Janumet XR 100mg/1000mg MSD tablet supports diet, improving blood sugar control 2 (28 tablets)

Uncommon, 1/1000

Patients with acute or chronic metabolic acidosis, including diabetes metonic acidosis, with or without coma.

Should stop Janumet XR temporarily in patients with X -rays with intravenous contrast injection of radioactive iodine, because using such substances can cause acute renal function.

Caution when using

Janumet XR

Do not use Janumet XR for patients with diabetes type 1 or to treat diabetes metonic acidosis.

Pancreatitis

There have been reports on acute pancreatitis, including dematitis or fatal and non -fatal necrosis in patients using sitagliptin. It is advisable to notify patients with the typical symptoms of acute pancreatitis is severe and continuous abdominal pain. Pancreatitis is recovered after stopping the use of sitagliptin. If pancreatitis is suspected, Janumet XR should be stopped and other suspected drugs.

Kidney function supervision

metformin and sitagliptin are excreted mainly through the kidneys. The risk of metformin accumulation and lactic acidosis increases with the degree of renal failure. Contraindicated to use Janumet XR in patients with severe renal impairment (EGFR

It is advisable to evaluate the kidney function before starting treatment with Janumet XR and then at least every year. It is advisable to evaluate the kidney function more often in patients who are predicted to have kidney dysfunction and stop using Janumet XR if there is evidence of kidney failure.

Hypoglycemia in therapy combined with sulfonylurea (Su) or with insulin

Like other hyperglycemic drugs, observing hypoglycemia when using sitagliptin and metformin combined with insulin or a rubber drug. Therefore, to reduce the risk of hypoglycemia caused by Su or insulin, it is possible to consider reducing su or insulin dose.

sitagliptin phosphate

Hypoglycemia in therapy combined with sulfonylurea (Su) or with insulin

In clinical trials with single -therapy sitagliptin and use in combination with drugs that are known not to cause hypoglycemia (such as Metformin or PPAR DRY - THIAZOLIDIONES), the rate of hypoglycemia reports when using sitagliptin is similar to the patient using Placebo. Like other hyperglycemic drugs, observing hypoglycemia when using sitagliptin combined with insulin or a Su group of Su. Therefore, to reduce the risk of hypoglycemia due to su or insulin, can consider reducing the dose or insulin.

Hypersensitivity reaction

There have been reports on serious hypersensitivity reactions in patients using sitagliptin. These reactions include anaphylactic reaction, angioedema and peeling diseases including Stevens - Johnson syndrome. Because these reactions are voluntarily reported from the unknown population of the sample size, it is often not possible to make sure the frequency or establish a causal relationship with the use of the drug. These reactions began to appear in the first 3 months of treatment with sitagliptin, with several reports that occurred after the first dose. If there is suspicion of hypersensitivity reactions, Janumet XR must be stopped, assessing other potential causes and using other diabetes therapy instead.

metformin hydrochloride

Lactic acidosis

Lactic acidosis is a rare but serious metabolic complication, which can occur due to metformin accumulation during treatment with Janumet XR that can cause death of about 50% of cases. Lactic acidosis can also occur with a number of other pathophysiological conditions, including diabetes and anytime there is a reduction in tissue osical and oxygen in the blood. Lactic acidosis is characterized by increased lactate in the blood (> 5 mmol/l), reducing blood pH, electrolyte disorders with an increase in anion space and increasing lactate/pyruvate ratio. When Metformin is considered to be the cause of lactic acidosis, usually Metformin levels in plasma> 5 ng/ml.

Lactic acidosis rate is very low in patients using metformin hydrochloride. Cases occur mainly in patients with diabetes with significant kidney failure, including kidney disease and reducing kidney perfusion, usually when there are many health/surgical problems that occur at the same time and taking many drugs at the same time.

Patients with congestive heart failure need to be treated with drugs, especially people with unstable or acute congestive heart failure, which is at risk of reducing perfusion and reducing blood oxygen, increasing the risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal failure and the age of patient. Therefore, it is possible to significantly reduce the risk of lactic acidosis by regular monitoring of kidney function in patients using metformin (especially the elderly) and the minimum metformin dose is effective. Do not start the metformin treatment in patients> 80 years old unless normal kidney function is because these patients are more likely to be acidosis. In addition, stop using Metformin as soon as there is any condition related to reducing blood oxygen, dehydration or infection. Because liver function can significantly limit the ability to eliminate lactate, it is often avoided to use metformin in patients with clinical evidence or testing for liver disease.

Patients should be careful to avoid drinking alcohol when taking Metformin, whether taken in a short or prolonged time, because alcohol has the ability to increase the impact of metformin hydrochloride on lactate metabolism. In addition, temporary metformin should be stopped before X -rays have intravenous contrast injection and before surgery.

Lactic acidosis is often not easy to detect and only accompanied by nonspecific symptoms such as fatigue, muscle pain, respiratory loss, increased drowsiness and abdominal pain. Can be lowered, hypotension and slow heartbeat still withstand more obvious acidosis.

Instruct the patient to notify the doctor immediately if they occur. Metformin should be stopped until solving these conditions. It may be helpful when measuring the concentration of electrolytes, keratoma in serum, blood sugar and if indicated, measured blood pH, blood lactate and metformin levels in the blood.

Once the patient has stabilized any dose of Metformin, the symptoms in the gastrointestinal tract are common at the beginning of the therapy that is likely not related to the drug. Gastrointestinal symptoms occur later may be caused by lactic acidosis or other serious diseases.

Lactate concentration in venous plasma is higher than the maximum allowable but Lactic acidosis is an emergency medical condition, which needs to be treated at the hospital. Metformin should be discontinued as soon as the patient has lactic acidosis and immediately treated with general support measures. Because it is possible to separate metformin hydrochloride (with a purification of up to 170 ml/minute in good hemodynamics), it is recommended that instant hemolysis to adjust acidosis and to eliminate cumulative metformin. Such treatment often loses symptoms and instant recovery.

Hypoglycemia

Hypoglycemia does not occur in patients using single metformin in cases of drug use as usual, but may occur if not enough calories to compensate for excessive activity, or while simultaneous use of other blood sugar drugs (such as sulfonylurea and insulin) and alcohol (ethanol). Elderly patients, weak strength, malnutrition, adrenal or pituitary insertion, alcohol poisoning, especially sensitive to hypoglycemic effects. It may be difficult to identify hypoglycemia in the elderly and in people who are taking receptor blockers β - adrenergic.

Timultant use of drugs can affect kidney function or Metformin elimination

Be careful when using the medications that can affect kidney function or significantly change hemodynamics or can hinder the elimination of metformin, such as cation drugs that are excreted through the excretion of the renal tubules.

X -rays with radioactive iodine injections (for example, a urinary tract with contrast, biliary tract with contrast injection, arterial angiography and computing layer cut with venous contrast substance)

X -ray tips with radioactive iodine injections can lead to changes in acute renal function and often linked to lactic acidosis in patients using metformin. Therefore, if you plan to conduct any X -ray tricks, you should temporarily stop using Janumet XR at the time of shooting or before taking the shooting, until 48 hours after shooting and reusing the medication after evaluating the normal kidney function.

Oxygen reduction

Cardiovascular collapse (shock) due to any cause, acute congestion, acute myocardial infarction and other diseases that have a characteristic of reducing blood oxygen are often associated with lactic acid infections and can also cause hematoma due to the cause of the kidneys (increased concentration of nitrogen waste in the blood). Janumet XR should be stopped immediately if such events occur.

Surgery

Stop using Janumet XR temporarily when performing any surgery (except for small procedures, not accompanied by restrictions on water and food collection) and only re -use when the patient can eat, drink through the mouth and the kidney function normally evaluate.

Drinking alcohol

Alcohol has been known to increase the impact of metformin on lactate metabolism. Therefore, patients should not drink much alcohol in a short (acute) or prolonged (chronic) while using Janumet XR.

Liver function

Due to the common liver function is often associated with some cases of lactic acidosis, it is often avoided to use Janumet XR in patients with clinical evidence or testing for liver disease.

Vitamin B12 concentration

Metformin can reduce vitamin B12 levels below normal but no clinical manifestations. The reduction of vitamin B12 may be due to obstructing the absorption of B12 from the intrinsic factor complex - B12, but it is rare with anemia and fast recovery when stopping metformin or vitamin B12 supplements. Hematology parameters should be assessed every year in patients using Janumet XR and checking and managing unclear abnormal changes. Those who absorb or absorb not enough vitamin B12 or calcium are likely to have vitamin B12 levels below normal. In these patients, vitamin B12 serum levels can be measured every 2-3 years.

Change the clinical condition of the patient who has well controlled Type 2 diabetes previously

If patients with type 2 diabetes are previously well -controlled with Janumet XR, there are abnormal test results or clinical pathology (especially unclear and difficult to determine), should be evaluated immediately to find evidence of ceton acidosis or lactic acidosis. The assessment of electrolytes and ceton forms in serum, blood glucose and if indicated, blood pH, lactate, pyruvate and metformin levels in the blood. Janumet XR must be stopped immediately and started using other appropriate treatments if the acidosis occurs due to one of these two forms of acidosis.

Unbelievable blood glucose

When the patient is stabilizing with a certain diabetes treatment regimen, stresses such as fever, trauma, infection or surgery may occur temporarily. At such times, it may be necessary to stop using Janumet XR and temporarily use insulin. Janumet XR can be reused after this exacerbation.

Use in children

Not yet established the safety and effectiveness of Janumet XR in children under 18 years of age.

Used in the elderly

Janumet XR: Because sitagliptin and metformin are eliminated mainly through the kidneys and kidney functions often decrease in age, careful use of Janumet XR when age is higher. Should be cautious when choosing the dose and should be based on careful and regular monitoring.

Sitagliptin phosphate: In clinical studies, the safety and effectiveness of sitagliptin in the elderly (> 65 years) similar to patients

metformin hydrochloride: There is no difference in response to the treatment between elderly patients and younger patients. Metformin is eliminated mainly in the kidneys and because of the risk of serious adverse reactions to the drug occurs higher in patients with renal impairment, so only Metformin is used in patients with normal kidney function.

The ability to drive and operate machinery

has not conducted studies on the impact of Janumet XR on the ability to drive and operate machinery or people working on high and other cases. However, it is thought that Janumet XR does not affect the ability to drive and operate machinery or people working on high and other cases.

Pregnancy

There are no good studies and good control in pregnant women using Janumet XR or with each ingredient of the drug, so it is not known the safety of the drug in pregnant women. Like other medications for hyperglycemia, it is not recommended to use Janumet XR during pregnancy.

The period of breastfeeding

is still unknown whether the sitagliptin has excreted in human milk or not. Therefore, Janumet XR should not be used for breastfeeding women.

Drug interaction

sitagliptin and metformin

Use a multi -dosage of sitagliptin (50 mg x 2 times/day) and Metformin (1000 mg x 2 times/day) does not change the pharmacokinetic significance of sitagliptin or metformin in patients with diabetes type 2.

sitagliptin phosphate

Sitagliptin does not have clinical significance on the pharmacokinetics of the following drugs: metformin, Rosiglitazone, Glyburide, Simvastatin, Warfarin and Oral Ballets. Sitagliptin does not inhibit iszymes CYP is CYP3A4, 2C8 or 2C9. Based on in vitro data, it is thought that sitagliptin does not inhibit CYP2D6, 1A2, 2C19 or 2B6 or causing CYP3A4 induction.

Commonly used drugs in patients with type 2 diabetes do not cause clinical significance on the Sitagliptin pharmacokinetic including blood cholesterol (statin, fibrate, ezetimibe), platelag antacids (clopidogrel), hypertension drugs (enzyme inhibitors, Angiotensin receptor blockers, Calcium receptors, calcium receptors hydrochlorothiazide), nonsteroidal analgesics and anti -inflammatory anti -inflammatory (Naproxen, Diclofenac, Celecoxib), Treatment of depression (Bupropion, Fluoxetine, Sertraline), antihistamine (Cetirizine), Proton pump inhibitors (Omeprazole, Lansoprazole), and other drugs for oxygen treatment (Sildenafil).

The area under the curve and the average of the peak concentration of digoxin increases slightly when used with sitagliptin. This level of increase is not considered clinical significance. Should monitor patients using digoxin appropriately.

metformin hydrochloride

glyburide

Use a single metformin combination of glyburide does not cause any pharmacokinetics or pharmacokinetical changes of Metformin. Glyburide's AUC and CMAX decreases, but the variation is great. Because the nature of the dosage is used for the day (single dose) of this study and the glyburide level in the blood is not correlated with the pharmacological effects, the clinical significance of this interaction is uncertain.

Furosemide

The pharmacokinetic parameters of both drugs are affected when shared. Furosemide increases plasma, CMAX and AUC metformin levels without significantly changing metformin clearance in the kidneys. When used with Metformin, CMAX, AUC and Furosemide's disposal time, they all decreased, but not significantly changing the Furosemide clearance coefficient in the kidney. There is no information on interaction between Metformin and Furosemide when shared.

nifedipine

Taking drugs with Nifedipine has increased the cmax of Metformin in plasma and AUC, while increasing the amount of waste drugs in urine. Tmax and the semi -discharged time are not affected. Nifedipine increases metformin absorption. Metformin has a significant effect on Nifedipine.

Medications reduce Metformin clearance

Simultaneous use of drugs that obstructs the common transportation system in the renal tubules involved in the renal metformin elimination (for example, organic cation Cation - 2 (Organic Cationic Transporter - 2 [OCT2])/Mate inhibitors (Multidrug and Toxin Extrusion [Mate] Inhitals such as Ranolazine, Vandetanib, DolutGravir, and DoluteG Cimetidine) may increase body contact with Metformin and may increase the risk of lactic acidosis.

Other drugs

There are drugs that tend to cause hyperglycemia and may cause loss of blood sugar control, including Thiazide group and other diuretics, corticosteroids, phenothiazine, thyroid hormones, estrogen, birth control pills, phenytoin, nicotine acids, sympathetic adhesive drugs, inhibitors of calcium channel and ISONIAZID. When taking these drugs with Janumet XR, the patient must be closely monitored to maintain appropriate blood sugar control.

pharmacokinetics of Metformin and Propranolol, Metformin and Ibuprofen are not affected when shared in drug interactive studies with the unique dosage mode in healthy volunteers.

Metformin is not significantly connected to plasma proteins, and therefore is not able to interact with high -binding drugs such as Salicylate, Sulfonamide, Chloramphenicol and Probenecid, when compared to sulfonylurea drugs that are strongly connected to serum blood proteins.