HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PREGABALIN safely and effectively. See full prescribing information for PREGABALIN.
PREGABALIN capsules, CV
PREGABALIN oral solution, CV
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Pregabalin is indicated for:
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). (6.1)
Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
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