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LYRICA® CR, CV Patient Counseling Information (pregabalin extended-release)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Angioedema

Advise patients that LYRICA CR 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 CR and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1)].

Hypersensitivity

Advise patients that LYRICA CR has been associated with hypersensitivity reactions such as skin redness, blisters, hives, rash, dyspnea, and wheezing. Instruct patients to discontinue LYRICA CR and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2)].

Suicidal Thinking and Behavior

Counsel patients, their caregivers, and families that AEDs, including pregabalin, the active ingredient in LYRICA CR, 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. Instruct patients, caregivers, and families to report behaviors of concern immediately to a healthcare provider [see Warnings and Precautions (5.3)].

Respiratory Depression

Inform patients about the risk of respiratory depression. Include information that the risk is greatest for those using concomitant central nervous system (CNS) depressants (such as opioid analgesics) or in those with underlying respiratory impairment. Teach patients how to recognize respiratory depression and advise them to seek medical attention immediately if it occurs [see Warnings and Precautions (5.4)].

Dizziness and Somnolence

Inform patients that LYRICA CR 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 CR to gauge whether or not it affects their mental, visual, and/or motor performance adversely [see Warnings and Precautions (5.5)].

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 respiratory depression, somnolence, and dizziness [see Warnings and Precautions (5.4, 5.5) and Drug Interactions (7)]. Advise patients to avoid consuming alcohol while taking LYRICA CR, as LYRICA CR may potentiate the impairment of motor skills and sedating effects of alcohol [see Drug Interactions (7)].

Abrupt or Rapid Discontinuation

Advise patients to take LYRICA CR as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, anxiety, or diarrhea. Advise patients with seizure disorders that abrupt or rapid discontinuation may increase seizure frequency [see Warnings and Precautions (5.6)].

Missed Dose

Instruct patients that if they miss taking their dose of LYRICA CR after an evening meal, then they should take their usual dose of LYRICA CR prior to bedtime following a snack. If they miss taking the dose of LYRICA CR prior to bedtime, then they should take their usual dose of LYRICA CR following a morning meal. If they miss taking the dose of LYRICA CR following the morning meal, then they should take their usual dose of LYRICA CR at the usual time that evening following an evening meal.

Weight Gain and Edema

Inform patients that LYRICA CR may cause edema and weight gain. Advise patients that concomitant treatment with LYRICA CR and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. Advise patients with preexisting cardiac conditions that this may increase the risk of heart failure [see Warnings and Precautions (5.7, 5.8)].

Ophthalmological Effects

Counsel patients that LYRICA CR may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.10)].

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)].

Use in Pregnancy

Advise pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers that breastfeeding is not recommended during treatment with LYRICA CR [see Use in Specific Populations (8.2)].

Male Fertility

Inform men being treated with LYRICA CR who plan to father a child of the potential risk of male-mediated teratogenicity [see Nonclinical Toxicology (13.1) and Use in Specific Populations (8.3)].

Dermatopathy

Instruct diabetic patients to pay particular attention to skin integrity while being treated with LYRICA CR [see Nonclinical Toxicology (13.2)].

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