OXCARBAZEPINE suspension

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Hikma Pharmaceuticals USA Inc.

SNN (starptautisko nepatentēto nosaukumu):

OXCARBAZEPINE

Kompozīcija:

OXCARBAZEPINE 300 mg in 5 mL

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 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 with the use of ox

Produktu pārskats:

Oxcarbazepine Oral Suspension, USP 300 mg/5 mL (60 mg/mL) oral suspension is supplied as an off-white to slightly brown or red suspension. NDC 0054-0199-59: Bottle of 250 mL with a 10 mL dosing syringe and press-in bottle adapter Storage Store oxcarbazepine oral suspension in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
OxcarbazepineOral Suspension, USP
(ox” kar baz’ e peen)
Rx only
What is the most important information I should know about
oxcarbazepine?
Do not stop taking oxcarbazepine without first talking to your
healthcare provider. Stopping
oxcarbazepine suddenly can cause serious problems.
Oxcarbazepine can cause serious side effects, including:
1. Oxcarbazepine 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. 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.
2. Oxcarbazepine 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
•
painful sores in the mouth or around your eyes
•
yellowing of your skin or eyes
•
unusual bruising or bleeding
•
hives
•
fever, swollen glands, or sore throat that
do not go away or come and go
•
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. Tell your healthcare
provider if you are allergic to carbamazepine.
3. Like other antiepileptic drugs, oxcarbazepine may cause suici

Produkta apraksts

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
HIKMA PHARMACEUTICALS USA INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Oxcarbazepine oral suspension is indicated for:
•
•
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice-a-day
•
•
•
•
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.
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
Adults: Monotherapy or adjunctive therapy in the treatment of
partial-onset seizures
Pediatrics:
o
o
Monotherapy in the treatment of partial-onset seizures in children 4
to 16 years
Adjunctive therapy in the treatment of partial-onset seizures in
children 2 to 16 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 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 to 16 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 dose
should be achieved over 2 to 4 weeks and should not to exceed 60
mg/kg/day (2.4)
Conversion to Mo