Dilantin 125® (Phenytoin Oral Suspension USP) 125mg5ml

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

Phenytoin

Sẵn có từ:

VIATRIS PRIVATE LIMITED

Mã ATC:

N03AB02

Liều dùng:

125.00mg/5ml

Dạng dược phẩm:

SUSPENSION

Thành phần:

Phenytoin 125.00mg/5ml

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Pharmacia and Upjohn Company LLC

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2005-06-06

Tờ rơi thông tin

Page 1 of 19 
DILANTIN-125
 
(Phenytoin Oral Suspension, USP) 
(NOT FOR PARENTERAL USE) 

DESCRIPTION 
Dilantin (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; alcohol,
USP (maximum content not 
greater than 0.6 percent); banana flavor;
carboxymethylcellulose sodium, USP; citric acid, 
anhydrous, USP; glycerin, USP; magnesium
aluminum silicate, NF; orange oil concentrate; 
polysorbate 40, NSF; purified water, USP; sodium benzoate, NF;
sucrose, NF; vanillin, NF; and 
FD&C yellow No.6. 

PHARMACOLOGICAL PROPERTIES 
PHARMACODYNAMIC PROPERTIES 
Phenytoin is an anticonvulsant 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 the synaptic 
levels. Loss of post-tetanic 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. 

PHARMACOKINETIC PROPERTIES 
Phenytoin is a weak acid and has limited hydrosolubility, even in the
intestine. The compound 
undergoes a slow and somewhat variable absorption after oral
administration. After absorption is 
complete, it is rapidly distributed into all tissues. 

The plasma half-life in man after administration of phenytoin
averages 22 hours, with a range of 
7 to 42 hours. Steady state therapeutic levels

Đặc tính sản phẩm

DILANTIN-125

(Phenytoin Oral Suspension, USP)
(NOT FOR PARENTERAL USE)
1.
NAME OF MEDICINAL PRODUCT
Dilantin-125
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenytoin is an anticonvulsant drug, 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 oral suspension contains 125 mg-phenytoin, USP.
3.
PHARMACEUTICAL FORM
Oral Suspension
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dilantin-125
®
(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
Sections
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
and
5 PHARMACOLOGICAL
PROPERTIES
).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Serum concentrations should be monitored and care should be taken when
switching a patient
from the sodium salt to the free acid form. Phenytoin capsules and
solution for injection are
formulated with the sodium salt of phenytoin. The free acid form of
phenytoin is used in the
phenytoin suspensions (30 mg/5 mL [pediatric] and 125 mg/5 mL) and in
the phenytoin
tablets. 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 drug
level determinations may be necessary for optimal dosage adjustments.
Optimum control
without clinical signs of toxicity occurs more often with serum levels
between 10 mcg/mL
and 20 mcg/mL, although some mild cases of tonic-clonic (grand mal)
epilepsy may be
controlled with lower serum levels of phenytoin. With recommended
dosage, a period of 7 to
10 days may be required to achieve steady-state s