Irbesartan HCTZ MLabs 300/25 irbesartan 300 mg and hydrochlorothiazide 25 mg tablets blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

hydrochlorothiazide, Quantity: 25 mg; irbesartan, Quantity: 300 mg

可用日期:

Micro Labs Pty Ltd

INN（国际名称）:

Hydrochlorothiazide,Irbesartan

药物剂型:

Tablet, film coated

组成:

Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate type B; polysorbate 80; mannitol; hypromellose; magnesium stearate; povidone; titanium dioxide; iron oxide red; macrogol 3350; Carnauba Wax; iron oxide black

给药途径:

Oral

每包单位数:

30 (3x10 in carton)

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

產品總結:

Visual Identification: Brick red coloured, capsule shaped, biconvex, film-coated tablets, approx.18 mm long and 9 mm wide, debossed with 'IH1' on one face and plain other face.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

授权状态:

Licence status A

授权日期:

2017-03-14

产品特点

1
AUSTRALIAN PRODUCT INFORMATION
IRBESARTAN HCTZ MLABS 150/12.5 MG, 300/12.5 MG, 300/25 MG
(IRBESARTAN/HYDROCHLOROTHIAZIDE) TABLETS
1 NAME OF THE MEDICINE
Irbesartan/Hydrochlorothiazide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Irbesartan HCTZ MLabs 150/12.5 mg tablets contain 150mg of irbesartan
and 12.5mg of
hydrochlorothiazide.
Irbesartan HCTZ MLabs 300/12.5 mg tablets contain 300mg of irbesartan
and 12.5mg of
hydrochlorothiazide.
Irbesartan HCTZ MLabs 300/25 mg tablets contain 300mg of irbesartan
and 25mg of
hydrochlorothiazide
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
IRBESARTAN HCTZ MLABS 150/12.5MG FILM-COATED TABLETS:
Film-coated tablets containing 150mg of irbesartan and 12.5mg of
hydrochlorothiazide. Peach
coloured, capsule shaped, biconvex, film-coated tablets, approximately
14 mm long and 7 mm
wide, debossed with ‘IH’ on one face and plain on other face.
IRBESARTAN HCTZ MLABS 300/12.5 MG FILM-COATED TABLETS:
Film-coated tablets containing 300mg of irbesartan and 12.5mg of
hydrochlorothiazide. Peach
coloured, capsule shaped, biconvex, film-coated tablets, approximately
18 mm long and 9 mm
wide debossed with ‘IH2’ on one face and plain on other face.
IRBESARTAN HCTZ MLABS 300/25 MG FILM-COATED TABLETS:
Film-coated tablets containing 300mg of irbesartan and 25mg of
hydrochlorothiazide. Brick red
coloured, capsule shaped, biconvex, film-coated tablets, approximately
18 mm long and 9 mm
wide, debossed with ‘IH1’ on one face and plain on other face.
2
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irbesartan HCTZ MLabs is indicated for the treatment of hypertension.
Treatment should not be
initiated with this fixed-dose combination.
4.2 DOSE AND METHOD OF ADMINISTRATION
Irbesartan HCTZ MLabs should not be initiated as first-line therapy.
The daily dose can be
administered with or without food.
REPLACEMENT THERAPY
The combination may be substituted for the titrated components at the
same dose level.
DOSE TITRATION BY CLINICAL EFFECT
When clini