Adult Dosing

Multiple sclerosis

• 10 mg PO bid taken approximately 12 hrs apart
• Max: 20 mg

• Do not divide, crush, chew or dissolve the tablet
• Avoid taking double or extra doses if a dose is missed
• No additional benefit was demonstrated with doses > 10 mg bid, however, rates of adverse reactions may be higher
• Establish CrCl before initiating treatment

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• For improving walking speed in patients with multiple sclerosis (MS)

• Hypersensitivity to any of the ingredients of the product
• Moderate or severe renal impairment
• History of seizures

• N/A

Renal Dose Adjustment (Based on CrCl)

• 50 mL/min: Contraindicated
• 51-80 mL/min: Caution advised

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

See Supplemental Patient Information

• Dose escalation of dalfampridine is associated with increased risk of seizures. This drug is contraindicated in patients having history of seizures. Discontinue and do not restart therapy in patients experiencing seizures during course of therapy. Dalfampridine is not evaluated in patients with evidence of epileptiform activity on an EEG
• This drug is contraindicated in patients with moderate-severe renal impairment. Patients with mild renal impairment are prone to increased risk of seizures
• No additional benefit was demonstrated with doses > 10 mg bid, however, rates of adverse reactions may be higher
• Discontinue any product containing 4-aminopyridine before initiating treatment with dalfampridine to reduce the potential for dose-related adverse reactions
• Frequent urinary tract infections have been reported in patients receiving dalfampridine

Caution: Use cautiously in

• Mild renal impairment

Supplemental Patient Information

• Instruct patients to strictly follow dosing instructions

Pregnancy Category:C

Breastfeeding: Safety unknown. As per manufacturer's data, because of the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.

• CNS: Seizures, insomnia, dizziness, headache, balance disorder, multiple sclerosis relapse
• NEURO: Paresthesia
• GI: Nausea, constipation, dyspepsia
• GU: Urinary tract infection
• EENT: Nasopharyngitis, pharyngolaryngeal pain
• MUSC: Back pain
• MISC: Asthenia

• Broad spectrum potassium channel blocker; exact mechanism of action is unknown; inhibits potassium channels leading to increased conduction of action potentials in demyelinated nerve fibers
• Rapidly and completely absorbed from the GI tract
• Relative bioavailability: 96%
• Metabolized by liver; CYP450: 2E1
• Excretion: Urine 95.9% (90.3% unchanged) and feces (0.5%)
• Half-life: 5.2-6.5 hrs

US Trade Name(s)

• Ampyra

US Availability

Ampyra

• ETABS: 10 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Neurologic

Multiple Sclerosis Agents

Potassium Channel Blockers

Drug Name: 12 HR Ampyra 10 MG Extended Release Tablet

Ingredient(s): Dalfampridine

Imprint: A;10

Color(s): White

Shape: Oval

Size (mm): 13.00

Score: 1

Inactive Ingredient(s): hypromellose / cellulose, microcrystalline / silicon dioxide / magnesium stearate / titanium dioxide / polyethylene glycol

Drug Label Author:
Acorda Therapeutics, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: 12 HR Ampyra 10 MG Extended Release Tablet

Ingredient(s): Dalfampridine

Imprint: A;10

Color(s): White

Shape: Oval

Size (mm): 13.00

Score: 1

Inactive Ingredient(s): hypromellose / cellulose, microcrystalline / silicon dioxide / magnesium stearate / titanium dioxide / polyethylene glycol

Drug Label Author:
Elan Pharma International LTD

DEA Schedule:
Non-Scheduled