DILANTIN- phenytoin sodium capsule, extended release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

A-S Medication Solutions

INN (Διεθνής Όνομα):

PHENYTOIN SODIUM

Σύνθεση:

PHENYTOIN SODIUM 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)] . - 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 pregnant patients taking DILANTIN enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be d

Περίληψη προϊόντος:

Product: 50090-0029 NDC: 50090-0029-2 30 CAPSULE, EXTENDED RELEASE in a BOTTLE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

A-S Medication Solutions
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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?
1.
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).
2.
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.
3.
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
sympt

Αρχείο Π.Χ.Π.

DILANTIN- 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
DILANTIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DILANTIN .
DILANTIN (EXTENDED PHENYTOIN SODIUM CAPSULES), FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Warnings and Precautions (5.6)
10/2018
Warnings and Precautions, Angioedema (5.7)
11/2018
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 phen