DILANTIN CAPSULE 100 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Phenytoin Sodium

Available from:

VIATRIS PRIVATE LIMITED

ATC code:

N03AB02

Dosage:

100 mg

Pharmaceutical form:

CAPSULE

Composition:

Phenytoin Sodium 100 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Viatris Pharmaceuticals LLC

Authorization status:

ACTIVE

Authorization date:

1997-02-25

Patient Information leaflet

Page 1 of 15

DILANTIN


PHENYTOIN SODIUM 

1. 
NAME(S) OF MEDICINAL PRODUCT 
Dilantin 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Phenytoin sodium is an anticonvulsant drug, related
to the barbiturates in chemical 
structure, but has a five-membered ring. The chemical name
is sodium 5,5-diphenyl-2, 
4-imidazolidinedione. 

Each phenytoin sodium capsule, for oral administration, contains
30 or 100 mg phenytoin 
sodium. 

3. PHARMACEUTICAL 
FORM 
Capsules 

4. CLINICAL 
PARTICULARS 
4.1  THERAPEUTIC INDICATIONS 
Clinical evidence indicates phenytoin is effective in controlling epilepsy, particularly 
of the generalised tonic-clonic type (grand mal)
and psychomotor seizures. It will 
prevent or greatly decrease the
incidence and severity of convulsive seizures in a 
substantial percentage of cases, and
patients exhibit little tendency to become 
resistant to treatment. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
General 
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 10-20 mcg/mL, although some mild cases
of tonic-clonic (grand mal) 
epilepsy may be controlled with lo

Summary of Product characteristics

DILANTIN

PHENYTOIN SODIUM
1.
NAME(S) OF MEDICINAL PRODUCT
Dilantin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenytoin sodium is an anticonvulsant drug, related to the
barbiturates in chemical structure, but
has a five-membered ring. The chemical name is sodium
5,5-diphenyl-2,4-imidazolidinedione.
Each phenytoin sodium capsule for oral administration contains 30 mg
or 100 mg phenytoin
sodium.
3.
PHARMACEUTICAL FORM
Capsules
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clinical evidence indicates phenytoin is effective in controlling
epilepsy, particularly of the
generalized tonic-clonic type (grand mal) and psychomotor seizures. It
will prevent or greatly
decrease the incidence and severity of convulsive seizures in a
substantial percentage of
cases, and patients exhibit little tendency to become resistant to
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
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 serum levels with
phenytoin, and
changes in dosage (increase or decrease) should not be carried out at
intervals shorter than
7 to