SERPIVITE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SERPIVITE (SERPIVITE).

How it works

Selective serotonin reuptake inhibitor (SSRI); increases serotonin levels in the synaptic cleft by blocking reuptake via SERT inhibition.

What the body does with it

Metabolism	Hepatic via CYP2D6, CYP2C9, CYP3A4, and CYP2C19; major active metabolite: norfluoxetine.
Excretion	Renal excretion unchanged 70%, biliary/fecal 25%, metabolic clearance 5%
Half-life	Terminal elimination half-life 12 hours; prolonged to 24-36 hours in severe renal impairment (CrCl <30 mL/min)
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein
Volume of Distribution	Vd 0.25 L/kg (0.18-0.33 L/kg); indicates predominantly extracellular distribution
Bioavailability	Oral: 75% (range 60-85%); food decreases bioavailability by 20%
Onset of Action	Oral: 30-60 minutes; IV: immediate (within 5 minutes)
Duration of Action	Oral: 8-12 hours; IV: 6-8 hours; duration depends on renal function

Classification & Brands

Dosing & administration

1.5 mg/kg IV every 12 hours; maximum single dose 120 mg.

Dosage form	TABLET
Renal impairment	GFR >= 60 mL/min: no adjustment. GFR 30-59 mL/min: 1.2 mg/kg IV every 12 hours. GFR 15-29 mL/min: 0.8 mg/kg IV every 12 hours. GFR < 15 mL/min: 0.5 mg/kg IV every 12 hours.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: 1.2 mg/kg IV every 12 hours. Child-Pugh C: 0.9 mg/kg IV every 12 hours.
Pediatric use	2 mg/kg IV every 12 hours for children 1-12 years; maximum single dose 100 mg. For infants 1-12 months: 2.5 mg/kg every 12 hours.
Geriatric use	Start at lowest adult dose; consider 1.2 mg/kg IV every 12 hours if CrCl >= 60 mL/min. Monitor renal function closely; reduce dose per renal adjustment if CrCl < 60 mL/min.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SERPIVITE (SERPIVITE).

Breastfeeding	Contraindicated in breastfeeding. M/P ratio not established; potential for infant toxicity due to accumulation in breast milk.
Teratogenic Risk	FDA Pregnancy Category X. First trimester: High risk of neural tube defects, cardiac anomalies, and cleft palate due to folate antagonism. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and premature closure of ductus arteriosus. Avoid in pregnancy.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of MAOI therapy; known hypersensitivity to fluoxetine; use with pimozide or thioridazine due to QT prolongation risk.

Clinical Precautions

Precautions

Serotonin syndrome; bleeding risk; activation of mania/hypomania; hyponatremia; QT prolongation; weight loss in children; sexual dysfunction; withdrawal reactions; drug interactions with MAOIs, other serotonergics.

Clinical Tips & Counseling

Drug interactions

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SERPIVITE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SERPIVITE (SERPIVITE).

How it works

Selective serotonin reuptake inhibitor (SSRI); increases serotonin levels in the synaptic cleft by blocking reuptake via SERT inhibition.

What the body does with it

Metabolism	Hepatic via CYP2D6, CYP2C9, CYP3A4, and CYP2C19; major active metabolite: norfluoxetine.
Excretion	Renal excretion unchanged 70%, biliary/fecal 25%, metabolic clearance 5%
Half-life	Terminal elimination half-life 12 hours; prolonged to 24-36 hours in severe renal impairment (CrCl <30 mL/min)
Protein binding	98% bound to albumin and alpha-1-acid glycoprotein
Volume of Distribution	Vd 0.25 L/kg (0.18-0.33 L/kg); indicates predominantly extracellular distribution
Bioavailability	Oral: 75% (range 60-85%); food decreases bioavailability by 20%
Onset of Action	Oral: 30-60 minutes; IV: immediate (within 5 minutes)
Duration of Action	Oral: 8-12 hours; IV: 6-8 hours; duration depends on renal function

Classification & Brands

Dosing & administration

1.5 mg/kg IV every 12 hours; maximum single dose 120 mg.

Dosage form	TABLET
Renal impairment	GFR >= 60 mL/min: no adjustment. GFR 30-59 mL/min: 1.2 mg/kg IV every 12 hours. GFR 15-29 mL/min: 0.8 mg/kg IV every 12 hours. GFR < 15 mL/min: 0.5 mg/kg IV every 12 hours.
Liver impairment	Child-Pugh A: no adjustment. Child-Pugh B: 1.2 mg/kg IV every 12 hours. Child-Pugh C: 0.9 mg/kg IV every 12 hours.
Pediatric use	2 mg/kg IV every 12 hours for children 1-12 years; maximum single dose 100 mg. For infants 1-12 months: 2.5 mg/kg every 12 hours.
Geriatric use	Start at lowest adult dose; consider 1.2 mg/kg IV every 12 hours if CrCl >= 60 mL/min. Monitor renal function closely; reduce dose per renal adjustment if CrCl < 60 mL/min.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for SERPIVITE (SERPIVITE).

Breastfeeding	Contraindicated in breastfeeding. M/P ratio not established; potential for infant toxicity due to accumulation in breast milk.
Teratogenic Risk	FDA Pregnancy Category X. First trimester: High risk of neural tube defects, cardiac anomalies, and cleft palate due to folate antagonism. Second and third trimesters: Risk of fetal growth restriction, oligohydramnios, and premature closure of ductus arteriosus. Avoid in pregnancy.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders.

Side Effect Profile

Serious Effects

Absolute Contraindications

Concurrent use with MAOIs or within 14 days of MAOI therapy; known hypersensitivity to fluoxetine; use with pimozide or thioridazine due to QT prolongation risk.