dal-FAM-pri-deen

• Treatment of multiple sclerosis, to improve walking speed.

• Acts as a potassium channel blocker, which may increase conduction of action potentials.

• Increased walking speed in patients with multiple sclerosis.

Absorption: Rapidly and completely absorbed (96%).

Distribution: Unknown.

Metabolism/Excretion: 96% eliminated in urine, 0.5% in feces.

Half-life: 5.2–6.5 hr.

Contraindicated in:

• Hypersensitivity
• History of seizures
• Moderate/severe renal impairment (CCr 50 mL/min)(↑ risk of seizures).

Use Cautiously in:

• Mild renal impairment (CCr 51–80 mL/min) (↑ risk of seizures)
• OB: Safety not established in pregnancy
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children
• Geri: Consider age-related ↓ in renal function.

EENT: nasopharyngitis, pharyngolaryngeal pain.

GI: constipation, dyspepsia, nausea.

GU: urinary tract infection.

MS: back pain.

Neuro: SEIZURES, dizziness, headache, insomnia, weakness., balance disorder, multiple sclerosis relapse, paresthesia.

Misc: ANAPHYLAXIS.

Drug-Drug:

• Cimetidine may ↑ levels and ↑ risk of seizures.

• PO (Adults): 10 mg twice daily.

• Administer tablets twice daily approximately 12 hr apart without regard to food. DNC: Swallow tablets whole; do not break, crush, chew, or dissolve.

Ampyra

Fampyra

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification:

(Generic available)

• Extended-release tablets: 10 mg;

(improvement in walking speed)

• Assess walking speed in patients with multiple sclerosis prior to and periodically during therapy.
• Monitor for seizures during therapy, risk increases with increased dose. If seizure occurs, discontinue therapy.
• Monitor for signs and symptoms of anaphylaxis (dyspnea, wheezing, urticaria, angioedema of the throat or tongue) during therapy.

• Monitor CCr prior to and at least yearly during therapy; renal impairment may require dose reduction or discontinuation.

• Impaired walking (Indications).

• Instruct patient to take dalfampridine as directed, with approximately 12 hr between tablets. If a dose is missed, omit and take next scheduled dose on time; do not double doses. May increase risk of seizures. Advise patient to read Medication Guide prior to beginning therapy and with each Rx refill in case of changes.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• If a seizure or signs or symptoms of anaphylaxis occur, advise patient to notify health care professional immediately, to discontinue dalfampridine and do not restart medication.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breast feeding.

• Improved walking and increased walking speed in patients with multiple sclerosis.

NDC Code^*

• 0378- Mylan Pharmaceuticals Inc.
  • 0378-0509- dalfampridine
    • 0378-0509-91- 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0509-91)

• 10144- Acorda Therapeutics, Inc.
  • 10144-427- AMPYRA
    • 10144-427-60- 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)

• 16729- Accord Healthcare Inc.
  • 16729-292- Dalfampridine
    • 16729-292-12- 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16729-292-12)

• 42571- Micro Labs Limited
  • 42571-275- DALFAMPRIDINE
    • 42571-275-05- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)

• 42571- Micro Labs Limited
  • 42571-275- DALFAMPRIDINE
    • 42571-275-10- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)

• 42571- Micro Labs Limited
  • 42571-275- DALFAMPRIDINE
    • 42571-275-60- 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-429- Dalfampridine
    • 62756-429-86- 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62756-429-86)

• 65862- Aurobindo Pharma Limited
  • 65862-863- DALFAMPRIDINE
    • 65862-863-01- 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-01)

• 65862- Aurobindo Pharma Limited
  • 65862-863- DALFAMPRIDINE
    • 65862-863-05- 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-05)

• 65862- Aurobindo Pharma Limited
  • 65862-863- DALFAMPRIDINE
    • 65862-863-60- 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-863-60)

• 67877- Ascend Laboratories, LLC
  • 67877-444- Dalfampridine
    • 67877-444-05- 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-05)

• 67877- Ascend Laboratories, LLC
  • 67877-444- Dalfampridine
    • 67877-444-60- 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-60)

• 67877- Ascend Laboratories, LLC
  • 67877-444- Dalfampridine
    • 67877-444-90- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-444-90)