Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
OXCARBAZEPINE (UNII: VZI5B1W380) (OXCARBAZEPINE - UNII:VZI5B1W380)
West-Ward Pharmaceticals Corp.
OXCARBAZEPINE
OXCARBAZEPINE 150 mg
ORAL
PRESCRIPTION DRUG
Oxcarbazepine Tablets are 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 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 no adequate data on the developmental risks associated with the use of oxcarbaze
Oxcarbazepine Tablets, USP 150 mg tablets are supplied as a round, peach, speckled, biconvex tablet, debossed with product identification “54 331” on one side and a bisect on the other side. NDC 0054-0097-25: Bottle of 100 Tablets NDC 0054-0097-20: 2x5x10 Unit-Dose 300 mg tablets are supplied as a round, peach, speckled, biconvex tablet, debossed with product identification “54 515” on one side and a bisect on the other side. NDC 0054-0098-25: Bottle of 100 Tablets NDC 0054-0098-20: 2x5x10 Unit-Dose 600 mg tablets are supplied as a modified oval, peach, speckled, biconvex tablet, debossed with product identification “54 171” on one side and a bisect on the other side. NDC 0054-0099-25: Bottle of 100 Tablets NDC 0054-0099-20: 2x5x10 Unit-Dose Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF.
Abbreviated New Drug Application
West-Ward Pharmaceticals Corp. ---------- MEDICATION GUIDE Oxcarbazepine Tablets (ox” kar baz’ e peen) Rx Only What is the most important information I should know about oxcarbazepine? Do not stop taking oxcarbazepine without first talking to your healthcare provider. Stopping oxcarbazepine suddenly can cause serious problems. Oxcarbazepine can cause serious side effects, including: 1. Oxcarbazepine 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. 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. 2. Oxcarbazepine 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 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 carbamazepine. 3. Like other antiepileptic drugs, oxcarbazepine may cause suicidal thoughts or actions in a Lees het volledige document
OXCARBAZEPINE- OXCARBAZEPINE TABLET WEST-WARD PHARMACETICALS CORP. ---------- 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 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 • • • • • • • • • • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pe diatrics: o o 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) 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 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, target maintenance dose should be achieved over 2 weeks (2.4). For patients aged 2 to <4 years, maximum maintenance dose should be a Lees het volledige document