Classes
DEA Class; Rx
Common Brand Names; Ampyra
- Multiple Sclerosis Treatments;
- Potassium Channel Blockers;
- Cholinergic Agonists
Description
Oral potassium channel blocker, also known as 4-aminopyridine
Indicated to improve walking in adult patients with multiple sclerosis (MS); results are independent of immunomodulatory drug therapies
Major dose-limiting side effect is seizures; patients with moderate to severe renal dysfunction cannot receive the drug
Indications
Indicated for improved walking (i.e., improved walking speed) in patients with multiple sclerosis.
Contraindications
Hypersensitivity
Moderate or severe renal impairment (CrCl ≤50 mL/min)
History of seizure
Adverse Effects
- Urinary tract infection (12%)
- Insomnia
- Dizziness
- Headache
- Nausea
- Asthenia
- Back pain
- Balance disorder
- Multiple sclerosis relapse
- Paresthesia
- Nasopharyngitis
- Constipation
- Dyspepsia
- Pharyngolaryngeal pain
- Dose-related increased risk of seizures
- Postmarketing Reports
- Seizures; 4.6 per 1000 patient-years of use, which is comparable to the rate of seizures seen in the overall MS population
- Vomiting, vertigo
Warnings
Seizures reported; permanently discontinue if seizure occurs; majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures
Age-related decreases in renal function, and mild renal impairment is common after age 50 yr, plasma levels may approach those seen at dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; even when serum creatinine is normal, renal function should be assessed by estimating creatinine clearance
Do not take with other forms of 4-aminopyridine (4-AP, fampridine) to avoid adverse reaction due to the same active ingredient
Estimate CrCl before initiating (see Contraindications and Renal Impairment)
Do not double dose or take extra if dose missed
Anaphylaxis and severe allergic reactions; signs and symptoms have included respiratory compromise, urticaria, and angioedema of the throat and or tongue; discontinue immediately and do not restart (see Contraindications)
UTIs reported more frequently in clinical trials vs. placebo
Pregnancy and Lactation
There are no adequate data on developmental risk associated with use in pregnant women
There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Maximum Dosage
20 mg/day PO, administered as 10 mg every 12 hours.
20 mg/day PO, administered as 10 mg every 12 hours.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Dalfampridine
tablet, extended-release
- 10mg