Balentin Special Precautions

Pooled analysis if trials involving various antiepileptics (regardless of indication) showed an increased risk of suicidal thoughts/behavior; risk observed as early as one week after initiation and continued through duration of trials. Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify healthcare provider immediately if symptoms occur.
Angioedema has been reported during initial and chronic treatment; may be life threatening; use with caution in patients with a history of angioedema episodes. Concurrent use with other drugs known to cause angioedema (eg, ACE inhibitors) may increase risk. Discontinue treatment immediately if angioedema occurs.
Hypersensitivity reactions, including skin redness, blistering, hives, rash, dyspnea and wheezing; discontinue treatment if hypersensitivity occurs.
Dizziness and somnolence are commonly reported; effects generally occur shortly after initiation and occur more frequently at higher doses. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Visual disturbances (blurred vision, decreased acuity and visual field changes) have been associated with pregabalin therapy; patients should be instructed to notify their physician if these effects are noted.
Pregabalin has been associated with increase in creatine kinase and rare cases of rhabdomyolysis. Patients should be instructed to notify their prescriber if unexplained muscle pain, tenderness, or weakness, particularly if fever and/or malaise are associated with these symptoms. Discontinue treatment if myopathy is suspected or diagnosed or if markedly elevated creatine kinase levels occur.
Use may cause weight gain; weight gain generally associated with dose and duration (average weight gain was 5.2 kg for diabetic patients receiving pregabalin for ≥ 2 years); weight gain was not limited to patients with edema and did not appear to be associated with baseline BMI, gender, age, or loss of glycemic control in diabetic patients.
Use may cause peripheral edema; use with caution in patient with heart failure (NYHA Class III or IV) due to limited data in this patient population. In addition, effect on weight gain/edema may be additive with the thiazolidinedione class of antidiabetic agents; use caution when coadministering these agents, particularly in patients with prior cardiovascular disease. In a scientific statement from the American Heart Association, pregabalin has been determined to be an agent that may exacerbate underling myocardial dysfunction (magnitude: minor and moderate).
May decrease platelet count or prolong PR interval.
Has been noted to be tumorigenic (increased incidence of hemangiosarcoma) in animal studies; significance of these findings in humans is unknown.
Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually unless safety concerns require a more rapid withdrawal. Tapering over at least 1 week is recommended. Abrupt discontinued with pregabalin has been associated with anxiety, diarrhea, headache, hyperhidrosis, insomnia and nausea.
Use caution in renal impairment; dosage adjustment required.
Use with caution in patients with a history of substance abuse; potential for behavioral dependence in this population exists.
Potentially significant drug-drug interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy.