RUFINAMIDE suspension

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Aurobindo Pharma Limited

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Rufinamide oral suspension is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide oral suspension is contraindicated in patients with Familial Short QT syndrome [see Warnings and Precautions (5.3)] . Pregnancy Exposure Registry 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. Risk Summary 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 bac

পণ্য সারাংশ:

Rufinamide oral suspension is a white to off-white, orange flavored liquid supplied in a polyethylene terephthalate (PET) bottle with child-resistant closure. The oral suspension is packaged with a dispenser set which contains a calibrated oral dosing syringe and an adapter. Store the oral suspension in an upright position. Use within 90 days of first opening the bottle, then discard any remainder. The oral suspension is available in bottles of 460 mL (NDC 59651-563-60). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  Replace cap securely after opening. The cap fits properly in place when the adapter is in place.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

RUFINAMIDE - RUFINAMIDE SUSPENSION
Aurobindo Pharma Limited
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Medication Guide
Rufinamide Oral Suspension
(roo FIN a mide)
Read this Medication Guide before you start taking rufinamide oral
suspension 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
oral suspension?
Do not stop taking rufinamide oral suspension without first talking to
your healthcare provider.
Stopping rufinamide oral suspension suddenly can cause serious
problems.
Rufinamide oral suspension can cause serious side effects, including:
1. Like other antiepileptic drugs, rufinamide oral suspension 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 oral suspension without first talking to a
healthcare provider.
•
Stopping rufinamide oral

পণ্য বৈশিষ্ট্য

RUFINAMIDE - RUFINAMIDE SUSPENSION
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RUFINAMIDE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR RUFINAMIDE ORAL
SUSPENSION.
RUFINAMIDE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Rufinamide oral suspension is 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
Rufinamide oral suspension should be given with food. (2.2)
Measure oral suspension using provided adapter and dosing syringe
(2.2)
Pediatric patients 1 year and older:
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)
Adults:
Starting daily dose: 400 mg to 800 mg per day in two equally divided
doses (2.1)
Increase by 400 mg to 800 mg every other day until a maximum dose of
3200 mg per day, in two
divided doses, is reached (2.1)
DOSAGE FORMS AND STRENGTHS
Oral suspension: 40 mg/mL (3)
CONTRAINDICATIONS
Rufinamide oral suspension is contraindicated in patients with
Familial Short QT syndrome (4)
WARNINGS AND PRECAUTIONS
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 hypersensitivity reaction occurs
(5.4)
Withdraw rufinamide gradually to minimize the risk of precipitating
seizures, seizure exacerbation, or
status epilepticus (5.5)
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 AUROBI