Pregabalin

GENERIC NAME: pregabalin

DRUG CLASS AND MECHANISM
Pregabalin is an oral medication that is chemically related to gabapentin (Neurontin, Gabarone). It is used for treating pain caused by neurologic diseases such as postherpetic neuralgia as well as seizures. It also is used for treating fibromyalgia. The mechanism of action of pregabalin is unknown. Pregabalin binds to calcium channels on nerves and may modify the release of neurotransmitters (chemicals that nerves use to communicate with each other). Reducing communication between nerves may contribute to pregabalin's effect on pain and seizures. The FDA approved pregabalin in December 2004.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No.

PREPARATIONS: Capsules: 25, 50, 75, 100, 150, 200, 225, and 300 mg. Oral Solution: 20 mg/ml

STORAGE: Pregabalin should be stored at room temperature, between 15-30 C (59-86 F).

PRESCRIBED FOR
Pregabalin is used for neuropathic pain associated with diabetic peripheral neuropathy or postherpetic neuralgia and in combination with other drugs to treat partial onset seizures in adults. It also is used for treating fibromyalgia.

DOSING
Pregabalin may be taken with or without food. The initial dose for neuropathic pain is 50 mg three times a day (150 mg/day). The dose may be increased to a maximum dose of 100 mg 3 times daily (300 mg/day) after one week.

The recommended dose for postherpetic neuralgia is 75-150 mg twice daily or 50-100 mg three times daily. Begin dosing at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 100 mg 3 times daily (300 mg/day) after one week. If pain relief is inadequate after 2-4 weeks of treatment at 300 mg/day, the dose may be increased to 300 mg twice daily or 200 mg three times daily. Doses greater than 300 mg cause more side effects.

The recommended dose for treating seizures is 150-600 mg/day divided into 2 or 3 doses, starting at at 150 mg daily and increasing based on response and tolerability.

Fibromyalgia is treated with 300-450 mg/day in 2 or 3 divided doses.

DRUG INTERACTIONS
Alcohol and drugs that cause sedation may increase the sedative effects of pregabalin. Pioglitazone (Actos) and rosiglitazone (Avandia) cause weight gain, fluid retention and possibly heart failure. Therefore, combining pregabalin with these drugs may increase the occurrence of weight gain and fluid retention.

PREGNANCY: There are no adequate studies of pregabalin in pregnant women.

NURSING MOTHERS: It is not known whether pregabalin is excreted in human breast milk.

SIDE EFFECTS
The most common side effects of pregabalin are dizziness, drowsiness, dry mouth, edema (accumulation of fluid), blurred vision, weight gain, and difficulty concentrating. Other side effects include reduced blood platelet counts, and increased blood creatinine kinase levels. Increased creatinine kinase can be a sign of muscle injury, and in clinical trials three patients experienced rhabdomyolysis (severe muscle injury). Therefore, patients should report unexplained muscle pain, tenderness or weakness to their doctors, especially if associated with fever and malaise (reduced well-being). Pregabalin has rarely been associated with angioedema (swelling of the face, tongue, lips, and gums, throat and larynx).

Antiepileptic medications have been associated with increased risk of suicidal thinking and behavior. Anyone considering the use of antiepileptic drugs must balance this risk of suicide with the clinical need. Patients who are started on therapy should be closely observed for clinical worsening, suicidal thoughts, or unusual changes in behavior.

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