ELEPSIA XR- levetiracetam tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)

Available from:

Sun Pharma Advanced Research Company Limited

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 1000 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. ELEPSIA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including ELEPSIA XR, during pregnancy. Encourage women who are taking ELEPSIA XR 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 Prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see Human Data ] . In animal studies, levetirac

Product summary:

ELEPSIA XR tablets, 1000 mg are oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on the blue layer; imprinted with "574" with black ink on one side and plain on the other side. They are supplied as follows:         Bottles of 30 with child resistant cap…................... NDC 47133-574-83         Bottles of 100 with child resistant cap…................. NDC 47133-574-88         Bottles of 500 with non-child resistant cap………. NDC 47133-574-13 ELEPSIA XR tablets, 1500 mg are oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on the blue layer; imprinted with "575" with black ink on one side and plain on the other side. They are supplied as follows:         Bottles of 30 with child resistant cap…................... NDC 47133-575-83         Bottles of 100 with child resistant cap…................. NDC 47133-575-88         Bottles of 500 with non-child resistant cap………. NDC 47133-575-13 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Authorization status:

New Drug Application

Patient Information leaflet

ELEPSIA XR - LEVETIRACETAM TABLET, EXTENDED RELEASE
Sun Pharma Advanced Research Company Limited
----------
MEDICATION GUIDE
ELEPSIA™ XR (E LEP' SEE A EX ARE)
(LEVETIRACETAM)
EXTENDED-RELEASE TABLETS, FOR ORAL
USE
Read this Medication Guide before you start taking ELEPSIA XR and each
time you get a refill. There
may be new information. 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 ELEPSIA XR?
Like other antiepileptic drugs, ELEPSIA XR may cause suicidal thoughts
or actions in a very small
number of people, about 1 in 500 people taking it.
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
•
attempts 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
Do not stop ELEPSIA XR without first talking to a healthcare provider.
•
Stopping ELEPSIA XR suddenly can cause serious problems. Stopping a
seizure medicine
suddenly can cause seizures that will not stop (status epilepticus).
•
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.
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.
What is ELEPSIA XR?
ELEPSIA XR is a prescription medicine taken by mouth

Summary of Product characteristics

ELEPSIA XR - LEVETIRACETAM TABLET, EXTENDED RELEASE
SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELEPSIA XR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ELEPSIA XR.
ELEPSIA™ XR (LEVETIRACETAM) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
ELEPSIA XR is indicated as adjunctive therapy for the treatment of
partial-onset seizures in patients 12 years of age and
older (1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a dose of 1000 mg once daily; increase by 1000
mg every 2 weeks to a maximum recommended
dose of 3000 mg once daily (2.1)
ELEPSIA XR should be taken whole; do not split or cut tablets (2.1)
Not recommended for use in patients with moderate or severe renal
impairment; the maximum recommended dose in
patients with mild renal impairment is 2000 mg (2.2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets, 1000 mg, 1500 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4)
WARNINGS AND PRECAUTIONS
Behavioral abnormalities including psychotic symptoms, suicidal
ideation, irritability, and aggressive behavior have
been observed; monitor patients for psychiatric signs and symptoms
(5.1)
Suicidal Behavior and Ideation: Monitor patients for new or worsening
depression, suicidal thoughts/behavior, and/or
unusual changes in mood or behavior (5.2)
Monitor for somnolence and fatigue and advise patients not to drive or
operate machinery until they have gained
sufficient experience on ELEPSIA XR (5.3)
Serious Dermatological Reactions: Discontinue ELEPSIA XR at the first
sign of rash unless clearly not drug related
(5.5)
Coordination Difficulties: Monitor for ataxia, abnormal gait, and
incoordination. Advise patients to not drive or operate
machinery until they have gained experience on ELEPSIA XR (5.6)
Withdrawal Seizures: ELEPSIA XR must be gradually withdrawn (5.7)
ADVERSE REACTIONS
M