国家: 印度尼西亚
语言: 印度尼西亚文
来源: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LEVETIRACETAM
GLAXO WELLCOME INDONESIA - Indonesia
LEVETIRACETAM
500 MG
TABLET SALUT SELAPUT
DUS,2 BLISTER @ 10 TABLET SALUT SELAPUT
UCB PHARMA SA - Belgium
2019-12-06
ERS_leaKEPtab_Update PI to NCDS v.10_circ2_1Feb2021 Page 1 of 10 KEPPRA LEVETIRACETAM 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam, 250 mg, film-coated tablet Each film-coated tablet contains 250 mg of levetiracetam. Levetiracetam, 500 mg, film-coated tablet Each film-coated tablet contains 500 mg of levetiracetam. 2. PHARMACEUTICAL FORM Levetiracetam, 250 mg, film-coated tablet Blue, oblong film-coated tablet scored and debossed with the code ucb and 250 on one side. The score lines is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Levetiracetam, 500 mg, film-coated tablet Yellow, oblong film-coated tablet scored and debossed with the code ucb and 500 on one side. The score lines is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 3. CLINICAL INFORMATION 3.1 INDICATIONS Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in patients with epilepsy. 3.2 DOSAGE AND ADMINISTRATION The film-coated tablets must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food. After oral administration the bitter taste of levetiracetam may be experienced. The daily dose is administered in two equally divided doses. ADULTS AND ADOLESCENTS OLDER THAN 16 YEARS The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased up to 1,500 mg twice daily. Dose changes can be made in 500 mg twice daily increases or decreases every two to four weeks. ELDERLY (65 YEARS AND OLDER) Adjustment of the dose is recommended in elderly patients with compromised renal function. CHILDREN There are insufficient data to recommend the use of levetiracetam in children and adolescents under 16 years of age. RENAL IMPAIRMENT The daily dose must be individualised according to renal function. Refer to the followin 阅读完整的文件