Generic name: DALFAMPRIDINE 10mg
Dosage form: tablet, film coated, extended release
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The maximum recommended dose of AMPYRA is one 10 mg tablet twice daily, taken with or without food, and should not be exceeded. Doses should be taken approximately 12 hours apart. Tablets should only be taken whole; do not divide, crush, chew, or dissolve. Patients should not take double or extra doses if a dose is missed.
Estimated creatinine clearance (CrCl) should be known before initiating treatment with AMPYRA, and monitored at least annually during treatment with AMPYRA. CrCl can be estimated using the following equation (multiply by 0.85 for women):
|CrCl =||(140 - age) × weight( kg)|
|SerumCr( mg/ dl)× 72|
In patients with mild renal impairment (CrCl 51–80 mL/min), AMPYRA plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that 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 AMPYRA should be carefully considered against the risk of seizures in these patients [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.4)].
No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse reactions and discontinuations because of adverse reactions were more frequent at higher doses [see FDA-Approved Patient Information for complete "Instructions for Use"].