PHENYTOIN SODIUM capsule, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Sun Pharmaceutical Industries, Inc.

DCI (Denominação Comum Internacional):

PHENYTOIN SODIUM

Composição:

PHENYTOIN SODIUM 200 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 pregn

Resumo do produto:

Extended Phenytoin Sodium Capsules, USP are available containing 200 mg or 300 mg of phenytoin sodium, USP. The 200 mg capsule has a blue transparent cap and a light blue transparent body. The hard-shell gelatin capsule is filled with white to off-white powder. The capsule is printed axially with 299 in black ink on both the cap and the body. They are available as follows: Bottle of 30 with child-resistant cap...................NDC 62756-299-83 Bottle of 100 with child-resistant cap.................NDC 62756-299-88 Bottle of 100.........NDC 62756-299-08 Bottle of 500.........NDC 62756-299-13 The 300 mg capsule has a light blue transparent cap and a light blue transparent body. The hard-shell gelatin capsule is filled with white to off-white powder. The capsule is printed axially with 432 in black ink on both the cap and the body. They are available as follows: Bottle of 30 with child-resistant cap...................NDC 62756-432-83 Bottle of 100 with child-resistant cap.................NDC 62756-432-88 Bottle of 100.........NDC 62756-432-08 Bottle of 500.........NDC 62756-432-13 Store at 25°C (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 using a child resistant closure.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Extended Phenytoin (FEN-i-toyn) 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
•
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

Características técnicas

PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, 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)
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 200 mg and 300 mg
extended phenytoin sodium
capsules. (3) (3)
CONTRAINDI