RUFINAMIDE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

RUFINAMIDE (UNII: WFW942PR79) (RUFINAMIDE - UNII:WFW942PR79)

থেকে পাওয়া:

Mylan Pharmaceuticals Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablets are contraindicated in patients with Familial Short QT syndrome [see Warnings and Precautions (5.3)] . There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as rufinamide, during pregnancy. Encourage women who are taking rufinamide during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. There are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. In animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in

পণ্য সারাংশ:

Rufinamide Tablets, USP are available containing 200 mg or 400 mg of rufinamide, USP. The 200 mg tablets are pink, film-coated, oval, functionally scored tablets debossed with RU to the left of the score and 200 to the right of the score on one side of the tablet and a score on the other side. They are available as follows: NDC 0378-2330-91 bottles of 60 tablets NDC 0378-2330-78 bottles of 120 tablets NDC 0378-2330-05 bottles of 500 tablets The 400 mg tablets are pink, film-coated, oval, functionally scored tablets debossed with RU to the left of the score and 400 to the right of the score on one side of the tablet and a score on the other side. They are available as follows: NDC 0378-2331-91 bottles of 60 tablets NDC 0378-2331-78 bottles of 120 tablets NDC 0378-2331-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.  Replace cap securely after opening. 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

RUFINAMIDE- RUFINAMIDE TABLET, FILM COATED
Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE
Rufinamide Tablets, USP
(roo fin' a mide)
Read this Medication Guide before you start taking rufinamide tablets
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about rufinamide
tablets?
Do not stop taking rufinamide tablets without first talking to your
healthcare provider.
Stopping rufinamide tablets suddenly can cause serious problems.
Rufinamide tablets can cause serious side effects, including:
1.
Like other antiepileptic drugs, rufinamide tablets may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about
symptoms.
Do not stop rufinamide tablets without first talking to a healthcare
provider.
•
Stopping rufinamide tablets suddenly can cause serious problems.
Stopping

পণ্য বৈশিষ্ট্য

RUFINAMIDE- RUFINAMIDE TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RUFINAMIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RUFINAMIDE TABLETS.
RUFINAMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Rufinamide tablets are indicated for adjunctive treatment of seizures
associated with Lennox-Gastaut
Syndrome (LGS) in pediatric patients 1 year of age and older, and in
adults (1)
DOSAGE AND ADMINISTRATION
•
Pediatric patients 1 year and older:
•
•
Adults:
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Rufinamide tablets are contraindicated in patients with Familial Short
QT syndrome (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥ 10% and greater than placebo) were
headache, dizziness, fatigue,
somnolence, and nausea (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
•
•
USE IN SPECIFIC POPULATIONS
Rufinamide tablets should be given with food. Tablets can be
administered whole, as half tablets, or
crushed (2.2)
Starting daily dose: 10 mg/kg per day in two equally divided doses
(2.1)
Increase by 10 mg/kg increments every other day to maximum dose of 45
mg/kg per day, not to
exceed 3200 mg per day, in two divided doses (2.1)
Starting daily dose: 400-800 mg per day in two equally divided doses
(2.1)
Increase by 400-800 mg every other day until a maximum dose of 3200 mg
per day, in two divided
doses, is reached (2.1)
Film-coated tablets: 200 mg (pink), 400 mg (pink) (3)
Monitor patients for new or worsening depression, suicidal
thoughts/behavior, and unusual changes in
mood or behavior (5.1)
Central nervous system reactions can occur (5.2)
Use caution when administering rufinamide with other drugs that
shorten the QT interval (5.3)
Discontinue rufinamide if multi-organ hy