Lower phenytoin serum levels in persons switched from brand to generic phenytoin.
After generic phenytoin (PHT) was marketed, the authors identified eight adult patients (ages 34 to 49) whose seizures increased enough to require intervention after switching to generic PHT. The mean total PHT concentration on brand (before generic) was 17.7 +/- 5.3 mg/L, decreased to 12.5 +/- 2.7 mg/L with generic, and increased to 17.8 +/- 3.9 mg/L after brand was re-introduced. Brand and generic PHT do not yield equivalent concentrations in some patients and substitution should not be permitted without physician notification.
Burkhardt
R T
RT
MINCEP Epilepsy Care, Minneapolis, MN 55416, USA.
Leppik
I E
IE
Blesi
K
K
Scott
S
S
Gapany
S R
SR
Cloyd
J C
JC
D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000097:blood / Q000138:chemical synthesis / Q000493:pharmacokinetics; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D016568:Drugs, Generic / Q000008:administration & dosage / Q000378:metabolism* / Q000493:pharmacokinetics*; D004827:Epilepsy / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010672:Phenytoin / Q000008:administration & dosage / Q000097:blood* / Q000138:chemical synthesis / Q000493:pharmacokinetics*; D012189:Retrospective Studies; D018570:Risk Assessment; D055502:Secondary Prevention; D013810:Therapeutic Equivalency; D017211:Treatment Failure
D000927:Anticonvulsants; D016568:Drugs, Generic; D010672:Phenytoin