OXCARBAZEPINE- oxcarbazepine tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

A-S Medication Solutions

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Oxcarbazepine tablets are 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 pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures. Oxcarbazepine tablets are 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) ]. Clinical Considerations Oxcarbazepine levels may decrease during pregnancy [see Warnings and Precautions (5.10) ].   Pregnancy Category C Fetal Risk Summary 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. Data on a limited number of pregnancies from pregnancy registries suggest congenital malformations associate

Rezumat produs:

Product: 50090-3961 NDC: 50090-3961-0 33 TABLET, FILM COATED in a BOX, UNIT-DOSE / 1 in a BLISTER PACK

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
A-S Medication Solutions
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MEDICATION GUIDE
Oxcarbazepine Tablets
(ox kar baz' e peen),
for oral use
What is the most important information I should know about
oxcarbazepine tablets?
Do not stop taking oxcarbazepine tablets without first talking to your
healthcare provider. Stopping
oxcarbazepine tablets suddenly can cause serious problems.
Oxcarbazepine tablets can cause serious side effects, including:
1. Oxcarbazepine tablets 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 tablets. 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 tablets.
2. Oxcarbazepine tablets 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
•
•
painful sores in the mouth or around your
eyes
•
yellowing of your skin or eyes
•
unusual bruising or bleeding
•
severe fatigue or weakness
fever, swollen glands, or sore throat that do not
go away or come and go
•
severe muscle pain
•
frequent infections or infections that do
not go away
Many people who are allergic to carbamazepine are also allergic to
oxcarbazepine tablets. Tell your
healthcare provider if you are alle

Caracteristicilor produsului

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXCARBAZEPINE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXCARBAZEPINE
TABLETS.
OXCARBAZEPINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Oxcarbazepine tablets are 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
Known hypersensitivity to oxcarbazepine or to any of its components,
or to eslicarbazepine acetate (4, 5.2)
WARNINGS AND PRECAUTIONS
•
•
•
Dosage and Administration (2.1, 2.4) 11/2017
Contraindications (4) 3/2017
Warnings and Precautions (5.1, 5.3, 5.4, 5.6, 5.7, 5.8, 5.11) 3/2017
Adults: Monotherapy or adjunctive therapy in the treatment of partial
seizures
Pe diatrics:
-
-
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: withdrawal concomitant over 3 to 6 weeks;
reach maximum dose of oxcarbazepine
tablets 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