VIZZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIZZ (VIZZ).
Selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the CNS by inhibiting the reuptake of serotonin at the presynaptic neuronal membrane.
| Metabolism | Primarily hepatic via CYP2D6; active metabolite; undergoes glucuronide conjugation. |
| Excretion | Primarily hepatic metabolism with renal excretion of metabolites. Approximately 60% of a dose is excreted in urine as metabolites, 30% in feces, and <5% unchanged. |
| Half-life | Terminal elimination half-life is 18-24 hours. Steady-state is reached within 4-5 days; accumulation may occur in renal impairment. |
| Protein binding | 99% bound to plasma albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd is 2.5 L/kg, indicating extensive tissue distribution and accumulation in extravascular spaces. |
| Bioavailability | Oral bioavailability is 45% due to first-pass metabolism. Bioavailability via intramuscular route is 90%. |
| Onset of Action | Oral: 2-3 hours; peak effect at 6-8 hours. |
| Duration of Action | Duration of action is 12-24 hours based on dose. Clinical effects persist beyond serum levels due to tissue binding. |
80 mg orally once daily
| Dosage form | SOLUTION/DROPS |
| Renal impairment | GFR ≥60 mL/min: no adjustment; GFR 30-59 mL/min: 40 mg once daily; GFR <30 mL/min: not recommended |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 40 mg once daily; Child-Pugh C: not recommended |
| Pediatric use | 1-2 mg/kg orally once daily, maximum 80 mg/day |
| Geriatric use | Initiate at 40 mg orally once daily; titrate based on renal function and tolerability |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIZZ (VIZZ).
| Breastfeeding | VIZZ is excreted in human milk (M/P ratio 1.2). Peak milk concentration occurs 2 hours after maternal dose. Relative infant dose is 10% of maternal weight-adjusted dose. Monitor infant for sedation, poor feeding. Use with caution; consider alternative if infant is premature or has impaired hepatic function. |
| Teratogenic Risk | First trimester: Based on animal studies, VIZZ showed increased risk of structural anomalies (neural tube defects, cardiac malformations) at clinically relevant doses. Second and third trimesters: Risk of fetal growth restriction and oligohydramnios. Human data insufficient; avoid use in pregnancy unless benefit outweighs risk. Placental transfer occurs (F/M ratio 0.8). |
■ FDA Black Box Warning
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS - Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies.
| Serious Effects |
Concomitant use with MAOIs or within 14 days of MAOI discontinuation; known hypersensitivity to drug or any component.
| Precautions | May cause suicidal thoughts; risk of serotonin syndrome; may increase bleeding risk; caution with concomitant use of MAOIs; possible hyponatremia. |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and renal function. In pregnancy, perform serial ultrasound for fetal growth, amniotic fluid index, and ductus arteriosus patency. Nonstress test or biophysical profile for fetal well-being after 28 weeks. Note: VIZZ may cause fetal bradycardia. |
| Fertility Effects | VIZZ has been associated with reversible decreases in sperm motility and count in male human studies; returns to baseline within 3 months of discontinuation. In females, menstrual cycle irregularities and anovulation observed in preclinical models; human data limited. May reduce fertility in both sexes during treatment. |