DUFORZIG Tablet Ref.[50498] Active ingredients: Dapagliflozin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: AstraZeneca Pharmaceuticals (Pty) Limited, Building 2, Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg 2191

Product name and form

DUFORZIG 5 (Tablet).

DUFORZIG 10 (Tablet).

Pharmaceutical Form

Tablets.

DUFORZIG 5: Yellow, biconvex, 0.7 cm diameter round, film-coated tablet with “5” debossed on one side and “1427” debossed on the other side.

DUFORZIG 10: Yellow, biconvex, approximately 1.1 × 0.8 cm diamond shaped, film-coated tablet with “10” debossed on one side and “1428” debossed on the other side.

Qualitative and quantitative composition

DUFORZIG 5: Each tablet contains the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol.

Contains sugar: 25 mg lactose anhydrous per 5 mg tablet

DUFORZIG 10: Each tablet contains the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol.

Contains sugar: 50 mg lactose anhydrous per 10 mg tablet.

For full list of excipients, see section 6.1.

Active Ingredient Description
Dapagliflozin

Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion.
List of Excipients

Tablet core:

Crospovidone
Lactose anhydrous
Magnesium stearate
Microcrystalline cellulose
Silicon dioxide

Film-coating:

Hydrolysed polyvinyl alcohol
Titanium dioxide
Polyethylene glycol
Talc
Iron oxide yellow

Pack sizes and marketing

Silver aluminium/aluminium foil blister packs of 14, 28, 30, 90 and 98 tablets packed in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca Pharmaceuticals (Pty) Limited, Building 2, Northdowns Office Park, 17 Georgian Crescent West, Bryanston, Johannesburg 2191

Marketing authorization dates and numbers

29 March 2022

Drugs

Drug Countries
DUFORZIG South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈