WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . PRISTIQ is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ( 5.1 ). • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). • PRISTIQ is not approved for use in pediatric patients ( 8.4 ).
Adult Dosing
General dosing
Recommended dose: 50 mg once daily with or without food . • There was no evidence that doses greater than 50 mg per day confer any additional benefit . • The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients . • Discontinuation: Reduce dose gradually whenever possible . • Take tablets whole; do not divide, crush, chew, or dissolve . • Moderate renal impairment: Maximum dose 50 mg per day . • Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day . • Moderate to severe hepatic impairment: Maximum dose 100 mg per day . 2.1 General Instructions for Use The recommended dose for PRISTIQ is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. PRISTIQ should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. In clinical studies, doses of 10 mg to 400 mg per day were studied.
Max: 50 mg per day
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