Buy Mysoline Online

Mysoline (primidone)

THERAPEUTIC CLASS

Pyrimidinedione derivative

DEA CLASS

RX

INDICATIONS

Alone or with other anticonvulsants in the control of grand mal, psychomotor and focal epileptic seizures. May also control grand mal seizures refractory to other anticonvulsant therapy.

ADULT DOSAGE

Seizures

Grand Mal, Psychomotor, and Focal Epileptic Seizures (Alone or w/ Other Anticonvulsants):

No Prior Antiepileptic Therapy:
Initial:
Days 1-3: 100-125mg qhs
Days 4-6: 100-125mg bid
Days 7-9: 100-125mg tid
Days 10/Maint: 250mg tid
Usual Maint: 250mg tid or qid
Max: 500mg qid

Already Receiving Other Anticonvulsants:
Initial: 100-125mg qhs
Titrate: Increase gradually to maint dose as other drug is gradually decreased. Continue until satisfactory dosage level achieved or other medication is completely withdrawn. When therapy w/ primidone alone is the objective, transition from concomitant therapy should not be completed in <2 weeks
Max: 2g/day

May also control grand mal seizures refractory to other anticonvulsant therapy

PEDIATRIC DOSAGE

Seizures

Grand Mal, Psychomotor, and Focal Epileptic Seizures (Alone or w/ Other Anticonvulsants):

<8 Years:
Days 1-3: 50mg qhs
Days 4-6: 50mg bid
Days 7-9: 100mg bid
Days 10/Maint: 125-250mg tid
Usual Maint: 125-250mg tid or 10-25mg/kg/day in divided doses

≥8 Years:
No Prior Antiepileptic Therapy:
Initial:
Days 1-3: 100-125mg qhs
Days 4-6: 100-125mg bid
Days 7-9: 100-125mg tid
Days 10/Maint: 250mg tid
Usual Maint: 250mg tid or qid
Max: 500mg qid

Already Receiving Other Anticonvulsants:
Initial: 100-125mg qhs
Titrate: Increase gradually to maint dose as other drug is gradually decreased. Continue until satisfactory dosage level achieved or other medication is completely withdrawn. When therapy w/ primidone alone is the objective, transition from concomitant therapy should not be completed in <2 weeks
Max: 2g/day

May also control grand mal seizures refractory to other anticonvulsant therapy

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 50mg*, 250mg* *scored

CONTRAINDICATIONS

Porphyria, phenobarbital hypersensitivity.

WARNINGS/PRECAUTIONS

Avoid abrupt withdrawal; may precipitate status epilepticus. Increased risk of suicidal thoughts or behavior; monitor for emergence or worsening of depression, suicidal thoughts/behavior, or any unusual changes in mood or behavior. Increased incidence of birth defects reported; encourage pregnant patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Neonatal hemorrhage reported in newborns; give pregnant women prophylactic vitamin K1 therapy for 1 month prior to, and during, delivery.

ADVERSE REACTIONS

Ataxia, vertigo, granulocytopenia, agranulocytosis, red-cell hypoplasia, aplasia.

PREGNANCY AND LACTATION

Safety not known in pregnancy, not for use in nursing.

MECHANISM OF ACTION

Pyrimidinedione derivative; not established. Raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals.

PHARMACOKINETICS

Distribution: Found in breast milk. Metabolism: Phenobarbital, phenylethylmalonamide (metabolites).

ASSESSMENT

Assess for porphyria, hypersensitivity to phenobarbital, prior anticonvulsant therapy, depression, and pregnancy/nursing status.

MONITORING

Monitor for status epilepticus, emergence or worsening of depression, suicidal thoughts/behavior, and any unusual changes in mood or behavior. Monitor CBC, drug serum blood level, and sequential multiple analysis-12 test every 6 months.

PATIENT COUNSELING

Counsel patients, their caregivers, and families that the therapy may increase risk of suicidal thoughts and behavior and advise to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct to immediately report behaviors of concern to healthcare providers. Encourage pregnant patients to enroll in the NAAED Pregnancy Registry (1-888-233-2334).

STORAGE

20-25°C (68-77°F).

TAGS

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