Komboglyze XR 5mg/500mg Astrazeneca tablets support blood sugar control (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Metformin, saxagliptin
Ingredient
| Composition information | Content |
| Metformin | 500mg |
| Saxagliptin | 5mg |
Uses
indications
Komboglyze XR is indicated in the following cases:
Komboglyze XR combines two anti -hypertension drugs with additional mechanisms to improve blood sugar control in patients with diabetes tube 2: Saxagliptin - A dipeptidyl -peptidase inhibitor 4 (DPP4) and metformin hydrochloride - a biguanide.
saxagliptin
The concentration of invoretin hormones such as GLP-1 (Glucagon-Like Peptide-1) and GIP (Glucose-Dependent insulinotropic polypeptide) increases due to the release of these hormones from the small intestine into the bloody intestinal response to meals, causing insulin release from Beta cells of the pancreatic gland depending on the glucose level. At the same time, GLP-1 also reduces the amount of glucagon secreted from the alpha cell of the pancreas, reducing the synthesis of glucose in the liver. These hormones will be inactivated by the DPP4 enzyme (dipeptidyl peptidase-4) within a few minutes.
In patients with type 2 diabetes, the GLP-1 concentration decreases but the response of insulin with the GLP-1 has not changed. Saxagliptin is a DPP4 competitive inhibitor that reduces the inactivity of hormone incoretin. In patients with type 2 diabetes, using saxagliptin will inhibit the enzyme activity DPP-4 for 24 hours. After using oral glucose or after meals, the inhibition of DPP-4 will increase 2-3 times the concentration of GLP-1 and GIP activity in the blood, reduce glucagon levels and increase the release of insulin from beta cells of the pancreatic gland depending on the glucose level. Increasing insulin levels and reducing glucagon concentrations are associated with reducing glucose concentrations at hunger and reducing glucose after taking glucose or after meals.
metformin hydrochloride
Metformin improves glucose tolerance in patients with type 2 diabetes, lowering basic blood glucose and after eating. Metformin reduces the synthesis of glucose in the liver, reduces the absorption of glucose in the intestine and improves insulin sensitivity through increased absorption and use of peripheral glucose.
Unlike sulfonylurea, metformin does not cause hypoglycemia in patients with type 2 diabetes or healthy subjects, except for abnormal cases and does not cause increased blood insulin. When treated with metformin, the insulin secretion is constant even though the concentration of insulin is hungry and the plasma insulin response level can really decrease.
Dynamic pharmacology
metformin hydrochloride
After the dose repeats the prolonged release metformin, the metformin does not accumulate in the blood. Metformin is excreted in the form of unchanged urine and is not metabolized through the liver.
absorption
saxagliptin
Average time to achieve maximum plasma concentrations (TMAX) after using the dose at 5 mg/1 time/day is 2 hours for saxagliptin and 4 hours for active metabolites. Use at the same time with high -fat foods that increase TMAX Saxagliptin about 20 minutes compared to hunger. Saxagliptin's AUC increased by about 27% when used at the same time with food compared to hunger. Saxagliptin can be used during or outside meals. Food does not affect the pharmacokinetics of saxagliptin when used in the form of combined tablets.
metformin hydrochloride
After taking the single -metformin single -dose, CMAX reaches the median value after 7 hours and ranges from 4 to 8 hours. Although Metformin's absorption level in the form of tablets on the release extends to about 50% when used with food, food does not affect Metformin's CMAX and TMAX.
distribution
saxagliptin
In vitro research shows the cohesion of saxagliptin and its active metabolites with negligible human serum protein.
metformin hydrochloride
Studies on the distribution of prolonged release have not been conducted. However, the apparent integral (V/F) of Metformin after taking the single dose of Metformin instantaneous release 850 mg average is 654 ± 358 L. Metformin is negligible with plasma protein.
transformation
saxagliptin
Metabolism of saxagliptin mainly occurs through the cytochrome P450 3A4/5 (CYP3A4/5). The activity of Saxagliptin also has the effect of inhibiting DPP-4 and has an active half of the saxagliptin. Therefore, strong inhibitors and touches CYP3A4/5 will change the kinetics of saxagliptin and its active metabolites.
metformin hydrochloride
metformin is excreted unchanged through urine and not metabolized through the liver or excreted through bile. Studies on metabolism of long -lasting release tablets have not been conducted.
Elimination
saxagliptin
Saxagliptin is eliminated through both kidney and liver. After taking a single dose of Saxagliptin 50 mg, the intact saxagliptin, the active metabolic form and increased the radioactive compounds excreted through the urine with a rate of 24%, 36% and 75% of the dose used. The average retention of the kidneys of saxagliptin (~ 230 ml/min) is higher than the average estimated glomerular filtration (EGFR) (~ 120 ml/min), showing active excretory mechanisms in the kidneys.
About 22% of the radioactive substance is present in the feces, proving that there is a part of Saxagliptin excreted through one and/or a part that is not absorbed through the gastrointestinal tract. After taking a single dose of Saxagliptin 5 mg on healthy objects, the average selling time of saxagliptin and metabolites is active in plasma, respectively 2.5 hours and 3.1 hours respectively.
metformin hydrochloride
The renal clearance is about 3.5 times higher than the creatinine clearance, which shows the excretion in the renal tubules is the main metformin elimination. After drinking, about 90% of the absorption drug is excreted through the kidneys within the first 24 hours, with the time of discharging in plasma about 6.2 hours. In the blood, the sale time is about 17.6 hours, showing that red blood cells can be a preventive medicine.
Before taking Komboglyze XR 5mg/500mg Astrazeneca tablets support blood sugar control (4 blisters x 7 tablets)
How to use
Komboglyze XR tablets are often used once a day at dinner, drinking whole tablets without chewing, no break, no crushing.
Dosage
Dosage of Komboglyze XR should be concretized on each patient based on current condition, efficiency and tolerance. Adjust the dose gradually to reduce side effects on the digestive tract due to metformin.
The recommended starting dose of Komboglyze XR in patients who need 5 mg of saxagliptin and currently has not been treated with Metformin: 1 tablet with 5 mg of saxagliptin/500 mg of prolonged release, taken 1 time daily with increased adjustment dose to reduce side effects on the stomach - intestines caused by metformin.
Maximum daily dose is 5 mg of saxagliptin and 2000 mg of prolonged release.
Patients need 2.5 mg Saxagliptin in combination with prolonged release metformin that can be treated with Komboglyze XR 2.5 mg/ 1000 mg. Patients who need a dose of 2.5 mg of saxagliptin but do not need Metformin or need to use metformin doses higher than 1000 mg, they should use drugs containing separate active ingredients.
In patients being treated with Metformin: Komboglyze XR should be selected can provide metformin equivalent to the metformin dose under treatment or with the most appropriate dose.
For patients who move from a combination form of a saxagliptin and a separate Metformin tablet: should choose the same dose as the saxagliptin and metformin dose of treatment.
For patients who have not controlled adequate blood sugar when coordinating insulin and metformin, or for patients who have stabilized control with combination therapy of 3 drugs insulin, metformin and saxagliptin in the form of drugs containing individual active ingredients: Choose Komboglyze XR dose can provide Saxagliptin 5 MG and Metformin dose equivalent to the modified dose. When using Komboglyze XR in combination with insulin, low doses should be used with insulin to limit the risk of hypoglycemia.
For patients who have not controlled adequate blood sugar with combination combination therapy Sulfonylurea and Metformin, or for patients transferring from combination therapy 3 Saxagliptin, Metformin and Sulfonylurea drugs in the form of drugs containing individual active ingredients: Choose Komboglyze XR do the Saxagliptin 5 MG and Metformin dose equivalent to the dose of treatment. When using Komboglyze XR combination with 1 sulfonylurea drug, low doses of low doses should be used to limit the risk of hypoglycemia.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?
saxagliptin
In case of overdose, appropriate supportive treatments are required based on the patient's clinical condition, saxagliptin and its active metabolites can be excluded through dialysis (23% dose in 4 hours).
metformin hydrochloride
Overdose of metformin hydrochloride, including a dose of over 50 grams. About 10% of hypoglycemia is reported, but it has not yet been determined whether it is related to the use of metformin hydrochloride. About 32% of shifts overdose metformin infected with lactic acidic acidosis. The clearance of Metformin is up to 170 ml/minute in good hemodynamics. Therefore, dialysis can help eliminate the drug accumulated from the body in patients suspected of using metformin overdose.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using komboglyze XR , you may experience unwanted effects (ADR):
saxagliptin
Common, ADR> 1/100
Common, ADR> 1/100
The number of patients (5%)
saxagliptin 5mg + metformin
n = 320
Placebo + Metformin
n = 328
headache
24 (7.5)
17 (5,2)
22 (6,9)
13 (4.0)
When experiencing the side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Komboglyze XR contraindicated in the following cases:
Be cautious when using
komboglyze XR has not been studied in patients with a history of pancreatitis. It is unclear whether the patient has a history of pancreatitis when using Komboglyze XR, which increases the risk of pancreatitis.
Do not use Komboglyze XR for patients with type 1 diabetes or ceto-acid infection due to diabetes.
After -sales surveillance process has recorded lactic acidosis related to metformin, including death, heat reduction, hypotension, prolonged slow arrhythmia, onset of lactic acidic acidosis related to metformin is often not easy to detect, accompanied by typical symptoms such as discomfort, muscle pain, respiratory insufficiency, and abdominal pain. Lactic acidic acidosis associated with metformin is symbolized by increased lactate levels in the blood (> 5 mmol/l), anion space (there is no evidence of keto urine or koto blood), increasing the ratio of laclat/pyruvate and plasma metformin levels in general increases> 5 mcg/ml.
Risk factors of lactic acidic acidosis related to Metformin include renal failure, simultaneous use with certain drugs (for example, carbonic inhibitors such as Topiramat), from 65 years of age and older, performing screens using contrast drugs, surgery and performing other tricks, reducing inhaled oxygen (eg acute congestion), drinking a lot of alcohol and liver failure.
kidney failure
Lactic acidosis related to Metformin during after -sales drug monitoring occurs mainly in patients with severe renal failure. The risk of metformin accumulation and lactic thermal heat is related to metformin increases with the severity of renal failure because metformin is excreted mainly through the kidneys. Clinical recommendations based on patient kidney function include:
Hepatic failure
Patients with hepatic impairment can progress to all lactic associated with metformin due to lactate elimination decrease, leading to increased lactate levels in the blood. Therefore, avoid using Komboglyze XR in patients who have been diagnosed with liver disease through testing or clinical evidence.
Inhalation oxygen reduction
The after -sales monitoring process has recorded a number of lactic acidosis associated with metformin occurring in acute congestive heart failure (especially when accompanied by reduced perfusion and hypoxemia). Cardiovascular (shock), acute myocardial infarction, lots of blood bacteria and other diseases related to hypoxemia are associated with lactic acidosis and can also cause nitrogen nitrogen before the kidneys. When these events occur, stop Komboglyze XR.
Pancreatitis
Acute pancreatitis in patients using saxagliptin has been recorded after the drug circulates on the market. After suffering, starting to use Komboglyze XR, patients should be monitored with kidney base signs and symptoms of pancreatitis. If there is a suspected pancreatitis, Komboglyze XR should be suspected and properly treated. It is unclear whether the patient has a history of pancreatitis when using Komboglyze XR, which increases the risk of pancreatitis.
surgery or other surgery
Food and fluid storage during surgery or performing other procedures may increase the risk of decreased volume, hypotension and kidney failure. Komboglyze XR should be stopped temporarily when the patient has a limited amount of food and deposits.
Elderly
Elderly patients are most likely to be impaired renal function. Due to the contraindication to Metformin in patients with renal impairment, the renal function should be monitored in the elderly and cautiously using Komboglyze XR as the age gradually increases.
If there is suspicion of lactic -related to metformin, it is advisable to stop using Komboglyze XR, quickly take patients to the hospital and take treatment measures. In patients who have been treated with Komboglyze XR, have been diagnosed with lactic acidosis or suspicion of high likelihood of lactic acidosis, quickly recommend filtering to regulate acidosis and remove the accumulated Metformin part (metformin hydrochloride can be separated with 170 mL/minute in good hemorrhage conditions). Dialysis may reverse symptoms and recover.
Vitamin B12 concentration
has recorded a decrease below the normal level of vitamin B in patients using Metformin. This reduction may be due to the intervention to the ability to absorb B vitamins, from the internal factor complex of Vitamin B ... Patients who use Komboglyze XR are recommended to check the annual hematological parameters, and if any abnormalities manifest should be surveyed and properly treated.
Oxygen deficiency
Cardiovascular (shock), acute congestion heart failure, acute myocardial infarction and other diseases characterized by hypoxia, lactic acid infection and can cause blood urea before the kidneys. When these events appear in patients being treated with Komboglyze XR, the drug should be stopped immediately.
Hypersensitivity reaction
There have been reports that record serious hypersensitivity reactions in patients using saxagliptin after the drug circulates on the market. These reactions include anaphylactic reaction, angioed, and flaky skin condition. These reactions occur within the first 3 months of treatment with saxagliptin, some cases occurred after the first dose. If the hypersensitivity reaction is suspected, the Komboglyze XR is suspected, assessing the hidden causes of the event, and looking for an alternative treatment for diabetes.
Use cautiously for patients with a history of angioedema with other dipeptidyl peptidase-4 (DPP4) inhibitors because they still know if these patients may have angioed with Komboglyze XR or not.
Be cautious when using Komboglyze XR for patients with risk factors for hospitalization due to heart failure such as a history of heart failure or medium to severe kidney failure.
joint pain, there may be severe cases, which have been recorded in the DPP4 inhibitors after the drug circulated on the market.
The ability to drive and operate machinery
No research on the impact of Komboglyze XR or Saxagliptin on the ability to drive and operate machinery.
Saxagliptin or Metformin may not be significantly affected by driving and operating machinery. It should be noted that dizziness has been recorded in studies with saxagliptin.
Pregnant women
have not had enough studies with them about the use of Komboglyze XR or the individual ingredients of the drug in pregnant women. Because animal reproductive studies cannot always be used to predict the response occurs in humans, Komboglyze XR should not be used as well as other diabetes medications while pregnant from the truly needed.
The period of breastfeeding
There has been no research on nursing animals using the combined form of Komboglyze XR. In studies performed on each drug ingredient, both saxagliptin and metformin are excreted in milk in breastfeeding mice. No saxagliptin or metformin has not been determined whether or not to excrete in breast milk or not. Due to a lot of excreted drugs in breast milk, caution should be used when using Komboglyze XR in breastfeeding women.
Drug interaction
Strong enzyme inhibitors CYP3A4/5
saxagliptin: Ketoconazole significantly increases the level of saxagliptin in the body. Similarly, the increase in the concentration of saxagliptin in plasma also occurs when used simultaneously strong inhibitors CYP3A4/5 (such as Atazanavir, Clan, ... Indinavir, Itraconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir and Telithromycin).
Cationic ionic (Cationic)
metformin hydrochloride
Theoretically, positive ionized ions (such as amiloride, digoxin, morphine, processaamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, ... or vancomycin) are excreted through the excretion of the renal tubules, which are capable of interacting with metformin by competing on the normal kidney system.
The interaction between Metformin and Cimetidine oral cimetidine in this form has been recorded on healthy volunteers. Although this type of interaction exists only theoretically (except for Cimetidine), it is recommended to be careful to monitor patients closely and adjust the dose of komboglyze XR and/or use more interventions in patients who are taking cationic drugs excreted through near renal system.
alcohol (alcohol)
Increased risk of lactic acid infection when acute alcohol poisoning (especially in the case of hunger, malnutrition or failure) due to the active ingredient Metformin in KomBoglyze XR.
contrast substance contains iodine
Reflective substances containing iodine are added to the blood vessels in X-rays can lead to renal failure, causing metformin accumulation and the risk of lactic acid infection. Therefore, the patient must stop Komboglyze XR first, or at the time of shooting and not taking the drug within 48 hours later. Only continue to take the drug after the kidney function is re -evaluated and confirmed as normal.
Hypoglycemia when used simultaneously with sulfonylurea or insulin
saxagliptin
When using saxagliptin in combination with sulfonylurea or with insulin, are drugs that cause hypoglycemia, frequency of hypoglycemia that is diagnosed higher when using placebo in combination with sulfonylurea or with insulin. Therefore, low dose of insulin or insulin stimulants should be used to minimize the risk of lowering glucose in the blood when used in combination with Komboglyze XR.
metformin hydrochloride
Hypoglycemia does not occur in patients using single metformin under normal conditions. However, it can occur when the amount of calories inserted into the body is deficient or when exercising is severe but not compensated by adding the corresponding calorie amount. Or when used simultaneously with drugs that reduce blood glucose (such as sulfonylurea and insulin), or alcohol.
Older patients with depression or malnutrition and patients with adrenal insufficiency or pituitary insertion or alcohol poisoning are especially sensitive to hypoglycemia. Hypoglycemia may be difficult to identify in older patients and patients who are taking beta sympathetic inhibitors.
Some drugs can cause hyperglycemia and lead to loss of blood sugar control
These drugs include Thiazide and other diuretics, corticosteroids, phenothiazine, .. thyroid preparations, female sex hormones, oral contraceptives, nicotinic acid phenytoin, sympathetic nerve stimulants, calcium inhibitors and isoniazid.
When taking the above drugs in patients who are undergoing Komboglyze XR, patients should be closely monitored by blood sugar. When stopping taking this drug in patients who are taking Komboglyze XR should closely monitor patients to avoid blood sugar drops.
Storage
Store at temperatures below 30 ° C, avoid light and avoid moisture.
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