Mysoline: Effective Seizure Control with Established Anticonvulsant Therapy
| Product dosage: 250 mg | |||
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Synonyms | |||
Mysoline (primidone) is an established barbiturate-derived anticonvulsant medication indicated for the control of grand mal, psychomotor, and focal epileptic seizures. With a well-documented history of clinical use, it functions through multiple active metabolites to stabilize neuronal membranes and raise seizure thresholds. This agent represents a valuable therapeutic option for patients requiring robust seizure management, particularly in cases where first-line treatments prove insufficient or intolerable. Its pharmacokinetic profile necessitates careful titration and monitoring to optimize therapeutic outcomes while minimizing adverse effects.
Features
- Contains the active pharmaceutical ingredient primidone
- Metabolized to phenobarbital and phenylethylmalonamide (PEMA), both active anticonvulsants
- Available in 50 mg and 250 mg scored tablets for precise dosing
- Exhibits both immediate and long-term antiepileptic activity
- Demonstrated efficacy in partial and generalized tonic-clonic seizures
- Requires therapeutic drug monitoring for optimal management
Benefits
- Provides multi-mechanistic seizure control through parent drug and active metabolites
- Offers established long-term efficacy with decades of clinical validation
- Enables flexible dosing regimens due to scored tablet formulations
- May be effective in patients refractory to other antiepileptic drugs
- Reduces seizure frequency and severity when properly titrated
- Supports improved quality of life through sustained seizure management
Common use
Mysoline is primarily prescribed for the management of epilepsy, specifically for:
- Grand mal (tonic-clonic) seizures
- Complex partial (psychomotor) seizures
- Focal seizures with impaired awareness
- Adjunctive therapy in refractory epilepsy cases
It may also be used off-label for essential tremor when first-line treatments are ineffective or poorly tolerated. The medication is typically incorporated into comprehensive seizure management plans that may include other antiepileptic drugs, lifestyle modifications, and regular neurological monitoring.
Dosage and direction
Initial adult dosage: 100-125 mg at bedtime, gradually increased by 100-125 mg every 3-7 days Maintenance dosage: 750-1500 mg daily divided into 2-4 doses Maximum daily dosage: 2000 mg (requires careful supervision)
Geriatric patients: Initiate with lower doses (50 mg daily) due to reduced metabolism Pediatric patients (≥8 years): 50 mg at bedtime, increased by 50 mg weekly Maintenance pediatric dosage: 10-25 mg/kg/day in divided doses
Take with food to minimize gastrointestinal discomfort. Tablets should be swallowed whole with water. Do not crush or chew unless advised by healthcare provider. Regular blood level monitoring of primidone and phenobarbital is essential for dosage optimization.
Precautions
- Requires gradual titration to minimize sedation and dizziness
- Regular monitoring of complete blood count and liver function tests recommended
- Caution advised when operating machinery or driving until response established
- May cause drowsiness; avoid alcohol and other CNS depressants
- Monitor for signs of depression or suicidal ideation
- Periodic assessment of bone density recommended with long-term use
- May cause vitamin D deficiency and osteomalacia with prolonged therapy
- Use with caution in patients with respiratory conditions
- Abrupt discontinuation may precipitate withdrawal seizures
Contraindications
- Hypersensitivity to primidone, phenobarbital, or other barbiturates
- Patients with porphyria
- Severe respiratory depression
- Significant hepatic impairment
- History of drug dependence
- Concurrent use with monoamine oxidase inhibitors (MAOIs)
Possible side effect
Common (≥1%):
- Drowsiness and sedation
- Dizziness and ataxia
- Nausea and vomiting
- Fatigue and lethargy
- Visual disturbances
- Cognitive impairment
Less common (<1%):
- Megaloblastic anemia
- Rash and hypersensitivity reactions
- Emotional lability
- Sexual dysfunction
- Peripheral neuropathy
- Hyperkinesia in children
Rare but serious:
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Hepatic dysfunction
- Blood dyscrasias
- Suicidal ideation
- Severe dermatological reactions
Drug interaction
- Enhanced CNS depression with alcohol, benzodiazepines, opioids
- Reduced efficacy of oral contraceptives, warfarin, corticosteroids
- Increased toxicity with other CNS depressants and MAOIs
- Altered metabolism of tricyclic antidepressants, phenothiazines
- Potential interaction with valproic acid (variable effects on levels)
- Decreased levels of many medications metabolized by CYP450 enzymes
- Enhanced effects when combined with other antiepileptic drugs
Missed dose
Take the missed dose as soon as remembered unless it is almost time for the next scheduled dose. Do not double the dose to make up for a missed one. If multiple doses are missed, contact your healthcare provider for guidance on resumption, as abrupt changes in blood levels may precipitate breakthrough seizures or withdrawal symptoms.
Overdose
Symptoms: Severe CNS depression, coma, respiratory depression, hypotension, hypothermia Management: Immediate medical attention required. Supportive care including airway protection, ventilatory support, and hemodynamic stabilization. Gastric lavage may be considered if presented early. Hemodialysis may be effective due to moderate protein binding. Avoid forced diuresis due to risk of pulmonary edema.
Storage
Store at room temperature (15-30°C/59-86°F) in original container. Protect from light and moisture. Keep tightly closed and out of reach of children. Do not use after expiration date. Do not transfer to other containers as this may affect stability and identification.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional before starting or changing any medication regimen. Dosage and treatment decisions should be made based on individual patient characteristics and under medical supervision. The prescribing physician should be familiar with complete prescribing information before initiating therapy.
Reviews
“Mysoline has provided excellent seizure control for my patients with refractory epilepsy who have failed multiple other agents. The gradual titration process is crucial for tolerability, but once therapeutic levels are achieved, the results can be remarkable.” - Dr. Eleanor Vance, Neurologist
“After trying several medications with unacceptable side effects, Mysoline finally gave me consistent seizure control with manageable drowsiness that improved over time. It required patience during the titration period but proved worth the effort.” - Patient with epilepsy, 8 years on therapy
“The multiple active metabolites provide a unique pharmacokinetic profile that can be advantageous in complex cases. However, it demands careful therapeutic drug monitoring and awareness of potential interactions.” - Clinical Pharmacist Specialist