OXCARBAZEPINE suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

EPIC PHARMA, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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 Oral Suspension, during pregnancy. Encourage women who are taking Oxcarbazepine Oral Suspension 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 d

Produktsammanfattning:

Oxcarbazepine Oral Suspension Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL (60 mg/mL), off-white to light yellow uniform suspension. Available in amber glass bottles 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 42806-600-22 Store Oxcarbazepine Oral Suspension in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

EPIC PHARMA, LLC
----------
This Medication Guide has been approved by the
U.S. Food and Drug Administration
Dispense with Medication Guide available at:
www.epic-pharma.com/medguide/Oxcarbazepine-Oral-
Suspension.pdf.
MEDICATION GUIDE
Oxcarbazepine (ox-kar-BAY-zeh-peen)
Oral Suspension, USP
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
• confusion
• tiredness (lack of energy)
• more frequent or more severe seizures
• headache
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
• Painful sores in the mouth or around your eyes
• trouble swallowing or breathing
• yellowing of your skin or eyes
• a skin rash
• unusual bruising or bleeding
• hives
• severe fatigue or weakness
• fever, swollen glands, or sore throat that do
not go away or come and go
• severe muscle

Produktens egenskaper

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
EPIC PHARMA, LLC
----------
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:
Adults: Monotherapy or adjunctive therapy in the treatment of
partial-onset seizures
Pediatrics:
- Monotherapy in the treatment of partial-onset seizures in children
4-16 years
- Adjunctive therapy in the treatment of partial-onset seizures in
children 2-16 years (1)
DOSAGE AND ADMINISTRATION
Adults: initiate with a dose of 600 mg/day, given twice a day
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)
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.
Adjunctive Patients (Aged 2-16 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 Monotherapy for Patients (Aged 4-16 Years): Maximum
increment of 10 mg/kg/day at
weekly intervals, concomitant antiepileptic drugs (AEDs) can be
completely wi