J Korean Neurol Assoc.
1991 Dec;9(4):456-464.
Clinical Study of Controlled Release Form (Orfil Retard(R)) of Sodium Valproate
- Affiliations
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- 1Department of Neurology, Yonsei University, Korea.
- 2Department of Clinical Pathology, Yonsei University, Korea.
Abstract
- A cross-over study was conducted to compare the pharmacokinetic properties of controled release form of Sodium Valproate (Orfil Retard(R)) with that of conventional forrnulation (Orfil(R) in healthy adult volunteers. The clinical efficacy of Orfil Retard(R) was also investigated in 15 epileptic patients under Orfil(R) monotherapy by replacing an equivalent bid dosage of Orfil Retard(R) for 2 months. Orfil Retard(R) achieved more stable blood level than Orfil(R), which was statistically significant(P;0.0051). Orfil Retard(R) was associated with less side effect. Especially of gastrointestinal system. None of epileptic patients showed worsening of seizure control after switch to the equivalent b.I.d. dosage of Orfil Retard(R). Our results indicate that Orfil Retard(R) offers more advantage than Orfil(R) in terms of more stable blood level and less side effect. Clinically. Orfil Retard(R) in equivalent b I d dose is as effective as Orfil(R) in b.I.d. or t.I.d. dosing schedule.
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