Traction pills film-coated 5mg N30
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Description
Trazhenta pills - oral hypoglycemic drug. It is used in the treatment of type 2 diabetes.
Active ingredients
Linagliptin
Release form
Pills
Composition
Linagliptin 5 mg. Adjuvants: mannitol - 130.9 mg, pregelatinized starch - 18 mg, corn starch - 18 mg, copovidone - 5.4 mg, magnesium stearate - 2.7 mg. The composition of the shell: pink opadra (02F34337) - 5 mg (hypromellose 2910 - 2.5 mg, titanium dioxide (E171) - 1.25 mg, talc - 0.875 mg, macrogol 6000 - 0.25 mg, iron dye red oxide (E172) - 0.125 mg).
Indications
Type 2 diabetes mellitus: - as monotherapy in patients with inadequate glycemic control only on the background of diet and exercise, with intolerance to metformin or contraindicated for its use due to renal failure, - as a two-component combination therapy with metformin, sulfonylurea derivatives or thiazolidinedione in failure of diet therapy, exercise and monotherapy with these drugs, as a three-component combination therapy with metformin and derivatives of sulfonylurea in case of failure of diet therapy, exercise and combination therapy with these drugs - as a two-component combination therapy with insulin or multicomponent therapy with insulin, metformin and / or pioglitazone and / or derivatives of sulfonylurea in the case of ineffectiveness of diet therapy, physical exercises. drugs.
Precautionary measures
The use of the drug Trazhent is contraindicated in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycemia The frequency of hypoglycemia in the case of using linagliptin as monotherapy was comparable to placebo. In clinical studies, it was reported that the incidence of hypoglycemia in the case of linagliptin in combination with drugs which are not believed to cause hypoglycemia (metformin, derivatives of thiazolidinedione), was similar to the corresponding placebo effect. The production Sulfonylureas are known to cause hypoglycemia. Therefore, if linagliptin is used in combination with sulfonylurea derivatives, caution should be exercised.If necessary, a reduction in the dose of sulfonylurea derivatives is possible. The use of linagliptin does not increase the risk of developing cardiovascular diseases. Linagliptin in combination therapy with other oral hypoglycemic drugs was used in patients with severe renal insufficiency. Linagliptin provided a significant reduction in the concentration of glycated hemoglobin and glucose concentration by inactivate. in patients over the age of 70 years. The use of linagliptin resulted in Momo reduce glycated hemoglobin A (HbA1c) (0.64% compared with placebo, starting HbA1c level was about 7.8%). The use of linagliptin also led to a significant decrease in plasma glucose on an empty stomach. Cardiovascular riskLinagliptin treatment does not lead to an increase in cardiovascular risk. The primary endpoint (combination of incidence or time before cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization due to unstable angina) was significantly less common in patients treated with linagliptin than in the combined group of patients receiving active drugs comparisons and placebo (relative risk 0.78, 95% confidence interval 0.55, 1.12). Postmarketing experience of using patients taking linagliptin were ksirovany cases of acute pancreatitis. In case of suspected pancreatitis, the use of the drug should be discontinued. Effect on the ability to drive vehicles and mechanisms Studies of the effect of the drug on the ability to drive vehicles and mechanisms have not been conducted. However, due to the possible development of vertigo, caution should be exercised when driving vehicles and machinery.
Use during pregnancy and lactation
The use of linagliptin during pregnancy and during breastfeeding is contraindicated. The data obtained in preclinical studies in animals indicate the release of linagliptin and its metabolite in breast milk. The risk of exposure to infants and children during breastfeeding is not excluded. If you need to use linagliptin during lactation, breastfeeding should be stopped.
Dosage and administration
The drug is taken orally, at any time of the day, regardless of the meal. The recommended dose is 5 mg (1 tab.) 1 time / day. When you skip the next dose, the patient should take the drug as soon as he remembers. You should not take a double dose in one day. Dose adjustment when using the drug in patients with impaired renal function, liver and elderly patients is not required.
Side effects
The frequency of side effects when using linagliptin at a dose of 5 mg was similar to the frequency of side effects when using placebo. Termination of therapy due to adverse events was higher in the group of patients who received placebo (4.4%) than in the group who received lingliptin 5 mg ( 3.5%). When monotherapy with linagliptin, the following side effects were observed: On the part of the immune system: hypersensitivity reactions. On the part of the respiratory system: cough. On the part of the digestive system: pancreatitis. Infectious diseases: nasopharing T. When using linagliptin with metformin: On the part of the immune system: hypersensitivity reactions. On the part of the respiratory system: cough. On the part of the digestive system: pancreatitis. Infectious diseases: nasopharyngitis. On using linagliptin with sulfonylureas: On the part of the immune system: hypersensitivity reactions. Metabolic disorders: hypertriglyceridemia. On the part of the respiratory system: cough. On the part of the digestive system: pancreatitis. Infectious diseases: nasopharyngitis. When applied and linagliptin with pioglitazone: On the part of the immune system: hypersensitivity reactions. Metabolic disorders: hyperlipidemia. On the part of the respiratory system: cough. On the part of the digestive system: pancreatitis. Infectious diseases: nasopharyngitis. Others: increase in body mass. side of the immune system: hypersensitivity reactions. On the part of the respiratory system: cough. On the part of the digestive system: pancreatitis, constipation. Infectious diseases: nasopharyngitis. inagliptina with metformin and sulfonylureas: Immune system: giperchuvstvitelnost.Metabolicheskie violations: gipoglikemiya.So the respiratory system: kashel.So the digestive system: pankreatit.Infektsionnye disease:Nasopharyngitis. When using linagliptin with metformin and pioglitazone: On the part of the immune system: hypersensitivity reactions. Metabolic disorders: hyperlipidemia. On the part of the respiratory system: cough. On the part of the digestive system: pancreatitis. Infectious diseases: nasopharyngitis. Older: an increase in mass. use: On the part of the immune system: angioedema, urticaria. On the part of the digestive system: ulceration of the oral mucosa. On the side of the skin: sy item
Overdose
During controlled clinical trials in healthy volunteers, a single dose of linagliptin at a dose of 600 mg (120 times the recommended dose) was well tolerated. There is no experience of using linagliptin at a dose exceeding 600 mg. Treatment: in case of overdose, it is recommended to use usual supportive measures, for example, removal of an unabsorbed drug from the gastrointestinal tract, implementation of clinical control and symptomatic therapy.
Interaction with other drugs
Evaluation of drug interactions in vitro. Linagliptin is a weak competitive inhibitor of the CYP3A4 isoenzyme. Linagliptin does not inhibit other isoenzymes of CYP and does not induce them. Linagliptin is a substrate for P-glycoprotein and inhibits to a small extent P-glycoprotein-mediated digoxin transport. Linagliptin has no clinically significant effect on the pharmacokinetics of metformin, glibenclamide, simvastatin, pioglitazone, warfarin, digoxin, and oral counter. tseptivnyh drugs that shown in conditions in vivo, and is based on a low capacity linagliptina cause drug interactions with substrates for CYP3A4, CYP2C9, CYP2C8, and P-glycoprotein transport kationov.Metformin organic molecules. The combined use of metformin (repeated daily dose of 850 mg 3 times / day) and linagliptin 10 mg 1 time / day. (higher than the therapeutic dose) in healthy volunteers did not lead to clinically significant changes in the pharmacokinetics of linagliptin or metformin. Thus, linagliptin is not an inhibitor of the transport of organic cations. Sulfonylurea derivatives.The pharmacokinetics of linagliptin (5 mg) did not change when combined with glibenclamide (a single dose of glyburide 1.75 mg) and repeated intake of linagliptin orally (5 mg). However, there was a clinically insignificant decrease in the AUC and Cmax values of glibenclamide by 14%. Since glibenclamide is metabolized primarily by CYP2C9, this data also supports the conclusion that linagliptin is not a CYP2C9 inhibitor. No clinically significant interactions are expected with other sulfonylurea derivatives (for example, glipizide and glimepiride), which, like glibenclamide, are mainly metabolized with the participation of CYP2C9. Thiazolidinediones. The combined use of multiple doses of Linagliptin 10 mg / day. (higher than therapeutic dose) and pioglitazone 45 mg / day. (repeated administration), which is a substrate for CYP2C8 and CYP3A4, did not have a clinically significant effect on the pharmacokinetics of linagliptin or pioglitazone, or the active metabolites of pioglitazone. This indicates that linagliptin in vivo is not an inhibitor of metabolism mediated by CYP2C8, and confirms the conclusion that there is no significant inhibitory effect of linagliptin in vivo on CYP3A4. Ritonavir. The combined use of linagliptin (single dose of 5 mg orally) and ritonavir (repeated intake of 200 mg orally), an active inhibitor of P-glycoprotein and the isoenzyme CYP3A4, increased the AUC and Cmax values of linagliptin, approximately 2 times and 3 times, respectively. However, these changes in linagliptin pharmacokinetics were not considered significant. Therefore, a clinically significant interaction with other inhibitors of P-glycoprotein and CYP3A4 is not expected, and a dose change is not required. Rifampicin. Repeated combined use of linagliptin and rifampicin, the active inducer of P-glycoprotein and CYP3A4 isoenzyme, led to a decrease in the AUC and Cmax values of linagliptin, respectively by 39.6% and 43.8%, and to a decrease in inhibition of the basal activity of dipeptidyl peptidase-4, by about 30%. Thus, it is expected that the clinical efficacy of linagliptin, which is used in combination with active inducers of P-glycoprotein, will be maintained, although it may not manifest fully. Digoxin. The combined repeated use of linagliptin (5 mg / day) and digoxin (0.25 mg / day) in healthy volunteers did not affect the pharmacokinetics of digoxin.Thus, linagliptin in vivo is not an inhibitor of transport mediated by P-glycoprotein. Warfarin. Linagliptin, administered repeatedly at a dose of 5 mg / day, did not change the pharmacokinetics of warfarin, which is a substrate for CYP2C9, which indicates that linagliptin does not have the ability to inhibit CYP2C9. Simvastatin. Linagliptin, used in healthy volunteers many times at a dose of 10 mg / day. (above the therapeutic dose), had a minimal effect on the pharmacokinetic parameters of simvastatin, which is a sensitive substrate for CYP3A4. After taking linagliptin at a dose of 10 mg together with simvastatin, used at a daily dose of 40 mg for 6 days, the AUC value of simvastatin increased by 34% and the Cmax value by 10%. Thus, linagliptin is a weak inhibitor of CYP3A4-mediated metabolism. Changes in dose while taking with drugs that are metabolized with the participation of CYP3A4, is considered inappropriate. Oral contraceptive drugs. The combined use of linagliptin 5 mg with levonorgestrel or ethinyl estradiol did not change the pharmacokinetics of these drugs.