Dalfampridinedosage
12 HR dalfampridine 10 MG Extended Release Oral Tablet
Dosage and administration
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. In patients with mild renal impairment (CrCl 51 to 80 mL/min), dalfampridine extended-release tablets may reach plasma levels associated with a greater risk of seizures, and the potential benefits of dalfampridine extended-release tablets should be carefully considered against the risk of seizures in these patients
2.1 Dosage Information
The maximum recommended dosage of dalfampridine extended-release tablet is one 10 mg tablet twice daily and should not be exceeded. Take doses approximately 12 hours apart. There is no evidence of additional benefit at doses greater than 10 mg twice daily. Adverse reactions, including seizures, and discontinuations because of adverse reactions were more frequent at higher doses.
2.2 Administration
Instructions Dalfampridine extended-release tablet can be taken with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve dalfampridine extended-release tablets. If a dose is missed, patients should not take double or extra doses.
2.3 Renal Monitoring
Prior to and During Treatment Estimated creatinine clearance (CrCl) should be known before initiating treatment with dalfampridine extended-release tablets, and monitored at least annually during treatment with dalfampridine extended-release tablets. CrCl can be estimated using the following equation (multiply by 0.85 for women): dalfampridine-equa
2.4 Dosage in
Patients with Renal Impairment In patients with mild renal impairment (CrCl 51 to 80 mL/min), dalfampridine extended-release tablet plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that is 1.5 times the maximum recommended dose and may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients. The potential benefits of dalfampridine extended-release tablet should be carefully considered against the risk of seizures in these patients. Dalfampridine extended-release tablet is contraindicated in patients with moderate or severe renal impairment (CrCl≤50 mL/min).
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 28, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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