PHENYTOIN suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Atlantic Biologicals Corps

INN (שם בינלאומי):

Phenytoin

הרכב:

Phenytoin 125 mg in 5 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Phenytoin Oral Suspension 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 ADMINISTRATION CLINICAL PHARMACOLOGY Phenytoin Oral Suspension is contraindicated in those patients with a history of hypersensitivity to phenytoin or other hydantoins. Serum concentrations should be monitored and care should be taken when switching a patient from the sodium salt to the free acid form. The free acid form of phenytoin is used in Phenytoin Oral Suspension. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa. Dosage should be individualized to provide maximum benefit. In some cases serum b

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PHENYTOIN- PHENYTOIN SUSPENSION
ATLANTIC BIOLOGICALS CORPS
----------
PHENYTOIN ORAL SUSPENSION, USP (NOT FOR PARENTERAL USE)
125 MG/5 ML
RX ONLY
DESCRIPTION
Phenytoin is related to the barbiturates in chemical structure, but
has a five-membered ring. The
chemical name is 5,5-Diphenylhydantoin, having the following
structural formula:
Each 5 mL (teaspoonful) of suspension contains 125 mg of phenytoin,
USP with an alcohol content of
0.35 percent. Also contains carboxymethylcellulose sodium, citric acid
anhydrous, dehydrated alcohol,
FD&C Yellow No. 6, glycerin, liquid sugar, magnesium aluminum
silicate, orange flavor, polysorbate
40, purified water, sodium benzoate, sodium citrate dihydrate and
vanillin. It may contain 10% citric acid
solution or 10% sodium citrate solution to adjust pH. The pH range is
between 3.6 and 5.2.
CLINICAL PHARMACOLOGY
Phenytoin is an antiepileptic drug which can be useful in the
treatment of epilepsy. The primary site of
action appears to be 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.
_the motor cortexstabilize_
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 tha