OXCARBAZEPINE- oxcarbazepine tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Lake Erie Medical DBA Quality Care Products LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 associated

Обзор продуктов:

Tablets 150 mg Film-Coated Tablets: yellow, film coated oval, biconvex tablets with deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and "13" and "7" engraved on either side of the deep break line on the other side of the tablet. Bottle of 100.........NDC 68462-137-01 Bottle of 500.........NDC 68462-137-05 300 mg Film-Coated Tablets: yellow, film coated oval, biconvex tablets with deep break line on both sides and "G" and "4" engraved on either side of the deep break line on one side of the tablet. Bottle of 100.........NDC 68462-138-01 Bottle of 500.........NDC 68462-138-05 600 mg Film-Coated Tablets: yellow, film coated oval, biconvex tablets with deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and "13" and "9" engraved on either side of the deep break line on the other side of the tablet. Bottle of 100.........NDC 68462-139-01 Bottle of 500.........NDC 68462-139-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
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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•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 brusing
or bleeding•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 carbam

Характеристики продукта

OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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
Contraindications (4)
3/2017
Warnings and Precautions (5.1, 5.3, 5.4, 5.6, 5.7, 5.8, 5.11)
3/2017
INDICATIONS AND USAGE
Oxcarbazepine tablets are indicated for:
• Adults: Monotherapy or adjunctive therapy in the treatment of
partial seizures
• Pediatrics:
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
•
•
•
•
•
•
- 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 16
years, t