Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
URODOXA 1 mg (Tablet).
URODOXA 2 mg (Tablet).
URODOXA 4 mg (Tablet).
URODOXA 8 mg (Tablet).
| Pharmaceutical Form |
|---|
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URODOXA 1 mg: White to off-white, coloured, circular, biconvex shaped uncoated tablets debossed with ‘H’ on one side and ‘01’ on other side. URODOXA 2 mg: White to off-white, coloured, caplet shaped uncoated tablets debossed with ‘H02’ on one side and breakline on other side. URODOXA 4 mg: White to off-white, coloured, diamond shaped uncoated tablets debossed with ‘H03’ on one side and breakline on other side. URODOXA 8 mg: White to off-white, coloured, caplet shaped uncoated tablets debossed with ‘H04’ on one side and breakline on other side. |
URODOXA 1 mg: Each uncoated tablet contains doxazosin mesilate equivalent to doxazosin 1 mg.
URODOXA 2 mg: Each uncoated tablet contains doxazosin mesilate equivalent to doxazosin 2 mg.
URODOXA 4 mg: Each uncoated tablet contains doxazosin mesilate equivalent to doxazosin 4 mg.
URODOXA 8 mg: Each uncoated tablet contains doxazosin mesilate equivalent to doxazosin 8 mg.
The other ingredients of the formulations are cellulose microcrystalline, lactose anhydrous, sodium starch glycolate and magnesium stearate.
| Active Ingredient | Description | |
|---|---|---|
| Doxazosin |
Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure. |
| List of Excipients |
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|
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URODOXA 1 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
URODOXA 2 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
URODOXA 4 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
URODOXA 8 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
URODOXA 1 mg: 45/7.1/0150
URODOXA 2 mg: 45/7.1/0151
URODOXA 4 mg: 45/7.1/0152
URODOXA 8 mg: 45/7.1/0153
Date of registration: 18 February 2016
| Drug | Countries | |
|---|---|---|
| URODOXA | South Africa |
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