Based on response and tolerability, increase dose at weekly intervals by 50 mg poiv bid. The infusion maybe administered at the dose andrate the patient tolerated in the most recent infusion. Vimpat lacosamide oralinjection uses, side effects. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vimpat lacosamide skip to. In addition, the present study supports prior studies that have proven lacosamide as an effective adjunctive therapy for the treatment of resistant partial epilepsy. Group 2 and group 3 had creatinine clearances ranging from 14. Abuse of lacosamide may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule iv. Lacosamide lakoesamide oral solution, cv lacosamide. National drug monograph national drug monograph addendum. Really retrospective study of lacosamide as early addon along one year was a multicenter, retrospective, 1year, reallife study.
Medication guide vimpat vimpat lacosamide film coated. One 20ml vial contains 200 mg of lacosamide drug substance. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Keep the medication in a place where others cannot get to it. Lacosamide also has only a few interactions with other agents, including immunosuppressive. Lacosamide definition of lacosamide by medical dictionary. The historical control consisted of a pooled analysis of the control groups from 8 studies of similar design, which utilized a subtherapeutic dose of an aed as a control. Lacosamide oral solution fda prescribing information, side. The volume of distribution v d of lacosamide in plasma is 0. Also, you can add more pdfs to combine them and merge them into one single document. With the pdf reflow feature available in word 20 and 2016, you can open and edit pdf content, such as. It is approved to be used alone or with other medicines to treat partialonset seizures.
These highlights do not include all the information needed to use vimpat safely and effectively. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. Lacosamide has a currently accepted medical use in treatment in the united states. Vimpat is used together with other medications to treat partialonset seizures in adults and children with epilepsy. While most side effects are minor and do not require medical attention, certain problems may be more serious and should be reported to your healthcare provider right away. Lacosamide has a low potential for abuse relative to the drugs or other substances in schedule iv. Lacosamide is approved for use in children 4 years and older. The initial dose should be 50 mg twice daily 100 mg per day. Lacosamide comes as a tablet and as an solution liquid to take by mouth. Apr 15, 2016 monitor patients for suicidal behavior and ideation lacosamide may cause dizziness and ataxia cardiac rhythm and conduction abnormalities. There are other medicines similar to vimpat lacosamide that are available as generic and are much cheaper. Zonegran zonisamide package insert page 3 of 23 renal insufficiency. Lacosamide package insert in the united states, companies that manufacture medicines are required to publish certain kinds of information about each product.
Lacosamide injection is given as an infusion into a vein. Specifically, it is approved for use in combination with other seizure medications to treat partialonset seizures in people age 17 years old and older. The inactive ingredients are sodium chloride and water for injection. Vimpat lacosamide tablet, film coated for oral use vimpat lacosamide injection for intravenous use initial u. Lacosamide appeared to have low risks of significant changes in cognition or moodquality of life. Vimpat, innlacosamide european medicines agency europa eu. When using lacosamide oral solution, it is recommended that a calibrated measuring device be obtained and used.
Group 1 was a healthy group with a creatinine clearance ranging from 70152 mlmin. Lacosamide fda prescribing information, side effects and. Lacosamide oral solution fda prescribing information. Vimpat lacosamide dosing, indications, interactions. Side effects of lacosamide dizziness, nausea, and vomiting are some of the most common side effects of lacosamide. The clinical effectiveness of lacosamide has been demonstrated in randomized, doubleblind, parallelgroup, placebocontrolled, adjunctivetherapy trials in patients with refractory partial seizures. Nct00800215 study no sp616 these results are supplied for informational purposes only. This emedtv article covers the uses of lacosamide in more detail, including information on offlabel uses and detail on how this medication is thought to work. Vimpat is a prescription medicine that has been approved to treat partialonset seizures in people 4 years of age and older. If you just want to reuse some of the text from a pdf for example, a short passagetry copying and pasting it. Vimpat tablets and oral solution are for use in adults and children who are at least 4 years old. Do not give vimpat to other people, even if they have the same.
Lacosamide tablets 150 mg are tan, oval, filmcoated tablets debossed with 1 on one side and plain on the other side. Lacosamide for the treatment of partialonset seizures. If left untreated, metabolic acidosis can cause brittle or soft bones osteoporosis, osteomalacia, osteopenia, kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Lacosamide accord, innlacosamide european medicines agency. See the package insert for details on starting and dosing of this medicine in children. The dosing of lacosamide in children is based on weight. Key wordsanticonvulsants, lacosamide, new drugs, seizure. Decreased feeling or sensitivity, difficulty in articulating words, disturbance in. Proprietary drug name vimpat inn lacosamide therapeutic area and indications postherpetic neuralgia name of sponsor. You must submit final promotional materials and package insert s, accompanied by a form. Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention. A healthcare provider will give you this injection if you are unable to take the medicine by mouth. Vimpat lacosamide is an antiepileptic drug, also called an anticonvulsant.
Prescribing decisions should be made based on the approved package insert. Do not use vimpat for a condition for which it was not prescribed. The overall risk ratio for a 50% or greater reduction in seizure frequency for all doses of lacosamide compared with placebo was 1. By dragging your pages in the editor area you can rearrange them or delete single pages. Patients included were aged older than 16 years, had partialonset seizures, and were treated with lacosamide as addon therapy after one or two prior aeds. Action mechanism is not known, but may involve enhancement of slow inactivation of sodium channels with resultant membrane stabilization therapeutic effects decreased incidence and. Lacosamide is an anticonvulsant compound approved for the adjunctive. Lacosamide is used to prevent and control seizures. Nct00238511 study no sp690 these results are supplied for informational purposes only. Monotherapy and addon therapy for focal seizures with or without focal to bilateral seizures. For the lacosamide 400 mgday group, the estimated percentage of patients meeting at least.
Efficacy and safety of lacosamide as first addon or later. Both patient groups reported improvements from baseline in quality of life outcomes. The infusion rate of kadcylashould be slowed or interrupted if the patient developsan. Pdf the mechanism of action of several antiepileptic drugs aeds rests on their ability to modulate the activity of voltagegated sodium. N, nbis 2chloroethylphosphoric acid diamide ifosphoramide and acrolein are also found. Included in this submission is the revised package insert containing the new unit dose configuration for each strength in the.
Mar 23, 2020 lacosamide oral solution is indicated in patients 17 years and older with partialonset seizures as adjunctive therapy. Troubles with your memory, thinking or finding words, confusion. Isoniazid tablets usp rx only warning severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. Do not drive, operate heavy machinery, or do other dangerous activities until you know how lacosamide tablets affects you. Department of health and human services food and drug administration silver spring md 20993 nda 022253s023. However, instead of getting a pdf icon to click on in order to open the pdf file, i get a small copy of the pdf file. Intravenous injection can be administered in the same dosing regimens. Vimpat lacosamide tablets, injection, oral solution. For example, you may not be able to safely use lacosamide if you have certain medical conditions such as depression or kidney disease or if you are using certain medications.
Monotherapy and addon therapy for focal seizures with or without focal to bilateral seizures from age 4. Lacosamide fda prescribing information, side effects and uses. Single 300 mg zonisamide doses were administered to three groups of volunteers. Primary compounds excreted were unchanged lacosamide approximately 40% of the dose, its odesmethyl metabolite approximately 30%, and a structurally unknown polar fraction 20%. Topamax can increase the level of acid in your blood metabolic acidosis. Side effects of lacosamide nervous system home page.
Proprietary drug name vimpat inn lacosamide therapeutic area and indications painful distal diabetic neuropathy. Office of prescription drug promotion opdp 5901b ammendale road. Vimpat oral solution prescription and dosage sizes information for physicians and healthcare professionals. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always take the medicine as prescribed and at the same time everyday. If your healthcare provider has prescribed lacosamide oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of lacosamide oral solution.
The safety of vimpat injection in pediatric patients has not been established. In patients already taking an antiepileptic drug aed, maintain lacosamide at recommended maintenance dose of 150200 mg po bid for at least 3 days before initiating withdrawal of the previous aed. Accuracy a study of recovery of lacosamide from spiked placebo was conducted at five different spike levels i. Tablets are indicated for adjunctive therapy in patients. Dosage in adolescents and children weighing 50 kg or more is the same as in adults see above. Information and translations of lacosamide in the most comprehensive dictionary definitions resource on the web. There were four suicides in drugtreated patients in the trials and none in placebotreated patients, but the number of events is too small to allow any conclusion about drug effect on suicide. Act fdca for vimpat lacosamide tablets, vimpat lacosamide injection, and vimpat lacosamide oral solution. To merge pdfs or just to add a page to a pdf you usually have to buy expensive software. Action mechanism is not known, but may involve enhancement of slow inactivation of sodium channels with resultant membrane stabilization therapeutic effects decreased. Read this medication guide before you start taking lacosamide oral solution and each time you get a refill.
Proprietary drug name vimpat proposed inn lacosamide therapeutic area and indications diabetic neuropathic pain. Vimpat lacosamide injection, for intravenous use, cv. Information for the patient vimpat 10 mgml solution. The spl will be accessible from publicly available labeling repositories. Department of health and human services silver spring. A post hoc analysis of the clinical trials was conducted to assess the response during the lacosamide titration phase and evaluate other antiepileptic drugs aed used. Nct00220337 study no sp830 these results are supplied for informational purposes only. Read all of this leaflet carefully before you start using this medicine because it contains.
Prior to tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. Take lacosamide at around the same times every day. I want to embed the pdf file into the word document, so that it can be opened, and copied onto another location in its original form, not as a. Ecg before beginning lacosamide, and after lacosamide is titrated to steadystate maintenance dose is recommended in patients with known cardiac conduction problems, taking drugs known to induce pr interval prolongation, or with severe cardiac disease. Nct00238524 study no sp743 these results are supplied for informational purposes only. Vimpat is a prescription medicine used to treat partialonset seizures in people 4 years of age and older. Highlights of prescribing information these highlights do. Vimpat can be initiated with either oral or intravenous administration. Valproate increases lamotrigine concentrations more than 2fold. Information for the patient vimpat 50 mg filmcoated. Vimpat injection is indicated for the treatment of partialonset seizures only in adult patients 17 years of age and older. An awareness of the precautions and warnings with lacosamide can help to ensure a safe treatment process. Lacosamide is ampiphilic and is thus hydrophilic while also lipophilic enough to cross the bloodbrain barrier.
Lacosamide 300400 mgday was efficacious as a first or later addon for pos. It is usually taken twice a day morning and night with or without food. Vimpat can be increased at weekly intervals by 100 mgday given as two divided doses up to the recommended maintenance dose of 200 to 400 mgday, based on. Discard any unused vimpat oral solution remaining after seven 7 weeks of first opening the bottle. The safety and tolerability of an adjunctive vimpat loading dose was evaluated in a phase iiib, multicenter, openlabel, sequential cohort trial with a single, intravenous loading dose, followed by oral administration of an equivalent dose divided twicedaily for 6. Lacosamide tablets may cause you to have an irregular heartbeat or may cause you to faint. The relative contribution of other cyp isoforms or noncyp enzymes in the metabolism of lacosamide is not known. Keep vimpat and all medicines out of the reach of children. Lacosamide tablets may cause you to feel dizzy, have double vision, feel sleepy, or have problems with coordination and walking. Lacosamide is an alternative agent that may be used. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. You must submit final promotional materials and package inserts, accompanied by a form.
Vimpat lacosamide tablets and injection page 5 of 29 approximately one case of suicidal thinking or behavior for every 530 patients treated. Lacosamide, sold under the brand name vimpat among others, is a medication used in the adjunctive treatment of partialonset seizures and diabetic neuropathic pain. Usually, youll get plain text without the formatting. It works by reducing the spread of seizure activity in the brain. Lacosamide is approved for use in combination with other medications to treat partial seizures. R medical university in partial fulfillment for the award of the degree of master of pharmacy pharmaceutical. Vimpat lacosamide is a controlled medicine, so you can only get a limited amount per month. May 22, 2019 lacosamide tablets 100 mg are yellow, oval, filmcoated tablets debossed with 12 on one side and plain on the other side. Vimpat may be used on its own or with other antiepileptic medicines. The effects of lacosamide on cognition, qualityoflife.
Vimpat injection is a clear, colorless, sterile solution containing 10 mg lacosamide per ml for intravenous infusion. Medicines are sometimes prescribed for purposes other than thoselisted in a medication guide. Isoniazid tablets usp national institutes of health. Lacosamide is a recently approved antiepileptic drug for the adjunctive treatment of partialonset seizures in adults. General information about the safe and effective use of vimpat. With the issuance of this final rule, the deputy administrator of the dea places the substance lacosamide r2acetoamidonbenzyl 3methoxypropionamide and any material, compound, mixture, or preparation which contains any quantity of lacosamide into schedule v of the controlled substances act csa. This document is commonly known as a package insert because it is usually included with each package of the medicine.
Vimpat lacosamide approved by fda for pediatric use. See full prescribing information for complete boxed warning. Lacosamide oral solution may be taken with or without food. Side effects of lacosamide seen in children are similar to those in adults. Vimpat injection for intravenous useindicated as shortterm replacement when oral administration is not feasible. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vimpat lacosamide. Pharmacology, adverse reactions, warnings and side effects. Vimpat lacosamide film coated tablet, for oral use, cv. The analysis concluded that lacosamide treatment showed a reduction in seizures, regardless of the concomitant aed used. Vimpat lacosamide cv oral formulations are approved as a monotherapy or adjunctive therapy in patients four years of age and older with partialonset seizures pos 1 pediatric epilepsy is the most common, serious, treatable neurological disorder among.
697 1477 764 1204 42 485 703 218 429 662 20 787 1318 12 477 590 1243 785 641 267 349 977 642 1449 392 543 188 355 227 1473 510 340 1163 1043 1485 533