LYRICA- pregabalin capsule
Lake Erie Medical DBA Quality Care Products LLC
17 PATIENT COUNSELING INFORMATION17.1 Medication Guide
Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking LYRICA. Instruct patients to take LYRICA only as prescribed.
Advise patients that LYRICA may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue LYRICA and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1)].
Advise patients that LYRICA has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue LYRICA and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2)].
17.4 Suicidal Thinking and Behavior
Patients, their caregivers, and families should be counseled that AEDs, including LYRICA, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.4)].
17.5 Dizziness and Somnolence
Counsel patients that LYRICA may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on LYRICA to gauge whether or not it affects their mental, visual, and/or motor performance adversely. [see Warnings and Precautions (5.6)].
17.6 Weight Gain and Edema
Counsel patients that LYRICA may cause edema and weight gain. Advise patients that concomitant treatment with LYRICA and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure. [see Warnings and Precautions (5.5 and 5.7)].
17.7 Abrupt or Rapid Discontinuation
Advise patients to take LYRICA as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, or diarrhea. [see Warnings and Precautions (5.8)].
17.8 Ophthalmological Effects
Counsel patients that LYRICA may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.10)].
17.9 Creatine Kinase Elevations
Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. [see Warnings and Precautions (5.11)].
17.10 CNS Depressants
Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as somnolence.
Tell patients to avoid consuming alcohol while taking LYRICA, as LYRICA may potentiate the impairment of motor skills and sedating effects of alcohol.
17.12 Use in Pregnancy
Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy [see Use In Specific Populations (8.1) and (8.3)].
Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 [see Use In Specific Populations (8.1)].
17.13 Male Fertility
Inform men being treated with LYRICA who plan to father a child of the potential risk of male-mediated teratogenicity. In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical significance of this finding is uncertain [see Nonclinical Toxicology (13.1)].
Instruct diabetic patients to pay particular attention to skin integrity while being treated with LYRICA. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with LYRICA was observed in clinical trials [see Nonclinical Toxicology (13.2)].
Capsules manufactured by:
Pfizer Pharmaceuticals LLC
Vega Baja, PR 00694
Oral Solution manufactured by:
Kalamazoo, MI 49001