Vilazodone: uses, dosing, side effects & brands

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( 5.1 )]. Serotonin Syndrome [see Warnings and Precautions ( 5.2 )]. Increased Risk of Bleeding [see Warnings and Precautions ( 5.3 )]. Activation of Mania or Hypomania [see Warnings and Precautions ( 5.4 )]. Discontinuation Syndrome [see Warnings and Precautions ( 5.5 )]. Seizures [see Warnings and Precautions ( 5.6 )] . Angle-Closure Glaucoma [see Warnings and Precautions ( 5.7 )]. Hyponatremia [see Warnings and Precautions ( 5.8 )]. Sexual Dysfunction [see Warnings and Precautions ( 5.9 )]. Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The most commonly observed adverse reactions in VIIBRYD-treated patients with major depressive disorder (MDD) in…

VIIBRYD is contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ) , Drug Interactions ( 7 ) ] . Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 )

CYP3A4 Inhibitors: The VIIBRYD dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors ( 2.4 , 7 ). CYP3A4 Inducers: Consider increasing VIIBRYD 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 ( 2.4 , 7 ). 7.1 Drugs Having Clinically Important Interactions With VIIBRYD Table 4: Clinically Important Drug Interactions with VIIBRYD Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of MAOIs and serotonergic drugs including VIIBRYD increases the risk of serotonin syndrome. VIIBRYD is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications ( 4 ), Dos age and Administration ( 2.3 ) , and Warnings and Precautions ( 5.2 )]. Other Serotonergic Drugs Concomitant use of VIIBRYD with other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during VIIBRYD initiation. If serotonin syndrome occurs, consider discontinuation of VIIBRYD and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )]. Antiplatelet Agents and Anticoagulants Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with VIIBRYD may potentiate the risk of bleeding. Inform patients of the increased risk of bleeding with the concomitant use of VIIBRYD and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating, titrating, or discontinuing VIIBRYD [see Warnings and Precautions ( 5.3 )]. Strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin, voriconazole) The concomitant use of VIIBRYD and strong CYP3A4 inhibitors increased the exposure of vilazodone compared to the use of VIIBRYD alone [see Clinical Pharmacology ( 12.3 )]. The VIIBRYD dose should not exceed 20 mg once daily with the concomitant use of a strong CYP3A4 inhibitor [see Dosage and Administration ( 2.4 ) , Clinical Pharmacology ( 12.3 ) ] . Strong CYP3A4 Inducers (e.g., carbamazepine, phenytoin, rifampin) The concomitant use of VIIBRYD and strong CYP3A4 inducers decreased the exposure of vilazodone compared to the use of VIIBRYD alone [see Clinical Pharmacology ( 12.3 )]. Based on clinical response, consider increasing the dosage of VIIBRYD, over 1 to 2 weeks in patients taking strong CYP3A4 inducers for greater than 14 days [see Dosage and Administration ( 2.4 ) , Clinical Pharmacology ( 12.3 ) ]. Digoxin Digoxin is a narrow therapeutic index drug. Concomitant use of VIIBRYD increased digoxin concentrations [see Clinical Pharmacology ( 12.3 )] . Measure serum digoxin concentrations before initiating concomitant use of VIIBRYD. Continue monitoring and reduce digoxin dose as necessary. 7.2 Drugs Having No Clinically Important Interactions With VIIBRYD Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are substrates of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and/or P-glycoprotein (except narrow therapeutic index drugs, e.g., digoxin), when VIIBRYD is administered concomitantly [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] .