MYSOLINE- primidone tablet
Valeant Pharmaceuticals North America
DESCRIPTION
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione.
ysoline* (primidone) 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.
Mysoline 50 mg and 250 mg tablets contain the following inactive ingredients: Microcrystalline Cellulose, NF; Lactose, USP; Methylcellulose, USP; Sodium Starch Glycolate, NF; Talc, USP; Sodium Lauryl Sulfate, NF; Magnesium Stearate, NF; Water, USP, Purified.
Mysoline 250 mg tablets also contain Ferric Oxide Yellow, NF.
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* Registered trademark of Valeant Pharmaceuticals North America LLC.
ACTIONS
Mysoline raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone�s antiepileptic action is not known.
Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals.
Mysoline Indications and Usage
Mysoline, 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.
