LACOSAMIDE - lacosamide injection 
Indoco Remedies Limited

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SPL MEDGUIDE SECTION

MEDICATION GUIDE

Lacosamide (la KOE sa mide) injection, for intravenous use, CV

 


Read this Medication Guide before you start taking lacosamide and each time you get a refill. There may be new information. This Medication Guide describes important safety information about lacosamide. 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?

Do not stop taking lacosamide 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 can cause serious side effects, including:

  1. Like other antiepileptic drugs, lacosamide 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)
  • 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?

2. Lacosamide may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide affects you.

3. Lacosamide may cause you to have an irregular heartbeat or may cause you to faint. In rare cases, cardiac arrest has been reported. Call your healthcare provider right away if you:

  • have a fast, slow, or pounding heartbeat or feel your heart skip a beat
  • feel lightheaded
  • fainted or if you feel like you are going to faint
  • have shortness of breath
  • have chest pain
 

If  you have fainted or feel like you are going to faint you should lay down with your legs raised.

4. Lacosamide is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your lacosamide in a safe place, to protect it from theft. Never give your lacosamide 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?

Before you take lacosamide, 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 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?

If you take too much lacosamide, call your healthcare provider or local Poison Control Center right away. 


What should I avoid while taking lacosamide

Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide affects you.  Lacosamide 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?

  • a skin rash, hives
  • swelling of the legs
  • fever or swollen glands that do not go away
  • yellowing of the skin or whites of the eyes
  • shortness of breath
  • dark urine
  • tiredness (fatigue)
 

The most common side effects of lacosamide include:

  • double vision
  • nausea
  • headache
  • sleepiness
  • dizziness
 

These are not all of the possible side effects of lacosamide. 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 toFDA at 1-800-FDA-1088.


How should I store Lacosamide injection

Keep lacosamide and all medicines out of the reach of children. 


General Information about the safe and effective use of lacosamide.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lacosamide 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. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lacosamide that is written for health professionals.


What are the ingredients in Lacosamide injection?

Active ingredient: lacosamide

Injection inactive ingredients: sodium chloride (7.60 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.


Manufactured By

Indoco Remedies Limited

L- 32, 33 & 34,

Verna Industrial Estate,

Verna, Goa - 403722, India.


July 2022


For more information, call [+1-855-642-2594]


This Medication Guide has been approved by the U.S. Food and Drug Administration.


Revised 07/2022


Revised: 10/2022
Indoco Remedies Limited