OXCARBAZEPINE suspension

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

OXCARBAZEPINE (UNII: VZI5B1W380) (OXCARBAZEPINE - UNII:VZI5B1W380)

Beschikbaar vanaf:

Akorn

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine oral suspension is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see Warnings and Precautions (5.2, 5.3) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as oxcarbazepine, during pregnancy. Encourage women who are taking oxcarbazepine 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 wit

Product samenvatting:

Suspension 300 mg/5 mL (60 mg/mL) Oral Suspension: off-white to slightly brown or slightly red suspension. Available in PET amber bottle containing 250 mL of oral suspension. Supplied with a 10 mL dosing syringe and press-in bottle adapter. Bottle containing 250 mL of oral suspension………….…………………NDC 50383-312-84 Store Oxcarbazepine Oral Suspension, USP in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Akorn
----------
MEDICATION GUIDE
MEDICATION GUIDE
OxcarbazepineOral Suspension
(ox” kar baz’ e peen)
What is the most important information I should know about
Oxcarbazepine Oral
Suspension?
Do not stop taking Oxcarbazepine Oral Suspension without first talking
to your
healthcare provider. Stopping Oxcarbazepine Oral Suspension suddenly
can cause
serious problems.
Oxcarbazepine Oral Suspension can cause serious side effects,
including:
1. Oxcarbazepine Oral Suspension may cause the level of sodium in your
blood to
be low. Symptoms of low blood sodium include:
•
nausea
•
tiredness (lack of energy)
•
headache
•
confusion
•
more frequent or more severe seizures
Similar symptoms that are not related to low sodium may occur from
taking
Oxcarbazepine Oral Suspension. You should tell your healthcare
provider if you
have any of these side effects and if they bother you or they do not
go away.
Some other medicines can also cause low sodium in your blood. Be sure
to tell
your healthcare provider about all the other medicines that you are
taking.
Your healthcare provider may do blood tests to check your sodium
levels during
your treatment with Oxcarbazepine Oral Suspension.
2. Oxcarbazepine Oral Suspension may also cause allergic reactions or
serious
problems which may affect organs and other parts of your body like the
liver or
blood cells. You may or may not have a rash with these types of
reactions.
Call your healthcare provider right away if you have any of the
following:
•
swelling of your face, eyes, lips, or tongue
•
trouble swallowing or breathing
•
a skin rash
•
hives
•
fever, swollen glands, or sore throat that do not go away or come and
go
•
painful sores in the mouth or around your eyes
•
yellowing of your skin or eyes
•
unusual bruising or bleeding
•
severe fatigue or weakness
•
severe muscle pain
•
frequent infections or infections that do not go away
Many people who are allergic to carbamazepine are also allergic to
Oxcarbazepine
Oral Suspension. Tell your healthcare provi

Productkenmerken

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
AKORN
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXCARBAZEPINE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR OXCARBAZEPINE
ORAL SUSPENSION.
OXCARBAZEPINE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Oxcarbazepine oral suspension is indicated for: (1)
•
•
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice-a-day (2)
•
•
•
•
Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For
patients aged 2 to <4 years and under
20 kg, a starting dose of 16 to 20 mg/kg/day may be considered.
Recommended daily dose is dependent
upon patient weight. (2)
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to oxcarbazepine or to any of its components,
or to eslicarbazepine acetate (4,
5.2) (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
Adults: Monotherapy or adjunctive therapy in the treatment of
partial-onset seizures
Pediatrics:
- Monotherapy in the treatment of partial-onset seizures in children 4
to16 years
- Adjunctive therapy in the treatment of partial-onset seizures in
children 2 to16 years (1)
Adjunctive Therapy: Maximum increment of 600 mg/day at approximately
weekly intervals. The
recommended daily dose is 1200 mg/day (2.1)
Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;
reach maximum dose of
oxcarbazepine oral suspension in 2 to 4 weeks with increments of 600
mg/day at weekly intervals to a
recommended daily dose of 2400 mg/day (2.2)
Initiation of Monotherapy: Increments of 300 mg/day every third day to
a dose of 1200 mg/day (2.3)
Initiate at one-half the usual starting dose and increase slowly in
patients with a creatinine clearance
<30 mL/min, (2.7)
Adjunctive Patients (Aged 2 to16 Years): For patients aged 4 to 16
years, target maintenance dose
should be achieved over 2 weeks (2.4). For patients aged 2 to <4
years, maximum maintenance dos