DILANTIN

Страна: Індонезія

мова: індонезійська

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

Активний інгредієнт:

PHENYTOIN SODIUM

Доступна з:

PFIZER INDONESIA - Indonesia

ІПН (Міжнародна Ім'я):

PHENYTOIN SODIUM

Дозування:

250.00 MG

Фармацевтична форма:

INJEKSI

Одиниць в упаковці:

DUS, 10 VIAL @ 5 ML

Виробник:

PFIZER MANUFACTURING BELGIUM NV - Belgium

Дата Авторизація:

2020-06-06

Характеристики продукта

Generic Name: Phenytoin sodium
Trade Name: Dilantin Injection
CDS Effective Date: July 15, 2021
Supersedes: May 24, 2019
Approved by BPOM:
2021-0068319, 2021-0068320, 2021-0068321
Page 1 of 22
PT PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Phenytoin sodium
Trade Name: Dilantin Injection
CDS Effective Date: July 15, 2021
Supersedes: May 24, 2019
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 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 and/or severe head injury. Phenytoin also has been used
in the treatment
of migraine, trigeminal neuralgia and certain psychoses. It also has
been used in the
treatment of cardiac arrhythmias, digitalis intoxication, and
post-event treatment of
myocardial infarction.
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
DISETUJUI OLEH BPOM: 27/01/2022
ID REG: EREG10024112100738
Generic Name: Phenytoin sodium
Trade Name: Dilantin Injection
CDS Effective Date: July 15, 2021
Supersedes: May 24, 2019
Approved by BPOM:
2021-0068319, 2021-0068320, 2021-0068321
Page 2 of 22
switching from a product formulated with the free acid to a product
formulat