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Pregnancy: Pregnancy category C: There are no adequate and well-controlled studies of pregabalin in pregnant women; however, based on animal studies, pregabalin may cause fetal harm.
The definition is one of the following. Animal studies have shown a harmful effect such as teratogenic, embrycidal or others. There are no well-controlled studies in pregnant women or both pregnant women studies and animal studies. Potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Pregabalin is distributed into human milk at steady state concentrations approximately 76% of those in maternal plasma. Following administration of maternal dosages of 300 mg daily, the estimated average infant dose of pregabalin from breast milk is 0.31 mg/kg daily (approximately 7% of the maternal dose). Because of the potential for tumorigenicity, breastfeeding is not recommended during pregabalin therapy.
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