Pregabalin

DEA Class;  Rx

Common Brand Names; Lyrica, Lyrica CR

Hypersensitivity

Lyrica CR

• Dizziness (3.4-17.1%)

• Somnolence (0.5-11.4%)

Lyrica

• Dizziness (8-45%)

• Somnolence (lethargy, sluggishness, hypersomnia; 4-36%)

• Peripheral edema (16%)

• Ataxia (1-20%)

• Fatigue (5-11%)

• Xerostomia (1-15%)

• Weight gain (16%)

• Tremor (11%)

• Blurred vision (1-12%)

• Diplopia (12%)

Peripheral edema may occur; higher frequencies of weight gain and peripheral edema were observed in patients taking both pregabalin and a thiazolidinedione antidiabetic agent compared to patients taking either drug alone; monitor these patients for possible exacerbation of congestive heart failure symptoms when using pregabalin

Pregabalin may cause dizziness and somnolence; inform patients that pregabalin may impair their ability to perform tasks such as driving or operating machinery; concomitant use of pregabalin with other central nervous system (CNS) depressants may exacerbate these effects; for patients 1 month to less than 4 years of age, somnolence includes related terms lethargy, sluggishness, and hypersomnia

Weight gain may occur; long-term cardiovascular effects of pregabalin-associated weight gain are unknown

Symptoms including, insomnia, nausea, headache, anxiety, and diarrhea were reported following abrupt or rapid discontinuation of treatment; increased seizure frequency may occur in patients with seizure disorders and have rapid discontinued treatment; taper pregabalin gradually over a minimum of 1 week rather than discontinuing the drug abruptly

Unexpectedly high incidence of hemangiosarcoma was identified in 2 different strains of mice; the clinical significance of this finding is unknown

In controlled studies, blurred vision and other vision-related events were reported with treatment; clinical significance of the ophthalmologic findings is unknown, inform patients to notify their physician if changes in vision occur; if visual disturbance persists, consider further assessment

Creatine kinase elevations has been associated with treatment; monitor for symptoms (eg, unexplained muscle pain, tenderness, or weakness, particularly if these muscle symptoms are accompanied by malaise or fever); discontinue treatment if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur

There are no adequate and well-controlled studies with pregabalin in pregnant women

Small amounts of pregabalin have been detected in the milk of lactating women

Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant