RUFINAMIDE suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Glasshouse Pharmaceuticals Limited Canada

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 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. gene

Produktsammanfattning:

Rufinamide oral suspension is an 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 71428-009-46). Store the oral suspension at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Replace cap securely after opening. The cap fits properly in place when the adapter is in place.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Glasshouse Pharmaceuticals Limited Canada
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Medication Guide
Rufinamide (roo fin' a mide)
Oral Suspension
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 suspension sudden

Produktens egenskaper

RUFINAMIDE- RUFINAMIDE SUSPENSION
GLASSHOUSE PHARMACEUTICALS LIMITED CANADA
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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.
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: 400-800 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)
DOSAGE FORMS AND STRENGTHS
Oral suspension: 40 mg/mL ( 3)
CONTRAINDICATIONS
Rufinamide 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 ORAL SUSPENSION with other
drugs that shorten the QT
interval ( 5.3)
Discontinue RUFINAMIDE ORAL SUSPENSION if multi-organ hypersensitivity
reaction occurs ( 5.4)
Withdraw RUFINAMIDE ORAL SUSPENSION 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