Europe — EMA
Mysoline (Primidone)
GNH USA supplies Mysoline (Primidone), a barbiturate anticonvulsant for generalized tonic-clonic and partial seizures. Request a quote for global supply.
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What is Primidone?
Primidone, the active ingredient in Mysoline, is a barbiturate anticonvulsant presented as an oral tablet for oral use. It treats generalized tonic-clonic seizures and partial seizures in patients with epilepsy.
GNH USA supplies Mysoline as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Primidone used for?
Mysoline, a barbiturate anticonvulsant, is employed in the management of seizure disorders.
- Generalized tonic-clonic seizures: reduces the frequency and severity of convulsive episodes. - Partial seizures: controls focal seizure activity and prevents progression. - Epilepsy: contributes to overall seizure control as part of a comprehensive treatment plan.
What are the side effects of Primidone?
Primidone may cause a range of adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Drowsiness: feeling unusually sleepy or fatigued. - Dizziness: sensation of lightheadedness or loss of balance. - Nausea: upset stomach often accompanied by an urge to vomit. - Ataxia: impaired coordination affecting gait and fine motor tasks. - Blurred vision: temporary visual disturbances. - Rash: mild skin irritation or erythema.
Serious or Rare Side Effects: - Severe skin reactions: such as Stevens-Johnson syndrome. - Blood dyscrasias: including agranulocytosis or aplastic anemia. - Hepatic dysfunction: signs of liver injury like jaundice. - Suicidal ideation: emergence of depressive thoughts or behaviors. - Respiratory depression: marked slowing of breathing, especially with CNS depressants. - Severe neutropenia: markedly reduced neutrophil count increasing infection risk.
What precautions apply to Primidone?
When prescribing or dispensing Mysoline, several safety considerations should be observed.
- Monitor blood counts: perform regular complete blood count assessments. - Assess liver function: check hepatic enzymes periodically. - Avoid abrupt discontinuation: taper the dose under medical supervision to prevent withdrawal seizures. - Caution in renal impairment: adjust dosing as needed based on renal function. - Pregnancy: risk category unknown; use only if potential benefit justifies the potential risk. - Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Primidone interact with?
Primidone can interact with other medicines, influencing its efficacy or safety.
Major Interactions (Avoid): - CYP3A4 inhibitors (e.g., ketoconazole): may increase primidone plasma levels. - CNS depressants (e.g., benzodiazepines, alcohol): additive sedation and respiratory depression. - Anticoagulants (e.g., warfarin): enhanced anticoagulant effect increasing bleeding risk.
Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., carbamazepine): may reduce primidone effectiveness. - Antihypertensives: potential for increased hypotensive effect. - Oral contraceptives: may lower contraceptive efficacy, requiring additional protection.



