DILANTIN CAPSULE 30MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

PHENYTOIN SODIUM

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

PHENYTOIN SODIUM

Unit dalam pakej:

200Capsule Capsules

Dikeluarkan oleh:

VIATRIS PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DILANTIN
® CAPSULES
Phenytoin sodium (30 mg, 100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What
DILANTIN
CAPSULES
are
used for
2.
How DILANTIN CAPSULES work
3.
Before
you
use
DILANTIN
CAPSULES
4.
How to use DILANTIN CAPSULES
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of DILANTIN
CAPSULES
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT DILANTIN CAPSULES ARE USED
FOR
DILANTIN
CAPSULES
are
used
to
control epilepsy. Epilepsy is a condition
where you have repeated seizures (fits).
There are many different types of seizures,
ranging from mild to severe.
HOW DILANTIN CAPSULES WORK
DILANTIN
CAPSULES
belong
to
a
group of medicines called anticonvulsants.
These
drugs
are
thought
to
work
by
controlling brain chemicals, which send
signals to nerves so that seizures do not
happen.
BEFORE YOU USE DILANTIN CAPSULES
-
_When you must not use it_
Do not take DILANTIN CAPSULES
•
if you are allergic to Phenytoin or to
the inactive ingredients of DILANTIN
CAPSULES
or
other
hydantoin
medicines;
•
if you are taking Delavirdine (used in
the treatment of HIV infection).
_Pregnancy and lactation_
DILANTIN CAPSULES may affect your
developing baby, if you take it during
pregnancy. However, it is very important
to control your fits while you are pregnant.
If
it
is
necessary
for
you
to
take
DILANTIN CAPSULES, your doctor can
help you decide whether or not to take it
during
pregnancy.
Your
doctor
will
prescribe DILANTIN CAPSULES only if
the benefits to you outweigh the risk to
your baby and will measure phenytoin
levels in your body periodically.
When appropriate, pregnant women and
women of childbearing potential should be
counseled
about
alternative
therapeutic
options.
Women of childbearing potential who are
not
planning
a
pregnancy
should
be
advised
regarding
the
use
of
effective
contraception during treatment.
Tell your doctor if you are breastfeeding
or
intend
to
breastfeed.
It
is
not
recommended to brea

Ciri produk

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
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
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