dalfampridine

(redirected from Ampyra)

dalfampridine

Ampyra

Action

Unknown. May increase conduction of action potentials in demyelinated axons through inhibition of potassium channels.

Availability

Tablets (extended release): 10 mg

Indications and dosages

To improve walking in patients with multiple sclerosis

Adults: 10 mg P.O. q 12 hours

Dosage adjustments

• Mild renal impairment

Contraindications

• History of seizures

• Moderate or severe renal impairment

Precautions

Use cautiously in:

• mild renal impairment

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).

Administration

• Check creatinine clearance before starting drug.

• Administer with or without food.

Adverse reactions

CNS: insomnia, dizziness, headache, asthenia, balance disorder, paresthesia, seizures

EENT: nasopharyngitis, pharyngolaryngeal pain

GI: nausea, constipation, dyspepsia

GU: urinary tract infection

Musculoskeletal: back pain

Other: multiple sclerosis relapse

Interactions

None

Patient monitoring

Discontinue drug if seizure occurs.

• Monitor renal function tests regularly (especially creatinine clearance).

Patient teaching

• Instruct patient to take drug with or without food.

• Instruct patient to swallow tablet whole and not to break, crush, chew, or dissolve it.

Advise patient to discontinue drug and immediately report to prescriber if seizures occur.

• Instruct patient to promptly report urinary tract problems.

• As appropriate, review all other significant and life-threatening adverse reactions.

dalfampridine

(dal-fam-pri-deen) ,

Ampyra

(trade name),

Fampyra

(trade name)

Classification

Therapeutic: anti multiple sclerosis agents
Pharmacologic: potassium channel blockers
Pregnancy Category: C

Indications

Treatment of mutiple sclerosis, to improve walking speed.

Action

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

Therapeutic effects

Increased walking speed in patients with multiple sclerosis.

Pharmacokinetics

Absorption: Rapidly and completely absorbed (96%).
Distribution: Unknown.
Metabolism and Excretion: 96% eliminated in urine, 0.5% in feces.
Half-life: 5.2–6.5 hr.

Time/action profile (improvement in walking speed)

ROUTEONSETPEAKDURATION
POunk3–4 hr24 hr

Contraindications/Precautions

Contraindicated in: HypersensitivityHistory of seizures;Moderate/severe renal impairment (CCr ≤50 mL/min)(↑ risk of seizures); Lactation: Avoid use.
Use Cautiously in: Mild renal impairment (CCr 51–80 mL/min) (↑ risk of seizures) Geriatric: Consider age-related ↓ in renal function; Obstetric: Use only if potential benefit justifies potential risk to fetus; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • dizziness
  • headache
  • insomnia
  • weakness

Ear, Eye, Nose, Throat

  • nasopharyngitis
  • pharyngolaryngeal pain

Gastrointestinal

  • constipation
  • dyspepsia
  • nausea

Genitourinary

  • urinary tract infection

Musculoskeletal

  • back pain

Neurologic

  • balance disorder
  • multiple sclerosis relapse
  • paresthesia

Miscellaneous

  • anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Oral (Adults) 10 mg twice daily.

Availability

Extended-release tablets: 10 mg

Nursing implications

Nursing assessment

  • 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.
  • Lab Test Considerations: Monitor creatinine clearance prior to and at least yearly during therapy; renal impairment may require dose reduction or discontinuation.

Potential Nursing Diagnoses

Impaired walking (Indications)

Implementation

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

Patient/Family Teaching

  • Instruct patient to take dalfampridine as directed, with approximately 12 hrs 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; new information may be available.
  • 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 to report the event to Acorda (manufacturer) at 1-800-367-5109.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Improved walking and increased walking speed in patients with multiple sclerosis.
References in periodicals archive ?
Acorda also markets the branded AMPYRA (dalfampridine) Extended Release Tablets, 10 mg.
The analyst notes that the loss of exclusivity for the company's flagship Ampyra product has led to Inbrija - its inhaled levodopa product for the treatment of OFF episodes in Parkinson's disease - to the forefront of its lineup.
(165) On February 10, 2014, Bass filed IPR petitions challenging the validity of Ampyra, a prescription drug that helps multiple sclerosis patients walk.
Mylan NV (NASDAQ : MYL ), a global pharmaceutical company, has launched its Dalfampridine Extended-Release Tablets, 10mg, the authorised generic version of Acorda's Ampyra, in the United States, it was reported on Friday.
Global Banking News-September 24, 2018-Mylan unveils authorised generic Ampyra Tablets for treating multiple sclerosis
years--belongs to Ampyra (dalfampridine), a potassium channel blocker
Visit Multiple Sclerosis Treatment Market by Drug Class (Immunomodulators - Ampyra, Avonex/Plegridy, Betaseron/Extavia, Copaxone, Gilneya, Rebif, Tecifidera, Tysabri; and Immunosuppressants - Aubagio, Lemtrada, Ocrelizumab, Zinbryta) and Forecast 2017-2021 at https://www.ihealthcareanalyst.com/report/multiple-sclerosis-treatment-market/.
The two drugs include Dalfampridine (Ampyra) used to improve the body organs' movement in MS patients and Neurotek to treat the diabetic patients.
"In two decisions handed down late last month, the PTAB refused to initiate trials on two petitions filed by Bass to challenge two patents on Acorda Therapeutics Inc.'s multiple sclerosis drug Ampyra," Engellenner told InsideCounsel.
"Regarding Acorda specifically, the Bass fund has apparently decided to 'double down' on its bet, filing another petition against each of the previously challenged Acorda patents on September 2nd as well as new petitions against two other Acorda patents covering the Ampyra drug on September 3rd."
The study was conducted in Canada and Europe with prolonged-release fampridine (Fampyra), known as dalfampridine (Ampyra) in the United States.