LACOSAMIDE ORAL SOLUTION - lacosamide oral solution solution
Ascend Laboratories, LLC
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Lacosamide (la koe' sa mide) Oral Solution, USP CV
Read this Medication Guide before you start taking lacosamide oral solution and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide oral solution. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about lacosamide oral solution?
Do not stop taking lacosamide oral solution without first talking to your healthcare provider. Stopping lacosamide oral solution suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Lacosamide oral solution can cause serious side effects, including:
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)
• attempt 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?
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If you have fainted or feel like you are going to faint you should lay down with your legs raised.
4. Lacosamide oral solution is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide oral solution in a safe place, to protect it from theft. Never give your lacosamide oral solution to anyone else, because it may harm them. Selling or giving away this medicine is against the law.
What is Lacosamide oral solution?
Lacosamide oral solution is a prescription medicine used:
It is not known if lacosamide oral solution is safe and effective for partial-onset seizures in children under 1 month of age.
What should I tell my healthcare provider before taking lacosamide oral solution?
Before you take lacosamide oral solution, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking lacosamide oral solution 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 and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take lacosamide oral solution?
What should I avoid while taking lacosamide oral solution?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide oral solution affects you.
Lacosamide oral solution may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
What are the possible side effects of lacosamide oral solution?
Lacosamide oral solution may cause other serious side effects including:
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The most common side effects of lacosamide oral solution include:
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These are not all of the possible side effects of lacosamide oral solution. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider about 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 lacosamide oral solution?
Keep lacosamide oral solution and all medicines out of the reach of children.
General Information about the safe and effective use of lacosamide oral solution.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lacosamide oral solution for a condition for which it was not prescribed. Do not give lacosamide oral solution to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about lacosamide oral solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lacosamide oral solution that is written for health professionals.
What are the ingredients in lacosamide oral solution?
Active ingredient: lacosamide, USP
Oral solution inactive ingredients: acesulfame potassium, carboxymethylcellulose sodium, citric acid anhydrous, glycerin, methyl paraben, noncrystallizing sorbitol solution, polyethylene glycol, sodium chloride, strawberry flavor (propylene glycol, artificial flavors, acetic acid), masking flavor (propylene glycol, water, acetic acid, artificial flavors, ammoniated glycyrrhizin, aspartame acesulfame).
Additional pediatric use information is approved for UCB, Inc.’s VIMPAT® (lacosamide) oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Manufactured by:
Alkem Laboratories Ltd.,
INDIA.
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
For more information, call 1-877-272-7901.
This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised: November, 2022
PT3566-06