VIGABATRIN tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

VIGABATRIN (UNII: GR120KRT6K) (VIGABATRIN - UNII:GR120KRT6K)

제공처:

Padagis US LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions (5.1)] . Vigabatrin tablets are not indicated as a first line agent for complex partial seizures. Vigabatrin tablets are indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (5.1)] . None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including vigabatrin, during pregnancy. Encourage women who are taking vigabatrin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334

제품 요약:

Vigabatrin Tablets, USP, 500 mg are oval-shaped tablets, white, film-coated, biconvex, scored on one side and debossed with "D500" on the other side. They are supplied as bottles of 100 (NDC 0574-0201-01). Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

VIGABATRIN- VIGABATRIN TABLET
Padagis US LLC
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MEDICATION GUIDE
MEDICATION GUIDE
Vigabatrin (vye ga' ba trin) Tablets
What is the most important information I should know about vigabatrin
tablets?
Vigabatrin tablets can cause serious side effects, including:
• Permanent vision loss
• Magnetic resonance imaging (MRI) changes in babies with infantile
spasms (IS)
• Risk of suicidal thoughts or actions
1. Permanent vision loss:
Vigabatrin tablets can damage the vision of anyone who takes it. Some
people can have severe loss
particularly to their ability to see to the side when they look
straight ahead (peripheral vision). With severe
vision loss, you may only be able to see things straight in front of
you (sometimes called “tunnel vision”).
You may also have blurry vision. If this happens, it will not get
better.
•
Vision loss and use of vigabatrin tablets in adults and children 2
years and older: Because of the risk of
vision loss, vigabatrin tablets are used to treat complex partial
seizures (CPS) only in people who do
not respond well enough to several other medicines.
Tell your healthcare provider right away if you (or your child):
◦
might not be seeing as well as before starting vigabatrin tablets.
◦
start to trip, bump into things, or are more clumsy than usual.
◦
are surprised by people or things coming in front of you that seem to
come out of nowhere.
•
These changes can mean that you (or your child) have damage to your
vision.
•
It is recommended that your healthcare provider test your (or your
child’s) vision (including peripheral
vision) and visual acuity (ability to read an eye chart) before you
(or your child) start vigabatrin tablets
or within 4 weeks after starting vigabatrin tablets, and at least
every 3 months after that until vigabatrin
tablets are stopped. It is also recommended that you (or your child)
have a vision test about 3 to 6
months after vigabatrin tablets are stopped. Your vision loss may get
worse after you stop taking
vigabatrin tablets.
•
Some people

제품 특성 요약

VIGABATRIN- VIGABATRIN TABLET
PADAGIS US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIGABATRIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VIGABATRIN TABLETS.
VIGABATRIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: PERMANENT VISION LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
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INDICATIONS AND USAGE
Vigabatrin tablets are indicated for the treatment of:
•
•
DOSAGE AND ADMINISTRATION
Refractory Complex Partial Seizures
•
•
•
•
Infantile Spasms
•
Renal Impairment: Dose adjustment recommended (2.4, 8.5, 8.6)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Vigabatrin can cause permanent bilateral concentric visual field
constriction, including tunnel
vision that can result in disability. In some cases, vigabatrin may
also decrease visual acuity
(5.1).
Risk increases with increasing dose and cumulative exposure, but there
is no dose or exposure
to vigabatrin known to be free of risk of vision loss (5.1).
Risk of new and worsening vision loss continues as long as vigabatrin
is used, and possibly after
discontinuing vigabatrin (5.1).
Baseline and periodic vision assessment is recommended for patients on
vigabatrin. However,
this assessment cannot always prevent vision damage (5.1).
Vigabatrin is available only through a restricted program called the
Vigabatrin REMS Program
(5.2).
Refractory Complex Partial Seizures as adjunctive therapy in patients
2 years of age and older who
have responded inadequately to several alternative treatments;
Vigabatrin tablets are not indicated
as a first line agent (1.1)
Infantile Spasms - monotherapy in infants 1 month to 2 years of age
for whom the potential benefits
outweigh the potential risk of vision loss (1.2)
Adults (17 years of age and older): Initiate at 1000 mg/day (500 mg
twice daily); increase total daily
dose weekly in 500 mg/day increments, to the recommended dose of 3000