LACOSAMIDE- lacosamide injection
Fosun Pharma USA
Lacosamide (la-KOE-sa-mide) Injection, USP
for intravenous use, CV
Read this Medication Guide before you start taking lacosamide injection and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide injection. 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 injection?
Do not stop taking lacosamide injection without first talking to your healthcare provider. Stopping lacosamide 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 injection can cause serious side effects, including:
|o thoughts about suicide or dying
o attempt to commit suicide
o new or worse depression
o new or worse anxiety
o feeling agitated or restless
o panic attacks
|o trouble sleeping (insomnia)
o new or worse irritability
o acting aggressive, being angry, or violent
o acting on dangerous impulses
o an extreme increase in activity and talking (mania)
o other unusual changes in behavior or mood
If you have fainted or feel like you are going to faint you should lay down with your legs raised.
4. Lacosamide injection is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide injection in a safe place, to protect it from theft. Never give your lacosamide injection to anyone else, because it may harm them. Selling or giving away this medicine is against the law.
What is lacosamide injection?
Lacosamide injection is a prescription medicine used:
It is not known if lacosamide 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 injection?
Before you take lacosamide injection, tell your healthcare provider about all of your medical conditions, including if you:
o If you become pregnant while taking lacosamide injection, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
o Breastfeeding during treatment with lacosamide may cause your baby to have more sleepiness than normal. If this happens, contact your baby’s healthcare provider.
o Talk to your healthcare provider about the best way to feed your baby if you take lacosamide injection.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking lacosamide injection 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 injection?
What should I avoid while taking lacosamide injection?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide injection affects you. Lacosamide injection 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 injection?
Lacosamide injection may cause other serious side effects including:
The most common side effects of lacosamide injection include:
These are not all of the possible side effects of lacosamide injection. 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 injection?
Keep lacosamide injection and all medicines out of the reach of children.
General Information about the safe and effective use of lacosamide injection.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lacosamide injection for a condition for which it was not prescribed. Do not give lacosamide 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 injection. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lacosamide injection that is written for health professionals. For more information, contact Fosun Pharma at 1-866-611-3762.
What are the ingredients in lacosamide injection?
Active ingredient: lacosamide
Injection inactive ingredients: sodium chloride (7.5 mg/mL), water for injection, hydrochloric acid (for pH adjustment)
Pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) injection. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Fosun Pharma USA Inc.
Princeton, NJ 08540
Made in India.
Revised: February 2023
This Medication Guide has been approved by the U.S. Food and Drug Administration