Nervica Special Precautions

Avoid use in older adults with a history of falls or fractures (unless used for seizure or mood disorders) as syncope, impaired psychomotor function or ataxia may occur. Reduce dose in older adults with CrCl less than 60 mL/min due to increased risk of adverse CNS effects. Avoid concomitant use of 3 or more CNS-active agents in any combination as this may increase the risk of falls. Avoid concomitant use of opioids due to increased risk of severe sedation-related adverse events including respiratory depression and death.
Cardiovascular: New York Heart Association Class III and IV congestive heart failure; increased risk of peripheral edema; monitoring recommended.
Peripheral edema has been reported; increased frequency of weight gain and peripheral edema with concomitant thiazolidinedione use; monitoring recommended during concomitant thiazolidinedione use.
PR interval prolongation has been reported.
Endocrine and Metabolic: Weight gain has been reported.
Hematologic: Thrombocytopenia has been reported.
Immunologic: Angioedema, including life-threatening cases, has been reported, especially in patients with prior episode of angioedema or concurrently taking medications associated with angioedema (eg, ACE inhibitors); discontinue immediately if symptoms develop.
Hypersensitivity reactions, including skin redness, blisters, hives, rash, dyspnea, and wheezing, have been reported; discontinue immediately if symptoms develop.
Musculoskeletal: Creatinine kinase elevations have been reported; discontinue if marked elevations occur, or if myopathy is suspected or diagnosed.
Neurologic: Significant dizziness and somnolence or sedation have been reported, including lethargy, sluggishness, and hypersomnia in patients less than 4 years old.
Ophthalmic: Vision-related events, including reduced visual acuity, visual field changes, and blurred vision have been reported.
Psychiatric: Suicidal ideation and behavior, worsening of depression, and unusual changes in mood or behavior may occur as early as 1 week following initiation; monitoring recommended.
Renal: Renal impairment (ie, CrCl less than 60 mL/min); dosage adjustment recommended.
Respiratory: Serious, life-threatening, or fatal respiratory depression has been reported both with and without coadministration of CNS depressants (eg, opioids) or in patients with underlying respiratory impairment; monitoring required for these patients, and dosage adjustment or discontinuation of pregabalin or coadministered CNS depressants may be recommended.
Withdrawal: Withdrawal seizure and other adverse effects (eg, insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea) may be precipitated by abrupt discontinuation; tapering over minimum of 1 week recommended.