Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
OXCARBAZEPINE (UNII: VZI5B1W380) (OXCARBAZEPINE - UNII:VZI5B1W380)
American Health Packaging
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 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)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as oxcarbazepine tablets, during pregnancy. Encourage women who are taking oxcarbazepine tablets 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 development
Oxcarbazepine Tablets, USP are provided as: 150 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B2 | 92" on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-845-01 300 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B | 293" on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-853-01 600 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B | 294" on one side and plain on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-867-01 Store at 20°-25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED American Health Packaging ---------- MEDICATION GUIDE 8284501/1219 Oxcarbazepine Tablets, USP (ox kar baz' e peen) film-coated tablets, for oral use Oxcarbazepine Tablets, USP contains FD&C yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. 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 Aqra d-dokument sħiħ
OXCARBAZEPINE- OXCARBAZEPINE TABLET, FILM COATED AMERICAN HEALTH PACKAGING ---------- 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 FILM-COATED TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2000 INDICATIONS AND USAGE Oxcarbazepine tablets are 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 4-16 years Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 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 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) 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 2-16 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 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withd Aqra d-dokument sħiħ