INVOKANA canagliflozin (as hemihydrate) 300 mg film-coated tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

Canagliflozin hemihydrate

Հասանելի է:

Janssen-Cilag Pty Ltd

INN (Միջազգային անվանումը):

Canagliflozin hemihydrate

Տեղեկատվական թերթիկ

INVOKANA
®
171031 ACMI
1
INVOKANA
®
_canagliflozin hemihydrate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Invokana.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING INVOKANA, ASK YOUR DOCTOR OR
PHARMACIST.
Your doctor and pharmacist have
more information.
Keep this information handy. You
can refer to it later if you have any
questions.
Please also refer to Consumer
Medicine Information documents of
other medicines your doctor may
have prescribed for use in
combination with Invokana. Ask
your doctor or pharmacist if you have
any questions.
WHAT INVOKANA IS USED
FOR
Invokana belongs to a group of
medicines called “oral
antihyperglycemics.” It may also be
known as a diabetes medicine.
Invokana is used to lower blood
glucose in patients with type 2
diabetes mellitus, (“non-insulin-
dependent diabetes” or “maturity
onset diabetes”) when diet and
exercise are not enough to control
your blood glucose.
Lowering and controlling blood
sugar may help prevent or delay
complications of diabetes, which
include kidney disease, blindness and
amputation.
Invokana has not been tested in
children and use in children is not
recommended.
Your doctor may prescribe Invokana
to be used alone, or in combination
with other medicines for treating
your diabetes. It is important to keep
following your doctor’s advice about
diet and exercise while you are
taking Invokana.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
_HOW IT WORKS _
Invokana contains the active
ingredient canagliflozin, which
works by inhibiting the activity of a
protein in your kidneys that
reabsorbs glucose (sugar) from the
urine. By inhibiting this protein,
Invokana increases glucose excretion
in your urine. In this way it lowers
elevated blood glucose levels to help
control your diabetes.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT USE IT _
DO NOT U

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INVOKANA(171025)API
INVOKANA
®
PRODUCT INFORMATION
NAME OF THE MEDICINE
Canagliflozin
The
chemical
name
is
(1_S_)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-
glucitol present in the tablets as the hemihydrate.
Molecular Formula: C
24
H
25
FO
5
S
.½ H
2
O
CAS: 928672-86-0(hemihydrate) and 842133-18-0(anhydrous)
MW: 453.53
DESCRIPTION
Canagliflozin hemihydrate drug substance is a white to off white
powder, soluble in many organic solvents
(ethanol, methanol, tetrahydrofuran, acetone) but insoluble in aqueous
media. The log P of the drug
substance is 3.44 at 20
o
C and pH=7. There is no pKa in the physiological pH range.
INVOKANA is available as film-coated tablets containing 100 and 300 mg
of canagliflozin present as 102 mg
and 306 mg of canagliflozin hemihydrate in each tablet strength,
respectively
.
Both strengths contain the
inactive ingredients microcrystalline cellulose, lactose anhydrous,
croscarmellose sodium, hydroxypropyl
cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide,
macrogol 3350 and talc-purified. In
addition, the 100 mg strength contains iron oxide yellow.
PHARMACOLOGY
MECHANISM OF ACTION
INVOKANA is an inhibitor of sodium-glucose co-transporter 2 (SGLT2).
SGLT2, expressed in the proximal renal
tubules, is responsible for the majority of the reabsorption of
filtered glucose from the tubular lumen.
Patients with diabetes have been shown to have elevated renal glucose
reabsorption which may contribute
to persistent elevated blood glucose concentrations. Canagliflozin is
an orally-active inhibitor of SGLT2. By
inhibiting SGLT2, canagliflozin reduces reabsorption of filtered
glucose and lowers the renal threshold for
glucose (RT
G
), and thereby increases urinary glucose excretion (UGE), lowering
elevated plasma glucose
CCDS170801
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INVOKANA(171025)API
concentrations by an insulin-independent mechanism in patients with
type 2 diabetes. Urinary glucose
excretion induced by canagliflozin leads to an osmotic diuresis, wh