Product Description.:
MYSOLINE 250
tablet , yellow , scored , square square
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H) pyrimidinedione.
Mysoline (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.
Each tablet, for oral administration, contains 250 mg primidone. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, ocusate sodium, magnesium stearate, microcrystalline cellulose, sodium benzoate, sodium starch glycolate and stearic acid.
INDICATIONS
Mysoline, used alone or concomitantly with other anticonvulsants, are indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
SIDE EFFECTS
The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and redcell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to Mysoline and to other anticonvulsants.The anemia responds to folic acid without necessity of discontinuing medication.