FIRDAPSE is contraindicated in seizure-prone or hypersensitive patients and requires caution with concomitant medications or comorbidities.

Contraindications and Risk Mitigation Strategies

FIRDAPSE is contraindicated in patients with a history of seizures or hypersensitivity to aminopyridines. Seizures may occur even at therapeutic doses (2% incidence); discontinuation is advised if seizures manifest. Hypersensitivity reactions, including anaphylaxis, necessitate immediate drug cessation. Concomitant use with seizure threshold-lowering agents (e.g., antipsychotics) or cholinergic drugs (e.g., cholinesterase inhibitors) increases adverse event risks. Renal/hepatic impairment or NAT2 poor metabolizer status mandates reduced initial dosing (15 mg/day). Pregnancy and lactation require risk-benefit assessment due to potential fetal harm (animal data) and unknown milk excretion. Pediatric use is unestablished. Geriatric patients may require conservative dosing due to comorbidities.