Vipidiya pills film-coated 12,5 mg N28
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Active ingredients
Alogliptin
Release form
Pills
Composition
Aogliptin benzoate 17 mg, which corresponds to an alogliptin content of 12.5 mg. Excipients: mannitol - 96.7 mg, microcrystalline cellulose - 22.5 mg, hyprolosis - 4.5 mg, croscarmellose sodium - 7.5 mg, magnesium stearate - 1.8 mg. The composition of the film shell: hypromellose 2910 - 5.34 mg, titanium dioxide - 0.6 mg, iron dye yellow oxide - 0.06 mg, macrogol 8000 - trace amounts, gray ink F1 (shellac - 26%, iron dye black oxide - 10%, ethanol - 26 %, butanol - 38%) - trace amounts.
Pharmacological effect
Hypoglycemic drug, potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4). Its selectivity for DPP-4 is more than 10,000 times greater than its effect for other related enzymes, including DPP-8 and DPP-9. DPP-4 is the main enzyme involved in the rapid destruction of the hormones of the incretin family: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (HIP). Hormones of the family of incretins are secreted in the intestine, their concentration increases in response to food intake. GLP-1 and HIP increase insulin synthesis and its secretion of pancreatic cells & # 946. GLP-1 also inhibits glucagon secretion and reduces the production of glucose by the liver. Therefore, by increasing the concentration of incretins, alogliptin increases glucose-dependent insulin secretion and decreases glucagon secretion at elevated blood glucose concentrations. In patients with type 2 diabetes mellitus with hyperglycemia, these changes in insulin and glucagon secretion lead to a decrease in the concentration of glycated hemoglobin HbA1C and a decrease in plasma glucose concentration in both fasting and postprandial glucose.
Indications
Type 2 diabetes in adults to improve glycemic control with the ineffectiveness of diet and exercise: - as a monotherapy. - in combination with other oral hypoglycemic agents or insulin.
Contraindications
- hypersensitivity to alogliptin or to any excipient, or serious hypersensitivity reactions to any DPP-4 inhibitor in history, including anaphylactic reactions,anaphylactic shock and angioedema. - diabetes mellitus type 1. - diabetic ketoacidosis. - Chronic heart failure (FC NYHA class III-IV). - severe liver failure (more than 9 points on the Child-Pugh scale) due to the lack of clinical data on the use. - severe renal failure. - pregnancy (due to the lack of clinical data on the application). - breastfeeding period (due to the lack of clinical data on the application). - children's and teenage age up to 18 years (due to the lack of clinical data on application).
Use during pregnancy and lactation
No studies have been conducted on the use of alogliptin in pregnant women. Experimental studies on animals did not show a direct or indirect negative impact of alogliptin on the reproductive system. However, as a precaution, the use of the drug Vipidia during pregnancy is contraindicated. It is not known whether alogliptin is excreted in human breast milk. Experimental studies on animals have shown that alogliptin is excreted in breast milk, so the risk of side effects in infants cannot be excluded. In this regard, the use of the drug during breastfeeding is contraindicated.
Dosage and administration
Vipidiya drug can be taken regardless of the meal. Tablets should be swallowed whole, not liquid, squeezed water. The recommended dose of Vipidia is 25 mg 1 time / day as monotherapy or in addition to metformin, thiazolidinedione, sulfonylurea derivatives or insulin, or as a three-component combination with metformin, thiazolidinedione or insulin. If a patient misses taking Vipidia, he should take the missed dose as soon as possible. Do not take a double dose of Vipidia on the same day. When prescribing Vipidia, in addition to metformin or thiazolidinedione, the dose of the last drugs should be left unchanged. When combining the drug Vipidiya with a sulfonylurea derivative or insulin, the dose of the latter should be reduced to reduce the risk of hypoglycemia.In connection with the risk of hypoglycemia, caution should be exercised in the appointment of a three-component combination of the drug Vipidia with metformin and thiazolidinedione. In the case of hypoglycemia, it is possible to consider reducing the dose of metformin or thiazolidinedione. The efficacy and safety of alogliptin when taken in triple combination with metformin and a sulfonylurea derivative have not been studied. Patients with renal failure Patients with mild renal insufficiency (CC from> 50 to & # 8804 .80 ml / min) do not require dose adjustment for Vipidia. In patients with moderately severe renal failure (QC from & # 8805 .30 to & # 8804 .50 ml / min), the dose of Vipidia is 12.5 mg 1 time / day. Aogliptin should not be used in patients with severe renal failure and in patients with end-stage renal disease who need hemodialysis (CC <30 ml / min). In patients with renal insufficiency, it is recommended to evaluate kidney function before starting treatment with Vipidia and periodically during treatment. Patients with liver failure It is not necessary to adjust the dose of Vipidium in patients with mild to moderate hepatic insufficiency (from 5 to 9 points on the Child-Pugh scale). The drug has not been studied in patients with severe liver failure (more than 9 points on the Child-Pugh scale), so it should not be used in this group of patients. Patients over 65 years of age Do not require dose adjustment of Vipidia in patients over 65 years of age. Nevertheless, it is necessary to carefully select the dose of alogliptin in connection with the potential for reducing renal function in this group of patients.
Side effects
On the part of the nervous system: often - a headache. On the part of the digestive system: often - pain in the epigastric region, gastroesophageal reflux disease. frequency is not installed - acute pancreatitis. On the part of the liver and biliary tract: the frequency is not installed - impaired liver function, incl. liver failure. From the skin and subcutaneous tissues: often - itching, rash. frequency not established - exfoliative skin diseases, including Stevens-Johnson syndrome, angioedema, urticaria.On the part of the respiratory system: often - upper respiratory tract infections, nasopharyngitis. On the part of the immune system: frequency not established - hypersensitivity reactions, including an anaphylactic reaction.
special instructions
On the part of the nervous system: often - a headache. On the part of the digestive system: often - pain in the epigastric region, gastroesophageal reflux disease. frequency is not installed - acute pancreatitis. On the part of the liver and biliary tract: the frequency is not installed - impaired liver function, incl. liver failure. From the skin and subcutaneous tissues: often - itching, rash. frequency not established - exfoliative skin diseases, including Stevens-Johnson syndrome, angioedema, urticaria. On the part of the respiratory system: often - upper respiratory tract infections, nasopharyngitis. On the part of the immune system: frequency not established - hypersensitivity reactions, including an anaphylactic reaction.