Drug Interaction:
None identified
Indication:
Proprietary Name- Ampyra
Established Name - Dalfampridine
Applicant- Accordia Therapeutic Inc
Indication-
Indicated to improve walking ability of patients in Multiple sclerosis(MS).
This was demonstrated in walking speed
Approved by FDA on 22-1-2011 (Ref- FDA approved List- 2010)
Adverse Reaction:
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
Contra-Indications:
CONTRAINDICATIONS
History of seizure
Moderate or severe renal impairment (CrCl.50 mL/min)
History of hypersensitivity to AMPYRA or 4-aminopyridine
WARNINGS AND PRECAUTIONS
AMPYRA can cause seizures; the risk of seizures increases with increasing
AMPYRA doses. Discontinue AMPYRA and do not restart if a seizure occurs
AMPYRA should not be taken with other forms of 4-aminopyridine (4AP, fampridine),
since the active ingredient is the same.
AMPYRA can cause anaphylaxis.
Discontinue and do not restart AMPYRA if this occurs
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
AMPYRAR (dalfampridine) is a potassium channel blocker indicated to
improve walking in patients with multiple sclerosis (MS).
This was demonstrated by an increase in walking speed
DOSAGE AND ADMINISTRATION
The maximum recommended dose is 10 mg twice daily (approximately
12 hours apart), with or without food. Tablets should only be taken whole;
do not divide, crush, chew, or dissolve
Estimated creatinine clearance (CrCl) should be known before initiating
treatment with AMPYRA.
In patients with mild renal impairment (CrCl 51¡V80 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
Patients should not take double or extra doses if a dose is missed.
No additional benefit was demonstrated at doses greater than 10 mg
twice daily and adverse events, including seizures, were more frequent
at higher doses
DOSAGE FORMS AND STRENGTHS
10 mg tablets
Patient Information:
1 Risk of Seizures
Inform patients that AMPYRA can cause seizures, and that they must
discontinue use of AMPYRA if they experience a seizure.
2 AMPYRA dosing-
Instruct patients to take AMPYRA exactly as prescribed.
Instruct patients not to take a double dose after they miss a dose,
as this would increase their risk of seizure.
3. Instruct patients not to take more than 2 tablets in a 24-hour period
and to make sure that there is an approximate 12-hour interval between doses.
4. Anaphylaxis
Advise patients to discontinue AMPYRA and seek medical care if
they develop signs and symptoms of anaphylaxis.
5. Storage
Advise patients to store AMPYRA at 25°C (77°F).
6.Advise patients to safely throw away AMPYRA that is out of date
or no longer needed
Pharmacology/ Pharmacokinetics:
1 Mechanism of action
The mechanism by which dalfampridine exerts its therapeutic effect has not
been fully elucidated. Dalfampridine is a broad spectrum potassium
channel blocker. In animal studies, dalfampridine has been shown to
increase conduction of action potentials in demyelinated axons through
inhibition of potassium channels.
2 Pharmacodynamics
AMPYRA does not prolong the QTc interval and does not have a clinically
important effect on QRS duration.
3 Pharmacokinetics
Absorption and Distribution:
Orally administered dalfampridine is rapidly and completely absorbed
from the gastrointestinal tract. Absolute bioavailability of extended
release AMPYRA tablets has not been assessed, but relative bioavailability
is 96% when compared to an aqueous oral solution.
The extended release tablet delays absorption of dalfampridine
relative to the solution formulation, giving a slower rise to a lower peak
concentration (Cmax), with no effect on the extent of absorption (AUC).
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
Pregnancy:
Based on animal data, may cause fetal harm
Nursing Mothers:
Discontinue drug or nursing taking into consideration importance
of drug to mother
Geriatric use:
Because elderly patients are more likely to have decreased
renal function, it is particularly important to know the estimated
CrCl in these patients before initiating AMPYRA treatment
Manufacturer Details