Label: DALFAMPRIDINE tablet, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 12, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DALFAMPRIDINE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DALFAMPRIDINE EXTENDED-RELEASE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Dalfampridine extended-release tablet is indicated as a treatment to improve walking in  adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage Information - The maximum recommended dosage of dalfampridine is one 10 mg tablet twice daily and should not be exceeded. Take doses approximately 12 hours apart. There is no ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Dalfampridine extended-release tablet is available in a 10 mg strength and is white to off-white colored, oval shaped, biconvex, film coated tablet debossed with “C51” on one side and plain on ...
  • 4 CONTRAINDICATIONS
    The use of dalfampridine is contraindicated in the following conditions: History of seizure - [see - Warnings and Precautions (5.1)] Moderate or ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Seizures - Dalfampridine can cause seizures. Increased incidence of seizures has been observed at 20 mg twice daily (2 times the maximum recommended dosage) in controlled clinical studies of ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described in more detail elsewhere in the labeling: Seizures - [see Warnings and Precautions - (5.1) ...
  • 7 DRUG INTERACTIONS
    7.1 OCT2 Inhibitors - Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine - [see - Clinical Pharmacology ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate data on the developmental risk associated with use of dalfampridine in pregnant women. Administration of dalfampridine to animals during ...
  • 10 OVERDOSAGE
    Three cases of overdose were reported in controlled clinical trials with dalfampridine, involving two MS patients. The first patient took six times the currently recommended dose (60 mg) and was ...
  • 11 DESCRIPTION
    Dalfampridine extended-release tablet is a potassium channel blocker, available in a 10 mg tablet strength. Each tablet contains 10 mg dalfampridine, formulated as an extended-release tablet for ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Two-year dietary carcinogenicity studies of dalfampridine were conducted in mice and rats. In mice, the doses ...
  • 14 CLINICAL STUDIES
    The effectiveness of dalfampridine in improving walking in patients with multiple sclerosis was evaluated in two adequate and well controlled trials involving 540 patients. Patients in these two ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Dalfampridine extended-release tablets, 10 mg are film-coated, white to off-white colored oval shaped, biconvex, film coated tablet debossed with “C51” on one side and plain on other side. Tablet ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Risk of Seizures - Inform patients that dalfampridine can cause seizures, and that they must discontinue use of ...
  • MEDICATION GUIDE
    Dalfampridine (dal-FAM-pri-deen) Extended-Release Tablets - Read this Medication Guide before you start taking dalfampridine extended-release tablets and each time you get a refill. There may ...
  • PRINCIPAL DISPLAY PANEL
    Dalfampridine 10 mg ER Tablets #60
  • INGREDIENTS AND APPEARANCE
    Product Information