Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
OXCARBAZEPINE (UNII: VZI5B1W380) (OXCARBAZEPINE - UNII:VZI5B1W380)
DIRECT RX
OXCARBAZEPINE
OXCARBAZEPINE 300 mg
ORAL
PRESCRIPTION DRUG
Oxcarbazepine tablets USP 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 children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures. Oxcarbazepine tablets should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components. 8.1 Pregnancy Oxcarbazepine levels may decrease during pregnancy [see Warnings and Precautions (5.10)]. Pregnancy Category C 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. Given this fact, and the results of the animal studies described, it is likely that oxcarbazepine is a human teratogen. Oxcarbazepine should be used during pregnancy only if the potential benefit justifies the potential risk to the
Abbreviated New Drug Application
TRILEPTAL- OXCARBAZEPINE TABLET DIRECT RX ---------- Oxcarbazepine Tablets USP (ox kar baz' e peen) Read this Medication Guide before you start taking oxcarbazepine tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. 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. 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 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 all Pročitajte cijeli dokument
TRILEPTAL- OXCARBAZEPINE TABLET DIRECT RX ---------- OXCARBAZEPINE Oxcarbazepine tablets USP 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 children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures. All dosing should be given in a twice-a-day regimen. Oxcarbazepine tablets should be kept out of the reach and sight of children. Oxcarbazepine tablets can be taken with or without food [see Clinical Pharmacology (12.3)]. 2.1 Adjunctive Therapy for Adults Treatment with oxcarbazepine tablets should be initiated with a dose of 600 mg/day, given in a twice-a- day regimen. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant AEDs be monitored during the period of oxcarbazepine tablets titration, as these plasma levels may be altered, especially at oxcarbazepine tablets doses greater than 1200 mg/day [see Drug Interactions (7.1)]. 2.2 Conversion to Monotherapy for Adults Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with oxcarbazepine tablets at 600 mg/day (given in a twice-a-day regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of oxcarbazepine tablets should be reached in about 2-4 weeks. Oxcarbazepine tablets may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. A daily d Pročitajte cijeli dokument