Fampridine Extended-Release Tablets (Fampyra) are a potassium channel blocker approved by the U.S. FDA to improve walking ability in patients with multiple sclerosis (MS).

Indications for Fampridine Extended-Release Tablets (Fampyra)

Target Population

Adult patients with multiple sclerosis, for the purpose of improving their walking ability.

Clinical studies have shown a significant improvement in patients’ walking speed (based on the Timed 25-foot Walk test).

Pharmacological Action

By blocking potassium channels, it enhances the action potential conduction of demyelinated axons, thereby improving nerve signal transmission.

Usage Restrictions

Not applicable to patients under 18 years old; its effectiveness has not been established.

Patients with a history of epilepsy, moderate to severe renal impairment (CrCl ≤ 50 mL/min), and those allergic to 4-aminopyridine must be excluded from use.

Specifications and Properties of Fampridine Extended-Release Tablets (Fampyra)

Dosage Form and Strength

10mg extended-release tablets: White to off-white biconvex oval film-coated tablets, engraved with "A10" on one side and flat on the other side.

Ingredient Composition

Active ingredient: Each tablet contains 10mg of dalfampridine (i.e., 4-aminopyridine).

Excipients: Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Formulation Characteristics

Extended-release technology is used to ensure the drug is released slowly within 12 hours, avoiding a sudden rise in blood drug concentration.

Tablets must be swallowed whole; they cannot be split, chewed, or dissolved, to prevent damage to the extended-release structure and subsequent sudden drug release.

Storage Methods for Fampridine Extended-Release Tablets (Fampyra)

Temperature Requirement

Store at 25°C (77°F) under normal conditions; short-term storage at 15°C to 30°C (59°F to 86°F) is allowed.

Precautions

Avoid moisture, high temperatures, and direct sunlight to prevent denaturation of the film coating.

Keep the original packaging (60 tablets/bottle) sealed, and close the cap tightly immediately after taking the tablets.