Lacosamide (intravenous)

Lacosamide (intravenous)

Uses for lacosamide

This medicine should only be administered by or under your doctor's direct supervision.

Before using lacosamide

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Appropriate studies have not been conducted on the relationship between age and the effects of lacosamide injection in children less than 4 years of age for the treatment of primary generalized tonic-clonic seizures and in children less than 1 month of age for the treatment of partial seizures. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of lacosamide injection in the elderly. However, older patients are at higher risk of age-related liver, kidney, or heart problems, which may require caution and dose adjustment in patients receiving lacosamide injection.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Acebutolol
• Acecainid
• Acepromazin
• Ajmaline
• Alfentanil
• Alprazolam
• Amiodaron
• Amitriptylin
• Amlodipin
• Amobarbital
• Anileridin
• Aprindin
• Aranidipin
• Aripiprazol
• Aripiprazol Lauroxil
• Asenapin
• Atazanavir
• Atenolol
• Baclofen
• Benperidol
• Benzhydrocodon
• Bepridil
• Betaxolol
• Bisoprolol
• Bretylium
• Bromazepam
• Buprenorphin
• Buspiron
• Butabarbital
• Butorphanol
• Calcifediol
• Calciumoxybat
• Cannabidiol
• Cannabis
• Carbinoxamin
• Carisoprodol
• Carphenazin
• Carteolol
• Carvedilol
• Celiprolol
• Cetirizin
• Chloralhydrat
• Chlordiazepoxid
• Chlorpromazin
• Chlorzoxazon
• Cilnidipin
• Clevidipin
• Clobazam
• Clonazepam
• Clorazepat
• Clozapin
• Kodein
• Cyclobenzaprin
• Daridorexant
• Dexmedetomidin
• Diacetylmorphin
• Diazepam
• Dichloralphenazon
• Difenoxin
• Dihydrocodein
• Diltiazem
• Diphenhydramin
• Diphenoxylat
• Disopyramid
• Dofetilid
• Dolasetron
• Doxylamin
• Dronedaron
• Droperidol
• Encainid
• Enfluran
• Esketamin
• Eslicarbazepinacetat
• Esmolol
• Estazolam
• Eszopiclon
• Ethchlorvinyl
• Ethopropazin
• Ethylmorphin
• Felodipin
• Fentanyl
• Flecainid
• Flibanserin
• Flunitrazepam
• Fluphenazin
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Haloperidol
• Halothan
• Hexobarbital
• Hydrocodon
• Hydromorphon
• Hydrochinidin
• Hydroxyzin
• Ibutilid
• Indecainid
• Isofluran
• Isradipin
• Ketamin
• Ketazolam
• Ketobemidon
• Labetalol
• Lercanidipin
• Levobunolol
• Levocetirizin
• Levorphanol
• Lidocain
• Lopinavir
• Lorazepam
• Loxapin
• Magnesiumoxybat
• Manidipin
• Meclizin
• Melperon
• Meperidin
• Mephobarbital
• Meprobamat
• Meptazinol
• Mesoridazin
• Metaxalone
• Methadon
• Methdilazin
• Methocarbamol
• Methohexital
• Methotrimeprazin
• Methylenblau
• Metipranolol
• Metoprolol
• Mexiletin
• Midazolam
• Molindon
• Moricizin
• Morphium
• Morphinsulfat-Liposom
• Nadolol
• Nalbuphin
• Nebivolol
• Nicardipin
• Nicomorphin
• Nifedipin
• Nimodipin
• Nisoldipin
• Nitrazepam
• Nitrendipin
• Lachgas
• Olanzapin
• Opium
• Opiumalkaloide
• Orlistat
• Orphenadrin
• Oxazepam
• Oxprenolol
• Oxycodon
• Oxymorphon
• Papaveretum
• Paregorisch
• Penbutolol
• Pentazocin
• Pentobarbital
• Perampanel
• Perazin
• Periciazin
• Perphenazin
• Phenobarbital
• Pimozid
• Pindolol
• Piperacetazin
• Pipotiazin
• Piritramid
• Kaliumoxybat
• Prajmaline
• Prazepam
• Primidon
• Procainamid
• Prochlorperazin
• Promazin
• Promethazin
• Propafenon
• Propofol
• Propranolol
• Quazepam
• Quetiapin
• Chinidin
• Chinin
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxiprid
• Ritonavir
• Saquinavir
• Secobarbital
• Sertindol
• Natriumoxybat
• Sotalol
• Sparteine
• Sufentanil
• Sulpirid
• Suvorexant
• Tapentadol
• Tedisamil
• Temazepam
• Thiethylperazin
• Thiopental
• Thiopropazat
• Thioridazin
• Tilidin
• Timolol
• Tizanidin
• Tocainid
• Toloniumchlorid
• Topiramat
• Tramadol
• Triazolam
• Trifluoperazin
• Trifluperidol
• Triflupromazin
• Trimeprazin
• Verapamil
• Zaleplon
• Zolpidem
• Zopiclon
• Zotepin

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Ethanol

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Brugada-Syndrom (genetische Erkrankung) oder
• Depression, Geschichte von oder
• Drogen- oder Alkoholmissbrauch oder -abhängigkeit, Vorgeschichte von oder
• Herzinfarkt bzw
• Herzblock bzw
• Herzerkrankungen (z. B. Herzinsuffizienz, Myokardischämie) oder
• Herzinsuffizienz bzw
• Herzrhythmusstörungen (z. B. verlängertes PR-Intervall) oder
• Geisteskrankheit, Vorgeschichte von oder
• Sick-Sinus-Syndrom (Art von Herzrhythmusstörungen), ohne Herzschrittmacher – mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Diabetische Neuropathie (durch Diabetes verursachtes Nervenproblem) oder
• Herz- oder Blutgefäßerkrankungen – Kann das Risiko schwerwiegenderer Nebenwirkungen erhöhen.

• Nierenerkrankung, schwere oder
• Lebererkrankung, leicht bis mittelschwer – mit Vorsicht anwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

• Schwere Lebererkrankung – sollte bei Patienten mit dieser Erkrankung nicht angewendet werden.

Correct use of lacosamide

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle inserted into one of your veins. The medicine must be injected slowly, so your IV tube must remain in place for at least 15 to 60 minutes.

This medicine should be accompanied by a medication guide. It is very important that you read and understand this information. Ask your doctor if you have any questions.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have concerns about this, talk to your doctor.

Precautions when using lacosamide

Your doctor will closely monitor your progress while you are receiving this medicine. This will help your doctor determine whether the medicine is working properly and decide whether you should continue to receive it. Blood and urine tests may be needed to check for adverse effects.

If you develop any unusual or strange thoughts and behavior while taking lacosamide injection, be sure to discuss this with your doctor. Some changes that have occurred in people receiving this medicine are similar to those seen in people who drink too much alcohol. Other changes may include confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual agitation, nervousness, or irritability.

This medicine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, sleepiness, sleepiness, or difficulty thinking. Do not drive or do other dangerous activities until you know how this medicine affects you. If these side effects are particularly bothersome, contact your doctor.

This medicine can cause changes in your heart's rhythm, including a condition called PR prolongation. It can change the way your heart beats and cause drowsiness, fainting, or serious side effects in some patients. Contact your doctor immediately if you have symptoms of a heart rhythm disorder, including fast, slow, or irregular heartbeat.

Lacosamide injection can cause a condition called drug reaction with eosinophilia and systemic symptoms (DRESS), which is a serious allergic reaction that affects multiple body organs (e.g. liver or kidney). Consult your doctor immediately if you have fever, dark urine, headache, rash, stomach pain, swollen, painful, or tender lymph glands in the neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

Breastfeeding while taking this medicine may cause your baby to become more sleepy. Talk to your doctor if you have concerns.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of lacosamide

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Schwindel
• Zittern und unsicherer Gang
• Schläfrigkeit oder ungewöhnliche Schläfrigkeit
• Zittern oder Zittern der Hände oder Füße
• Unsicherheit, Zittern oder andere Probleme mit der Muskelkontrolle oder -koordination

Less common

• Vergesslich sein
• Blutungen, Blasenbildung, Brennen, Kälte, Verfärbung der Haut, Druckgefühl, Nesselsucht, Infektion, Entzündung, Juckreiz, Klumpen, Taubheitsgefühl, Schmerzen, Hautausschlag, Rötung, Narbenbildung, Schmerzen, Stechen, Schwellung, Empfindlichkeit, Kribbeln, Geschwürbildung oder Wärme an der Injektionsstelle
• Entmutigung
• sich traurig oder leer fühlen
• Reizbarkeit
• juckende Haut
• Appetitlosigkeit
• Verlust der Gleichgewichtskontrolle
• Verlust von Interesse oder Vergnügen
• Stimmungsschwankungen oder mentale Veränderungen
• Einreißen der Haut
• Müdigkeit
• Konzentrationsschwierigkeiten
• Probleme mit dem Schlafen
• Schwierigkeiten beim Gehen

Rarely

• Schmerzen oder Unwohlsein in der Brust
• Rötung oder Rötung der Haut
• Benommenheit, Schwindel oder Ohnmacht
• langsamer oder unregelmäßiger Herzschlag
• ungewöhnliche Müdigkeit
• ungewöhnlich warme Haut

Incident not known

• Abnormales oder vermindertes Berührungsempfinden
• schwarzer, teeriger Stuhl
• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Kribbeln, Kribbeln oder Kribbeln
• Veränderungen in den Mustern und Rhythmen der Sprache
• Schüttelfrost
• anhaltendes Klingeln oder Summen oder andere unerklärliche Geräusche in den Ohren
• Husten
• schneller, unregelmäßiger, hämmernder oder rasender Herzschlag oder Puls
• betrunken fühlen
• Fieber
• Schwerhörigkeit
• Schmerzen im unteren Rücken oder an der Seite
• schmerzhaftes oder schwieriges Wasserlassen
• blasse Haut
• undeutliches Sprechen
• Halsentzündung
• Atembeschwerden
• Schwierigkeiten bei der Ausführung von Routineaufgaben
• Probleme mit dem Gleichgewicht
• Schwierigkeiten beim Sprechen
• Geschwüre, Wunden oder weiße Flecken im Mund
• ungewöhnliche Blutungen oder Blutergüsse

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Verschwommene Sicht
• Doppeltsehen
• Kopfschmerzen
• Brechreiz
• doppelt sehen
• Erbrechen

Less common

• Durchfall
• Gefühl der ständigen Bewegung von sich selbst oder der Umgebung
• Mangel oder Verlust der Kraft
• Gefühl des Drehens
• unkontrollierte Augenbewegungen

Incident not known

• Saurer oder saurer Magen
• Aufstoßen
• Blasenbildung, Abschälen, Ablösung der Haut
• Verstopfung
• Schwierigkeiten beim Stuhlgang
• trockener Mund
• Sodbrennen
• vermehrtes Schwitzen
• Verdauungsstörungen
• Große, bienenstockartige Schwellung im Gesicht, an Augenlidern, Lippen, Zunge, Hals, Händen, Beinen, Füßen oder Genitalien
• Muskelkrämpfe
• rote, gereizte Augen
• rote Hautläsionen, oft mit violettem Zentrum
• Magenbeschwerden, Magenverstimmung oder Schmerzen

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Vimpat

Available dosage forms:

• Lösung

Therapeutic class: Anticonvulsant

More information