DALFAMPRIDINE tablet, film coated, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Mylan Pharmaceuticals Inc.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske 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 extended-release tablets is contraindicated in the following conditions: Risk Summary There are no adequate data on the developmental risk associated with use of dalfampridine extended-release tablets 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% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis result

Proizvod sažetak:

Dalfampridine Extended-Release Tablets are available containing 10 mg of dalfampridine, USP. The 10 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and DF10 on the other side. They are available as follows: NDC 0378-4504-91 bottles of 60 tablets NDC 0378-4504-80 bottles of 180 tablets NDC 0378-4504-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST:  Dispense a Medication Guide with each prescription.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Dalfampridine Extended-Release Tablets
(dal fam' pri deen)
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 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

Svojstava lijeka

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS 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 extended-release tablets are 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
51-80 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
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse events (incidence ≥ 2% and at a rate greater
than the placebo rate) for
dalfampridine extended-release tablets were urinary tract infection,
insomnia, dizziness, headache,
nausea, asthenia, back pain, balance disorder, multiple sclerosis
relapse, paresthesia, nasopharyngitis,
constipation, dyspepsia, and pharyngolaryngea