TURQOZ
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TURQOZ (TURQOZ).
TURQOZ is a selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the central nervous system by inhibiting the reuptake of serotonin at the synaptic cleft, leading to increased serotonin levels.
| Metabolism | Primarily hepatic via CYP2C19, CYP2D6, and CYP3A4; forms active metabolite norfluoxetine. Inhibits CYP2D6. |
| Excretion | Primarily renal (80% unchanged) with 10% fecal, 5% biliary, 5% other |
| Half-life | Terminal half-life 12-15 hours; prolonged in renal impairment (up to 30 hours) requiring dose adjustment |
| Protein binding | 85-90% bound primarily to albumin |
| Volume of Distribution | 0.5-0.7 L/kg; moderate tissue distribution |
| Bioavailability | Oral: 60-70% (first-pass effect); IV: 100% |
| Onset of Action | Oral: 1-2 hours; IV: 5-10 minutes |
| Duration of Action | Oral: 8-12 hours; IV: 6-8 hours; duration extended in hepatic impairment |
400 mg orally once daily.
| Dosage form | TABLET |
| Renal impairment | GFR ≥30 mL/min: no adjustment; GFR 15-29 mL/min: 200 mg once daily; GFR <15 mL/min: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 200 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Not approved for pediatric use. |
| Geriatric use | No specific adjustment; monitor renal function due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TURQOZ (TURQOZ).
| Breastfeeding | Excretion into human milk is unknown. Due to potential for serious adverse reactions in nursing infants, breastfeeding is not recommended during therapy and for 2 weeks after the last dose. M/P ratio not established. |
| Teratogenic Risk | TURQOZ is contraindicated in pregnancy. First trimester: high risk of major congenital malformations including CNS, cardiovascular, and musculoskeletal defects. Second/third trimester: increased risk of preterm labor, intrauterine growth restriction, and fetal demise. Advise effective contraception during treatment and for 1 month after final dose. |
■ 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. Close monitoring is required during initial treatment and dose adjustments.
| Serious Effects |
Concomitant use with MAOIs (including linezolid and methylene blue), use of pimozide, thioridazine, or other drugs that prolong QTc interval, hypersensitivity to TURQOZ or any component, and use within 14 days of MAOI therapy.
| Precautions | Serotonin syndrome, bleeding risk, activation of mania/hypomania, seizures, angle-closure glaucoma, hyponatremia, sexual dysfunction, withdrawal syndrome upon discontinuation, and potential for QT prolongation at high doses. |
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| Fetal Monitoring | Monitor maternal blood pressure, renal function, hepatic function, and complete blood count monthly. Fetal ultrasound every 4-6 weeks to assess growth and anatomy. Nonstress test or biophysical profile weekly in third trimester if continued use. |
| Fertility Effects | TURQOZ may impair fertility in females based on animal studies showing ovarian toxicity and altered estrous cycles. In males, reduced sperm count and motility observed in animal models. Reversal of effects after discontinuation is unknown. |