Dalfampridine Extended-Release Tablets (Fampyra) is a prescription medication developed by Acorda Therapeutics, which was first approved for marketing in the United States in 2010. A potassium channel blocker formulated with proprietary extended-release technology, it is indicated to improve walking ability in specific patients with multiple sclerosis.

What Are the Indications for Dalfampridine Extended-Release Tablets (Fampyra)?

Primary Indications

The primary indication of dalfampridine extended-release tablets is to improve walking ability in adult patients with multiple sclerosis (MS).

Its efficacy is demonstrated by the increase in patients’ walking speed.

Population Eligibility and Restrictions

This medication is only indicated for adult patients (18 years of age and older). Its efficacy in children and adolescents has not been established.

Efficacy is primarily reflected in improved walking speed; the drug is not effective for all MS symptoms. In addition, its use is subject to several contraindications and warnings, and must be initiated following a comprehensive medical evaluation.

Dosage Form and Appearance of Dalfampridine Extended-Release Tablets (Fampyra)

Dosage Form

Dalfampridine extended-release tablets are available in one dosage strength only: each tablet contains 10 mg of dalfampridine.

Double-dose or other strengths are not available. Unauthorized dose escalation will significantly increase the risk of serious adverse events such as seizures.

Appearance

The tablets are film-coated extended-release formulations, appearing white to off-white, biconvex oval-shaped, with smooth edges and no score lines on the surface.

One side of each tablet is embossed with “A10” for identification purposes.

The extended-release design enables slow release of the active pharmaceutical ingredient in the gastrointestinal tract, thereby delaying absorption and achieving a flatter peak plasma concentration. This is the key reason why the tablets must be swallowed whole without crushing or breaking.

Composition

The active ingredient in each tablet is dalfampridine.

Inactive ingredients include colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. These excipients together form the extended-release structure of the tablets.

Storage Instructions for Dalfampridine Extended-Release Tablets (Fampyra)

Storage Conditions

The tablets should be stored at room temperature, specifically within the range of 15°C to 30°C (59°F to 86°F), with short-term temperature fluctuations within this range permitted.

The optimal storage temperature is 25°C (77°F).

Avoid exposing the medication to extreme temperatures. Do not freeze in refrigerators, and keep away from humid environments such as bathrooms or heat sources such as kitchen stoves.

Packaging and Handling

Dalfampridine extended-release tablets are typically supplied in bottles containing 60 tablets.

After use, tightly close the bottle cap to keep the container sealed, preventing moisture damage or contamination of the medication.

Disposal and Precautions

Expired or unused medication should be disposed of safely in accordance with pharmaceutical disposal guidelines or local regulations.

Do not dispose of the medication in household garbage or flush it down the drain to avoid environmental pollution or potential harm to others.

All medications should be stored out of the reach and sight of children to prevent accidental ingestion.