Dosing and uses of Neurelan (fampridine)
Multiple Sclerosis (Orphan)
Data limited
Fampridine-SR: 10 mg PO q12hr
Spinal Cord Injury (Orphan)
Data limited
9-15 mg/hr continuous IV infusion for ~2 hr, Or
24 mg total cumulative dose, administered as 2 mg IV q20min (Slow IV push or continuous infusion)
Orphan indication sponsor
- Acorda Therapeutics, Inc; 15 Skyline Dr; Hawthorne, NY 10532
Renal Impairment
90% excreted unchanged
Decrease dose (specific guidelines unavailable)
Pediatric dosage forms and strengths
Safety/efficacy not established
Geriatric dosage forms and strengths
Multiple Sclerosis (Orphan)
Data limited
Fampridine-SR: 10 mg PO q12hr
Spinal Cord Injury (Orphan)
9-15 mg/hr continuous IV infusion for ~2 hr, Or
24 mg total cumulative dose, administered as 2 mg IV q20min (Slow IV push or continuous infusion)
Neurelan (fampridine) adverse (side) effects
Frequency not defined
Seizures (dose-dependent)
Acute confusional episodes
Anxiety
Agitation
Restlessness
Asthenia
Back pain
Paresthesia
Dizziness
Gait instability
Insomnia
Diaphoresis
Inj site pain
Nausea, vomiting
Xerostomia
Abd pain
Incr mean arterial pressure
Warnings
Contraindications
Hypersensitivity to fampridine or 3,4-diaminopyridine
History of seizures
Cautions
Avoid pregnancy
Hypertension, arrhythmias, cardiac conduction defects
Renal impairment
Pregnancy and lactation
Pregnancy category: effects during pregnancy not known, avoid pregnancy
Lactation: not known whether distributed in breast milk, do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Neurelan (fampridine)
Mechanism of action
Potassium channel blocker; incr CNS and neuromuscular junction acetylcholine release; possibly restores conduction in central demyelinated axons
Pharmacokinetics
Half-Life: 3 hr (PO), 3.5 hr (IV)
Bioavailability: 95%
Peak Plasma Time: 2 min (IV); 3-4 hr (PO)
Protein Binding: Negligible
Vd: 2.6 L/kg
Metabolism: Not metabolized to significant extent
Excretion: Urine (90%)
Administration
IV Preparation
Dilute in dextrose/saline (concentration unspecified)
IV Administration (Data limited)
9-15 mg/hr via continuous IV infusion for ~2 hr
24 mg administered in segments by either 2 mg IV q20min (2 mg/30 sec) or 2 mg IV infused over 20 min
