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AMPYRA- dalfampridine tablet, film coated, extended release


  1. Patient Information
  2. Do Not Take Ampyra If You:
  3. Before You Take Ampyra, Tell Your Doctor If You:
  4. How Should I Take Ampyra?
  5. Ampyra May Cause Serious Side Effects, Including:
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Revised: 9/2017document Id:

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 10502

Revised 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

Tablets

Rx ONLY

10 mg

PHARMACIST: Dispense the accompanying

Medication Guide to each patient

60 tablets

sharp-bottle

AMPYRA
dalfampridine tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10144-427
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DALFAMPRIDINE(UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)DALFAMPRIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white to off-white)Scoreno score
ShapeOVAL (biconvex)Size13mm
FlavorImprint CodeA;10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10144-427-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02225003/01/2010
Labeler -Acorda Therapeutics, Inc. (963845136)
Establishment
NameAddressID/FEIBusiness Operations
Alkermes Gainesville LLC057585150pack(10144-427) , label(10144-427)
Establishment
NameAddressID/FEIBusiness Operations
Sharp Corporation143696495label(10144-427) , pack(10144-427)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Inc., Toronto Regional Operations240769596manufacture(10144-427) , pack(10144-427) , label(10144-427) , analysis(10144-427)
Establishment
NameAddressID/FEIBusiness Operations
Alkermes Pharma Ireland Limited896838492manufacture(10144-427)

Revised: 9/2017document Id: 

5a970cb6-fb01-1f85-e053-2a91aa0a4608Set id: 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Version: 12Effective Time: 20170929Acorda Therapeutics, Inc.



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