PHENYTOIN suspension

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Phenytoin (UNII: 6158TKW0C5) (Phenytoin - UNII:6158TKW0C5)

Beschikbaar vanaf:

ATLANTIC BIOLOGICALS CORP.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Phenytoin is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin serum level determinations may be necessary for optimal dosage adjustments (see and sections). DOSAGE AND ADMINISTRATIONCLINICAL PHARMACOLOGY Phenytoin is contraindicated in those patients with a history of hypersensitivity to phenytoin 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.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

PHENYTOIN- PHENYTOIN SUSPENSION
ATLANTIC BIOLOGICALS CORP.
----------
MEDICATION GUIDE
Phenytoin Oral Suspension, USP
Read this Medication Guide before you start taking Phenytoin Oral
Suspension, USP 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 Phenytoin
Oral Suspension, USP ask your healthcare provider or pharmacist.
What is the most important information I should know about Phenytoin
Oral Suspension, USP?
Do not stop taking Phenytoin Oral Suspension, USP without first
talking to your healthcare provider.
Stopping Phenytoin Oral Suspension, USP suddenly can cause serious
problems.
Phenytoin Oral Suspension, USP can cause serious side effects
including:
1.
Like other antiepileptic drugs, Phenytoin Oral Suspension, USP 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 Phenytoin Oral Suspension, USP without first
talking to a healthcare provider.
Stopping Phenytoin Oral Suspension, USP suddenly can cause serious
problems. S

Productkenmerken

PHENYTOIN- PHENYTOIN SUSPENSION
ATLANTIC BIOLOGICALS CORP.
----------
PHENYTOIN ORAL SUSPENSION, USP
(FOR ORAL ADMINISTRATION ONLY; NOT FOR PARENTERAL USE)
RX ONLY
DESCRIPTION
Phenytoin is related to the barbiturates in chemical structure, but
has a five-membered ring. The
chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the
following structural formula:
Each 5 mL of suspension contains 125 mg of phenytoin, USP. Also
contains carboxymethylcellulose
sodium, citric acid anhydrous, FD&C yellow no. 6, magnesium aluminum
silicate, orange flavor spray
dry natural and artificial, polysorbate 60, purified water, sodium
benzoate, sucrose and vanilla flavored
powder artificial.
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 where spread of seizure activity is
inhibited. Possibly by promoting sodium
efflux from neurons, phenytoin tends to the threshold against
hyperexcitability caused by excessive
stimulation or environmental changes capable of reducing membrane
sodium gradient. This includes the
reduction of posttetanic potentiation at synapses. Loss of posttetanic
potentiation prevents cortical
seizure foci from detonating adjacent cortical areas. Phenytoin
reduces the maximal activity of brain
stem centers responsible for the tonic phase of tonic-clonic (grand
mal) seizures. _motor cortexstabilize_
PHARMACOKINETICS AND DRUG METABOLISM
The plasma half-life in man after oral administration of phenytoin
averages 22 hours, with a range of 7
to 42 hours. Steady-state therapeutic levels are achieved at least 7
to 10 days (5–7 half-lives) after
initiation of therapy with recommended doses of 300 mg/day.
When serum level determinations are necessary, they should be obtained
at least 5–7 half-lives after
treatment initiation, dosage change, or addition or subtraction of
another drug to the regimen so that
equilibrium or steady-state will have been achieved. Trough levels
provide information