DALFAMPRIDINE tablet, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Sun Pharmaceutical Industries, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Dalfampridine extended-release tablets are 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 extended-release tablets are 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 the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognize

leaflet_short:

Dalfampridine extended-release tablets, 10 mg are white to off-white, round, biconvex, beveled edged, film-coated tablets imprinted with “429” in black ink on one side and plain on the other side. They are available as: Bottles of 60 with Child-resistant Cap ………….….. NDC 62756-429-86 Store dalfampridine extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
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 many
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 prescription medicines 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 tablets are 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

מאפייני מוצר

DALFAMPRIDINE - DALFAMPRIDINE TABLET, EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 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
extended-release tablets. In patients with mild renal impairment (CrCl
51 to 80 mL/min), dalfampridine
extended-release tablets may reach plasma levels associated with a
greater risk of seizures, and the
potential benefits of dalfampridine extended-release tablets 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 extended-release tablets
or 4-aminopyridine (4)
WARNINGS AND PRECAUTIONS
Dalfampridine extended-release tablets can cause seizures; the risk of
seizures increases with
increasing dalfampridine extended-release tablets doses; discontinue
dalfampridine extended-release
tablets and do not restart if a seizure occurs (