Pristiq (desvenlafaxine) extended-release tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009, December 2010 and April 2011
- vertigo information..."feeling that your surroundings are moving"...
WARNINGS AND PRECAUTIONS
Clinical Worsening and Suicide Risk
- provides for changes to correctly bold a mandatory class-labeling statement
WARNINGS and PRECAUTIONS
Elevated Blood Pressure
- Has occurred with Pristiq. hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment.
- Reduces the clearance of Pristiq. Dosage adjustment is necessary in severe and ESRD. In moderate renal impairment, the dose should not exceed 50 mg/day.
Clinical Studies Experience
- Adverse reactions in patients in short-term fixed-dose studies (incidence ≥ 5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders
USE IN SPECIFIC POPULATIONS
- Dosage adjustment is recommended in patients with severe renal impairment and end-stage renal disease The dose should not be escalated in moderate to severe impairment or in ESRD
- For elderly patients, the possibility of reduced renal clearance of desvenlafaxine should be considered when determining dose.