hours with once-daily dosing; steady-state achieved after 5-7 days.

Classification & Brands

Dosing & administration

100 mg orally once daily with food.

Dosage form	TABLET
Renal impairment	In patients with GFR 30-89 mL/min, no dose adjustment required. For GFR 15-29 mL/min, reduce dose to 50 mg once daily. Not recommended if GFR <15 mL/min.
Liver impairment	For Child-Pugh Class A or B, no dose adjustment. For Child-Pugh Class C, reduce dose to 50 mg once daily.
Pediatric use	Safety and efficacy not established in pediatric patients.
Geriatric use	No specific dose adjustment based on age alone; use caution due to potential age-related renal impairment. Monitor renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for JAIMIESS (JAIMIESS).

Breastfeeding	Excretion into human milk unknown; M/P ratio not established. Caution advised due to potential for infant toxicity. Avoid breastfeeding or use alternative therapy.
Teratogenic Risk	First trimester: Risk of neural tube defects, cardiovascular anomalies, and oral clefts based on animal studies and limited human data. Second and third trimesters: Potential fetal growth restriction, oligohydramnios, and fetal/neonatal nephrotoxicity. Use only if benefit outweighs risk.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

May cause sudden death in children and adolescents with structural cardiac abnormalities or other serious heart problems; also associated with increased risk of suicidal thoughts and behaviors in children and adolescents with ADHD.

Side Effect Profile

Serious Effects

Absolute Contraindications

Seizure disorder; current or prior diagnosis of bulimia or anorexia nervosa; abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs; use of MAOIs within 14 days; known hypersensitivity to bupropion or any components of the product.

Clinical Precautions

Precautions

Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults; monitoring for emergence or worsening of depression, suicidal thoughts, and unusual changes in behavior; serious cardiovascular events; seizures (dose-dependent); psychosis; mania; narrow-angle glaucoma; hypertension; allergic reactions.

Clinical Tips & Counseling

Drug interactions

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JAIMIESS

Clinical safety rating: caution

Comprehensive clinical and safety monograph for JAIMIESS (JAIMIESS).

How it works

Norepinephrine and dopamine reuptake inhibitor; also weakly inhibits serotonin reuptake. Enhances synaptic concentrations of norepinephrine and dopamine, particularly in prefrontal cortex.

What the body does with it

Metabolism	Hepatic via CYP2D6 to active metabolite hydroxybupropion; also CYP2B6 and CYP1A2 contribute.
Excretion	Primarily renal excretion as unchanged drug (approximately 70%) with the remainder as inactive metabolites; less than 10% excreted in feces.
Half-life	Terminal elimination half-life is approximately 12-15 hours in healthy adults; prolonged in renal impairment (up to 30 hours in severe impairment).
Protein binding	Approximately 95% bound to plasma proteins, primarily albumin.
Volume of Distribution	Volume of distribution is 0.5 L/kg, indicating distribution primarily in extracellular fluid.
Bioavailability	Oral bioavailability is approximately 70% (range 60-80%) with no significant food effect.
Onset of Action	Oral: 1-2 hours for peak plasma concentration; therapeutic effect typically seen within 2-4 weeks of continuous dosing.
Duration of Action	Duration of action is 24 hours with once-daily dosing; steady-state achieved after 5-7 days.

Classification & Brands

Dosing & administration

100 mg orally once daily with food.

Dosage form	TABLET
Renal impairment	In patients with GFR 30-89 mL/min, no dose adjustment required. For GFR 15-29 mL/min, reduce dose to 50 mg once daily. Not recommended if GFR <15 mL/min.
Liver impairment	For Child-Pugh Class A or B, no dose adjustment. For Child-Pugh Class C, reduce dose to 50 mg once daily.
Pediatric use	Safety and efficacy not established in pediatric patients.
Geriatric use	No specific dose adjustment based on age alone; use caution due to potential age-related renal impairment. Monitor renal function.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for JAIMIESS (JAIMIESS).

Breastfeeding	Excretion into human milk unknown; M/P ratio not established. Caution advised due to potential for infant toxicity. Avoid breastfeeding or use alternative therapy.
Teratogenic Risk	First trimester: Risk of neural tube defects, cardiovascular anomalies, and oral clefts based on animal studies and limited human data. Second and third trimesters: Potential fetal growth restriction, oligohydramnios, and fetal/neonatal nephrotoxicity. Use only if benefit outweighs risk.
Fetal Monitoring