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Avaglim is a brand name for Rosiglitazone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AVAGLIM is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control on optimal dosage of sulphonylurea monotherapy, and for whom metformin is inappropriate because of contraindication or intolerance.
Verbatim from this product's EMA label. Tap a section to expand.
AVAGLIM therapy should be individualised for each patient. 4). AVAGLIM should be taken once daily shortly before or during a meal (usually the first main meal of the day). If a dose is forgotten, the following dose must not be increased.
For patients inadequately controlled on glimepiride monotherapy (typically 4 mg). Concomitant administration should be considered before the patient is switched to AVAGLIM. Where clinically appropriate, direct change from glimepiride monotherapy to AVAGLIM may be considered.
The starting dose is 4 mg/day rosiglitazone plus 4 mg/day glimepiride (given as one tablet AVAGLIM 4 mg/4 mg). 4). Rosiglitazone 4 mg should be administered concomitantly with the dose of sulphonylurea already being taken. Once glycaemic control is stable at these doses, AVAGLIM may be introduced at a starting dose of 4 mg rosiglitazone/4 mg glimepiride once daily.
AVAGLIM may be used to substitute concomitant sulphonylurea and rosiglitazone in established dual oral therapy providing the patient has achieved at least half-maximum dose of sulphonylurea. The dose of the rosiglitazone component can be increased after 8 weeks if required.
The maximum recommended daily dose is 8 mg rosiglitazone/4 mg glimepiride (given as one AVAGLIM tablet 8 mg/4 mg, once daily). 8). If hypoglycaemic symptoms occur, the patient should revert to concomitant therapy and adjust the glimepiride dose as appropriate.
4). 4). Appropriate monitoring is advised. 3). 3). Children and adolescents AVAGLIM is not recommended for use in children below 18 years of age as there are no data available on its safety and efficacy.
Adverse reactions are presented below for each of the component parts of AVAGLIM. An adverse reaction is only presented for the fixed dose combination if it has not been seen in one of the component parts of AVAGLIM or if it occurred at a higher frequency than that listed for a component part.
Medicinal product no longer authorised8 AVAGLIM Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
Limited data with AVAGLIM is also consistent with this combined adverse reaction profile. Rosiglitazone 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 with rosiglitazone Adverse reaction Frequency of adverse reaction by treatment regimen Rosiglitazone monotherapy Rosiglitazone with sulphonylurea Blood and the lymphatic system disorders anaemia Common Common leucopaenia Common thrombocytopaenia Common Metabolism and nutrition disorders hypercholesterolaemia1 Common Common hypertriglyceridaemia Common Common hyperlipaemia Common Common weight increase Common Common increased appetite Common Uncommon hypoglycaemia Very common Nervous system disorders dizziness* Common Cardiac disorders cardiac failure2 Common cardiac ischaemia3* Common Common Gastrointestinal disorders constipation Common Common Musculoskeletal and connective tissue disorders bone fractures4 Common Common General disorders and administration site conditions oedema Common Very common Medicinal product no longer authorised9 *The frequency category for the background incidence of this event, as taken from placebo group data from clinical trials, is 'common'.
AVAGLIM is not indicated for combination use with metformin and therefore should not be used in triple oral therapy of diabetes. The following statements refer to AVAGLIM or the two individual active substances (rosiglitazone and glimepiride).
8). It is advised that patients established on rosiglitazone and chlorpropamide concomitant therapy should not switch to AVAGLIM as chlorpropamide has a long half-life which may increase the risk of hypoglycaemia. 5) or if the patient’s life-style changes) it may be necessary to revert to concomitant therapy and down titrate the glimepiride dose.
g. trauma, surgery, infections). Medicinal product no longer authorised4 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 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.
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.
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.
e. creatinine clearance less than 30 ml/min (including renal dialysis). − insulin dependant diabetes − diabetic ketoacidosis or diabetic coma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rosiglitazone in European Union.
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3% of patients treated with rosiglitazone (monotherapy or dual 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).
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)]. The risk of fracture appeared to be higher in females relative to control […]
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 AVAGLIM 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 AVAGLIM 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 Medicinal product no longer authorised5 oedema if patients report disturbances in visual acuity and appropriate ophthalmologic referral should be considered.
4). Appropriate monitoring is advised. Premenopausal anovulatory women Premenopausal women have received rosiglitazone during clinical studies. 3), no significant undesirable effects associated with menstrual disorders have been observed.
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