VIMPAT- lacosamide tablet, film coated

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)

Հասանելի է:

REMEDYREPACK INC.

INN (Միջազգային անվանումը):

LACOSAMIDE

Կազմը:

LACOSAMIDE 100 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

VIMPAT is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of VIMPAT injection in pediatric patients has not been established, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 years of age and older). None . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as VIMPAT, during pregnancy. Encourage women who are taking VIMPAT during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risks associated with the use of VIMPAT in pregnant women. Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Developmental neurotoxici

Ապրանքի ամփոփագիր:

100 mg are dark yellow, oval, film-coated tablets debossed with "SP" on one side and "100" on the other. They are supplied as follows: NDC: 70518-0257-00 PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 VIMPAT (lacosamide) Tablets VIMPAT (lacosamide) Injection VIMPAT (lacosamide) Oral Solution Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F 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.

Լիազորման կարգավիճակը:

New Drug Application

Տեղեկատվական թերթիկ

REMEDYREPACK INC.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Revised: 6/2019
MEDICATION GUIDE
VIMPAT (VIM-păt)
(lacosamide)
film coated tablet, for oral use, CV
VIMPAT (VIM-păt)
(lacosamide)
injection, for intravenous use, CV
VIMPAT (VIM-păt)
(lacosamide)
oral solution, CV
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. Stopping seizure medicine suddenly in a
patient who has epilepsy can cause
seizures that will not stop (status epilepticus).
VIMPAT can cause serious side effects, including:
•
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

Ապրանքի հատկությունները

VIMPAT- LACOSAMIDE TABLET, FILM COATED
REMEDYREPACK INC.
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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) FILM COATED TABLET, FOR ORAL USE, CV
VIMPAT (LACOSAMIDE) INJECTION, FOR INTRAVENOUS USE, CV
VIMPAT (LACOSAMIDE) ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration ( 2.5)
6/2019
Warnings and Precautions ( 5.3)
11/2018
INDICATIONS AND USAGE
VIMPAT is indicated for the treatment of partial-onset seizures in
patients 4 years of age and older.
As the safety of VIMPAT injection has not been established in
pediatric patients, VIMPAT injection is indicated for the
treatment of partial-onset seizures only in adult patients (17 years
of age and older) ( 1)
DOSAGE AND ADMINISTRATION
_Adults (17 years and older): _Initial dosage for monotherapy is 100
mg twice daily; initial dosage for adjunctive therapy is
50 mg twice daily; maximum recommended dosage for monotherapy and
adjunctive therapy is 200 mg twice daily (
2.1)
_Pediatric Patients 4 Years to less than 17 years_: The recommended
dosage is based on body weight and is administered
orally twice daily ( 2.1)
Increase dosage based on clinical response and tolerability, no more
frequently than once per week ( 2.1)
Injection: for intravenous and adult use only when oral administration
is temporarily not feasible; dosing regimen is the
same as oral regimen; administer over 15 to 60 minutes; obtaining ECG
before initiation is recommended in certain
patients ( 2.6, 5.3)
Dose adjustment is recommended for severe renal impairment ( 2.3,
12.3)
Dose adjustment is recommended for mild or moderate hepatic
impairment; use in patients with severe hepatic
impairment is not recommended ( 2.4, 12.3)
DOSAGE FORMS AND STRENGTHS
50 mg, 100 mg, 150 mg, 200 mg tablets ( 3)
200 mg/20 mL single-dose vial for intravenous use ( 3)
10 mg/mL oral solution ( 3)
CONTRAINDICATIONS
None ( 4)
WARNING