Source: Web Search Revision Year: 2020 Publisher: Alphapharm Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000 www.mylan.com.au
Glucovance.
Metformin hydrochloride and Glibenclamide.
| Pharmaceutical Form |
|---|
|
Oral. Film-coated tablets. Glucovance 250/1.25: Yellow film-coated, capsule-shaped, biconvex tablets, engraved with “250” on one side and “1.25” on the other side. Glucovance 500/2.5: Pale orange film-coated, capsule-shaped, biconvex tablets, engraved with “2.5” on one side. Glucovance 50/5: Yellow film-coated, capsule-shaped, biconvex tablets, engraved with “5” on one side. |
Glucovance contains metformin hydrochloride and glibenclamide combination and is available in three strength combinations:
Each Glucovance 250/1.25 tablet contains 250 mg metformin hydrochloride and 1.25 mg glibenclamide.
Each Glucovance 500/2.5 tablet contains 500 mg metformin hydrochloride and 2.5 mg glibenclamide.
Each Glucovance 500/5 tablet contains 500 mg metformin hydrochloride and 5 mg glibenclamide.
Glucovance also contains trace amounts of lactose.
For the full list of excipients, see Section 6.1 List of excipients.
Metformin hydrochloride:
Chemical name: 1,1-dimethylbiguanide hydrochloride
Molecular formula: C4H11N5, HCl
Molecular weight: 165.6
Metformin hydrochloride is a white, crystalline powder, which is odourless or almost odourless and hygroscopic. It is freely soluble in water, slightly soluble in ethanol (96%), and practically insoluble in chloroform and in ether.
Glibenclamide:
Chemical name: 1-{4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzene-sulphonyl}-3-cyclohexylurea
Molecular formula: C23H28ClN3O5S
Molecular weight: 494
Glibenclamide is a white or almost white, crystalline powder; odourless or almost odourless. It is practically insoluble in water and in ether, slightly soluble in ethanol and methanol and sparingly soluble in chloroform.
Metformin hydrochloride: 1115-70-4
Glibenclamide: 10238-21-8
| Active Ingredient | Description | |
|---|---|---|
| Glibenclamide |
Glibenclamide, a second-generation, short half-life sulphonylurea, is a hypoglycaemic agent that reduces blood-glucose by stimulating insulin release by the pancreas. Sulphonylureas act on pancreatic beta-cells by inhibiting ATP-sensitive potassium channels. |
|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
| List of Excipients |
|---|
|
Glucovance 250/1.25, Glucovance 500/2.5 and Glucovance 500/5 tablets contain croscarmellose sodium, povidone, magnesium stearate, cellulose – microcrystalline. Glucovance 250/1.25 tablet also contains Opadry II complete film coating system OY-L-22903 Yellow. Glucovance 500/2.5 tablet also contains Opadry II complete film coating system OY-L-24808 Pink Glucovance 500/5 tablet also contains Opadry II complete film coating system 31F22700 Yellow. All three tablets strengths are gluten free. |
Glucovance 250/1.25: Blister pack 10s, 30s, 60s, 90s, 120s.
Glucovance 500/2.5: Blister pack 10s, 30s, 60s, 90s, 120s.
Glucovance 500/5: Blister pack 10s, 30s, 60s, 90s, 120s.
Some strengths and/or pack sizes may not be marketed.
Alphapharm Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000
www.mylan.com.au
Date of first approval: 9 September 2008
| Drug | Countries | |
|---|---|---|
| GLUCOVANCE | Brazil, Ecuador, France, Hong Kong, Mexico, Nigeria, Netherlands, Romania, Singapore, Tunisia, South Africa |
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