Generic Mysoline

PRIMIDONE
Tablets: 50 mg (Rx) Mysoline (Wyeth-Ayerst)
Tablets: 250 mg (Rx) Various, Mysoline (Wyeth-Ayerst)
Oral Suspension: 250 mg/5 ml (Rx) Mysoline (Wyeth-Ayerst)

Indications
Epilepsy: For control of grand mal, psychomotor, or focal epileptic seizures, either alone or with other anticonvulsants. It may control grand mal seizures refractory to other anticonvulsants.
Unlabeled uses: Benign familial tremor (essential tremor, 750 mg/day).

Administration and Dosage
Individualize dosage.
Adults and children (> 8 years of age): Patients who have received no previous treatment may be started on primidone according to the following regimen:
Days 1 to 3 - 100 to 125 mg at bedtime.
Days 4 to 6-100 to 125 mg twice/day.
Days 7 to 9 - 100 to 125 mg 3 times/day.
Day 10 - maintenance - 250 mg 3 to 4 times/day. If required, increase dose to 250 mg 5 to 6 times/day, but do not exceed doses of 500 mg 4 times/day (2 g/day).
Children ( Days I to 3 - 50 mg at bedtime.
Days 4 to 6 - 50 mg twice/day.
Days 7 to 9 - 100 mg twice/day.
Day 10 - maintenance - 125 to 250 mg 3 times/day, or 10 to 25 mg/kg/day in divided doses.
Patients already receiving other anticonvulsants: Start primidone at 100 to 125 mg at bedtime; gradually increase to maintenance level as the other drug is gradually decreased. When therapy with primidone alone is the objective, the transition should not be completed in

Actions
Pharmacology: Primidone's mechanism of antiepileptic action is not known.
Primidone and its 2 metabolites, phenobarbital and phenylethylmalonamide (ÐÅÌÀ) have anticonvulsant activity.
Pharmacokinetics: Primidone is readily absorbed from the GI tract. Phenobarbital appears in plasma after several days of continuous therapy. Therapeutic plasma concentrations are 5 to 12 mcg/mL for primidone and 15 to 40 mcg/mL for phenobarbital. ÐÅÌÀ and phenobarbital have longer half-lives (10 to 18 hours and 53 to 140 hours, respectively) and accumulate with chronic use. About 40% of primidone is excreted unchanged in the urine.

Contraindications
Porphyria; hypersensitivity to phenobarbital.

Warnings
Status epilepticus: Abrupt withdrawal of antiepileptic medication may precipitate status epilepticus.
Therapeutic efficacy: Therapeutic efficacy of a dosage regimen takes several weeks to assess.
Pregnancy: The effects of primidone in pregnancy are unknown.
Lactation: Primidone appears in breast milk in substantial quantities.

Precautions
Monitoring: Because therapy generally extends over prolonged periods, perform complete blood counts and a sequential multiple analysis test every 6 months. Hazardous tasks: Patients should use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.

Drug Interactions
Drugs that may affect primidone include acetazolamide, carbamazepine, hydantoins, isoniazid, nicotinamide, and succinimides. Drugs that may be affected by primidone include carbamazepine.

Adverse Reactions
Adverse reactions may include ataxia, vertigo, fatigue, hyper-irritability, emotional disturbances, diplopia, nystagmus, drowsiness, personality deterioration with mood changes, paranoia, nausea, anorexia, vomiting, megaloblastic anemia, thrombocytopenia, impotence, morbilliform or maculopapular skin eruptions, crystalluria.
EPILEPSY

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