SITAGLIPTIN LUPIN sitagliptin (as hydrochloride monohydrate) 50 mg tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

sitagliptin hydrochloride monohydrate, Quantity: 56.686 mg (Equivalent: sitagliptin, Qty 50 mg)

可用日期:

Lupin Australia Pty Limited

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; calcium hydrogen phosphate; microcrystalline cellulose; hyprolose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

给药途径:

Oral

每包单位数:

28's

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Sitagliptin Lupin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,? monotherapy when metformin is considered inappropriate due to intolerance; or,? in combination with other antihyperglycaemic agents, including insulin.,(See Section 5.1 Pharmacodynamic Properties - Clinical Trials and Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for available data on different add-on combination therapies.)

產品總結:

Visual Identification: Light beige colored, round shaped, biconvex, film-coated tablet debossed S50 on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Registered

授权日期:

2020-05-21

资料单张

Sitagliptin Lupin v2
1
SITAGLIPTIN LUPIN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SITAGLIPTIN LUPIN?
Sitagliptin Lupin contains the active ingredient sitagliptin (as
hydrochloride monohydrate). Sitagliptin Lupin is used to lower
blood sugar levels in adults with type 2 diabetes mellitus.
For more information, see Section 1. Why am I using Sitagliptin Lupin?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SITAGLIPTIN LUPIN?
Do not use if you have ever had an allergic reaction to Sitagliptin
Lupin or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Sitagliptin Lupin? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sitagliptin Lupin and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SITAGLIPTIN LUPIN?
•
Take Sitagliptin Lupin once a day by mouth, with or without food.
More instructions can be found in Section 4. How do I use Sitagliptin
Lupin? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SITAGLIPTIN LUPIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sitagliptin Lupin.
•
Call your doctor straight away if you become pregnant while taking
Sitagliptin Lupin.
THINGS YOU
SHOULD NOT DO
•
Do not stop taking this medicine suddenly.
•
Do not give Sitagliptin Lupin to anyone else, even if they have the
same condition as you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets in the blister pack until it is time to take them.
•
Store Sitagliptin Lupin in a cool dry place away from moisture, heat
or sunlight.
For more information, see Section 5. What should I kno

产品特点

AUSTRALIAN PRODUCT INFORMATION – SITAGLIPTIN LUPIN
(SITAGLIPTIN HYDROCHLORIDE MONOHYDRATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Sitagliptin hydrochloride monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sitagliptin Lupin is available for oral use as film coated tablets
containing sitagliptin hydrochloride
monohydrate equivalent to 25, 50 or 100 mg of free base.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sitagliptin Lupin 25 mg tablet: A pink, round, biconvex, film-coated
tablet debossed with ”S25” on one
side and plain on the other.
Sitagliptin Lupin 50 mg tablet: A light beige, round, biconvex,
film-coated tablet debossed with ”S50”
on one side and plain on the other.
Sitagliptin Lupin 100 mg tablet: A beige, round, biconvex, film-coated
tablet debossed with ”STG” on
one side and plain on the other.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sitagliptin Lupin is indicated for the treatment of diabetes mellitus
type 2 in persons 18 years of age and
older who have failed dietary measures and exercise:
•
as monotherapy, as an adjunct to diet and exercise to improve
glycaemic control in patients with
type 2 diabetes mellitus, when metformin cannot be used.
•
as dual combination therapy, with a sulfonylurea.
•
as triple combination therapy with metformin and a sulfonylurea when
combination therapy with
both agents does not provide adequate glycaemic control.
•
as add-on combination therapy with insulin (with or without
metformin).
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose of sitagliptin is 100 mg once daily as
monotherapy, or as combination therapy
with a sulfonylurea (clinical experience is with glimepiride as dual
therapy), insulin (with or without
metformin), or combination therapy with metformin and a sulfonylurea
(clinical experience is with
addition of sitagliptin to glimepiride or gliclazide and metformin as
triple therapy). Sitagliptin can be
taken with or without food.
Sitagliptin Lupin PI v3
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