OXCARBAZEPINE (Page 7 of 8)

14.2 Oxcarbazepine Tablets Adjunctive Therapy Trials

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.

Table 8: Summary of Percentage Change in Partial-Onset Seizure Frequency from Baseline for Placebo-Controlled Adjunctive Therapy Trials
Trial Treatment Group N Baseline Median Seizure Rate * Median % Reduction
*
= number of seizures per 28 days
p=0.0001;
1 (pediatrics) Oxcarbazepine tablets 136 12.5 34.8
Placebo 128 13.1 9.4
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
Placebo 173 8.6 7.6

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).

16 HOW SUPPLIED/STORAGE AND HANDLING

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).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Administration Information

Counsel patients that oxcarbazepine tablets may be taken with or without food.

Hyponatremia

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)] .

Multi-Organ Hypersensitivity

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) ].

Hematologic Events

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) ].

Drug Interactions

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.

Pregnancy Registry

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) ].

Distributed by:
BRECKENRIDGE PHARMACEUTICAL, INC.
Berlin, CT 06037

Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614

6835
Rev 09/2020

Marketed/Packaged by: GSMS, Inc.

Camarillo, CA USA 93012

This Medication Guide has been approved by the U.S. Food and Drug Administration
*
Contains FD&C Yellow No. 6 as a color additive.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. 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.
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:
  • 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.
  • 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
  • frequent infections or infections that do not go away
  • 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
Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets. Tell your healthcare provider if you are allergic to carbamazepine.
  • Like other antiepileptic drugs, oxcarbazepine tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts about suicide or dying
  • trouble sleeping (insomnia)
  • attempts to commit suicide
  • new or worse irritability
  • new or worse depression
  • acting aggressive, being angry, or violent
  • new or worse anxiety
  • acting on dangerous impulses
  • feeling agitated or restless
  • an extreme increase in activity and talking (mania)
  • panic attacks
  • other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop taking oxcarbazepine tablets without first talking to a healthcare provider.
  • Stopping oxcarbazepine tablets suddenly can cause serious problems.
  • Stopping a seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions may be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What are oxcarbazepine tablets? Oxcarbazepine tablets are a prescription medicine used:
  • alone or with other medicines to treat partial-onset seizures in adults
  • alone to treat partial-onset seizures in children 4 years and older
  • with other medicines to treat partial-onset seizures in children 2 years and older
It is not known if oxcarbazepine tablets is safe and effective for use alone to treat partial-onset seizures in children less than 4 years of age or for use with other medicines to treat partial-onset seizures in children less than 2 years of age.
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:
  • have or have had suicidal thoughts or actions, depression or mood problems
  • have liver problems
  • have kidney problems
  • are allergic to carbamazepine. Many people who are allergic to carbamazepine are also allergic to oxcarbazepine tablets.
  • use birth control medicine. Oxcarbazepine tablets may cause your birth control medicine to be less effective. Talk to your healthcare provider about the best birth control method to use.
  • are pregnant or plan to become pregnant. Oxcarbazepine tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking oxcarbazepine tablets. You and your healthcare provider will decide if you should take oxcarbazepine tablets while you are pregnant. If you become pregnant while taking oxcarbazepine tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • are breastfeeding or plan to breastfeed. Oxcarbazepine passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take oxcarbazepine tablets.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking oxcarbazepine tablets with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Oxcarbazepine tablets?
  • Do not stop taking oxcarbazepine tablets without talking to your healthcare provider. Stopping oxcarbazepine tablets suddenly can cause serious problems, including seizures that will not stop (status epilepticus).
  • Take oxcarbazepine tablets exactly as prescribed. Your healthcare provider may change your dose. Your healthcare provider will tell you how much oxcarbazepine tablets to take.
  • Take oxcarbazepine tablets 2 times a day.
  • Take oxcarbazepine tablets with or without food.
  • If you take too many oxcarbazepine tablets, call your healthcare provider right away.
What should I avoid while taking Oxcarbazepine tablets?
  • Do not drive or operate machinery until you know how oxcarbazepine tablets affects you. Oxcarbazepine tablets may slow your thinking and motor skills.
  • Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking oxcarbazepine tablets until you talk to your healthcare provider. Oxcarbazepine tablets taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
What are the possible side effects of oxcarbazepine tablets? See ” What is the most important information I should know about oxcarbazepine tablets?Oxcarbazepine tablets may cause other serious side effects including:
  • trouble concentrating
  • problems with your speech and language
  • feeling confused
  • feeling sleepy and tired
  • trouble with walking and coordination
  • seizures that can happen more often or become worse, especially in children
Get medical help right away if you have any of the symptoms listed above or listed in “What is the most important information I should know about oxcarbazepine tablets?”
The most common side effects of oxcarbazepine tablets include:
  • dizziness
  • sleepiness
  • double vision
  • tiredness
  • nausea
  • vomiting
  • problems with vision
  • trembling
  • problems with walking and coordination (unsteadiness)
  • rash
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?
  • Store Oxcarbazepine Tablets at 20° — 25°C (77°F); excursions permitted to 15° — 30°C (59° — 86°F).
  • Keep oxcarbazepine tablets dry.
Keep oxcarbazepine tablets and all medicines out of the reach of children.
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? Active ingredient: oxcarbazepine Inactive ingredients:
  • Film-coated tablets: microcrystalline cellulose, crospovidone, hypromellose, colloidal silicon dioxide, magnesium stearate, talc. Coating: polyvinyl alcohol, talc, titanium dioxide, polyethylene glycol, *FD&C Yellow No. 6 aluminum lake, lecithin, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 5 aluminum lake.
Allergen Statement: This product contains soy.

Distributed by:
BRECKENRIDGE PHARMACEUTICAL, INC.
Berlin, CT 06037

Manufactured by:
LGM Pharma Solutions, LLC
Irvine, CA 92614

Rev 09/2020


Marketed/Packaged by:
GSMS, Inc.
Camarillo, CA USA 93012

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