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. |
| Molecular Weight | 347.45 |
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 | No human data; animal studies show no teratogenicity. Use only if benefit outweighs risk. |
| 2nd trimester | Limited data; no known fetal harm. Monitor fetal growth if used. |
| 3rd trimester | Potential risk of preterm labor or uterine hyperstimulation if used near term. Avoid after 37 weeks. |
Clinical note
Comprehensive clinical and safety monograph for VIZZ (VIZZ).
| Placental transfer | Crosses placenta; animal studies show fetal plasma levels 10% of maternal. |
| Breastfeeding | Excreted into breast milk in low concentrations. No adverse effects reported in infants. Consider risk-benefit for premature or ill infants. |
| Lactation Rating |
■ 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 |
Hypersensitivity to VIZZ or any excipientActive vaginal bleeding of unknown etiologySevere renal impairment (CrCl <30 mL/min)
| Precautions | May cause suicidal thoughts; risk of serotonin syndrome; may increase bleeding risk; caution with concomitant use of MAOIs; possible hyponatremia. |
| Food/Dietary | Food does not affect the absorption of VIZZ. No specific dietary restrictions, but avoid grapefruit and grapefruit juice as they may increase anticoagulant effect. |
Loading safety data…
| L2 (Limited data - probably compatible) |
| 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). |
| 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. |
| Clinical Pearls |
| VIZZ is a direct-acting oral anticoagulant. Monitor renal function prior to initiation and periodically, as dose adjustment is required in severe renal impairment (CrCl <30 mL/min). Avoid use in patients with mechanical heart valves. Reversal agent: andexanet alfa for life-threatening bleeding. |
| Patient Advice | Take VIZZ exactly as prescribed, at the same time each day. · Do not skip doses; if a dose is missed, take it as soon as remembered on the same day, but do not double the next dose. · Avoid aspirin, NSAIDs, and other blood thinners unless directed by your doctor. · Seek immediate medical attention for signs of bleeding: unusual bruising, red or dark urine, black or bloody stools, coughing up blood, or prolonged bleeding from cuts. · Inform all healthcare providers that you are taking VIZZ before any surgery or dental procedure. |