DILANTIN- phenytoin sodium capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, 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 control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY sections). Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
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MEDICATION GUIDE
DILANTIN (Dī lan' tĭn)
(Phenytoin sodium)
Extended Oral Capsules (30 mg and 100mg)
Read the Medication Guide before you or your family member start
taking DILANTIN and each time you
get a refill. There may be new information. This information does not
take the place of talking to your
healthcare provider about your medical condition or treatment. If you
have any questions about
DILANTIN, ask your healthcare provider or pharmacist.
What is the most important information I should know about DILANTIN?
DILANTIN may cause rare but serious, even life-threatening, allergic
reactions.
Contact your healthcare provider right away if you have any of these
symptoms after taking DILANTIN:
•
Skin rash and blisters, hives (raised bumps), fever or itching
•
Swelling of your face, mouth, lips, gums, tongue or neck
•
Trouble breathing
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 activity and talking (mania)
•
other unusual changes in behavior or mood
If you have suicidal thoughts or actions, do not stop DILANTIN without
first talking to your healthcare
provider.
•
Stopping DILANTIN suddenly can increase the possibility of side
effects including increased
seizure frequency.
•
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

Summary of Product characteristics

DILANTIN - PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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DILANTIN
(EXTENDED PHENYTOIN SODIUM CAPSULES, USP)
DESCRIPTION
Phenytoin sodium is an antiepileptic drug. Phenytoin sodium is related
to the barbiturates in chemical
structure, but has a five-membered ring. The chemical name is sodium
5,5-diphenyl-2, 4-
imidazolidinedione, having the following structural formula:
Each Dilantin— _Extended Phenytoin Sodium Capsule_, USP—contains
30 mg phenytoin sodium, USP.
Also contains lactose monohydrate,, NF; confectioner's sugar, NF;
talc, USP; and magnesium stearate,
NF. The capsule shell cap and body components contain Titanium Dioxide
(cap and body); gelatin (cap
and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap).Product _in
vivo_ performance is
characterized by a slow and extended rate of absorption with peak
blood concentrations expected in 4 to
12 hours as contrasted to _Prompt Phenytoin Sodium Capsules,_ USP with
a rapid rate of absorption with
peak blood concentration expected in 1½ to 3 hours.
_USP dissolution test pending_
_and_
Each Dilantin—_ 100 mg Extended Oral Capsule_—contains 100 mg
phenytoin sodium. Also contains
lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and
magnesium stearate, NF. The capsule
body contains titanium dioxide, USP and gelatin, NF. The capsule cap
contains FD&C red No. 28;
FD&C yellow No. 6; and gelatin NF. Product _in vivo_ performance is
characterized by a slow and
extended rate of absorption with peak blood concentrations expected in
4 to 12 hours as contrasted to
_Prompt Phenytoin Sodium Capsules_, USP with a rapid rate of
absorption with peak blood concentration
expected in 1½ to 3 hours.
CLINICAL PHARMACOLOGY
Phenytoin is an antiepileptic drug which can be used in the treatment
of epilepsy. The primary site of
action appears to be the _motor cortex_ where spread of seizure
activity is inhibited. Possibly by
promoting sodium efflux from neurons, phenytoin tends to _stabilize_
the threshold against
hyperexcitabilit