Primidone, USP is a white, crystalline, highly stable substance, M. P. 279-284° C. It is poorly soluble in water (60 mg per 100 mL at 37° C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione.
Primidone tablets, USP, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
Published Studies Related to Primidone
Comparison of add-on valproate and primidone in carbamazepine-unresponsive patients with partial epilepsy. [2009.03]
PURPOSE: Evaluation of the efficacy of add-on valproate (VPA) or primidone (PRM) in patients with partial epilepsy unresponsive to carbamazepine (CBZ)... CONCLUSION: Our results indicated that the efficacy of the CBZ/VPA combination tends to be greater than the efficacy of the CBZ/PRM combination.
Clinical Trials Related to Primidone
Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant [Enrolling by invitation]
The purpose of this study is to determine whether adding primidone will improve the
metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and
platelet response to clopidogrel in patients who were previously found to lack adequate
response to clopidogrel. This information could help overcome clopidogrel resistance in
patients who are at risk for stroke or transient ischemic attack (TIA).
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions [Completed]
The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of
Dr. Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc,
in healthy, adult, human subjects under fasting conditions.
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets [Completed]
Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database [Completed]
Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy;
however, complete seizure control remains elusive for many patients. Uncontrolled or
refractory epilepsy is associated with a higher risk of mortality, physical injuries, and
depression or anxiety compared with patients with controlled epilepsy. Higher resource
utilization for patients with poor control is likely to be associated with higher economic
costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists,
recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one
seizure per month and 2.) a history of drug failures.
The objective of this study is to identify patients with uncontrolled epilepsy in both a
Medicaid database and a private health plan database, to describe patient characteristics
and AED treatment patterns between cohorts of patients with uncontrolled versus
well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus
For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases
from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second
quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter
1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and
medical and pharmacy claims in an private health plan database.
The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient
records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy
(at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1
epilepsy-related inpatient or emergency department (ED) visit within 365 days),
well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits),
and intermediate epilepsy (not classified as uncontrolled or well-controlled).
Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma [Withdrawn]
The primary objective of this study is to determine the maximum tolerated dose (MTD) and
dose limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide
(TMZ). Secondary objectives are: To further evaluate the safety and tolerability of
dasatinib plus protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when
administered with protracted, daily TMZ among recurrent malignant glioma patients who are on
and not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for
anti-tumor activity with this regimen in this patient population.
Reports of Suspected Primidone Side Effects
Maternal Exposure Timing Unspecified (10),
Patent Ductus Arteriosus (9),
Choanal Atresia (5),
Maternal Drugs Affecting Foetus (4),
Drug Ineffective (4),
Speech Disorder (4), more >>
Page last updated: 2009-10-20