VIMPAT- lacosamide tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

lacosamide (UNII: 563KS2PQY5) (lacosamide - UNII:563KS2PQY5)

Mevcut itibaren:

Physicians Total Care, Inc.

INN (International Adı):

lacosamide

Kompozisyon:

lacosamide 50 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

VIMPAT (lacosamide) tablets and oral solution are indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. VIMPAT (lacosamide) injection for intravenous use is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older when oral administration is temporarily not feasible. None. Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated with clinically relevant plasma exposures. Lacosamide has been shown in vitro to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal out

Ürün özeti:

VIMPAT (lacosamide) Tablets 50 mg are pink, oval, film-coated tablets debossed with "SP" on one side and "50" on the other. They are supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Do not freeze Vimpat injection or oral solution. Discard any unused Vimpat oral solution remaining after seven (7) weeks of first opening the bottle.

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

VIMPAT - LACOSAMIDE TABLET, FILM COATED
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
VIMPAT (VIM-păt) CV
(lacosamide)
Tablet, Oral Solution and Injection for Intravenous Use
Read this Medication Guide before you start taking VIMPAT and each
time you get a refill. There may be
new information. This Medication Guide describes important safety
information about VIMPAT. 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 VIMPAT?
Do not stop taking VIMPAT without first talking to your healthcare
provider.
Stopping VIMPAT suddenly can cause serious problems.
VIMPAT can cause serious side effects, including:
1.
Like other antiepileptic drugs, VIMPAT 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
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or
feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
•
Call your healthcare provider between visits as needed, especially if
you are worried about
symptoms.
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have
suicidal thoughts or actions, your healthcare provider may check for
other causes.
•
Do not stop VIMPAT without first talking to a healthcare provider.
Stopping VIMPAT
suddenly can cau

Ürün özellikleri

VIMPAT - LACOSAMIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIMPAT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIMPAT.
VIMPAT (LACOSAMIDE) TABLET, FILM COATED FOR ORAL USE, CV
VIMPAT (LACOSAMIDE) INJECTION FOR INTRAVENOUS USE, CV
VIMPAT (LACOSAMIDE) ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
VIMPAT is indicated for:
PARTIAL-ONSET SEIZURES (1.1): Tablets and oral solution are indicated
for adjunctive therapy in patients ≥17 years.
Injection is indicated as short term replacement when oral
administration is not feasible in these patients.
DOSAGE AND ADMINISTRATION
PARTIAL-ONSET SEIZURES (2.1): Initially, give 50 mg twice daily (100
mg/day). The dose may be increased, based on
clinical response and tolerability, at weekly intervals by 100 mg/day
given as two divided doses to a daily dose of 200 to
400 mg/day. VIMPAT injection may be given without further dilution or
mixed in compatible diluent and should be
administered intravenously over a period of 30 to 60 minutes. (2.1)
ORAL-INTRAVENOUS REPLACEMENT THERAPY (2.1): When switching from oral
VIMPAT, the initial total daily intravenous
dosage of VIMPAT should be equivalent to the total daily dosage and
frequency of oral VIMPAT. At the end of the
intravenous treatment period, the patient may be switched to VIMPAT
oral administration at the equivalent daily
dosage and frequency of the intravenous administration.
See full prescribing information for compatibility and stability (2.1)
and dosing in patients with renal impairment (2.2)
and hepatic impairment (2.3).
DOSAGE FORMS AND STRENGTHS
50 mg (pink), 100 mg (dark yellow), 150 mg (salmon), 200 mg (blue)
film-coated tablets (3)
200 mg/20 mL single-use vial for intravenous use (3)
10 mg/mL oral solution (3)
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation (5.1)
Patients should be advised that VIMPAT may cause dizziness and atax