Neurica Special Precautions

This drug may cause drowsiness, do not drive a motor vehicle or operate machinery, or drink alcoholic beverages while taking the drug.
This drug may cause hematologic disorder.
Using this drug in pregnant woman is contraindicated because it may cause teratogenesis.
Use this drug with caution in patients with liver and/or kidney disease.
Angioedema: Angioedema, including life-threatening cases with respiratory compromise requiring emergency treatment, has been reported during post marketing surveillance in patients receiving initial and chronic pregabalin therapy. Specific symptoms included swelling of the face, mouth (e.g., tongue, lips, gums), and neck (e.g., throat, larynx). Pregabalin should be immediately discontinued in patients with these symptoms. Caution is advised if the drug is used in patients who have had a previous episode of angioedema. Patients receiving concomitant drugs associated with angioedema (e.g., angiotensin converting enzyme ACE inhibitors) may be at increased risk of developing angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions (i.e., skin redness, blisters, hives, rash, dyspnea, wheezing) have been reported during post-marketing surveillance in patients shortly after initiation of pregabalin therapy. Pregabalin should be immediately discontinued in patients with symptoms of hypersensitivity.
Suicidality Risk: An increased risk of suicidality (suicidal behavior or ideation) has been observed in an analysis of studies using various anticonvulsants, including pregabalin, compared with placebo. This increased suicidality risk was consistent among anticonvulsants with varying mechanisms of action and across a range of indications and was observed as early as 1 week after beginning therapy. Because most of these studies did not extend beyond 24 weeks, the suicidality risk beyond 24 weeks is not known. Although patients treated with an anticonvulsant for epilepsy, psychiatric disorders, and other conditions were all found to have an increased suicidality risk compared with those receiving placebo, the relative suicidality risk was higher for patients with epilepsy compared to those receiving anticonvulsants for other conditions.
Clinicians should inform patients, their families, and caregivers of the potential for an increased risk of suicidality with anticonvulsant therapy. All patients currently receiving or beginning therapy with any anticonvulsant should be closely monitored for notable changes that may indicate the emergence or worsening of suicidal thoughts or behavior or depression.
Clinicians who prescribe pregabalin or any other anticonvulsant should balance the risk of suicidality with the risk of untreated illness. Epilepsy and many other illnesses for which anticonvulsants are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. If suicidal thoughts or behavior emerge during anticonvulsant therapy, the clinician should consider whether these symptoms may be related to the illness being treated.
Respiratory Depression: Serious, life threatening, or fatal respiratory depression has been reported in patients receiving gabapentinoids (i.e., gabapentin and pregabalin). In the majority of cases, the drugs were used in combination with an opiate analgesic (or other CNS depressant), in patients with pre-existing respiratory risk factors (e.g., COPD), or in geriatric patients.
Because of the risk of respiratory depression when gabapentinoids are used in combination with opiate analgesics or other CNS depressants (e.g., benzodiazepines) or in the setting of underlying respiratory impairment, patients should be monitored for respiratory depression and sedation in these situations. Consideration should be given to initiating pregabalin therapy at the lowest dosage and titrating the dosage carefully; appropriate dosage adjustments should be made in patients with renal impairment and those undergoing hemodialysis. Patients should be advised to seek immediate medical attention if signs or symptoms of respiratory depression occur. Management of respiratory depression may include supportive measures and reduction or withdrawal of CNS depressants, including pregabalin. If the decision is made to discontinue pregabalin, dosage should be reduced gradually.
Dizziness and Somnolence: Pregabalin may cause dizziness and somnolence. These adverse effects occurred more frequently at higher doses and, in some cases, persisted throughout therapy.
Discontinuance of Therapy: As with all anticonvulsant agents, there is a potential for increased seizure frequency when pregabalin therapy is withdrawn abruptly. When discontinuing pregabalin therapy, dosage should be reduced gradually over at least 1 week. Abrupt or rapid discontinuance of pregabalin has been associated with symptoms suggestive of physical dependence (e.g., insomnia, nausea, headache, anxiety, hyperhidrosis, diarrhea).
Peripheral Edema: Pregabalin may cause peripheral edema. In short term clinical trials of patients without clinically important cardiac or peripheral vascular disease, there was no apparent association between peripheral edema and cardiovascular complications (e.g., hypertension, congestive heart failure). Peripheral edema was not associated with deterioration of renal or hepatic function.
Concomitant use of pregabalin with a thiazolidinedione antidiabetic agent has been associated with a greater risk of developing weight gain and peripheral edema than use of either drug alone.
Because there are limited data regarding use of pregabalin in patients with New York Heart Association (NYHA) class III or IV heart failure, the drug should be used with caution in these patients.
Weight Gain: Pregabalin may cause weight gain. Pregabalin-associated weight gain appeared to be related to dosage and duration of exposure; however, weight gain did not appear to be associated with baseline body mass index (BMI), gender, or age and was not limited to patients with edema.
Although weight gain was not associated with clinically important changes in blood pressure in short term controlled studies, the long term cardiovascular effects of such weight gain have not been elucidated. In addition, while the effects of pregabalin-associated weight gain on glycemic control have not been systematically assessed in controlled and longer term open label clinical trials in diabetic patients, pregabalin therapy did not appear to be associated with loss of glycemic control.
Carcinogenicity: Possible carcinogenicity of pregabalin (e.g., hemangiosarcoma) has been demonstrated in animals.
In clinical studies across various patient populations, comprising 6396 patient years of exposure in those 12 years of age or older, new or worsening pre-existing tumors were reported in 57 patients; however, a causal relationship to the drug has not been established.
Ocular Effects: Patients receiving pregabalin should inform their clinician if any changes in vision occur. If visual disturbance persists, further ophthalmologic assessment should be considered, while more frequent assessment should be considered in patients who already are monitored for ocular conditions.
Creatine Kinase Elevations: In clinical trials in adults, increases in serum creatinine kinase (CK)), creatine phosphokinase, (CPK) concentrations at least 3 times the upper limit of normal have been reported in 1.5 or 0.7% of patients receiving pregabalin or placebo, respectively.
Rhabdomyolysis has been reported rarely in pre-marketing clinical trials. However, a definite causal relationship between these musculoskeletal effects and the drug has not been fully elucidated because the cases had documented factors that may have caused or contributed to these events.
Pregabalin treatment should be discontinued if myopathy is diagnosed or suspected or if markedly elevated CK (CPK) concentrations occur.
Thrombocytopenia: In controlled clinical trials in adults, potentially clinically important decreases in platelet count (thrombocytopenia; defined as 20% below baseline value and less than 150,000/mm³) have been reported in 3 or 2% of patients receiving pregabalin or placebo, respectively. Pregabalin treated patients experienced a mean maximal decrease in platelet count of 20,000/mm³ compared with 11,000/mm³ in placebo recipients. Severe thrombocytopenia with a platelet count less than 20,000/mm³ has been reported in at least one patient who received pregabalin. In randomized controlled trials, pregabalin was not associated with an increase in bleeding-related adverse effects.
PR Interval Prolongation: Prolongation of the PR interval (mean increase: 3-6 msec) has been reported in adults receiving pregabalin dosages of at least 300 mg daily. Subgroup analyses in a limited number of patients suggest that those with preexisting PR prolongation at baseline or those receiving drugs that prolong the PR interval do not appear to have an increased risk for developing prolongation of the PR interval.
Abuse Potential and Dependence: In controlled clinical studies using conventional pregabalin, 4 or 1% of patients receiving the drug or placebo, respectively, reported euphoria as an adverse event; in some patient populations studied, the rate of euphoria was higher and ranged from 1-12%. In clinical studies, abrupt or rapid discontinuance of pregabalin has resulted in withdrawal symptoms (e.g., insomnia, nausea, headache, diarrhea).
Pregabalin is not known to be active at receptor sites associated with drugs of abuse. However, the drug is subject to control as a dangerous drug.
As with any CNS active drug, clinicians should carefully evaluate patients for a history of drug abuse and observe them for signs of pregabalin misuse or abuse (e.g., development of tolerance, dose escalation, drug seeking behavior).
This medicine contains lactose.
Patients with lactose intolerance should not take this medicine.