Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.
In adults, Brot may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
In children from 10 years of age and adolescents, Brot may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure (see section 5.1).
The usual starting dose is one tablet 2 or 3 times daily given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin is 3 g daily, taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.
Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin is given at the usual starting dose of one tablet 2-3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4).
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
| GFR mL/min | Total maximum daily dose (to be divided into 2-3 daily doses) | Additional considerations |
|---|---|---|
| 60-89 | 3000mg | Dose reduction may be considered in relation to declining renal function. |
| 45-59 | 2000mg | Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin. The starting dose is at most half of the maximum dose. |
| 30-44 | 1000mg | |
| <30 | - | Metformin is contraindicated. |
Brot can be used in children from 10 years of age and adolescents
The usual starting dose is one tablet of 500mg or 850mg once daily, given during meals or after meals. Tablet of 500mg is also available.
After 10 or 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin is 2 g daily, taken as 2 or 3 divided doses.
Hypoglycaemia has not been seen with metformin doses of up to 85g, although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.
5 years.
This medicinal product does not require any special storage conditions.
Blister packs (PVC-aluminium): 10 tablets/blister and 5 and 10 blisters/pack.
Not all pack sizes may be marketed.
No special requirements.
© 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.
