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Avandamet is a brand name for Rosiglitazone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AVANDAMET is indicated in the treatment of type 2 diabetes mellitus patients, particularly overweight patients: - who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. - in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control…
Verbatim from this product's EMA label. Tap a section to expand.
The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus 2000 mg/day metformin hydrochloride. Rosiglitazone can be increased to 8 mg/day after 8 weeks if greater glycaemic control is required. The maximum recommended daily dose of AVANDAMET is 8 mg rosiglitazone plus 2000 mg metformin hydrochloride.
The total daily dose of AVANDAMET should be given in two divided doses. Dose titration with rosiglitazone (added to the optimal dose of metformin) may be considered before the patient is switched to AVANDAMET. When clinically appropriate, direct change from metformin monotherapy to AVANDAMET may be considered.
Taking AVANDAMET with or just after food may reduce gastrointestinal symptoms associated with metformin. 4) Medicinal product no longer authorised3 - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
8). - Patients established on triple oral therapy: when appropriate, AVANDAMET may substitute rosiglitazone and metformin doses already being taken. Where appropriate, AVANDAMET may be used to substitute concomitant rosiglitazone and metformin in existing dual or triple oral therapy to simplify treatment.
4). g. 4). 2).
Adverse reactions are presented below for each of the component parts of AVANDAMET. An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVANDAMET or if it occurred at a higher frequency than that listed for a component part.
Medicinal product no longer authorised8 Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency. For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone.
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics. Adverse reaction frequency categories assigned based on clinical trial experience may not reflect the frequency of adverse events occurring during normal clinical practice.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000 including isolated reports). AVANDAMET Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and metformin is similar to that of the combined adverse reaction profile for the two medicinal products.
Data with AVANDAMET is also consistent with this combined adverse reaction profile. Clinical trial data (addition of insulin to established AVANDAMET therapy) In a single study (n=322) where insulin was added to patients established on AVANDAMET, no new adverse events were observed in excess of those already defined for either AVANDAMET or rosiglitazone combination therapies.
However, the risk of both fluid related adverse events and hypoglycaemia are increased when AVANDAMET is used in combination with insulin. Rosiglitazone Clinical trial data Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Lactic acidosis Lactic acidosis is a very rare, but serious, metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure.
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors such as poorly controlled diabetes, ketosis, Medicinal product no longer authorised4 prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia.
Diagnosis:
Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l and an increased anion gap and lactate/pyruvate ratio.
9). Renal function As metformin is excreted by the kidney, serum creatinine concentrations should be determined regularly: - at least once a year in patients with normal renal function - at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly patients.
Decreased renal function in elderly patients is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with an NSAID.
Fluid retention and cardiac failure Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure. Rosiglitazone can cause dose-dependent fluid retention. The possible contribution of fluid retention to weight gain should be individually assessed as rapid and excessive weight gain has been reported very rarely as a sign of fluid retention.
g. 4) - lactation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For dose-related adverse reactions the frequency category reflects the higher dose of rosiglitazone. Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Table 1 lists adverse reactions identified from an overview of clinical trials involving over 5,000 rosiglitazone-treated patients. Within each system organ class, adverse reactions are presented in the table by decreasing frequency for the rosiglitazone monotherapy treatment regimen.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Medicinal product no longer authorised9 Table 1. The frequency of adverse reactions identified from clinical trial data with rosiglitazone Adverse reaction Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with metformin Rosiglitazone with metformin and sulphonylurea Blood and the lymphatic system disorders anaemia Common Common Common granulocytopaenia Common Metabolism and nutrition disorders hypercholesterolaemia1 Common Common Common hypertriglyceridaemia Common hyperlipaemia Common Common Common weight increase Common Common Common increased appetite Common hypoglycaemia Common Very common Nervous system disorders dizziness* Common headache* Common Cardiac disorders cardiac failure2 Common Common cardiac ischaemia3* Common Common Common Gastrointestinal disorders constipation Common Common Common Musculoskeletal and connective tissue disorders bone fractures4 Common Common myalgia* Common General disorders and administration site conditions oedema Common Common Very common *The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is 'common'.
3% of patients treated with rosiglitazone (monotherapy, dual or triple oral therapy). The elevated total cholesterol levels were associated with an increase in both LDLc and HDLc, but the ratio of total cholesterol: HDLc was unchanged or improved in long term studies.
Overall, these increases were generally mild to moderate and usually did not require discontinuation of treatment. 2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
4% for metformin plus sulphonylurea dual therapy. 1%. 5% on placebo. 69)]. This risk was increased when rosiglitazone was added to established insulin and in patients receiving nitrates for known ischaemic heart disease. 354)]. 5 […]
All patients, particularly those receiving concurrent insulin but also sulphonylurea therapy, those at risk for heart failure, and those with reduced cardiac reserve, should be monitored for signs and symptoms of adverse reactions relating to fluid retention, including weight gain and heart failure.
AVANDAMET must be discontinued if any deterioration in cardiac status occurs. 8). The decision to initiate AVANDAMET in combination with a sulphonylurea should include consideration of alternative therapies. Increased monitoring of the patient is recommended if AVANDAMET is used in combination particularly with insulin but also with a sulphonylurea.
Heart failure was also reported more frequently in patients with a history of heart failure; oedema and heart failure was also reported more frequently in elderly patients and in patients with mild or moderate renal failure. Caution should be exercised in patients over 75 years because of the limited experience in this patient group.
Since NSAIDs, insulin and rosiglitazone are all associated with fluid retention, concomitant administration may increase the risk of oedema. Combination with insulin An increased incidence of cardiac failure has been observed in clinical trials when rosiglitazone is used in combination with insulin.
Insulin and rosiglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema and could increase the risk of ischaemic heart disease. Insulin should only be added to established rosiglitazone therapy in exceptional cases and under close supervision.
Myocardial Ischaemia A retrospective analysis of data from 42 pooled short-term clinical studies indicated that treatment with rosiglitazone may be associated with an increased risk of myocardial ischaemic events. 8). There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease.
Therefore, as a precaution, the use of rosiglitazone is not recommended in these patients, particularly those with myocardial ischaemic symptoms. Medicinal product no longer authorised5 Acute Coronary Syndrome (ACS) Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials.
3). 8). 5 times the upper limit of normal). Therefore, liver enzymes should be checked prior to the initiation of therapy with AVANDAMET in all patients and periodically thereafter based on clinical judgement. 5 times the upper limit of normal) or with any other evidence of liver disease.
If ALT levels are increased to > 3 times the upper limit of normal during AVANDAMET therapy, liver enzyme levels should be reassessed as soon as possible. If ALT levels remain > 3 times the upper limit of normal, therapy should be discontinued.
If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked. The decision whether to continue the patient on therapy with AVANDAMET should be guided by clinical judgement pending laboratory evaluations.
If jaundice is observed, therapy should […]