Patient Information ⮝
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risk of Seizures
Inform patients that AMPYRA can cause seizures, and that they must discontinue use of AMPYRA if they experience a seizure [
AMPYRA can cause seizures.
- You could have a seizure even if you never had a seizure before.
- Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50.
- Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking AMPYRA.
- Do not take AMPYRA if you have ever had a seizure.
- Before taking AMPYRA tell your doctor if you have kidney problems.
- Take AMPYRA exactly as prescribed by your doctor.
AMPYRA is a prescription medicine used to help improve walking in adults with multiple sclerosis (MS). This was shown by an increase in walking speed.
It is not known if AMPYRA is safe or effective in children less than 18 years of age.
Do Not Take Ampyra If You: ⮝
- have ever had a seizure
- have certain types of kidney problems
- are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA
Before You Take Ampyra, Tell Your Doctor If You: ⮝
- have any other medical conditions
- are taking compounded 4-aminopyridine (fampridine, 4-AP)
- are taking any other medicines, including over-the-counter medicines such as cimetidine
- are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby. You and your doctor will decide if you should take AMPYRA while you are pregnant
- are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both.
Tell your doctor about all the medicines you take,including prescription and non-prescription medicines, vitamins and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How Should I Take Ampyra? ⮝
- Take AMPYRA exactly as your doctor tells you to take it. Do not change your dose of AMPYRA.
- Take one tablet of AMPYRA 2 times each day about 12 hours apart. Do not take more than 2 tablets of AMPYRA in a 24-hour period.
- Take AMPYRA tablets whole. Do not break, crush, chew or dissolve AMPYRA tablets before swallowing. If you cannot swallow AMPYRA tablets whole, tell your doctor.
- AMPYRA is released slowly over time. If the tablet is broken, the medicine may be released too fast. This can raise your chance of having a seizure.
- AMPYRA can be taken with or without food.
- If you miss a dose of AMPYRA, do not make up the missed dose. Do not take 2 doses at the same time. Take your next dose at your regular scheduled time.
- If you take too much AMPYRA, call your doctor or go to the nearest hospital emergency room right away.
- Do not take AMPYRA together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).
Ampyra May Cause Serious Side Effects, Including: ⮝
- serious allergic reactions. Stop taking AMPYRA and call your doctor right away or get emergency medical help if you have:
- shortness of breath or trouble breathing
- swelling of your throat or tongue
- hives
- Store AMPYRA at 59 F to 86 F (15 C to 30 C).
- Safely throw away AMPYRA that is out of date or no longer needed.
Keep AMPYRA and all medicines out of the reach of children.
General Information about the safe and effective use of AMPYRA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMPYRA for a condition for which it was not prescribed. Do not give AMPYRA to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about AMPYRA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about AMPYRA that is written for health professionals.
For more information, go towww.AMPYRA.comor call 1-800-367-5109.
Active Ingredient: ⮝
dalfampridine (previously called fampridine)
Inactive Ingredients: ⮝
colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.Distributed by: Acorda Therapeutics, Inc.
Ardsley, NY 10502Revised 09/2017
This Medication Guide has been approved by the U.S. Food and Drug Administration.
AMPYRA is a registered trademark of Acorda Therapeutics, Inc.
Manufactured for Acorda under license from Alkermes Pharma Ireland Limited (APIL), Athlone, Ireland, utilizing APIL's MatriX Drug Absorption System (MXDAS ) technology.
MXDAS is a registered trademark of Alkermes Pharma Ireland Limited (APIL).
U.S. Patent Nos.: US 5,540,938; US 8,007,826; US 8,354,437; US 8,440,703; and US 8,663,685
2017 Acorda Therapeutics, Inc. All rights reserved.0917427AK-0
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Label
ampyra
(dalfampridine)
Extended Release
TabletsRx ONLY
10 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient60 tablets
AMPYRA
dalfampridine tablet, film coated, extended release
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10144-427 Route of Administration ORAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DALFAMPRIDINE(UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9) DALFAMPRIDINE 10 mg
Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U) HYPROMELLOSES(UNII: 3NXW29V3WO) SILICON DIOXIDE(UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE(UNII: 70097M6I30) TITANIUM DIOXIDE(UNII: 15FIX9V2JP) POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
Product Characteristics Color white (white to off-white) Score no score Shape OVAL (biconvex) Size 13mm Flavor Imprint Code A;10 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10144-427-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022250 03/01/2010
Labeler -Acorda Therapeutics, Inc. (963845136)
Establishment Name Address ID/FEI Business Operations Alkermes Gainesville LLC 057585150 pack(10144-427) , label(10144-427)
Establishment Name Address ID/FEI Business Operations Sharp Corporation 143696495 label(10144-427) , pack(10144-427)
Establishment Name Address ID/FEI Business Operations Patheon Inc., Toronto Regional Operations 240769596 manufacture(10144-427) , pack(10144-427) , label(10144-427) , analysis(10144-427)
Establishment Name Address ID/FEI Business Operations Alkermes Pharma Ireland Limited 896838492 manufacture(10144-427)
Revised: 9/2017document Id: ⮝
5a970cb6-fb01-1f85-e053-2a91aa0a4608Set id: 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Version: 12Effective Time: 20170929Acorda Therapeutics, Inc.