DILANTIN- phenytoin sodium capsule, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

REMEDYREPACK INC.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

DILANTIN is 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. DILANTIN 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 DILANTIN, during pregnancy. Physicians are advised to recommend that p

Podsumowanie produktu:

DILANTIN 30 mg extended capsules are available as a size 4 hemispherical Coni-Snap capsule with a white opaque body and pale pink opaque cap containing a white powder. Capsule is imprinted with black rectified radial print, "PD" on cap and "DILANTIN 30 mg" on body. NDC: 70518-0980-00 NDC: 70518-0980-01 NDC: 70518-0980-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

REMEDYREPACK INC.
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This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: 12/2018
MEDICATION GUIDE
DILANTIN (Dī lan' tĭn)
(extended phenytoin sodium capsules)
What is the most important information I should know about DILANTIN?
•
Do not stop taking DILANTIN without first talking to your healthcare
provider.
•
Stopping DILANTIN 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).
•
Like other antiepileptic drugs, DILANTIN 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.
•
DILANTIN 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 of these symptoms:

Charakterystyka produktu

DILANTIN- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DILANTIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DILANTIN
.
DILANTIN (EXTENDED PHENYTOIN SODIUM CAPSULES), FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
INDICATIONS AND USAGE
DILANTIN is 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 DILANTIN
extended 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 DILANTIN
extended capsules daily, once-a-day dosage with 300 mg DILANTIN
extended 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
DILANTIN is available as 30 mg and 100 mg extended phenytoin sodium
capsules. ( 3)
CONTRAINDICATIONS
Hypersensitivity to phenytoin, its ingredients, or other hydantoins (
4, 5.5)
A history of prior acute hepatotoxicity attributable to p