PHENYTOIN INFATABS- phenytoin tablet, chewable

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

NCS HealthCare of KY, LLC dba Vangard Labs

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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: - A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5)] . Reactions have included angioedema. - A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8)]. - Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. 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 increased incidence of major malformations, including orofacial clefts and cardiac defects. In addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see Data] . There have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. Administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see Data]. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Disease-associated maternal risk An increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. Periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see Dosage and Administration (2.4, 2.8)] . However, postpartum restoration of the original dosage will probably be indicated [see Clinical Pharmacology (12.3)]. Fetal/Neonatal Adverse Reactions A potentially life-threatening bleeding disorder related to decreased levels of vitamin K-dependent clotting factors may occur in newborns exposed to phenytoin in utero . This drug-induced condition can be prevented with vitamin K administration to the mother before delivery and to the neonate after birth. Data Human Data Meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. An increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. The fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. Animal Data Administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. Malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100, 75, and 12.5 mg/kg, respectively. Risk Summary Phenytoin is secreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition. Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see Dosage and Administration (2.3)]. Phenytoin clearance tends to decrease with increasing age [see Clinical Pharmacology (12.3)] . Lower or less frequent dosing may be required [see Dosage and Administration (2.7)] . The liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. Because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. Patients who are intermediate or poor metabolizers of CYP2C9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). Thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. If early signs of dose-related central nervous system (CNS) toxicity develop, serum concentrations should be checked immediately [see Clinical Pharmacology (12.5)].

Обзор продуктов:

Phenytoin Infatabs contain 50 mg phenytoin and are supplied in a yellow triangular scored chewable tablet as follows: 30's 50 mg NDC 0615-8424-39 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

NCS HealthCare of KY, LLC dba Vangard Labs
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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.
•
Stopping phenytoin suddenly can cause serious problems.
•
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

Характеристики продукта

PHENYTOIN INFATABS- PHENYTOIN TABLET, CHEWABLE
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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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
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)
DOSAGE FORMS AND STRENGTHS
Phenytoin Infatabs are available as 50 mg phenytoin scored chewable
tablets. (3)
CONTRAINDICATIONS
Hypersensitivity to phenytoin, its ingredients, or other hydantoins
(4, 5.5)
A history of prior acute hepatotoxicity attributable to phenytoin (4,
5.8)
Coadministration with delavirdine (4)
WARNINGS AND PRECAUTIONS
_Withdrawal Precipitated Seizure:_ May precipitate status epilepticus.
Dose reductions or discontinuation
should be done gradually. (5.1)
_Suicidal Behavior and Ideation:_ Monitor patients for the emergence
or worsening of depression, suicidal
thoughts or behavior, and/or any unusual changes in mo