Trajenta duo 2.5mg/850mg Boehringer treatment for type 2 diabetes (30 tablets)

In muscle, thanks to increasing insulin sensitivity, improving the absorption and use of peripheral glucose.

metformin hydrochloride stimulates intracellular glycogen synthesis due to the influence on glycogen synthase.

metformin hydrochloride increases the transport ability of all glucose transportation through the cell membrane (GLUT) to date.

In humans, metformin hydrochloride also has a favorable effect on lipid metabolism, independent of the effect on blood sugar. This effect is recorded in the dose of treatment in clinical studies with a long and long -term research time: Metformin hydrochloride reduces total cholesterol, LDL cholesterol and triglycerides.

pharmacokinetic

linagliptin

Absorption: The absolute bioavailability of Linagliptin is about 30%. Drinking Linagliptin along with a fat -rich meal without clinical effects on pharmacokinetics, Linagliptin can be used or not with food.

In vitro studies show that linagliptin is a substrate of p-glycoprotein and CYP3A4. Ritonavir, a powerful inhibitor P-Glycoprotein and CYP3A4 increases the concentration of drugs (AUC) 2 times and used many times simultaneously Linagliptin with Rifampicin, a strong induction for P-GP and CYP3A leading to a decrease of about 40% of the AUC concentration of Linagliptin in a stable state, perhaps due to Linagliptin increased by Linagliptin by the inhibition P-glycoprotein.

DISTRIBUTION: Due to tissue bonds, the average appointed distribution volume in a stable state after using a single -dose of 5mg of Linagliptin's intravenous lines in healthy people is about 1110 liters, showing that Linagliptin is widely distributed to tissues. Linagliptin's plasma protein bonds depend on concentration, reduced from about 99% at a concentration of 1 nmol/l to 75-89% at a concentration of ≥ 30 nmol/l, reflecting saturation associated with DPP-4 when increased Linagliptin concentration. At high concentrations, when DPP-4 is completely saturated, 70-80% Linagliptin is linked to other plasma proteins other than DPP-4, so 30-20% in non-binding form in plasma.

Metabolic: After taking a dose [14C] Linagliptin oral 10mg, about 5% of radioactive substances are excreted into the urine. Metabolism plays a secondary role in the elimination of linagliptin. A main metabolites with relatively 13.3% of Linagliptin dose in stable state are detected as non-pharmacological activity and therefore does not contribute to the activity of plasma DPP-4 plasma inhibitors of Linagliptin.

Elimination: After giving healthy people orally [14C] Linagliptin, about 85%of the doses of radioactive activity are eliminated by feces (80%) or urine (5%) within 4 days of taking the drug. The kidney removal in a stable state is about 70ml/min.

Renal failure: There is no need to adjust the linagliptin dose in patients with renal impairment at any level. In addition, mild kidney failure does not affect the pharmacokinetics of Linagliptin in patients with type 2 diabetes according to the pharmacokinetic analysis assessment of the research population.

Hepatic failure: There is no need to adjust the linagliptin dose for patients with mild, medium or severe liver failure.

metformin

Absorption: After 1 dose of oral metformin, TMAX is achieved after 2.5 hours. The absolute bioavailability of Metformin Hydrochloride 500mg or 850mg tablets in healthy volunteers is about 50 - 60%. After an oral dose, the non -absorbing drug is found in the feces of 20 - 30%. After oral use, Metformin Hydrochloride is absorbed incomplete and saturated. Pharmacoderminium absorption of Metformin Hydrochloride is thought to be non -linear.

Distribution: The drug is not significantly attached to plasma proteins. Metformin Hydrochloride is distributed into red blood cells. The peak concentration in the blood is lower than the peak concentration in plasma and appears at the same time. Many possibilities are a secondary distribution compartment. The average distribution volume (VD) is in the range of 63 - 276L.

Metabolism: metformin hydrochloride eliminated through urine in constant form. No metabolites in humans.

Elimination: The renal waste of the metformin hydrochloride> 400ml/min shows that the metformin hydrochloride is excreted by glomerular filtration and excreted through the renal tubules. After an oral dose, the apparent sale time is about 6.5 hours. When renal function decreases, the removal of drugs through the kidneys decreases proportional to the clearing of creatinine, so the sale time also lasts, resulting in an increase in plasma metformin hydrochloride levels in plasma.

Contraindicated Metformin in patients with EGFR below 30 ml/min/1.73m2.

Medicine interaction: Concomitant use of metformin with some drugs may increase the risk of lactic acidosis related to metformin.

Patients aged 65 and older: The risk of lactic acidosis is related to Metformin increases with the age of the patient because the elderly patients are likely to have liver failure, kidney failure, heart failure than younger patients. Need to evaluate kidney function more often for older patients.

Perform diagnostic tests using contrast drugs: Injecting contrast drugs into the intravascular disease in patients who are being treated metformin can lead to impaired renal function and cause lactic acidosis. Stop using Metformin before or at the time of performing screens using iodine-containing contrast drugs in patients with EGFR in the range of 30-60 ml /min /1.73m2, patients with a history of liver failure, alcoholism, heart failure or patients will use IOD contrast drugs in artery. Reassess EGFR 48 hours after screening and reuse Metformin if the kidney function is stable.

Surgery or other procedures: food storage and fluid during surgery or performing other procedures may increase the risk of decreased volume, hypotension and kidney failure. Metformin should be temporarily stopped temporarily when the patient has a limited amount of food and deposits.

Metformin hydrochloride must be stopped 48 hours before surgery under the program with systemic anesthesia, spinal anesthesia or external epidural. It is possible to reuse the drug after 48 hours from the surgery or after the patient is raised again by oral and only when the kidney function is determined to be normal.

Inhalation oxygen reduction: after -sales monitoring process has recorded a number of lactic acidosis related to metformin occurring in acute congestive heart failure (especially when accompanied by reduced perfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, bacterial infection and other diseases related to hypoxemia are associated with lactic acidosis and may also cause nitrogen nitrogen before the kidneys. When these events occur, stop Metformin.

drink alcohol.

Hepatic failure: Patients with hepatic impairment may progress to lactic acidosis related to metformin due to lactate excretion reduction leading to increased lactate levels in the blood. Therefore, avoid using Metformin in patients who have been diagnosed with liver disease through tested or clinical evidence ml/min/1.73m2, assessing risks - benefits of continuing the regimen.

Pancreatitis: There have been after -sales reports of acute pancreatitis, including fatal pancreatitis in patients using linagliptin. Read carefully about the possible signs and symptoms of pancreatitis. If suspected of pancreatitis, immediately stop using Trajenta Duo and start appropriate treatment. It is unknown whether the patient has a history of pancreatic inflammation, which increases or not the risk of pancreatic inflammation while using Trajenta Duo.

Heart function: Heart failure is at higher risk of oxygen and renal failure. In patients with stable chronic heart failure, Trajenta Duo can be used on the regular monitoring of heart and kidney function.

Contraindicated Trajenta Duo for patients with acute heart failure and unstable heart failure due to drugs containing metformin.

Pemphigoid puffer: There is a report after circulation of pemphigoid bulls in patients using linagliptin. If there is a suspected pemphigoid, it is necessary to stop using Trajenta Duo.

The ability to drive and operate machinery

There has been no research on the effect of the drug on the ability to drive and operate machinery.

Pregnancy

No appropriate and strict research has been conducted in pregnant women using Trajenta Duo or its individual active ingredients. The non -clinical studies on reproduction conducted on mice using trajenta duo drugs do not show the teratogenic effect of simultaneous use of Linagliptin and Metformin.

To be cautious, better to avoid using Trajenta Duo during pregnancy.

When a patient plans to get pregnant and during pregnancy, you should not treat diabetes with Trajenta Duo but should use insulin to maintain blood sugar level as close as normal as possible to reduce the risk of fetal deformities related to abnormalities.

Breastfeeding period

In humans, metformin has excreted breast milk. It is still unclear whether Linagliptin is excreted in breast milk or not. Do not use Trajenta Duo in breastfeeding women.

Drug interaction

linagliptin

Interrogen interaction assessment

Interaction assessment in vivo

metformin

The risk of increasing lactic acidic acidosis in acute alcoholic poisoning patients (especially in the case of fasting, malnutrition or liver failure) due to the active ingredient of trajenta duo (see the warning and cautious section). Alcohol and alcohol should be avoided.

Cation original drugs are excreted mainly through the renal tubules (for example, cimetidine) can interact with metformin due to competition for the renal tubular transportation system. Therefore, it is advisable to consider monitoring the blood sugar closely, adjust the dose in the recommended dose and change the treatment of diabetes when used simultaneously with cation removal drugs through the renal tubules.

ANHYDRASE CARBONS: Topiramate or carbon dioxide inhibitors (Zonisamide, Acetazolamide or Dichlorphenamide) regularly cause hype of serum bicarbonate and cause hypertension metabolism, without changing anion space. Concomitant use of these drugs can cause metabolic acidosis. Be careful to use these drugs in patients treated with Trajenta Duo because it can increase the risk of lactic acidic acidosis.

Injecting of the internal contrast drug in patients who are being treated for metformin can lead to impaired renal function and cause lactic acidosis. Stop using Metformin before or at the time of performing screens using iodine -containing contrast drugs in patients with EGFR in the range of 30 - 60 ml /min /1.73 m2, patients with a history of liver failure, alcoholism, heart failure or patients will use optical bumper containing iodine in artery lines. Reassess EGFR 48 hours after screening and reuse Metformin if the kidney function is stable.