OXCARBAZEPINE suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Oxcarbazepine Oral Suspension USP, 300 mg/5 mL (60 mg/mL), is supplied as off-white to slightly yellow colored suspension. Available in amber glass bottles containing 250 mL of oral suspension. Supplied with a 10 mL dosing syringe and press-in bottle adapter. NDC: 70518-2946-00 NDC: 70518-2946-01 NDC: 70518-2946-02 NDC: 70518-2946-03 PACKAGING: 10 in 1 BOX PACKAGING: 5 in 1 CUP UNIT DOSE PACKAGING: 10 in 1 CUP UNIT DOSE PACKAGING: 7.50 in 1 CUP UNIT DOSE 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° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

REMEDYREPACK INC.
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MEDICATION GUIDE
Oxcarbazepine (ox-kar-BAY-zeh-peen) Oral Suspension
W h at 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
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 pain
Many people who are allergic to carbamazepine are also allergic to
oxcarbazepine oral suspension. Tell your
healthcare provider if you are allergic to carbamazepine.
3. Like other antiepileptic drugs, oxcarbazepine oral suspension may
cause suicidal though

Résumé des caractéristiques du produit

OXCARBAZEPINE- OXCARBAZEPINE SUSPENSION
REMEDYREPACK 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
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
to 16 years
- Adjunctive therapy in the treatment of partial-onset seizures in
children 2 to 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 1,200 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 2,400 mg/day. ( 2.2)
Initiation of Monotherapy: Increments of 300 mg/day every third day to
a dose of 1,200 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 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 Monotherapy for Patients (Aged 4 to 16 Years): Maximum
increment of 10 mg/kg/day at
weekly intervals, concomitant antiepileptic drugs ca