Finished product reference

Dalfampridine

Tablet · Oral · 10 mg

List code
50771
Pharmacologic class
Potassium Channel Blocker

What it is and how it works

Mechanism of action The mechanism by which dalfampridine exerts its therapeutic effect has not been fully elucidated. Dalfampridine is a broad spectrum potassium channel blocker. In animal studies, dalfampridine has been shown to increase conduction of action potentials in demyelinated axons through inhibition of potassium channels.

Mechanism class: Potassium Channel Antagonists

Indications

Dalfampridine Extended-Release Tablets are indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed . Dalfampridine Extended-Release Tablets are a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1 , 14 ).

Dosage and administration (summary)

The maximum recommended dosage is 10 mg twice daily (approximately 12 hours apart). There is no evidence of additional benefit with doses greater than 10 mg twice daily. Adverse reactions, including seizures, were more frequent at higher doses. Take with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve Patients should not take double or extra doses if they miss a dose. Estimated creatinine clearance (CrCl) should be known before initiating treatment with Dalfampridine Extended-Release Tablets.

Contraindications

The use of Dalfampridine Extended-Release Tablets are contraindicated in the following conditions: History of seizure Moderate or severe renal impairment (CrCl≤50 mL/min) History of hypersensitivity to dalfampridine or 4-aminopyridine; reactions have included anaphylaxis History of seizure Moderate or severe renal impairment (CrCl≤50 mL/min) History of hypersensitivity to dalfampridine or 4-aminopyridine

Warnings and precautions

Dalfampridine can cause seizures; the risk of seizures increases with increasing Dalfampridine Extended-Release Tablets doses; discontinue Dalfampridine Extended-Release Tablets and do not restart if a seizure occurs Avoid concomitant use with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same Dalfampridine can cause anaphylaxis. Discontinue and do not restart Dalfampridine Extended-Release Tablets if this occurs Seizures Dalfampridine can cause seizures.

Pregnancy

Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of Dalfampridine Extended-Release Tablets in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses . In the U.S.

Storage and supply

Store at 25°C (77°F). Excursions permitted 15°C to 30°C (59°F to 86°F).

Source: Dalfampridine (Dalfampridine) — US FDA prescribing information, 2025-10-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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