OXCARBAZEPINE- oxcarbazepine suspension
Advagen Pharma Ltd
----------
MEDICATION GUIDE
Oxcarbazepine (ox-kar-BAY-zeh-peen) Oral Suspension, USP |
|
What is the most important information I should know about oxcarbazepine oral suspension?
Do not stop taking oxcarbazepine oral suspension without first talking to your healthcare provider. Stopping oxcarbazepine oral suspension suddenly can cause serious problems. Oxcarbazepine can cause serious side effects, including: 1. Oxcarbazepine may cause the level of sodium in your blood to be low. Symptoms of low blood sodium include: |
|
• nausea | • confusion |
• tiredness (lack of energy) | • more frequent or more severe seizures |
• headache | |
Similar symptoms that are not related to low sodium may occur from taking oxcarbazepine oral suspension. 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 oral suspension. 2. Oxcarbazepine 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 | • painful sores in the mouth or around your eyes |
• trouble swallowing or breathing | • yellowing of your skin or eyes |
• a skin rash | • unusual brusing or bleeding |
• hives | • severe fatigue or weakness |
• fever, swollen glands, or sore throat that do not go away or come and go | • severe muscle pain |
• frequent infections or infections that do not go away | |
Many people who are allergic to carbamazepine are also allergic to oxcarbazepine. Tell your healthcare provider if you are allergic to carbamazepine.
3. Like other antiepileptic drugs, oxcarbazepine 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?
Do not stop taking oxcarbazepine oral suspension without first talking to a healthcare provider.
|
|
What is oxcarbazepine oral suspension?
Oxcarbazepine oral suspension is a prescription medicine used:
|
|
Do not take oxcarbazepine oral suspension if you are allergic to oxcarbazepine or any of the other ingredients in oxcarbazepine oral suspension, or to eslicarbazepine acetate. See the end of this Medication Guide for a complete list of ingredients in oxcarbazepine oral suspension.
Many people who are allergic to carbamazepine are also allergic to oxcarbazepine. Tell your healthcare provider if you are allergic to carbamazepine. |
|
Before taking oxcarbazepine oral suspension, tell your healthcare provider about all your medical conditions, including if you:
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 oral suspension?
|
|
What should I avoid while taking oxcarbazepine oral suspension?
|
|
What are the possible side effects of oxcarbazepine?
See “ What is the most important information I should know about oxcarbazepine oral suspension?” Oxcarbazepine may cause other serious side effects, including:
The most common side effects of oxcarbazepine include: |
|
• dizziness | • problems with vision |
• sleepiness | • trembling |
• double vision | • problems with walking and coordination (unsteadiness) |
• tiredness | • rash |
• nausea | |
• vomiting | |
These are not all the possible side effects of oxcarbazepine. 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 oral suspension?
|
|
General Information about the safe and effective use of oxcarbazepine oral suspension.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use oxcarbazepine oral suspension for a condition for which it was not prescribed. Do not give oxcarbazepine oral suspension 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 oral suspension that is written for health professionals. |
|
What are the ingredients in oxcarbazepine oral suspension?
Active ingredient: oxcarbazepine Inactive ingredients: malic acid, microcrystalline cellulose and carboxymethyl cellulose sodium, methyl paraben, propyl paraben, polyethylene glycol, propylene glycol, purified water; sodium saccharin, sodium hydroxide, sorbitol, yellow plum lemon flavor. |
|
For more information, contact Advagen Pharma Ltd, at 888-413-0949 | |
Distributed by:
Advagen Pharma Ltd, 666 Plainsboro Road, Suite 605 Plainsboro, NJ 08536, USA. Rev. 12/2022 |
|
This Medication Guide has been approved by the U.S.Food and Drug Administration |