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Incresync is a brand name for Alogliptin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom…
Verbatim from this product's EMA label. Tap a section to expand.
5 mg/30 mg film-coated tablets. Adults (≥ 18 years old) The dose should be individualised on the basis of the patient’s current treatment regimen For patients intolerant to metformin or for whom metformin is contraindicated, inadequately controlled on pioglitazone alone, the recommended dose of Incresync is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
For patients inadequately controlled on dual therapy with pioglitazone and a maximally tolerated dose of metformin, the dose of metformin should be maintained, and Incresync administered concomitantly. The recommended dose is one tablet of 25 mg/30 mg or 25 mg/45 mg once daily, depending on the dose of pioglitazone already being taken.
4). In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered. For patients switching from separate tablets of alogliptin and pioglitazone, both alogliptin and pioglitazone should be dosed at the daily dose already being taken.
Maximum daily dose The maximum recommended daily dose of 25 mg alogliptin and 45 mg pioglitazone should not be exceeded. 4). However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.
2). For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered. 2). Incresync is not recommended for patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis.
4). 2). Paediatric population The safety and efficacy of Incresync in children and adolescents < 18 years old have not been established. No data are available. Method of administration Oral use. Incresync should be taken once daily with or without food.
The tablets should be swallowed whole with water. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
4). 4). Other reactions such as upper respiratory tract infections, sinusitis, headache, hypoglycaemia, nausea, weight increase and oedema may occur commonly (≥ 1/100 to < 1/10). Clinical studies conducted to support the efficacy and safety of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets. The information provided is based on a total of 3,504 patients with type 2 diabetes mellitus, including 1,908 patients treated with alogliptin and pioglitazone, who participated in 4 phase 3 double-blind, placebo- or active-controlled clinical studies.
These studies evaluated the effects of co-administered alogliptin and pioglitazone on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with pioglitazone alone (with or without metformin or a sulphonylurea), and as add-on therapy to metformin.
Tabulated list of adverse reactions The adverse reactions are listed by system organ class and frequency. 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 < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
11 Table 1: Adverse reactions System organ class Adverse reaction Frequency of adverse reactions Alogliptin Pioglitazone Incresync Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon Immune system disorders hypersensitivity not known hypersensitivity and allergic reactions not known Metabolism and nutrition disorders hypoglycaemia common common Nervous system disorders headache common common hypoaesthesia common insomnia uncommon Eye disorders visual disturbance common macular oedema not known Gastrointestinal disorders abdominal pain common common gastroesophageal reflux disease common diarrhoea common dyspepsia common nausea common acute pancreatitis not known Hepatobiliary disorders hepatic dysfunction including hepatic failure not known Skin and subcutaneous tissue disorders pruritus common common rash common exfoliative skin conditions including Stevens- Johnson syndrome not known erythema multiforme not known angioedema not known urticaria not known bullous pemphigoid not known Musculoskeletal and connective tissues disorders myalgia common fracture bone common General disorders and administration site conditions oedema peripheral common weight increased common Renal and urinary disorders interstitial nephritis not known Investigations weight increased common alanine aminotransferase increased not known 12 Description of selected adverse reactions Post-marketing spontaneous reports of hypersensitivity reactions in patients treated with pioglitazone include anaphylaxis, angioedema, and urticaria.
General Incresync should not be used in patients with type 1 diabetes mellitus. Incresync is not a substitute for insulin in insulin-requiring patients. 5 Fluid retention and cardiac failure Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start pioglitazone therapy with the lowest available dose and increase the dose gradually. Patients should be observed for signs and symptoms of heart failure, weight gain or oedema; particularly those with reduced cardiac reserve.
There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure. Patients should be observed for signs and symptoms of heart failure, weight gain and oedema when pioglitazone is used in combination with insulin.
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration may increase the risk of oedema. Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.
Incresync should be discontinued if any deterioration in cardiac status occurs. A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
5 years. This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study. Elderly patients In light of age-related risks (especially bladder cancer, fractures and heart failure associated with the pioglitazone component), the balance of benefits and risks should be considered carefully both before and during Incresync treatment in the elderly.
4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments. Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical studies.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%. The reports of oedema were generally mild to moderate and usually did not require discontinuation of treatment. 5 years duration. 7%). 5%). 5%) of female patients treated with comparator.
1%). 4). In active comparator-controlled studies, mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year. This is similar to that seen in a sulphonylurea active comparator group. 8 kg. 0 kg. In clinical studies with pioglitazone, the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo but less than that seen in metformin or sulphonylurea comparator groups.
Mean levels of liver enzymes decreased with treatment with pioglitazone. Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience. Although in very rare cases, fatal outcome has been reported, causal relationship has not been established.
Reporting of suspected adverse reactions Reporting suspected adverse […]
029). 02%) in control groups. Epidemiological studies have also suggested a small increased risk of bladder cancer in diabetic patients treated with pioglitazone, although not all studies identified a statistically significant increased risk.
g. cyclophosphamide or prior radiation treatment in the pelvic region). Any macroscopic haematuria should be investigated before starting therapy. Patients should be advised to promptly seek the attention of their physician if macroscopic haematuria or other symptoms such as dysuria or urinary urgency develop during treatment.
8). Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin. It is recommended, therefore, that patients treated with Incresync undergo periodic monitoring of liver enzymes. Liver enzymes should be checked prior to the initiation of therapy in all patients.
5 x upper limit of normal) or with any other evidence of liver disease. 6 Following initiation of therapy with Incresync, it is recommended that liver enzymes be monitored periodically based on clinical judgement. If ALT levels are increased to 3 x upper limit of normal during therapy, liver enzyme levels should be reassessed as soon as possible.
If ALT levels remain > 3 x 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 Incresync should be guided by clinical judgement pending laboratory evaluations. If jaundice is observed, the medicinal product should be discontinued. 2). Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
2). Weight gain In clinical studies with pioglitazone, there was evidence of dose-related weight gain, which may be due to fat accumulation and, in some cases, associated with fluid retention. In some cases, weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
Part of the treatment of diabetes is dietary control. Patients should be advised to adhere strictly to a calorie-controlled diet. 1% relative reduction) […]