DP-Febuxostat

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Febuxostat hemihydrate 120mg

Available from:

Douglas Pharmaceuticals Limited

Dosage:

120 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Febuxostat hemihydrate 120mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 85F42129 Purified water

Prescription type:

Prescription

Therapeutic indications:

Treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). DP-Febuxostat is indicated in adults. For the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/ACLAR/aluminium in outer carton - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/aluminium in outer carton - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/aluminium in outer carton - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/ACLAR/aluminium in outer carton - 90 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2021-01-11

Summary of Product characteristics

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
DP-Febuxostat, film coated tablet, 80 mg
DP-Febuxostat, film coated tablet, 120 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 80 mg of febuxostat (as hemihydrate).
Each film coated tablet contains 120 mg of febuxostat (as
hemihydrate).
EXCIPIENT(S) WITH KNOWN EFFECT
DP-Febuxostat contains lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DP-Febuxostat 80 mg tablets are pale yellow to yellow coloured,
capsule shaped biconvex, film
coated tablets, debossed with ‘80’ on one side and plain on other
side. The size is 17 mm x 6
mm.
DP-Febuxostat 120 mg tablets are pale yellow to yellow coloured,
capsule shaped biconvex, film
coated tablets, debossed with ‘120’ on one side and plain on other
side. The size is 19 mm x 8
mm.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
DP-FEBUXOSTAT 80 MG
DP-Febuxostat is indicated for the treatment of chronic hyperuricaemia
in patients with gout
(including a history, or presence of, tophus and/or gouty arthritis).
DP-Febuxostat is indicated in
adults.
DP-FEBUXOSTAT 120 MG
DP-Febuxostat is indicated for the treatment of chronic hyperuricaemia
in patients with gout
(including a history, or presence of, tophus and/or gouty arthritis).
DP-Febuxostat is indicated for the prevention and treatment of
hyperuricaemia in adult patients
undergoing chemotherapy for haematologic malignancies at intermediate
to high risk of Tumor
2 | P a g e
Lysis Syndrome (TLS).
DP-Febuxostat is indicated in adults.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_GOUT _
The recommended oral dose of DP-Febuxostat is 80 mg once daily with or
without food. If serum
uric acid is > 6 mg/dl (357 micromole/L) after 2-4 weeks,
DP-Febuxostat 120 mg once daily may
be considered.
Febuxostat 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
mg/dl (357micromole/L).
Gout flare prophylaxis of at l