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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

PHENYTOIN SODIUM

Composition:

PHENYTOIN SODIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Extended phenytoin sodium capsules, USP are indicated for the control of generalized tonic-clonic (grand mal) and 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). Extended phenytoin sodium capsules are contraindicated in those patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins. Coadministration of phenytoin is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

Product summary:

Extended Phenytoin Sodium Capsules, USP are available containing 100 mg of phenytoin sodium, USP. The 100 mg capsule is a hard-shell gelatin capsule with a light lavender opaque cap and white opaque body filled with one white to off-white capsule-shaped tablet. The capsule is axially printed with MYLAN over 1560 in black ink on both the cap and body. They are available as follows: NDC 0378-1560-01 bottles of 100 capsules NDC 0378-1560-10 bottles of 1000 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
EXTENDED PHENYTOIN SODIUM CAPSULES, USP
(fen′ i toin soe′ dee um)
100 mg
Read this Medication Guide before you start taking extended phenytoin
sodium capsules 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
extended phenytoin sodium capsules, ask your healthcare provider or
pharmacist.
What is the most important information I should know about extended
phenytoin sodium capsules?
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.
Extended phenytoin sodium capsules can cause serious side effects
including:
1.
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 activity and talking (mania)
•
other unusual changes in behavior or mood
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.
Do not stop taking extended phenytoin sodium capsules withou

Summary of Product characteristics

PHENYTOIN SODIUM- PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
DESCRIPTION
Phenytoin sodium is related to the barbiturates in chemical structure,
but has a five-membered ring. The
chemical name is 5,5-Diphenylhydantoin sodium salt, having a molecular
weight of 274.25 and having
the following structural formula and molecular formula:
Each extended phenytoin sodium capsule, USP, for oral administration,
contains 100 mg phenytoin
sodium, USP. Each capsule also contains the following inactive
ingredients: colloidal silicon dioxide,
hydroxyethyl cellulose, magnesium oxide, magnesium stearate,
microcrystalline cellulose, povidone
and sodium lauryl sulfate. In addition, each of the empty gelatin
capsules contains the following: D&C
Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, sodium lauryl
sulfate and titanium dioxide.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol and shellac glaze.
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.
Extended phenytoin sodium capsules USP, 100 mg meet _USP Dissolution
Test 2._
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Phenytoin is an antiepileptic drug which can be useful 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
hyperexcitability caused by excessive stimulation or environmental
changes capable of reducing
membrane sodium gradient. This includes the reduction of post tetanic
potentiation at synapses. Loss of
post tetanic potentiation prevents co