EXTENDED PHENYTOIN SODIUM- phenytoin sodium capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

PHENYTOIN SODIUM (UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)

可用日期:

A-S Medication Solutions

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Extended phenytoin sodium capsules are 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 extended phenytoin sodium capsules, during pregnancy. Physicians are advised to recommend that pregnan

產品總結:

Product: 50090-3165 NDC: 50090-3165-0 100 CAPSULE in a BOTTLE NDC: 50090-3165-1 90 CAPSULE in a BOTTLE, PLASTIC

授权状态:

Abbreviated New Drug Application

资料单张

EXTENDED PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE
A-S Medication Solutions
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MEDICATION GUIDE
Extended Phenytoin Sodium Capsules USP
(fen' i toin soe' dee um)
What is the most important information I should know about extended
phenytoin sodium capsules?
1. Do not stop taking extended phenytoin sodium capsules without first
talking to your healthcare provider.
•
Stopping extended phenytoin sodium capsules 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).
2. Like other antiepileptic drugs, extended phenytoin sodium capsules
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.
3. Extended phenytoin sodium capsules 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 cau

产品特点

EXTENDED PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXTENDED PHENYTOIN
SODIUM CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR EXTENDED
PHENYTOIN SODIUM CAPSULES.
EXTENDED PHENYTOIN SODIUM CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
Extended phenytoin sodium capsules are indicated for the treatment of
tonic-clonic (grand mal) and
psychomotor (temporal lobe) seizures and prevention and treatment of
seizures occurring during or
following neurosurgery. (1)
DOSAGE AND ADMINISTRATION
Adult starting dose in patients who have received no previous
treatment is one 100 mg extended
phenytoin sodium capsule three times a day, with dose adjustments as
necessary. For most adults, the
satisfactory maintenance dose will be one capsule three to four times
a day. An increase, up to two
capsules three times a day may be made, if necessary. (2.1)
Adult once-a-day dose: If seizure control is established with divided
doses of three 100 mg extended
phenytoin sodium capsules daily, once-a-day dosage with 300 mg
extended phenytoin sodium capsules
may be considered. (2.1)
Adult loading dose: reserved for patients in a clinic or hospital
setting who require rapid steady-state
serum levels and where intravenous administration is not desired.
Refer to full prescribing information.
(2.1)
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. (2.2)
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). (2.3)
DOSAGE FORMS AND STRENGTHS
Extended phenytoin sodium capsules are available as 100 mg extended
phenytoin sodium capsules. (3)
CONTRAINDICATIONS
Hypersensitivity to phenyto