DALFAMPRIDINE tablet, film coated, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Actavis Pharma, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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 the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% an

Povzetek izdelek:

Dalfampridine extended-release tablets, 10 mg are film-coated, white to off-white, biconvex, oval shaped, unscored tablets. The tablets are identified by a debossed code “WPI ” on one side and “2533 ” on the other side and are available as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Actavis Pharma, Inc.
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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 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 seizure
•
have certain typ

Lastnosti izdelka

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
ACTAVIS PHARMA, 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 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 (4AP,
fampridine), since the active
in