INVOKANA™ FILM-COATED TABLETS 300 MG

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Canagliflozin Hemihydrate 306mg eqv Canagliflozin

Boleh didapati daripada:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Kod ATC:

A10BK02

Dos:

300 mg

Borang farmaseutikal:

TABLET, FILM COATED

Komposisi:

Canagliflozin Hemihydrate 306mg eqv Canagliflozin 300 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Janssen Ortho, LLC

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2014-02-21

Risalah maklumat

1
PRODUCT NAME
INVOKANA™ (canagliflozin) film-coated tablets
DOSAGE FORMS AND STRENGTHS
100 mg – The tablet is yellow, capsule-shaped, immediate-release,
and film-coated, with “CFZ”
on one side and “100” on the other side. Each 100 mg tablet
contains 102 mg canagliflozin
hemihydrate, equivalent to 100 mg canagliflozin.
300 mg - The tablet is white, capsule-shaped, immediate-release, and
film-coated, with “CFZ” on
one side and “300” on the other side. Each 300 mg tablet contains
306 mg canagliflozin
hemihydrate, equivalent to 300 mg of canagliflozin.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
MONOTHERAPY AND COMBINATION THERAPY
INVOKANA™ is indicated as an adjunct to diet and exercise and
standard care therapy:
•
to improve glycemic control in adults with type 2 diabetes mellitus.
•
to reduce the risk of major adverse cardiovascular events
(cardiovascular death, nonfatal
myocardial infarction and nonfatal stroke) in adults with type 2
diabetes mellitus and
established cardiovascular disease (CVD) who have inadequate glycemic
control.
•
to reduce the risk of end-stage kidney disease (ESKD), doubling of
serum creatinine,
cardiovascular (CV) death, and hospitalization for heart failure in
adult patients with type
2 diabetes mellitus and diabetic nephropathy with albuminuria
>300mg/day.
DOSAGE AND ADMINISTRATION
DOSAGE – ADULTS 18 YEARS OF AGE AND OLDER
The recommended dose of INVOKANA™ is 100 mg or 300 mg once daily.
See Table 1 for dosage
recommendations based on estimated glomerular filtration rate (eGFR).
The 300 mg dose may be
considered for patients with an eGFR ≥ 60 mL/min/1.73 m
2
[CrCl ≥ 60 mL/min], who need tighter
glycemic control and
who have a low risk
of adverse
reactions associated with reduced
intravascular volume with INVOKANA™ treatment (see
_below_
and
_Warnings and Precautions_
).
A starting dose of 100 mg once daily should be used in patients on
loop diuretics and patients
≥ 75 years of age. In patients with evidence of reduc

Ciri produk

1
PRODUCT NAME
INVOKANA™ (canagliflozin) film-coated tablets
DOSAGE FORMS AND STRENGTHS
100 mg – The tablet is yellow, capsule-shaped, immediate-release,
and film-coated, with “CFZ”
on one side and “100” on the other side. Each 100 mg tablet
contains 102 mg canagliflozin
hemihydrate, equivalent to 100 mg canagliflozin.
300 mg - The tablet is white, capsule-shaped, immediate-release, and
film-coated, with “CFZ” on
one side and “300” on the other side. Each 300 mg tablet contains
306 mg canagliflozin
hemihydrate, equivalent to 300 mg of canagliflozin.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
MONOTHERAPY AND COMBINATION THERAPY
INVOKANA™ is indicated as an adjunct to diet and exercise and
standard care therapy:
•
to improve glycemic control in adults with type 2 diabetes mellitus.
•
to reduce the risk of major adverse cardiovascular events
(cardiovascular death, nonfatal
myocardial infarction and nonfatal stroke) in adults with type 2
diabetes mellitus and
established cardiovascular disease (CVD) who have inadequate glycemic
control.
•
to reduce the risk of end-stage kidney disease (ESKD), doubling of
serum creatinine,
cardiovascular (CV) death, and hospitalization for heart failure in
adult patients with type
2 diabetes mellitus and diabetic nephropathy with albuminuria
>300mg/day.
DOSAGE AND ADMINISTRATION
DOSAGE – ADULTS 18 YEARS OF AGE AND OLDER
The recommended dose of INVOKANA™ is 100 mg or 300 mg once daily.
See Table 1 for dosage
recommendations based on estimated glomerular filtration rate (eGFR).
The 300 mg dose may be
considered for patients with an eGFR ≥ 60 mL/min/1.73 m
2
[CrCl ≥ 60 mL/min], who need tighter
glycemic control and
who have a low risk
of adverse
reactions associated with reduced
intravascular volume with INVOKANA™ treatment (see
_below_
and
_Warnings and Precautions_
).
A starting dose of 100 mg once daily should be used in patients on
loop diuretics and patients
≥ 75 years of age. In patients with evidence of reduc