DALFAMPRIDINE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: There are no adequate and well-controlled studies of dalfampridine in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at doses similar to the maximum recommended human dose (MRHD) of 20 mg/day. Dalfampridine extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In developmental toxicity studies in rats and rabbits, dalfampridine was administered orally at doses up to 10 and 5 mg/kg/day, respectively, during the period of organogenesis. These doses are approximately 5 times the MRHD on a body surface area (mg/m2 ) basis. No evidence

Product summary:

Dalfampridine Extended-Release Tablets are available in a 10 mg strength and are film-coated, white to off-white, biconvex, oval shaped, non-scored tablets with a flat edge debossed with “A10” on one side. They are available in bottles of 60. Store at 25°C (77°F). Excursions permitted 15ºC to 30ºC (59ºF to 86ºF).

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

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 certa

Summary of Product characteristics

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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
10 mg tablets (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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 pharyngolaryngeal pain
(6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
OCT2 Inhibitors: Concomitant use may cause an increased exposure and
potential risk of seizures (7.1)
USE IN SPECIFIC POPULATIONS
•
•
•
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.