Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PHENYTOIN SODIUM
PFIZER INDONESIA - Indonesia
PHENYTOIN SODIUM
250.00 MG
INJEKSI
DUS, 10 VIAL @ 5 ML
PFIZER MANUFACTURING BELGIUM NV - Belgium
2020-06-06
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 Lue koko asiakirja