Pregabalin Disease Interactions

Anxiolytic, sedative, and hypnotic agents have the potential to cause dependence and abuse. Tolerance as well as physical and psychological dependence can develop, particularly after prolonged use of excessive dosages, and abrupt cessation and/or a reduction in dosage may precipitate withdrawal symptoms. In patients who have developed tolerance, overdosage can still produce respiratory depression and death. Therapy with anxiolytic, sedative, and hypnotic agents should be administered cautiously and for as brief a period as possible. Addiction-prone individuals, such as those with a history of alcohol or substance abuse, should be under careful surveillance or medical supervision when treated with these agents. In addition, it may be prudent to refrain from dispensing large quantities of medication to such patients. After prolonged use or if dependency is suspected, withdrawal of medication should be undertaken gradually using a dosage-tapering schedule.

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Antiepileptic drugs (AEDs) have been associated with an increased risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Pooled analyses of 199 placebo-controlled clinical studies involving the use of 11 different AEDs showed that patients receiving AEDs had approximately twice the risk of suicidal thinking or behavior compared to patients receiving placebo. AEDs should be administered cautiously in patients with depression or other psychiatric disorders; phentermine-topiramate should be avoided in patients with history of suicidal attempts or active suicidal ideation. The risk of suicidal thoughts and behavior should be carefully assessed against the risk of untreated illness, bearing in mind that epilepsy and many other conditions for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, caregivers, and families should be alert to the emergence or worsening of signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior. If patients have symptoms of suicidal ideation or behavior, a dosage reduction or treatment discontinuation should be considered.

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Angioedema has been reported during pregabalin therapy, including reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Therapy with pregabalin should be administered cautiously in patients at risk of developing angioedema or those with a previous episode of angioedema.

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The use of pregabalin has been associated with creatine kinase elevations. Use caution when treating patients with diagnosed of suspected myopathy or with significantly elevated creatine kinase levels.

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Pregabalin treatment may cause peripheral edema. There are limited data concerning the use of pregabalin in patients with congestive heart failure. Therapy with pregabalin should be administered cautiously in patients with New York Heart Association (NYHA) Class III or IV cardiac status.

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Pregabalin should be administered cautiously in patients with preexisting conduction abnormalities (e.g., marked first-degree AV block or second- or third-degree AV block), as it has been associated with PR interval prolongation. In a clinical trial, the mean PR interval increase was 3 to 6 msec with pregabalin at doses higher than or equal to 300 mg per day. This mean change difference was not associated with an increased risk of PR increase >=25% from baseline, an increased percentage of subjects with on-treatment PR >200 msec, or an increased risk of adverse reactions of second or third degree AV block. Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR prolongation or in patients taking other PR prolonging medications. However, these analyses cannot be considered definitive because of the limited number of patients in these categories.

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