AMPYRA 10 mg/1
Dalfampridine · TABLET, FILM COATED, EXTENDED RELEASE · Merz Pharmaceuticals, LLC
AMPYRA is a tablet, film coated, extended release containing dalfampridine at 10 mg/1, taken oral. Manufactured by Merz Pharmaceuticals, LLC.
Key Facts
- Brand Name
- AMPYRA
- Generic Name
- Dalfampridine
- NDC Code (Product)
0259-5010- Manufacturer
- Merz Pharmaceuticals, LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA022250
- Drug Class
- Potassium Channel Blocker [EPC]
- Marketing Start
- 03/01/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14) ]. AMPYRA ® (dalfampridine) is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1 , 14 ).
Dosage & Administration
2 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. ( 2.1 ) Take with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve ( 2.2 ) Patients should not take double or extra doses if they miss a dose. ( 2.2 ) Estimated creatinine clearance (CrCl) should be known before initiating treatment with AMPYRA. In patients with mild renal impairment (CrCl 51–80 mL/min), AMPYRA may reach plasma levels associated with a greater risk of seizures, and the potential benefits of AMPYRA should be carefully considered against the risk of seizures in these patients ( 2.3 , 5.2 , 8.6 ) 2.1 Dosage Information The maximum recommended dosage of AMPYRA 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…
Contraindications
4 CONTRAINDICATIONS The use of AMPYRA is contraindicated in the following conditions: History of seizure [ see Warnings and Precautions (5.1) ] Moderate or severe renal impairment (CrCl≤50 mL/min) [see Warnings and Precautions (5.2) ] History of hypersensitivity to AMPYRA or 4-aminopyridine; reactions have included anaphylaxis [see Warnings and Precautions (5.4) ] History of seizure ( 4 ) Moderate or severe renal impairment (CrCl≤50 mL/min) ( 4 ) History of hypersensitivity to AMPYRA or 4-aminopyridine ( 4 )
Drug Interactions
7 DRUG INTERACTIONS OCT2 Inhibitors: Concomitant use may cause an increased exposure and potential risk of seizures ( 7.1 ) 7.1 OCT2 Inhibitors Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine [ see Clinical Pharmacology (12.3) ]. Elevated levels of dalfampridine increase the risk of seizures [ see Warnings and Precautions (5.1 , 5.2) ]. The potential benefits of taking OCT2 inhibitors concurrently with AMPYRA should be considered against the risk of seizures in these patients. 7.2 Baclofen No interaction was identified between dalfampridine and baclofen [see Clinical Pharmacology (12.3) ].
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail elsewhere in the labeling: Seizures [see Warnings and Precautions (5.1) ] Anaphylaxis [see Warnings and Precautions (5.4) ] The most common adverse events (incidence ≥2% and at a rate greater than the placebo rate) for AMPYRA were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Acorda Therapeutics at 1-800-367-5109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In three placebo-controlled clinical trials of up to 14 weeks duration, 4% (15/400) of patients treated with AMPYRA 10 mg twice daily experienced one or more adverse reactions leading to discontinuation, compared to 2% (5/238…
Frequently Asked Questions
What is AMPYRA used for?
AMPYRA contains Dalfampridine. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is AMPYRA a controlled substance?
AMPYRA is not classified as a controlled substance by the DEA.
What is the generic name for AMPYRA?
The generic name for AMPYRA is Dalfampridine. There are 10 other brand versions of Dalfampridine.
What is the NDC code for AMPYRA 10 mg/1?
The NDC (National Drug Code) for AMPYRA 10 mg/1 is 0259-5010, listed by Merz Pharmaceuticals, LLC.