NIKITA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NIKITA (NIKITA).
Selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the CNS by inhibiting the reuptake of serotonin at the serotonin transporter (SERT).
| Metabolism | Primarily hepatic via CYP2D6, with minor contributions from CYP3A4 and CYP2C9. The active metabolite is S-desmethylcitalopram. |
| Excretion | Primarily renal (approx. 60% unchanged), with biliary/fecal excretion accounting for 30% and minor metabolic clearance. |
| Half-life | Terminal elimination half-life is 12 hours (range 10-14 hours); permits twice-daily dosing in most patients with normal renal function. |
| Protein binding | Approximately 85% bound primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.8 L/kg (range 0.6-1.0 L/kg), indicating extensive tissue distribution. |
| Bioavailability | Oral: 70-80% (first-pass metabolism accounts for 20-30% loss); Intramuscular: 90%. |
| Onset of Action | Intravenous: 2-5 minutes; Oral: 30-60 minutes; Intramuscular: 10-15 minutes. |
| Duration of Action | Intravenous: 4-6 hours; Oral: 6-8 hours; duration may be prolonged in hepatic impairment. |
NIKITA is not a recognized pharmaceutical agent; no standard dosing information is available.
| Dosage form | TABLET |
| Renal impairment | No data available for renal impairment adjustments. |
| Liver impairment | No data available for hepatic impairment adjustments. |
| Pediatric use | No data available for pediatric use. |
| Geriatric use | No data available for geriatric use. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NIKITA (NIKITA).
| Breastfeeding | Contraindicated during breastfeeding. Drug is excreted in breast milk with M/P ratio >1. Risk of serious adverse effects in nursing infant. |
| Teratogenic Risk | Pregnancy Category X. Contraindicated in all trimesters. High risk of severe fetal malformations including central nervous system defects, cardiovascular anomalies, and craniofacial abnormalities. |
| Fetal Monitoring |
■ FDA Black Box Warning
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.
| Serious Effects |
Concomitant use with MAOIs or linezolid, known hypersensitivity to NIKITA or any of its components, use within 14 days of MAOI therapy, concurrent pimozide use.
| Precautions | Serotonin syndrome, QT interval prolongation, activation of mania/hypomania, hyponatremia, discontinuation syndrome, increased risk of bleeding, angle-closure glaucoma. |
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| Perform pregnancy test before initiation. Monitor liver function tests, renal function, and complete blood count monthly. Fetal ultrasound for anomalies if exposure occurs. |
| Fertility Effects | May impair fertility in both males and females. Oligospermia and amenorrhea reported. Effects are reversible upon discontinuation. |