Vilazodone

Vilazodone is used for: Major Depressive Disorder

Oral Adult Major Depressive Disorder Recommended target dosage: 20 mg to 40 mg once daily with food. To titrate: start with initial dosage of 10 mg once daily for 7 days, followed by 20 mg once daily. The dose may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases. Gradually taper dose , upon discontinuation of antidepressant, to minimize withdrawal symptoms and allow for detection of re-emerging symptoms; in patients taking 40 mg/day, taper dose to 20 mg qDay for 4 ddays; follow by reducing dose to 10 mg qDay for 3 days; if patient is taking 20 mg/day, taper dose to 10 mg qDay for 7 days. Hepatic impairment (mild/moderate/severe): No dose adjustment recommended

Renal impairment (mild/moderate/severe): No dose adjustment recommended

Shouldl be taken with food.

Hypersensitivity Do not use MAOIs concomitantly or within 14 days before initiating vilazodone or within 14 days after discontinuing vilazodone

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans, amphetamines), but also when taken alone. Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. Activation of Mania/Hypomania: Screen patients for bipolar disorder. Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder. Angle Closure Glaucoma: Avoid use of antidepressants, including Vilazodone, in patients with untreated anatomically narrow angles. Sexual Dysfunction: Vilazodone may cause symptoms of sexual dysfunction

Pregnancy There are no adequate and well-controlled studies in pregnant women; a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at beginning of pregnancy; women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants; consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum Exposure in late pregnancy may lead to increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN); monitor neonates who were exposed to therapy in third trimester of pregnancy for PPHN and drug discontinuation syndrome Persistent pulmonary hypertension of the newborn Potential risk of PPHN when used during pregnancy Initial public health advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN FDA recommendation: FDA advises health-care professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program Lactation There are no data on presence in human milk, effects on breastfed infant, or on milk production; however, drug is excreted in rat milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

CYP3A4 Inhibitors: The Vilazodone dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors. CYP3A4 Inducers: Consider increasing Vilazodone dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days.

Side effects of Vilazodone : >10% Diarrhea (28%) Nausea (23%) 1-10% Dizziness (9%) Xerostomia (8%) Insomnia (6%) Vomiting (5%) Fatigue (4%) Abnormal dreams (4%) Libido decreased (4%) Abnormal orgasm (3%) Dyspepsia (3%) Flatulence (3%) Gastroenteritis (3%) Somnolence (3%) Paresthesia (3%) Arthralgia (3%) Restlessness/akathisia (3%) Jittery sensation (2%) Tremor (2%) Delayed ejaculation (2%) Erectile dysfunction (2%) Increased appetite (2%)

Mechanism of antidepressant effect is not fully understood, but may be related to serotonergic activity in the CNS through selective inhibition of serotonin reuptake; no effect on norepinephrine or dopamine reuptake Partial agonist of serotonergic 5-HT1A receptor whose activity may be altered in depression and anxiety