Febuton Film Coated Tablet 80mg (Febuxostat)

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

Febuxostat

Διαθέσιμο από:

MEDISPEC (M) SDN.BHD

INN (Διεθνής Όνομα):

Febuxostat

Μονάδες σε πακέτο:

2 x 14 Tablets

Κατασκευάζεται από:

STANDARD CHEM & PHARM CO LTD

Φύλλο οδηγιών χρήσης

Not Applicable

Αρχείο Π.Χ.Π.

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