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SITAGLIPTIN METFORMIN ZENTIVA is a brand name for Metformin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For adult patients with type 2 diabetes mellitus: Sitagliptin/Metformin is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose of antihyperglycaemic therapy with Sitagliptin/Metformin should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Adults with normal renal function (GFR ≥ 90 ml/min) For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Sitagliptin/Metformin should be initiated at the dose of sitagliptin and metformin already being taken.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
4). For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a PPARγ agonist The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
4). All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day. Special populations Renal impairment No dose adjustment is needed for patients with mild renal impairment (glomerular filtration rate [GFR] ≥ 60 ml/min).
A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. g. every 3-6 months. The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. 4) should be reviewed before considering initiation of metformin in patients with GFR < 60 ml/min.
2). Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported. 9%). Tabulated list of adverse reactions Sitagliptin and metformin Adverse reactions are listed below as MedDRA preferred term by system organ class and absolute frequency (Table 1).
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) and not known (cannot be estimated from the available data).
Table 1:
The frequency of adverse reactions identified from placebo-controlled clinical studies of sitagliptin and metformin alone, and post-marketing experience Adverse reaction Frequency of adverse reaction Blood and lymphatic system disorders thrombocytopenia Rare Immune system disorders hypersensitivity reactions including anaphylactic responses*,† Not known Metabolism and nutrition disorders hypoglycaemia† Common Vitamin B12 decrease/deficiency† Common Nervous system disorders somnolence Uncommon Respiratory, thoracic and mediastinal disorders interstitial lung disease* Not known Gastrointestinal disorders nausea Common flatulence Common vomiting Common diarrhoea Uncommon constipation Uncommon upper abdominal pain Uncommon acute pancreatitis*,†,‡ Not known fatal and non-fatal haemorrhagic and necrotizing pancreatitis*,† Not known Skin and subcutaneous tissue disorders pruritus* Uncommon angioedema*,† Not known rash*,† Not known urticaria*,† Not known cutaneous vasculitis*,† Not known exfoliative skin conditions including Stevens-Johnson syndrome*,† Not known bullous pemphigoid* Not known Musculoskeletal and connective tissue disorders arthralgia* Not known myalgia* Not known pain in extremity* Not known back pain* Not known arthropathy* Not known Renal and urinary disorders impaired renal function* Not known acute renal failure* Not known *Adverse reactions were identified through post-marketing surveillance.
General Sitagliptin/Metformin should not be used in patients with type 1 diabetes and must not be used for the treatment of diabetic ketoacidosis. Acute pancreatitis Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
If pancreatitis is suspected, Sitagliptin/Metformin and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Sitagliptin/Metformin should not be restarted. Caution should be exercised in patients with a history of pancreatitis.
Lactic acidosis Lactic acidosis, a rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
In case of dehydration (severe vomiting, diarrhoea, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended. Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients.
5). Patients and/or care-givers should be informed of the risk of lactic acidosis. Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio. Patients with known or suspected mitochondrial diseases In patients with known mitochondrial diseases such as Mitochondrial Encephalopathy with Lactic Acidosis, and Stroke-like episodes (MELAS) syndrome and Maternal inherited diabetes and deafness (MIDD), metformin is not recommended due to the risk of lactic acidosis exacerbation and neurologic complications which may lead to worsening of the disease.
4); - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment; - acute alcohol intoxication, alcoholism; - breast-feeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If no adequate strength of Sitagliptin/Metformin is available, individual monocomponents should be used instead of the fixed-dose combination. GFR ml/min Metformin Sitagliptin 60-89 Maximum daily dose is 3,000 mg. Dose reduction may be considered in relation to declining renal function.
Maximum daily dose is 100 mg. 45-59 Maximum daily dose is 2,000 mg. The starting dose is at most half of the maximum dose. Maximum daily dose is 100 mg. 30-44 Maximum daily dose is 1,000 mg. The starting dose is at most half of the maximum dose.
Maximum daily dose is 50 mg. <30 Metformin is contraindicated. Maximum daily dose is 25 mg. 2). Elderly As metformin and sitagliptin are excreted by the kidney, Sitagliptin/Metformin should be used with caution as age increases. 4). Paediatric population Sitagliptin/Metformin should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy.
2. Sitagliptin/Metformin has not been studied in paediatric patients under 10 years of age. Method of administration Sitagliptin/Metformin should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
4. ‡ See TECOS cardiovascular safety study below. Description of selected adverse reactions Some adverse reactions were observed more frequently in studies of combination use of sitagliptin and metformin with other anti-diabetic medicinal products than in studies of sitagliptin and metformin alone.
These included hypoglycaemia (frequency very common with sulphonylurea or insulin), constipation (common with sulphonylurea), peripheral oedema (common with pioglitazone), and headache and dry mouth (uncommon with insulin). Sitagliptin In monotherapy studies of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions reported were headache, hypoglycaemia, constipation, and dizziness.
Among these patients, adverse events reported regardless of causal relationship to medicinal product occurring in at least 5% included upper respiratory tract infection and nasopharyngitis. 5% higher among sitagliptin users than that in the control group).
Metformin Gastrointestinal symptoms were reported very commonly in clinical studies and post- marketing use of metformin. Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Additional adverse reactions associated with metformin include metallic taste (common); lactic acidosis, liver function disorders, hepatitis, urticaria, erythema, and pruritus (very rare). Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
Paediatric population In clinical studies with Sitagliptin/Metformin in paediatric patients with type 2 diabetes mellitus aged 10 to 17 years, the profile of adverse reactions was generally comparable to that observed in adults. In paediatric patients on or not on background insulin, sitagliptin was associated with an increased risk of hypoglycaemia.
73 m2), and 7,339 patients treated with placebo in the intention-to-treat population. Both treatments were added to usual care targeting regional standards for HbA1c and CV risk factors. The overall incidence of serious adverse events in patients receiving sitagliptin was similar to that in patients receiving placebo.
7% in placebo-treated patients. 2% in placebo-treated patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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In case of signs and symptoms suggestive of MELAS syndrome or MIDD after the intake of metformin, treatment with metformin should be withdrawn immediately and prompt diagnostic evaluation should be performed. 2). 3). Hypoglycaemia Patients receiving Sitagliptin/Metformin in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Therefore, a reduction in the dose of the sulphonylurea or insulin may be necessary. Hypersensitivity reactions Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. 8). Bullous pemphigoid There have been post-marketing reports of bullous pemphigoid in patients taking DPP-4 inhibitors including sitagliptin.
If bullous pemphigoid is suspected, Sitagliptin/Metformin should be discontinued. Surgery Sitagliptin/Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Administration of iodinated contrast agent Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. 5). Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Sitagliptin/Metformin who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels. If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated.
Vitamin B12 Deficiency Metformin may reduce vitamin B12 serum levels. The risk of low vitamin B12 levels increases with increasing metformin dose, treatment duration, and/or in patients with risk factors known to cause vitamin B12 deficiency.
In case of suspicion of vitamin B12 deficiency (such as anaemia […]