LYRICA CR

LYRICA CR has linear pharmacokinetics with dose‑proportional increases in maximum plasma concentration (C max ) and area under the plasma concentration‑time curve (AUC) from 82.5‑660 mg/day. Following repeated administration, steady state is achieved within approximately 48‑72 hours. LYRICA CR administered once daily following an evening meal has equivalent AUC and lower C max relative to a comparative dose of LYRICA administered without food twice daily (Table 5). Variability in C max and AUC f...

14.1 Management of Postherpetic Neuralgia (Study PHN CR) Support for efficacy of LYRICA CR for the management of PHN and diabetic peripheral neuropathy (DPN) was based on the efficacy of LYRICA for these indications along with an adequate and well‑controlled study in adults with PHN. This 19‑week randomized withdrawal study compared daily doses of LYRICA CR 82.5 mg, 165 mg, 247.5 mg, 330 mg, 495 mg, or 660 mg with placebo. Those enrolled were required to have pain present for more than 3 months after healing of the herpes zoster skin rash and a baseline pain score of greater than or equal to 4...

The following adverse reactions are described elsewhere in the labeling:

• Angioedema [see Warnings and Precautions (5.1) ]
• Hypersensitivity Reactions [see Warnings and Precautions (5.2) ]
• Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ]
• Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ]
• Respiratory Depression [see Warnings and Precautions (5.5) ]
• Dizziness and Somnolence [see Warnings and Precautions (5.6)...

LYRICA CR is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.1 , 5.2) , Adverse Reactions (6) ] . Known hypersensitivity to pregabalin or any of its components. ( 4 )

• Angioedema : Angioedema [e.g., swelling of the face, mouth (tongue, lips, and gums) and neck (throat and larynx)] can occur and may be associated with life-threatening respiratory compromise requiring emergency treatment. Discontinue LYRICA CR immediately in patients with these symptoms. ( 5.1 )
• Hypersensitivity Reactions : Hypersensitivity reactions (e.g., hives, dyspnea, and wheezing) can occur. Discontinue LYRICA CR immediately in these patients. ( 5.2 )
• Suicidal Behavior and Ideation :...

7 DRUG INTERACTIONS Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro studies showed that pregabalin is u...