The effectiveness of oxcarbazepine tablets as an adjunctive therapy for partial-onset seizures was established in 2 multicenter, randomized, double-blind, placebo-controlled trials, one in 692 patients (15 to 66 years of age) and one in 264 pediatric patients (3 to 17 years of age), and in one multicenter, rater-blind, randomized, age-stratified, parallel-group study comparing 2 doses of oxcarbazepine in 128 pediatric patients (1 month to <4 years of age).
Patients in the 2 placebo-controlled trials were on 1 to 3 concomitant AEDs. In both of the trials, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Patients who experienced at least 8 (minimum of 1 to 4 per month) partial-onset seizures during the baseline phase were randomly assigned to placebo or to a specific dose of oxcarbazepine tablets in addition to their other AEDs.
In these studies, the dose was increased over a 2-week period until either the assigned dose was reached, or intolerance prevented increases. Patients then entered a 14- (pediatrics) or 24-week (adults) maintenance period.
In the adult trial, patients received fixed doses of 600, 1200 or 2400 mg/day. In the pediatric trial, patients received maintenance doses in the range of 30 to 46 mg/kg/day, depending on baseline weight. The primary measure of effectiveness in both trials was a between-group comparison of the percentage change in partial-onset seizure frequency in the double-blind treatment phase relative to baseline phase. This comparison was statistically significant in favor of oxcarbazepine tablets at all doses tested in both trials (p=0.0001 for all doses for both trials). The number of patients randomized to each dose, the median baseline seizure rate, and the median percentage seizure rate reduction for each trial are shown in Table 8. It is important to note that in the high-dose group in the study in adults, over 65% of patients discontinued treatment because of adverse events; only 46 (27%) of the patients in this group completed the 28-week study [ see Adverse Reactions (6) ], an outcome not seen in the monotherapy studies.
|Trial||Treatment Group||N||Baseline Median Seizure Rate *||Median % Reduction|
|1 (pediatrics)||Oxcarbazepine tablets||136||12.5||34.8 †|
|2 (adults)||Oxcarbazepine tablets 2400 mg/day||174||10.0||49.9 †|
|Oxcarbazepine tablets 1200 mg/day||177||9.8||40.2 †|
|Oxcarbazepine tablets 600 mg/day||168||9.6||26.4 †|
Subset analyses of the antiepileptic efficacy of oxcarbazepine tablets with regard to gender in these trials revealed no important differences in response between men and women. Because there were very few patients over the age of 65 years in controlled trials, the effect of the drug in the elderly has not been adequately assessed.
The third adjunctive therapy trial enrolled 128 pediatric patients (1 month to <4 years of age) with inadequately-controlled partial-onset seizures on 1 to 2 concomitant AEDs. Patients who experienced at least 2 study-specific seizures (i.e., electrographic partial-onset seizures with a behavioral correlate) during the 72-hour baseline period were randomly assigned to either oxcarbazepine tablets 10 mg/kg/day or were titrated up to 60 mg/kg/day within 26 days. Patients were maintained on their randomized target dose for 9 days and seizures were recorded through continuous video-EEG monitoring during the last 72 hours of the maintenance period. The primary measure of effectiveness in this trial was a between-group comparison of the change in seizure frequency per 24 hours compared to the seizure frequency at baseline. For the entire group of patients enrolled, this comparison was statistically significant in favor of oxcarbazepine tablets 60 mg/kg/day. In this study, there was no evidence that oxcarbazepine tablets were effective in patients below the age of 2 years (N=75).
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.
|Bottle of 100||NDC 60429-061-01|
|Bottle of 500||NDC 60429-061-05|
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.
|Bottle of 100||NDC 60429-062-01|
|Bottle of 180||NDC 60429-062-18|
|Bottle of 500||NDC 60429-062-05|
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.
|Bottle of 100||NDC 60429-063-01|
|Bottle of 500||NDC 60429-063-05|
Store at 20°-25°C (77°F); excursions permitted to 15°- 30°C (59° — 86°F) [see USP Controlled Room Temperature].
Dispense in tight container (USP).
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Counsel patients that oxcarbazepine tablets may be taken with or without food.
Advise patients that oxcarbazepine tablets may reduce the serum sodium concentrations especially if they are taking other medications that can lower sodium. Instruct patients to report symptoms of low sodium like nausea, tiredness, lack of energy, confusion, and more frequent or more severe seizures [ see Warnings and Precautions (5.1) ].
Anaphylactic Reactions and Angioedema
Anaphylactic reactions and angioedema may occur during treatment with oxcarbazepine tablets. Advise patients to report immediately signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, tongue or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their physician [ see Warnings and Precautions (5.2) ].
Cross Hypersensitivity Reaction to Carbamazepine
Inform patients who have exhibited hypersensitivity reactions to carbamazepine that approximately 25% to 30% of these patients may experience hypersensitivity reactions with oxcarbazepine tablets. Patients should be advised that if they experience a hypersensitivity reaction while taking oxcarbazepine tablets they should consult with their physician immediately [ see Warnings and Precautions (5.3) ].
Serious Dermatological Reactions
Advise patients that serious skin reactions have been reported in association with oxcarbazepine tablets. In the event a skin reaction should occur while taking oxcarbazepine tablets, patients should consult with their physician immediately [ see Warnings and Precautions (5.4) ].
Suicidal Behavior and Ideation
Patients, their caregivers, and families should be counseled that AEDs, including oxcarbazepine tablets, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers [see Warnings and Precautions (5.5)] .
Driving and Operating Machinery
Advise patients that oxcarbazepine tablets may cause adverse reactions such as dizziness, somnolence, ataxia, visual disturbances, and depressed level of consciousness. Accordingly, advise patients not to drive or operate machinery until they have gained sufficient experience on oxcarbazepine tablets to gauge whether it adversely affects their ability to drive or operate machinery [ see Warnings and Precautions (5.7) and Adverse Reactions (6)] .
Instruct patients that a fever associated with other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately [ see Warnings and Precautions (5.8) ].
Advise patients that there have been rare reports of blood disorders reported in patients treated with oxcarbazepine tablets. Instruct patients to immediately consult with their physician if they experience symptoms suggestive of blood disorders [ see Warnings and Precautions (5.9) ].
Caution female patients of reproductive potential that the concurrent use of oxcarbazepine tablets with hormonal contraceptives may render this method of contraception less effective [see Drug Interactions (7.2) and Use in Specific Populations (8.1)] . Additional non-hormonal forms of contraception are recommended when using oxcarbazepine tablets.
Caution should be exercised if alcohol is taken in combination with oxcarbazepine tablets, due to a possible additive sedative effect.
Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy [ see Use in Specific Populations (8.1) ].
BRECKENRIDGE PHARMACEUTICAL, INC.
Berlin, CT 06037
LGM Pharma Solutions, LLC
Irvine, CA 92614
Marketed/Packaged by: GSMS, Inc.
Camarillo, CA USA 93012
|This Medication Guide has been approved by the U.S. Food and Drug Administration|
|MEDICATION GUIDE 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: |
| || |
|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.
| || |
|Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets. Tell your healthcare provider if you are allergic to carbamazepine.
|How can I watch for early symptoms of suicidal thoughts and actions? |
|What are oxcarbazepine tablets?
Oxcarbazepine tablets are a prescription medicine used:
|Do not take oxcarbazepine tablets if you are allergic to oxcarbazepine tablets or any of the other ingredients in oxcarbazepine tablets, or to eslicarbazepine acetate. See the end of this Medication Guide for a complete list of ingredients in oxcarbazepine tablets. Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets. Tell your healthcare provider if you are allergic to carbamazepine.|
|Before taking oxcarbazepine tablets, tell your healthcare provider about all your medical conditions, including if you: |
| How should I take Oxcarbazepine tablets? |
| What should I avoid while taking Oxcarbazepine tablets? |
|What are the possible side effects of oxcarbazepine tablets?
What is the most important information I should know about oxcarbazepine tablets?”
Oxcarbazepine tablets may cause other serious side effects including: |
|The most common side effects of oxcarbazepine tablets include:|
| || |
|These are not all the possible side effects of oxcarbazepine tablets. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
| How should I store oxcarbazepine tablets? |
|General Information about the safe and effective use of oxcarbazepine tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxcarbazepine tablets for a condition for which it was not prescribed. Do not give oxcarbazepine tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about oxcarbazepine tablets that is written for health professionals. For more information, go to www.bpirx.com or call 1-800-367-3395.|
|What are the ingredients in oxcarbazepine tablets?
Inactive ingredients: |
BRECKENRIDGE PHARMACEUTICAL, INC.
Berlin, CT 06037
LGM Pharma Solutions, LLC
Irvine, CA 92614
Camarillo, CA USA 93012
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