DILANTIN- extended phenytoin sodium capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Parke-Davis Div of Pfizer Inc

INN (International Name):

PHENYTOIN SODIUM

Composition:

PHENYTOIN SODIUM 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 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 done by calling the tollfree number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ Risk Summary In humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. Prenatal phenytoin exposure is associated with an increased incidence of major malformations, inc

Product summary:

DILANTIN (extended phenytoin sodium capsules, USP) is supplied as follows: 100's 30 mg NDC 0071-3740-66 100's 100 mg NDC 0071-0369-24 1000's 100 mg NDC 0071-0369-32 Unit Dose 100's 100 mg NDC 0071-0369-40 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. DILANTIN 100 mg extended capsules are available as hard, filled No. 3 capsules containing a white powder. The medium orange cap having "PD" printed in black ink and the white, opaque body having "DILANTIN" over "100 mg" printed in black ink. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Parke-Davis Div of Pfizer Inc
----------
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

Summary of Product characteristics

DILANTIN- EXTENDED PHENYTOIN SODIUM CAPSULE
PARKE-DAVIS DIV OF PFIZER 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 phenyt