DALFAMPRIDINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)

Available from:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dalfampridine extended-release tablet 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)]. The use of dalfampridine 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 dalfampridine or 4-aminopyridine; reactions have included anaphylaxis [see Warnings and Precautions (5.4)] Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [ see Data ]. In t

Product summary:

Dalfampridine extended-release tablets, 10 mg are film-coated, white to off-white colored oval shaped, biconvex, film coated tablet debossed with “C51” on one side and plain on other side. Tablet dimensions are approximately 13 mm (Length) and 8 mm (Width). Bottles of 60                           NDC 42571-275-60 Bottles of 500                         NDC 42571-275-05 Bottles of 1,000                      NDC 42571-275-10 Store at 25°C (77°F). Excursions permitted 15ºC to 30ºC (59ºF to 86ºF).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Micro Labs Limited
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MEDICATION GUIDE
Dalfampridine (dal-FAM-pri-deen) Extended-Release Tablets
Read this Medication Guide before you start taking dalfampridine
extended-release tablets and each time you
get a refill. There may be new information. This information does not
take the place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about
dalfampridine extended-release tablets?
Dalfampridine extended-release tablets 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
dalfampridine extended-release tablets
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 dalfampridine extended-release tablets.
•
Do not take dalfampridine extended-release tablets if you have ever
had a seizure.
•
Before taking dalfampridine extended-release tablets tell your doctor
if you have kidney problems.
•
Take dalfampridine extended-release tablets exactly as prescribed by
your doctor. See “How should I
take dalfampridine extended-release tablets?”
Stop taking dalfampridine extended-release tablets and call your
doctor right away if you have a seizure
while taking dalfampridine extended-release tablets.
What are dalfampridine extended-release tablets?
Dalfampridine extended-release tablets are 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 dalfampridine extended-release tablet is safe or
effective in children less than 18 years of
age.
Who should not take dalfampridine extended-release tablets?
Do not take dalfampridine extended-release tablets if you:
•
have ever had a seizure
•
have certain types of kidney problems
•
are allergic to dalfampridine (4-aminopyridine),

Summary of Product characteristics

DALFAMPRIDINE- DALFAMPRIDINE TABLET, EXTENDED RELEASE
MICRO LABS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DALFAMPRIDINE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DALFAMPRIDINE EXTENDED-RELEASE TABLETS.
DALFAMPRIDINE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
Dalfampridine extended-release tablet 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 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 dalfampridine. In
patients with mild renal impairment (CrCl 51 to 80 mL/min),
dalfampridine may reach plasma levels
associated with a greater risk of seizures, and the potential benefits
of dalfampridine should be carefully
considered against the risk of seizures in these patients ( 2.3, 5.2,
8.6)
DOSAGE FORMS AND STRENGTHS
10 mg tablets (3)
CONTRAINDICATIONS
History of seizure (4)
Moderate or severe renal impairment (CrCl≤50 mL/min) (4)
History of hypersensitivity to dalfampridine or 4-aminopyridine (4)
WARNINGS AND PRECAUTIONS
Dalfampridine can cause seizures; the risk of seizures increases with
increasing dalfampridine doses;
discontinue dalfampridine and do not restart if a seizure occurs (5.1)
Avoid concomitant use with other forms of 4-aminopyridine (4­
AP, fampridine), since the active ingredient is the same (5.3)
Dalfampridine can cause anaphyla