PHENYTOIN INFATABS- phenytoin tablet, chewable

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

PHENYTOIN (UNII: 6158TKW0C5) (PHENYTOIN - UNII:6158TKW0C5)

Sẵn có từ:

Prasco Laboratories

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Phenytoin Infatabs are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin is contraindicated in patients with: Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as phenytoin, during pregnancy. Physicians are advised to recommend that pregnant patients taking phenytoin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. Risk Summary In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Prenatal phenytoin exposure is associated with an inc

Tóm tắt sản phẩm:

Phenytoin Infatabs contain 50 mg phenytoin and are supplied in a yellow triangular scored chewable tablet as follows: 100's 50 mg NDC 66993-372-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

Prasco Laboratories
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MEDICATION GUIDE
PHENYTOIN INFATABS, CHEWABLE TABLETS, USP
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 11/2020
What is the most important information I should know about phenytoin?
•
Do not stop taking phenytoin without first talking to your healthcare
provider.
o
Stopping phenytoin suddenly can cause serious problems.
o
Stopping a seizure medicine suddenly can cause you to have seizures
more often or seizures
that will not stop (status epilepticus).
•
Like other antiepileptic drugs, phenytoin 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
•
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
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.
•
Phenytoin can cause a type of serious allergic reaction that may
affect different parts of the body
such as your liver, kidneys, blood, heart, skin or other parts of your
body. These can be very
serious and cause death. Call your healthcare provider right away if
you have any or all of these
MEDICATION GUIDE
PHENYTOIN

Đặc tính sản phẩm

PHENYTOIN INFATABS- PHENYTOIN TABLET, CHEWABLE
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PHENYTOIN INFATABS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PHENYTOIN
INFATABS .
PHENYTOIN INFATABS CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
Phenytoin Infatabs are indicated for the treatment of generalized
tonic-clonic (grand mal) and complex
partial (psychomotor, temporal lobe) seizures and prevention and
treatment of seizures occurring during
or following neurosurgery. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Phenytoin Infatabs are available as 50 mg phenytoin scored chewable
tablets. (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions are nervous system reactions,
including nystagmus, ataxia, slurred
speech, decreased coordination, somnolence, and mental confusion. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRASCO LABORATORIES AT
1-866-525-0688
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
®
®
®
NOT FOR ONCE-A-DAY DOSING (2.1)
Adult starting dose in patients who have received no previous
treatment is two Infatabs three times a
day, with dose adjustments as necessary. For most adults, the
satisfactory maintenance dose will be
six to eight Infatabs daily; an increase to twelve Infatabs daily may
be made, if necessary. (2.2)
Pediatric starting dose is 5 mg/kg/day in two to three equally divided
doses, with dosage adjustments
as necessary, up to a maximum of 300 mg daily. Maintenance dosage is 4
to 8 mg/kg/day. (2.3)
Serum blood level determinations may be necessary for optimal dosage
adjustments—the clinically
effective serum total concentration is 10 to 20 mcg/mL (unbound
phenytoin concentration is 1 to 2
mcg/mL). (2.4)
Hypersensitivity to phenytoin, its ingredients, or other hydantoins
(4, 5.5)
A history of prior acut