Manufacturer: Pfizer, Inc., Groton, CT Indication: Adjunctive treatment of partial-onset seizures in adults with epilepsy.

Drug Class: Pregabalin is a 3-substituted analogue of gamma-amino butyric acid (GABA), and it is a compound related to gabapentin.

Uniqueness of Drug: This agent is already approved for patients with pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. It is the first treatment approved by the Food and Drug Administration (FDA) for these neuropathic pain states. Pregabalin binds to calcium channels, modulating calcium influx and influencing GABA-ergic neurotransmission. This mode of action translates into antiepileptic, analgesic, and anxiolytic effects.

Warnings and Precautions: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication. In accordance with current clinical practice, some diabetic patients who gain weight after taking pregabalin may need to adjust their hypoglycemic medications.
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Pregabalin has been associated with dizziness and somnolence, which can increase the occurrence of accidental injury and falls in elderly patients. Patients should be advised to exercise caution until they are familiar with the potential effects of the medication.

Data are insufficient regarding the effects of the withdrawal of concomitant antiepileptic medicinal products, after seizures are controlled by pregabalin as an “add-on” (“second-line”) therapy; therefore, pregabalin cannot currently be used as monotherapy. If pregabalin needs to be discontinued, this should be done gradually over period of at least one week.

Side effects, such as dizziness and somnolence, are common in more than 10% of patients. Other ADEs, affecting from 1% to more than 10% of patients, include increased appetite, ataxia, blurred vision, and erectile dysfunction.

Dosage: Therapy can be started with day. According to the individual patient’s response and tol-erability, the dosage may be increased to 300 mg/day after one week. The maximum dosage of 600 mg/day may be achieved after an additional week.

Commentary: Over the past 15 years or so, the number of antiepileptic drugs on the market has nearly doubled. As a result, physicians have been able to offer many of their patients drugs with improved effectiveness, tolerability, and safety. Depending on the seizure type, certain standard antiseizure medications are usually used first for epilepsy (the “first-line” agents). If they are unsuccessful or if the patient becomes tolerant to the primary medications, the newer add-on or second-line drugs are tried, usually in combination with standard drugs.

The newer-generation antiepileptic drugs have several theoretical advantages over their predecessors: they have well-characterized mechanisms of action and improved tolerability, and their simpler pharmacokinetic properties are more predictable, especially when the agent is given in combination. In addition, pregabalin is not metabolized and does not bind to protein. Its linear and expected absorption is an advantage because of its predictable efficacy, and its side-effect profile is favorable.
The efficacy of 600 mg of pregabalin was reported to be clearly greater than that of 150 mg, but all ADEs occurred more often with 600 mg than with 150 mg. Somnolence, dizziness, ataxia, and weight gain were clearly dose-related.