Loading…
Avandia is a brand name for Rosiglitazone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus: as monotherapy – in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with – metformin, in…
Verbatim from this product's EMA label. Tap a section to expand.
Rosiglitazone therapy is usually initiated at 4 mg/day. This dose can be increased to 8 mg/day after eight weeks if greater glycaemic control is required. 8). Rosiglitazone may be given once or twice a day. Rosiglitazone may be taken with or without food.
Elderly (see section
Clinical trial data 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, < 1/10; and uncommon ≥ 1/1000, < 1/100.
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. Table 1. The frequency of adverse reactions identified from clinical trial data Adverse reaction Frequency of adverse reaction by treatment regimen RSG RSG + MET RSG + SU RSG +MET +SU Blood and the lymphatic system disorders anaemia Common Common Common Common leucopaenia Common thrombocytopaenia Common granulocytopaenia Common Metabolism and nutrition disorders hypercholesterolaemia1 Common Common Common Common hypertriglyceridaemia Common Common hyperlipaemia Common Common Common Common weight increase Common Common Common Common increased appetite Common Uncommon hypoglycaemia Common Very common Very common Nervous system disorders dizziness* Common Common headache* Common Cardiac disorders cardiac failure2 Common Common Common cardiac ischaemia3* Common Common Common CommonMedicinal product no longer authorised 7 Gastrointestinal disorders constipation Common Common Common Common Musculoskeletal and connective tissue disorders bone fractures4 Common Common Common myalgia* Common General disorders and administration site conditions oedema Common Common Very common Very common RSG - Rosiglitazone monotherapy; RSG + MET - Rosiglitazone with metformin; RSG + SU - Rosiglitazone with sulphonylurea; RSG + MET + SU - Rosiglitazone with metformin and sulphonylurea *The frequency category for the background incidence of these events, as taken from placebo group data from clinical trials, is 'common'.
4 Fluid retention and cardiac failure) No dose adjustment is required in patients with mild and moderate renal insufficiency. Limited data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min) and therefore rosiglitazone should be used with caution in these patients.
Patients with hepatic impairment Rosiglitazone should not be used in patients with hepatic impairment. Children and adolescents There are no data available on the use of rosiglitazone in patients under 10 years of age. 2). The available data do not support efficacy in the paediatric population and therefore such use is not recommended.
4) − hepatic impairment - diabetic ketoacidosis or diabetic pre-coma. 4 Special warnings and precautions for use 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.
All patients, particularly those receiving concurrent insulin or 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.
Increased monitoring of the patient is recommended if rosiglitazone is used in combination with metformin and insulin. Rosiglitazone should be discontinued if any deterioration in cardiac status occurs. 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.
4) − hepatic impairment - diabetic ketoacidosis or diabetic pre-coma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rosiglitazone in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
3% of patients treated with rosiglitazone (monotherapy, dual or triple oral therapy). The elevated total cholesterol levels were associated with 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)]. 16)]. Two other long-term prospective randomised controlled clinical trials (9,620 patients, study duration >3 years in each study), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded the potential risk of cardiac ischaemia.
In their entirety, the available data on the risk of cardiac ischaemia are inconclusive. 4 Long-term studies show an increased incidence of bone fracture in patients, particularly female patients, taking rosiglitazone. 3 patients per 100 patient years) for glibenclamide.
97)]. 41)], than in males relative to control […]
Caution should be exercised in patients over 75 years because of the limited experience in this patient group. Since NSAIDs and rosiglitazone are 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.
Acute Coronary Syndrome (ACS) Patients experiencing an ACS have not been studied in rosiglitazone controlled clinical trials. 3). 8). 5X upper limit of normal). Therefore, liver enzymes should be checked prior to the initiation of therapy with rosiglitazone in all patients and periodically thereafter based on clinical judgement.
5X upper limit of normal) or with any other evidence of liver disease. If ALT levels are increased to >3X upper limit of normal during rosiglitazone therapy, liver enzyme levels should be reassessed as soon as possible. If ALT levels remain >3X 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 rosiglitazone should be guided by clinical judgement pending laboratory evaluations.
If jaundice is observed, drug therapy should be discontinued. Eye disorders Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including rosiglitazone.
Many of these patients reported concurrent peripheral oedema. It is unclear whether or not there is a direct association between rosiglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
Weight gain In clinical trials with […]