PHENYTOIN SODIUM capsule, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Unichem Pharmaceuticals (USA), Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 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 extended phenytoin sodium capsules, during pregnancy. Physicians are advised to recommend that p

Ürün özeti:

Extended Phenytoin Sodium Capsules USP, 100 mg are hard gelatin capsules of size '3' with white to off white opaque cap and white to off white opaque body imprinted 'U' on cap and '379' on the body with black ink containing white to off white powder. Bottles of 100                       NDC 29300-379-01 Bottle of 500                         NDC 29300-379-05 Bottle of 1,000                      NDC 29300-379-10 Store at 20 to 25oC (68 to 77oF) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Unichem Pharmaceuticals (USA), Inc.
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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 cause death.
Call your healthcare
provider ri

Ürün özellikleri

PHENYTOIN SODIUM - PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
UNICHEM PHARMACEUTICALS (USA), 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
RECENT MAJOR CHANGES
Warnings and Precautions (5.3) 2/2021
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)
Pediatricstartingdoseis5mg/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
to2mcg/mL).(2.3)
DOSAGE FORMS AND STRENGTHS
Extended phenytoin sodium capsules is available as 100 mg extended
phenyto