- a skin rash, hives
- fever or swollen glands that do not go away
- shortness of breath
- tiredness (fatigue)
- swelling of the legs
- yellowing of the skin or whites of the eyes
- dark urine
The most common side effects of Vimpat in adults include:
Other Adverse Reactions
The following is a list of adverse reactions reported by patients treated with Vimpat in all clinical trials in adult patients with partial-onset seizures, including controlled trials and long-term open-label extension trials. Adverse reactions addressed in other tables or sections are not listed here.
- Blood and lymphatic system disorders:neutropenia, anemia
- Cardiac disorders:palpitations
- Ear and labyrinth disorders:tinnitus
- Gastrointestinal disorders:constipation, dyspepsia, dry mouth, oral hypoaesthesia
- General disorders and administration site conditions: irritability, pyrexia, feeling drunk
- Injury, poisoning, and procedural complications: fall
- Musculoskeletal and connective tissue disorders:muscle spasms
- Nervous system disorders: paresthesia, cognitive disorder, hypoaesthesia, dysarthria, disturbance in attention, cerebellar syndrome
- Psychiatric disorders: confusional state, mood altered, depressed mood
Side effects of Vimpat in children are similar to those seen in adults. These are not all of the possible side effects of Vimpat. 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 healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Does Vimpat cause addiction and withdrawal symptoms?
Vimpat is a federally controlled substance (CV) because it can be abused or lead to drug dependence. Keep your Vimpat in a safe place, to protect it from theft. Never give your Vimpat to anyone else, because it may harm them. Selling or giving away this medicine is against the law.
Abuse
- In a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria -type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug.
- The duration of the euphoria-type responses following lacosamide was less than that following alprazolam.
- A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300-800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%).
- However, the rate of euphoria reported as an adverse event in the Vimpat development program at therapeutic doses was less than 1%.
Dependence
- Abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence.
- However, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans.
IMAGES
What is the dosage for Vimpat?
- Take Vimpat exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how much Vimpat to take and when to take it.
- Your healthcare provider may change your dose if needed.
- Do not stop Vimpat without first talking to a healthcare provider. Stopping Vimpat suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
- Vimpat may be taken with or without food.
- Swallow Vimpat tablets whole with liquid. Do not cut Vimpat tablets.
- If your healthcare provider has prescribed Vimpat oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of Vimpat oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
- If you take too much Vimpat, call your healthcare provider or local Poison Control Center right away.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Vimpat affects you. Vimpat may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking.
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What drugs interact with Vimpat?
Strong CYP3A4 Or CYP2C9 Inhibitors
- Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to Vimpat. Dose reduction may be necessary for these patients.
Concomitant Medications That Affect Cardiac Conduction
- Vimpat should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia.
- In such patients, obtaining an ECG before beginning Vimpat, and after Vimpat is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered Vimpat through the intravenous route.
Is Vimpat safe to take while pregnant or breastfeeding?
Before you take Vimpat, tell your healthcare provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known if Vimpat can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Vimpat. You and your healthcare provider will decide if you should take Vimpat while you are pregnant.
- If you become pregnant while taking Vimpat, 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.
Summary
Lacosamide is a prescription medicine used to treat partial-onset seizures in people 4 years of age and older. This epilepsy drug may cause suicidal thoughts and is also potentially addictive. Vimpat is a federally controlled substance (CV) because it can be abused or lead to drug dependence. The most common side effects of Vimpat in adults include double vision, headache, dizziness, and nausea. Serious side effects of Vimpat include a serious allergic reaction.
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The vagus nerve is an important pathway to the brain in addition to helping to control seizures. Stimulation of the vagus nerve leads to the discharge of electrical energy into a wide area of the brain, disturbing the abnormal brain activity that causes seizures. The vagus nerve is used to treat seizures that do not respond to medications.
Febrile Seizures
Febrile seizures, or convulsions caused by fever, can be frightening in small children or infants. However, in general, febrile seizures are harmless. Febrile seizure is not epilepsy. It is estimated that one in every 25 children will have at least one febrile seizure. It is important to know what to do to help your child if he/she has a febrile seizure. Some of the features of a febrile seizure include losing consciousness, shaking, moving limbs on both sides of the body, and lasts 1-2 minutes. Less commonly, a febrile seizure may only affect one side of the body.
What Is a Cluster Seizure?
Cluster seizures are episodes of increased seizure activity in which two or more seizures occur in 24 hours. Multiple seizures occur one after the other typically with a recovery period between each seizure and are different from a person’s usual seizure pattern.
Epilepsy and Seizures: How to Treat?
A seizure is a sudden, uncontrolled electrical disturbance in the brain. Epilepsy is a neurological disorder where brain activities are abnormal, causing more than one or recurrent episodes of seizures. Most cases of seizures can be managed conservatively with medication and supportive treatments.
