Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Film-coated Tablets: 150 mg Film-Coated Tablets: Yellow, film-coated oval, biconvex tablets with a deep break line on both sides and “G” engraved on one side of the deep break line on one side of the tablet and “13” and “7” engraved on either side of the deep break line on the other side of the tablet. 300 mg Film-Coated Tablets: Yellow, film-coated oval, biconvex tablets with a deep break line on both sides and “G” and “4” engraved on either side of the deep break line on one side of the tablet. 600 mg Film-Coated Tablets: Yellow, film-coated oval, biconvex tablets with a deep break line on both sides and “G” engraved on one side of the deep break line on one side of the tablet and “13” and “9” engraved on either side of the deep break line on the other side of the tablet.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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 )].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions ( 5.1 )] Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.2 )] Cross Hypersensitivity Reaction to Carbamazepine [see Warnings and Precautions ( 5.3 )] Serious Dermatological Reactions [see Warnings and Precautions ( 5.4 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.5 )] Cognitive/Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.7 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions ( 5.8 )] Hematologic Events [see Warnings and Precautions ( 5.9 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
9 DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Oxcarbazepine Tablets USP are an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo- 5H -dibenz[b, f ]azepine-5-carboxamide, and its structural formula is: Oxcarbazepine, USP is a light orange to creamish white or off-white powder. It is soluble in acetic acid, sparingly soluble in chloroform, practically insoluble in water. Its molecular weight is 252.27 g/mol. Oxcarbazepine film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide (yellow), hypromellose, magnesium stearate, meglumine, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
The effectiveness of oxcarbazepine as adjunctive and monotherapy for partial-onset seizures in adults, and as adjunctive therapy in children aged 2 to 16 years was established in seven multicenter, randomized, controlled trials. The effectiveness of oxcarbazepine as monotherapy for partial-onset seizures in children aged 4 to 16 years was determined from data obtained in the studies described, as well as by pharmacokinetic/pharmacodynamic considerations.
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Tablets 150 mg Film-Coated Tablets: yellow, film-coated oval, biconvex tablets with a deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and “13” and “7” engraved on either side of the deep break line on the other side of the tablet. Bottle of 100.........NDC 68462-137-01 Bottle of 500.........NDC 68462-137-05 300 mg Film-Coated Tablets: yellow, film-coated oval, biconvex tablets with a deep break line on both sides and “G” and “4” engraved on either side of the deep break line on one side of the tablet. Bottle of 100.........NDC 68462-138-01 Bottle of 500.........NDC 68462-138-05 600 mg Film-Coated Tablets: yellow, film-coated oval, biconvex tablets with a deep break line on both sides and "G" engraved on one side of the deep break line on one side of the tablet and “13” and “9” engraved on either side of the deep break line on the other side of the tablet. Bottle of 100.........NDC 68462-139-01 Bottle of 500.........NDC 68462-139-05 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Administration Information Counsel patients that oxcarbazepine may be taken with or without food. Hyponatremia Advise patients that oxcarbazepine 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. 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. Patients should be advised that if they experience a hypersensitivity reaction while taking oxcarbazepine 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. In the event a skin reaction should occur while taking oxcarbazepine, 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, 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 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 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. 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 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. Caution should be exercised if alcohol is taken in combination with oxcarbazepine, 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 AEDs during pregnancy [see Use in Specific Populations ( 8.1 )] . Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com November 2025
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
MEDICATION GUIDE Oxcarbazepine Tablets (ox kar baz' e peen), for oral use 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 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 tablets. Tell your healthcare provider if you are allergic to carbamazepine. 3. Like other antiepileptic drugs (AEDs), 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 attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) 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 of age and older with other medicines to treat partial-onset seizures in children 2 years of age and older It is not known if oxcarbazepine tablets are 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. It is not known if 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. 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 much 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: di...
