Lybalin Special Precautions

Angioedema: Specific symptoms included swelling of the face, mouth (gums, lips, and tongue), and neck (larynx and throat). Discontinue pregabalin immediately in patients with these symptoms. Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema may be at increased risk of developing angioedema.
Discontinuation: Withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. Following abrupt or rapid discontinuation of pregabalin, some patients reported symptoms, including diarrhea, headache, insomnia, and nausea. Taper pregabalin gradually over a minimum of 1 week rather than discontinuing abruptly.
Suicidal Behavior and Ideation: Pregabalin increase the risk of suicidal thoughts or behavior in patients taking this drug for any indication. Monitor patients treated with pregabalin for any indication for the emergence of worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Peripheral Edema: Pregabalin treatment may cause peripheral edema.
Dizziness/Somnolence: Pregabalin may cause dizziness and somnolence. Pregabalin-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery.
Weight Gain: Pregabalin treatment may cause weight gain. Pregabalin-associated weight gain was related to dose and duration of exposure but did not appear to be associated with baseline body mass index, gender, or age. Weight gain was not limited to patients with edema.
Ophthalmic Effects: Inform patients to notify their health care provider if changes in vision occur. If visual disturbance persists, consider further assessment. Consider more frequent assessment for patients who are already routinely monitored for ocular conditions.
Creatine Kinase Elevations: Pregabalin treatment was associated with creatine kinase elevations. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever. Discontinue pregabalin treatment if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Decreased Platelet Count: Pregabalin treatment was associated with a decrease in platelet count.
PR Interval Prolongation: Pregabalin treatment was associated with PR interval prolongation.
Hypersensitivity Reactions: Adverse reactions included blisters, dyspnea, hives, rash, skin redness, and wheezing. Discontinue pregabalin immediately in patients with these symptoms.