Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Febuxostat
MEDISPEC (M) SDN.BHD
Febuxostat
2 x 14 Tablets
STANDARD CHEM & PHARM CO LTD
Not Applicable Baca dokumen lengkap
FEBUTON FILM COATED TABLET 80MG (FEBUXOSTAT) 1. NAME AND STRENGTH OF ACTIVE INGREDIENT : Each film coated tablet contains Febuxostat 80mg 2. LIST OF EXCIPIENTS: Microcrystalline Cellulose, Lactose, Magnesium Stearate, Hydroxypropylmethyl Cellulose-L, Sodium Croscarmellose, Opadry 3. DESCRIPTION : It occurs as an off-yellow to yellow, capsule shaped film-coated tablet, engraved with “980” on one surface and “S D” on the other side having a splitting line between S and D. 4. INDICATIONS : Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuton is indicated in adults. 5. DOSAGE AND ADMINISTRATION : The recommended oral dose of Febuton is 40 mg or 80 mg once daily without regard to food. The recommended starting dose of Febuton is 40 mg once daily. If serum uric acid is >6.0 mg/dL (357 μmol/L) after 2-4 weeks, Febuton 80 mg once daily may be considered. The 80 mg tablet can be divided into equal halves. In order to provide a 40 mg dose, the tablet should be split just before use. Prescribers should advise patients on how to break the tablets in half and to keep the other half for the next dose. Febuton works sufficiently quickly to allow retesting of the serum uric acid after 2 weeks. The therapeutic target is to decrease and maintain serum uric acid below 6.0 mg/dL (357 μmol/L). Gout flare prophylaxis of at least 6 months is recommended (see Precautions). _ _ _OLDER PEOPLE:_ No dose adjustment is required in the elderly (see Pharmacokinetics). _ _ _RENAL IMPAIRMENT:_ The efficacy and safety have not been fully evaluated in patients with severe renal impairment (creatinine clearance <30 mL/min, see Pharmacokinetics). No dose adjustment is necessary in patients with mild or moderate renal impairment. _HEPATIC IMPAIRMENT:_ The efficacy and safety of febuxostat has not been studied in patients with severe hepatic impairment (Child Pugh Class C). No dose adjustment is necessary in patients with mi Baca dokumen lengkap