OXCARBAZEPINE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

OXCARBAZEPINE

Composition:

OXCARBAZEPINE 60 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxcarbazepine oral suspension, USP is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures. Oxcarbazepine oral suspension should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components. Oxcarbazepine levels may decrease during pregnancy [see Warnings and Precautions (5.10)]. Pregnancy Category C There are no adequate and well-controlled clinical studies of oxcarbazepine in pregnant women; however, oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. Given this fact, and the results of the animal studies described, it is likely that oxcarbazepine is a human teratogen. Oxcarbazepine should be used during pregnancy only if the potential benefit justifies the potential risk to t

Product summary:

Oxcarbazepine oral suspension, USP is an off-white to slightly yellow liquid filled in 300 mL amber glass bottle with child resistant closure containing 250 mL of oral suspension and is supplied with a 10 mL dosing syringe and press-in bottle adapter. NDC 63304-653-25 Bottle containing 250 mL of oral suspension Store oxcarbazepine oral suspension, USP in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
Ranbaxy Pharmaceuticals Inc.
----------
MEDICATION GUIDE
OXCARBAZEPINE ORAL SUSPENSION, USP
Rx only
Read this Medication Guide before you start taking oxcarbazepine oral
suspension, USP 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
oxcarbazepine oral suspension, USP?
Do not stop taking oxcarbazepine oral suspension, USP without first
talking to your healthcare provider.
Stopping oxcarbazepine oral suspension, USP suddenly can cause serious
problems.
Oxcarbazepine oral suspension, USP can cause serious side effects,
including:
1. Oxcarbazepine oral suspension, USP 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, USP. 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.
2. Oxcarbazepine oral suspension, USP 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 weak

Summary of Product characteristics

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
RANBAXY PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXCARBAZEPINE ORAL SUSPENSION, USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXCARBAZEPINE
ORAL SUSPENSION, USP.
OXCARBAZEPINE ORAL SUSPENSION, USP FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 06/2014
INDICATIONS AND USAGE
Oxcarbazepine oral suspension, USP is an antiepileptic drug indicated
for: (1)
•
•
DOSAGE AND ADMINISTRATION
ADULTS: initiated with a dose of 600 mg/day, given in twice-a-day
regimen (2)
•
•
•
CHILDREN: initiation with 8 to 10 mg/kg/day, given in twice-a-day
regimen. 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)
•
•
Maximum increment of 10 mg/kg/day at weekly intervals, concomitant
antiepileptic drugs can be completely withdrawn
over 3 to 6 weeks (2.5) (2)
•
Increments of 5 mg/kg/day every third day (2.6) (2)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
Adults:
•
Monotherapy or adjunctive therapy in the treatment of partial seizures
Childre n:
•
•
Monotherapy in the treatment of partial seizures in children 4 to 16
years
Adjunctive therapy in the treatment of partial 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: Concomitant AEDs should be completely
withdrawn over 3 to 6 weeks, while maximum
dose of oxcarbazepine should be reached in about 2 to 4 weeks. Maximum
increment of 600 mg/day at approximately
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)
Adjunctive Patients (Aged 2 to 16 Years):