PHENYTOIN SODIUM- phenytoin sodium capsule, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

A-S Medication Solutions

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Extended phenytoin sodium capsules, USP 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 phen

Termék összefoglaló:

Product: 50090-3499 NDC: 50090-3499-0 33 CAPSULE, EXTENDED RELEASE in a BOTTLE

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

A-S Medication Solutions
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
MEDICATION GUIDE
Extended Phenytoin (fen´ i toin) Sodium Capsules, USP
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 v

Termékjellemzők

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
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
RECENT MAJOR CHANGES
Warnings and Precautions (5.11)
10/2017
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 mg/kg/day 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 mcg/mL to 20 mcg/mL (unbound phenytoin
concentration is 1 mcg/mL to 2 mcg/mL). (2.3)
DOSAGE FORMS AND STRENGTHS
Extended phenytoin sodium capsules are available as