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DOSAGE AND ADMINISTRATION
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) x weight(kg)/ SerumCr(mg / dl) x 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 and CLINICAL PHARMACOLOGY].
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”].
Dosage Forms And Strengths
AMPYRA is available in a 10 mg strength and is a film-coated, white to off-white, biconvex, oval shaped, non-scored tablet with flat edge, debossed with “A10” on one side.
Storage And Handling
AMPYRA (dalfampridine) Extended Release Tablets, 10 mg are film-coated, white to off-white, biconvex, oval shaped, non-scored tablets with flat edge. The tablets are identified by a debossed code “A10” on one side and are available in bottles of 60.
NDC 10144-427-60 bottles of 60 tablets
Store at 25°C (77°F). Excursions permitted 15–30°C (59–86°F).
Distributed by: Acorda Therapeutics, Inc. Ardsley, NY 10502. Issued 01/2013. Manufactured for Acorda under license from Alkermes Pharma Ireland Limited (APIL), Athlone, Ireland, utilizing APIL's MatriX Drug Absorption System (MXDAS®) technology. Revised: 01/2013
Last reviewed on RxList: 2/4/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Ampyra Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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