Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.
Oxcarbazepine extended-release tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine, to any of the components of oxcarbazepine extended-release tablets, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.2 , 5.3 )].
Oxcarbazepine extended-release tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine, to any of the components of oxcarbazepine extended-release tablets, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.2 , 5.3 )].
Extended-release tablets : 150 mg: Yellow, oval, biconvex film-coated tablet. Engraved “OX150” on one side, “APO” on the other side. 300 mg: Brown, oval, biconvex film-coated tablet. Engraved “OX300” on one side, “APO” on the other side. 600 mg: Brownish red, oval, biconvex film-coated tablet. Engraved “OX600” on one side, “APO” on the other side.
PRINCIPAL DISPLAY PANEL - 150 mg BOTTLE LABEL APOTEX CORP. NDC 60505-4128-7 OXCARBAZEPINE EXTENDED-RELEASE TABLETS 150 mg Rx 100 Tablets
PRINCIPAL DISPLAY PANEL - 300 mg BOTTLE LABEL APOTEX CORP. NDC 60505-4129-7 OXCARBAZEPINE EXTENDED-RELEASE TABLETS 300 mg Rx 100 Tablets
PRINCIPAL DISPLAY PANEL - 600 mg BOTTLE LABEL APOTEX CORP. NDC 60505-4130-7 OXCARBAZEPINE EXTENDED-RELEASE TABLETS 600 mg Rx 100 Tablets
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1365653 | OXcarbazepine 150 MG 24HR Extended Release Oral Tablet | PSN | 6 |
| 1365842 | OXcarbazepine 300 MG 24HR Extended Release Oral Tablet | PSN | 6 |
| 1365844 | OXcarbazepine 600 MG 24HR Extended Release Oral Tablet | PSN | 6 |
| 1365653 | 24 HR oxcarbazepine 150 MG Extended Release Oral Tablet | SCD | 6 |
| 1365842 | 24 HR oxcarbazepine 300 MG Extended Release Oral Tablet | SCD | 6 |
| 1365844 | 24 HR oxcarbazepine 600 MG Extended Release Oral Tablet | SCD | 6 |
| 1365653 | oxcarbazepine 150 MG 24 HR Extended Release Oral Tablet | SY | 6 |
| 1365842 | oxcarbazepine 300 MG 24 HR Extended Release Oral Tablet | SY | 6 |
| 1365844 | oxcarbazepine 600 MG 24 HR Extended Release Oral Tablet | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| OXCARBAZEPINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ca2a6da1-5711-44d0-9e79-c84d4265f98b | Product name | 3 | 20250724 |
| 536d5b6b-66f1-478b-2670-88fd15947e3b | Product name | 7 | 20250218 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-4128-5 | OXCARBAZEPINE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 6 | |
| 60505-4128-7 | OXCARBAZEPINE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 6 | |
| 60505-4129-5 | OXCARBAZEPINE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 6 | |
| 60505-4129-7 | OXCARBAZEPINE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 6 | |
| 60505-4130-5 | OXCARBAZEPINE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 6 | |
| 60505-4130-7 | OXCARBAZEPINE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 6 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-4128-7 | EA - Each | 60505-4128 | 089b4718-99de-4c5c-8718-f383d29c2b34 | 1 | 2024-09-09 |
| 60505-4129-7 | EA - Each | 60505-4129 | 2d1148c3-9ddc-4df1-b654-befe985339b4 | 1 | 2024-09-09 |
| 60505-4130-7 | EA - Each | 60505-4130 | 54ef40c9-f34c-4f96-90c8-8b554ebebbe1 | 1 | 2024-09-09 |
| Product NDC | Package NDC |
|---|---|
| 60505-4128 | 60505-4128-7, 60505-4128-5 |
| 60505-4129 | 60505-4129-7, 60505-4129-5 |
| 60505-4130 | 60505-4130-7, 60505-4130-5 |
Oxcarbazepine extended-release tablets are indicated for the treatment of partial-onset seizures in patients 6 years of age and older.
Extended-release tablets : 150 mg: Yellow, oval, biconvex film-coated tablet. Engraved “OX150” on one side, “APO” on the other side. 300 mg: Brown, oval, biconvex film-coated tablet. Engraved “OX300” on one side, “APO” on the other side. 600 mg: Brownish red, oval, biconvex film-coated tablet. Engraved “OX600” on one side, “APO” on the other side.
Oxcarbazepine extended-release tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine, to any of the components of oxcarbazepine extended-release tablets, or to eslicarbazepine acetate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.2 , 5.3 )].
The following serious adverse reactions are described in other sections of 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 )] Withdrawal of AEDs [see Warnings and Precautions ( 5.6 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity [see Warnings and Precautions ( 5.7 )] Hematologic Reactions [see Warnings and Precautions ( 5.8 )] Risk of Seizures in the Pregnant Patient [see Warnings and Precautions ( 5.9 )]
Oxcarbazepine extended-release tablet is an antiepileptic drug (AED). Oxcarbazepine extended-release tablets contain oxcarbazepine, USP for once-a-day oral administration. Oxcarbazepine, USP is 10,11-Dihydro-10-oxo- 5H -dibenz[ b,f ]azepine-5-carboxamide, and its structural formula is Oxcarbazepine is light orange to creamish white or off-white powder. Oxcarbazepine is soluble in acetic acid, sparingly soluble in chloroform and practically insoluble in water. The molecular formula is C 15 H 12 N 2 O 2 and its molecular weight is 252.27 g/mol. Oxcarbazepine extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, ferric oxide red (300 mg, 600 mg tablets only), ferric oxide yellow (150 mg, 300 mg tablets only), hydroxypropyl methyl cellulose, iron oxide black (300 mg tablet only), magnesium stearate, polyethylene glycol, polyvinyl alcohol, sorbitol, talc, titanium dioxide (300 mg, 600 mg tablets only).
Oxcarbazepine extended-release tablets has been evaluated as adjunctive therapy for partial-onset seizures in adults. The use of oxcarbazepine extended-release tablets for the treatment of partial-onset seizures in pediatric patients 6 years of age and older is based on adequate and well-controlled studies of oxcarbazepine extended-release tablets in adults, along with clinical trials of immediate-release oxcarbazepine in pediatric patients, and on pharmacokinetic evaluations of the use of oxcarbazepine extended-release tablets in pediatric patients.
Advise the patient to read the FDA-Approved patient labeling (Medication Guide). Administration Information Advise patients to take the tablet whole. Do not cut, chew, or crush the tablet. Advise patients to take oxcarbazepine extended-release tablets on an empty stomach. This means they should take oxcarbazepine extended-release tablets at least one hour before food or at least two hours after food [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)]. Hyponatremia Advise patients that oxcarbazepine extended-release tablets may reduce serum sodium concentrations especially if they are taking other medications that can lower sodium. Advise 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 extended-release tablets. Advise patients to immediately report 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 also experience hypersensitivity reactions with oxcarbazepine extended-release tablets. If patients experience a hypersensitivity reaction while taking oxcarbazepine extended-release tablets, advise them to 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 immediate-release oxcarbazepine. If patients experience a skin reaction while taking oxcarbazepine extended-release tablets, advise patients to consult with their physician immediately [see Warnings and Precautions (5.4)]. Suicidal Behavior and Ideation Counsel patients, their caregivers, and families that AEDs, including oxcarbazepine extended-release tablets, may increase the risk of suicidal thoughts and behavior and that they 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. Advise them to immediately report behaviors of concern to healthcare providers [see Warnings and Precautions (5.5)]. DRESS/Multi-Organ Hypersensitivity Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction, etc.) occurring during treatment with oxcarbazepine extended-release tablets may be drug-related, and advise them to consult their physician immediately [see Warnings and Precautions (5.7)]. Hematologic Reactions Advise patients that there have been rare reports of blood disorders reported in patients treated with immediate-release oxcarbazepine. Instruct patients to immediately consult with their physician if they experience symptoms suggestive of blood disorders during treatment with oxcarbazepine extended-release tablets [see Warnings and Precautions (5.8)]. Drug Interactions Warn female patients of childbearing age that the concurrent use of oxcarbazepine extended-release tablets with hormonal contraceptives may render this method of contraception less effective [see Drug Interactions (7.3) and Use in Specific Populations (8.1)]. Additional non-hormonal forms of contraception are recommended when using oxcarbazepine extended-release tablets. Pregnancy Registry Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during oxcarbazepine extended-release tablets therapy. 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)]. Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp APOTEX INC. OXCARBAZEPINE EXTENDED-RELEASE TABLETS 150 mg, 300 mg and 600 mg Manufactured by Manufactured for Apotex Inc. Toronto, Ontario Canada M9L 1T9 Apotex Corp. Weston, Florida USA 33326 Revision: 4
Oxcarbazepine (ox’’ kar baz’ e peen) extended-release tablets, for oral use Medication Guide available at https://www.apotex.com/products/us/mg.asp What is the most important information I should know about oxcarbazepine extended-release tablets? Do not stop taking oxcarbazepine extended-release tablets without first talking to your healthcare provider. Stopping oxcarbazepine extended-release tablets suddenly can cause serious problems. Oxcarbazepine extended-release tablets can cause serious side effects, including: 1. Oxcarbazepine extended-release 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 extended-release 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 extended-release tablets . 2. Oxcarbazepine extended-release 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 does not go away or comes and goes 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 that do not go away Many people who are allergic to carbamazepine are also allergic to oxcarbazepine extended-release tablets. Tell your healthcare provider if you are allergic to carbamazepine. 3. Like other antiepileptic drugs, oxcarbazepine extended-release tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your 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 extended-release tablets without first talking to a healthcare provider. Stopping oxcarbazepine extended-release 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 is oxcarbazepine extended-release tablets? Oxcarbazepine extended-release tablets are a prescription medicine used to treat partial onset seizures in adults and children 6 years of age and older. Oxcarbazepine extended-release tablets are not for use in children under 6 years of age. It is not known if oxcarbazepine extended-release tablets are safe and effective in children under 6 years of age. Who should not take oxcarbazepine extended-release tablets? Do not take oxcarbazepine extended-release tablets if you are allergic to oxcarbazepine or any of the other ingredients in oxcarbazepine extended-release tablets, or to eslicarbazepine acetate. See the end of this Medication Guide for a complete list of ingredients in oxcarbazepine extended-release tablets. What should I tell my healthcare provider before taking oxcarbazepine extended-release tablets? Before taking oxcarbazepine extended-release 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 extended-release tablets. use birth control medicine. Oxcarbazepine extended-release 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 extended-release tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking oxcarbazepine extended-release tablets. You and your healthcare provider will decide if you should take oxcarbazepine extended-release tablets while you are pregnant. If you become pregnant while taking oxcarbazepine extended-release 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 extended-release tablets passes into breast milk. Talk with your healthcare provider about the best way to feed your baby if you take oxcarbazepine extended-release tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking oxcarbazepine extended-release 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. Especially tell your healthcare provider if you take : carbamazepine, phenobarbital, phenytoin, or birth control medicine. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take oxcarbazepine extended-release tablets? Do not stop taking oxcarbazepine extended-release tablets without talking to your healthcare provider. Stopping oxcarbazepine extended-release tablets suddenly can cause serious problems, including seizures that will not stop (status epilepticus). Take oxcarbazepine extended-release tablets exactly as prescribed. Your healthcare provider may change your dose. Your healthcare provider will tell you how much oxcarbazepine extended-release tablets to take. Take oxcarbazepine extended-release tablets 1 time each day. Take oxcarbazepine extended-release tablets on an empty stomach. This means you should take oxcarbazepine extended-release tablets at least 1 hour before or at least 2 hours after a meal. Take oxcarbazepine extended-release tablets whole with water or other liquid. Do not cut, crush, or chew the tablets before swallowing. If you take too much oxcarbazepine extended-release tablets call your healthcare provider right away. What are the possible side effects of oxcarbazepine extended-release tablets? See “What is the most important information I should know about oxcarbazepine extended-release tablets?” Oxcarbazepine extended-release tablets may cause other serious side effects including: seizures that can happen more often or become worse, especia...
PRINCIPAL DISPLAY PANEL - 150 mg BOTTLE LABEL APOTEX CORP. NDC 60505-4128-7 OXCARBAZEPINE EXTENDED-RELEASE TABLETS 150 mg Rx 100 Tablets
PRINCIPAL DISPLAY PANEL - 300 mg BOTTLE LABEL APOTEX CORP. NDC 60505-4129-7 OXCARBAZEPINE EXTENDED-RELEASE TABLETS 300 mg Rx 100 Tablets
PRINCIPAL DISPLAY PANEL - 600 mg BOTTLE LABEL APOTEX CORP. NDC 60505-4130-7 OXCARBAZEPINE EXTENDED-RELEASE TABLETS 600 mg Rx 100 Tablets