PHENYTOIN SODIUM- phenytoin sodium capsule, extended release

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:

REMEDYREPACK INC.

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)] . -  A history of prior acute hepatotoxicity attributable to phenytoin [see  Warnings and Precautions (5.6)] . - 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 pregnant patients taking extended phenyt

產品總結:

Extended Phenytoin Sodium Capsules USP, 100 mg are supplied as follows: Transparent # 3 capsule, filled with white to off-white powder, with the code '402' imprinted on the cap and body. Bottles of 100: NDC 62756-402-01 Bottles of 100 Non Child Resistant Cap: NDC 62756-402-02 Bottles of 1000 Non Child Resistant Cap: NDC 62756-402-03 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].  Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

授权状态:

Abbreviated New Drug Application

资料单张

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
REMEDYREPACK INC.
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MEDICATION GUIDE
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 · New or worse anxiety · Trouble
sleeping (insomnia)
•
Acting on dangerous Impulses · Attempts to commit suicide · Feeling
agitated or restless
•
New or worse irritability · An extreme increase in activity and
talking (mania)
•
New or worse depression · Panic attacks · Acting aggressive, being
angry, or violent
•
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 cause death. Call your healthcare provider right away if
you have any or all

产品特点

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
REMEDYREPACK INC.
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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) (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) (3)
CONTRAINDICATIONS
Hypersensitivity t