Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PHENYTOIN SODIUM
PFIZER INDONESIA - Indonesia
PHENYTOIN SODIUM
100 MG
KAPSUL PELEPASAN LAMBAT
BOTOL @ 100 KAPSUL PELEPASAN LAMBAT
PFIZER INDONESIA - Indonesia
2017-02-08
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 Lugege kogu dokumenti