Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ADEFOVIR DIPIVOXIL
SMITH KLINE BEECHAM PHARMACEUTICAL IND. - Indonesia
ADEFOVIR DIPIVOXIL
10 MG
TABLET
DUS, BOTOL PLASTIK @ 30 TABLET
GLAXO SMITHKLINE Co. Ltd - (Tianjin) China
2017-12-06
Page 1 of 10 HEPSERA ADEFOVIR DIPIVOXIL 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet for oral use contains 10 mg adefovir dipivoxil. For excipients, see List of Excipients. 2. PHARMACEUTICAL FORM _HEPSERA_ tablets, 10 mg, are white to off-white, round, flat-faced tablets with a beveled edge and debossed with “GSK KNU” on one side and blank on the other side. 3. CLINICAL PARTICULARS 3.1 INDICATIONS _HEPSERA_ is indicated for the treatment of chronic hepatitis B in adults with evidence of hepatitis B viral replication. Reductions in viral replication and improvements in liver function have also been demonstrated in supportive studies in a limited number of chronic hepatitis B patients with genotypic evidence of lamivudine-resistance. 3.2 DOSAGE AND ADMINISTRATION ADULTS (18-65 YEARS) The recommended dose of _HEPSERA _is 10 mg (one tablet) once daily taken orally with or without food. The indication has been obtained primarily based on clinical trials of 48 weeks duration. The optimum duration of treatment is unknown. The relationship between treatment response and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known. Higher dose must not be administered. Patients should be monitored every six months for hepatitis B biochemical, virological and serological markers. _ _ CHILDREN AND ADOLESCENTS (<18 YEARS) The safety and efficacy of _ HEPSERA_ in patients under the age of 18 years have not been established (_see Warnings and Precautions_). ELDERLY (>65 YEARS) The safety and efficacy of _HEPSERA_ in patients over the age of 65 years have not been established (_see Warnings and Precautions_). Caution should be exercised when prescribing _HEPSERA_ to the elderly, keeping in mind the greater frequency of decreased renal or cardiac function in these patients, and the increase in concomitant diseases or use of other medicinal products concomitantly in the elderly. RENAL IMPAIRMENT Adefovir is eliminated by renal excretion, therefore adjustments of the dosing interval ar Baca dokumen lengkap