Pregabalin

Regulatory sources consulted

• openfda-label-4ac3a79c-4251-45e4-91c4-29396d131e78
• ema-epar-EMEA/H/C/004078
• aemps-cima-104279015
• OpenFDA · N02BF02
• RxNorm rxcui 187832 ↗

Approved indications

• Treatment of peripheral and central neuropathic pain in adults.
• Treatment of Generalised Anxiety Disorder (GAD) in adults.
• Adjunctive therapy in adults with partial seizures with or without secondary generalisation.
• Management of fibromyalgia.
• Management of neuropathic pain associated with spinal cord injury.

Contraindications

Clinical warnings

• Major warning · Respiratory Depression: Serious, life-threatening respiratory depression has been reported, especially when used with opioids or other CNS depressants. May be fatal. — FDA
• Major warning · Suicidal Behavior and Ideation: Increased risk of suicidal thoughts or behavior. Monitor for the emergence or worsening of depression, suicidal thoughts, or any unusual changes in behavior. — FDA
• Major warning · Angioedema: Cases of angioedema have been reported. Discontinue immediately if symptoms such as swelling of the face, mouth, or upper airway occur. — FDA

Drug interactions

• HighCNS Depressants (opioids, benzodiazepines, alcohol)

  Mechanism: Additive pharmacodynamic effect on cognitive and motor function, and increased risk of respiratory depression.

  Recommendation: Closely monitor for sedation and signs of respiratory depression. Consider dose reduction of one or both drugs. Avoid the combination if possible.

  FDA label

Adverse events

Pregnancy and lactation

FDA category: Not Classified

Observational data suggest a possible small increase in the rate of major birth defects. Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Breastfeeding is not recommended.