DILANTIN STERI-VIALS 250MG/5ML

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

PHENYTOIN SODIUM

Dostopno od:

UPJOHN (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

PHENYTOIN SODIUM

Enote v paketu:

5mL x 25 Vials

Izdeluje:

Pfizer Manufacturing Belgium NV

Lastnosti izdelka

Pfizer Confidential
1
PARENTERAL
DILANTIN
®
(Phenytoin Sodium Injection, USP)
1.
NAME(S) OF THE MEDICINAL PRODUCT
Dilantin Steri-Vials 250 mg/5 mL
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.
A 5 mL vial containing a clear colorless solution.
Each 5 mL of the sterile solution contains 250 mg phenytoin sodium.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenytoin
is
indicated
for
the
control
of
status
epilepticus
of
the
tonic-clonic
(grand mal)
type
and
prevention
and
treatment
of
seizures
occurring
during
or
following neurosurgery.
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
suspension
(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_.
Phenytoin serum level determinations may be necessary to achieve
optimal dosage
adjustments.
Optimum control without clinical signs of toxicity occurs most often
with serum
Pfizer Confidential
2
levels between 10 mcg/mL and 20 mcg/mL.
Parenteral phenytoin may be administered as a slow intravenous (IV)
bolus or it may
be administered via an IV infusion. Rapid infusion may be associated
with adverse
cardiovascular events (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE –
General).
Because
of
the
risks
of
cardiac
and
local
toxicity
associated
with
intravenous
phenytoin, oral phenytoin should be used whenever possible.
If administered in diluted form, parentera