DILANTIN

Land: Indonesien

Sprog: indonesisk

Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiv bestanddel:

PHENYTOIN SODIUM

Tilgængelig fra:

PFIZER INDONESIA - Indonesia

INN (International Name):

PHENYTOIN SODIUM

Dosering:

100.02 Mg

Lægemiddelform:

KAPSUL PELEPASAN LAMBAT

Enheder i pakken:

BOTOL @ 100 KAPSUL PELEPASAN LAMBAT

Fremstillet af:

PFIZER INDONESIA - Indonesia

Autorisation dato:

2020-09-20

Produktets egenskaber

Generic Name: Phenytoin sodium
Trade Name: Dilantin Sustained Release Capsule
CDS Effective Date: July 15, 2021
Supersedes: October 19, 2018
Approved by BPOM:
2021-0070990
Page 1 of 21
PT PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Phenytoin sodium
Trade Name: Dilantin Sustained Release Capsule
CDS Effective Date: July 15, 2021
Supersedes: October 19, 2018
1. NAME OF THE 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 sustained release capsule, for oral
administration, contains 100 mg
phenytoin sodium.
3. PHARMACEUTICAL FORM
Sustained Release Capsules
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phenytoin is indicated for the control of generalized tonic-clonic
(grand mal) and complex
partial (psychomotor, temporal lobe) seizures and for the prevention
and treatment of
seizures occurring during or following neurosurgery. Phenytoin has
also been used in the
treatment of trigeminal neuralgia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Phenytoin sustained release 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.
DISETUJUI OLEH BPOM : 21/02/2022
ID REG : EREG100241VR12100236
Generic Name: Phenytoin sodium
Trade Name: Dilantin Sustained Release Capsule
CDS Effective Date: July 15, 2021
Supersedes: October 19, 2018
Approved by BPOM:
2021-0070990
Page 2 of 21
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 pr