Xigduo XR 10mg/500mg Astrazeneca improves blood sugar control (4 blisters x 7 tablets)
Dosage form Box of 4 blisters x 7 tablets
Specifications Metformin, dapagliflozin
Ingredient
| Composition information | Content |
| Metformin | 500mg |
| Dapagliflozin | 10mg |
Uses
indications
Xigduo® XR 10 mg/500 mg is indicated in the following cases:
To be indicated as an additional therapy to the diet and exercise to improve blood sugar control in adults with type 2 diabetes when suitable for treatment with dapagliflozin and metformin:
Shelf life limit
It is not recommended to use Xigduo XR in patients with type 1 diabetes or cetonic acidosis on diabetes.
Pharmacokinus
Group of therapeutic effects: Drugs to treat diabetes, drugs in combination with oral blood glucose medications.
Mechanism of impact
Xigduo XR combines 2 anti -hypertension drugs with an additional mechanism of impact that improves blood sugar control in patients with diabetes Type 2: Dapagliflozin, an inhibitor of copper of Sodium - Glucose 2 (SGLT2), and Metformin hydrochloride, a drug belonging to BiguanID group.
dapagliflozin
Sodium - glucose 2 transport channel (SGLT2) is present in close renal tubules, responsible for most of the reabsorption of glucose filtered from the renal tubules. Dapagliflozin is SGLT2 inhibitor. By inhibiting SGLT2, dapagliflozin reduces the reabsorption of filtered glucose and reduces the glucose threshold in the kidneys and thus increases the secretion of glucose through the urine.
metformin hydrochloride
Metformin improves glucose tolerance in type 2 diabetes patients, reducing plasma glucose when hungry and after meals. Metformin reduces the production of glucose in the liver, reduces the absorption of glucose in the intestine and improves insulin sensitivity by increasing the absorption and use of peripheral glucose. Metformin does not cause hypoglycemia in patients with type 2 diabetes or in healthy people, except for abnormal cases and does not cause increased blood insulin. With metformin therapy, insulin secretion remains unchanged while insulin levels when hungry and plasma insulin meets a day that can actually decrease.
dapagliflozin
Increase the amount of glucose excretion in urine in healthy people and in patients with type 2 diabetes after using dapagliflozin.
dapagliflozin dose of 5 or 10 mg daily in patients with type 2 diabetes for 12 weeks has led to the excretion of about 70 g glucose in urine every day. The maximum maximum glucose secretion is observed at the dose of 20 mg dapagliflozin daily.
Increased glucose secretion in urine due to dapagliflozin also increases the volume of urine.
Heart physiological
dapagliflozin is not related to the extension of the clinical QTC interval with a daily dose of up to 150 mg (15 times the recommended dose) in a study on a healthy object. In addition, there has been no clinical impact on QTC after a single dose of up to 500 mg of dapagliflozin (50 times compared to the recommended dose) in healthy objects.
Dynamic pharmacokinetics
Xigduo XR is considered biological equivalent to the drinking simultaneously dapagliflozin and long -lasting release Metformin hydrochloride in the form of separate tablets.
The use of Xigduo XR in healthy subjects after a standard meal compared to fasting the result is the same level of contact with both dapagliflozin and long -lasting Metformin.
Compared to fasting, the standard meal has decreased by 35% and delayed 1-2 hours at the top concentration of dapagliflozin in plasma. The impact of this food is considered not clinically significant. Food does not have the effect of pharmacokinetics of Metformin when using a combination of Xigduo XR.
absorption
dapagliflozin
After taking dapagliflozin, the maximum plasma concentration (CMAX) is usually achieved within 2 hours in fasting. The value and AUC increases in proportion to the increase in dapagliflozin dose within the treatment dose range. The absolute bioavailability of dapagliflozin after taking 10 mg dose is 78%. The use of dapagliflozin with a fat -rich meal that reduces CMAX up to 50% and extends TMAX by about 1 hour, but does not change AUC compared to fasting. These changes are considered not clinical significance and dapagliflozin can be taken with or not with food.
metformin hydrochloride
After taking a single dose of long -lasting Metformin tablets, CMAX achieved an average value at 7 hours and the amplitude lasted from 4 to 8 hours. The level of metformin absorption (measured in AUC) from the meture -prolonged release increased by about 50% when serving the same meal. There is no influence of food on cmax and tmax of Metformin.
distribution
dapagliflozin
About 91 % dapagliflozin is attached to plasma proteins. The binding to protein does not change in patients with renal impairment or liver failure.
metformin hydrochloride
Prolonged distribution studies have not been conducted; However, the distribution volume (V/F) of Metformin after taking the only dose of Metformin release quickly 850 mg is approximately 654 ± 358 L. Metformin does not cohesive plasma proteins, whereas compared to sulfonylurea is a drug binding more than 90% plasma protein. Metformin attaches to red blood cells.
transformation
dapagliflozin
The metabolism of dapagliflozin is mainly via UGT1A9; The metabolism through CYP intermediaries is a small path to eliminate in humans. Dapagliflozin is widely metabolized, mainly into dapagliflozin 3 - O - Glucuronid, which is an inactive transformation. Dapagliflozin 3 - O - Glucuronid accounts for 61 % of the dose of 50 mg [14C] - dapagliflozin and is an outstanding ingredient related to drugs in human plasma.
metformin hydrochloride
The only dose intravenous studies in healthy objects show that metformin excreted in the form of constant urine and not metabolized through the liver (no metabolites are determined in humans) or excreted through bile.
Studies on drug metabolism of Metformin tablets have not been conducted.
Elimination
dapagliflozin
dapagliflozin and related metabolites are excreted mainly through the kidneys. After using a single dose of 50 mg [14C] dapagliflozin, and 75% of the total amount of radiation will be excreted in the urine and 21% of the total amount of radiation is excreted in the feces. In the urine, less than 2% of the dose is excreted in a constant form. In feces, about 15% of the dose is excreted in a constant form. The average half -life of plasma (T1/2) of dapagliflozin is about 12.9 hours after the single dose of 10 mg dapagliflozin.
metformin hydrochloride
The renal clearance is about 3.5 times the creatinine clearance, which shows that the excretion through the renal tubules is the main path of metformin elimination. After drinking, about 90% of the absorbing drugs are excreted by the urinary tract within the first 24 hours, with a half -life of plasma waste about 6.2 hours. In the blood, the sale time is about 17.6 hours, which shows that red blood cells can be a drug allocation channel.
Special population groups
Patients with renal failure
dapagliflozin:
dapagliflozin:
Elderly people
dapagliflozin:
Children
Gender
dapagliflozin:
metformin hydrochloride:
Race
dapagliflozin:
metformin hydrochloride:
dapagliflozin:
Before taking Xigduo XR 10mg/500mg Astrazeneca improves blood sugar control (4 blisters x 7 tablets)
How to use
Take oral use.
Swallow Xigduo® XR pills and do not be broken, cut or chewed. Typically, the excipients of Xigduo® XR will be eliminated in the form of a soft, wet block that can look almost like the original pill.
Dosage
Dosage recommended
The doctor should personalize the starting dose of Xigduo® XR based on the patient's current treatment.
Should drink xigduo® XR once a day in the morning, along with meals, adjust the dose increasing slowly to minimize Metformin's adverse effects on the stomach - intestines.
Can adjust the dose based on efficiency and tolerance but not daily overdose of 10 mg dapagliflozin and 2000 mg of metformin HCI.
Patients who are taking the evening dose of the Metformin XR extension should skip the last dose before starting to use Xigduo® XR.
In patients who are being reduced in the body's volume, should be treated to improve this condition before starting to use Xigduo® XR.
Patients with renal failure
Review kidney function before starting treatment with Xigduo® XR and periodic tests later.
Contraindicated use of Xigduo® XR in patients whose glomerular filtration is estimated at less than 60 ml/min/1.73m2. No need to adjust the dose of Xigduo® XR in patients with mild kidney failure (EGFR ≥ 60 ml/min/1.73m2).
Discontinue medication for diagnostic imaging with iodine contrast.
Stop Xigduo® XR at the time of contrast or before contrast photography in patients with a history of liver disease, alcoholism or heart failure; Or in patients will be injected with IDOD contrast drugs into the artery. Re -evaluating EGFR after 48 hours after contrasting; reuse Xigduo XR if the kidney function is stable.
Patients with liver failure
Use metformin in patients with liver failure related to some cases of lactic acid infection. It is not recommended to use Xigduo XR in patients with liver failure.
Children
Safety and effectiveness of Xigduo® XR drug in children under 18 years of age has not been established.
Elderly
No need to adjust the dose by age. Should regularly evaluate kidney function in elderly patients.
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?
dapagliflozin
There is no overdose report during the clinical development of dapagliflozin. In case of overdose, please contact the Hospital's Poisoning Unit. The use of supportive measures according to the patient's clinical condition is also appropriate. The removal of dapagliflozin with dialysis has not been studied.
metformin hydrochloride
There has been an overdose of metformin hydrochloride, including digestive dosage> 50 g. Hypoglycemia is reported in about 10% of cases, but there is no cause of causal association with metformin hydrochloride. Lactic acidosis has been reported in about 32% of Metformin overdose. Metformin can be separated with clearance of up to 170 ml/minute under good hemodynamic conditions. Therefore, dialysis can be helpful to eliminate the accumulated drugs from patients who suspect 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 Xigduo® XR 10 mg/500 mg, you may experience unwanted effects (ADR).
Very common, ADR> 1/10
Gastrointestinal disorders: Symptoms of digestive tract.
Common, 1/100 Uncommon, 1/1000 Disorders of metabolism and nutrition: Reduce the volume of circulation, thirst. Digestive disorders: constipation, dry mouth. Rare, 1/10000 ≤ ADR Very rare, ADR Liver disorders: liver dysfunction, hepatitis. Skin and subcutaneous tissue disorders: urticaria, pink, itching. Describe selective adultery reactions Hypoglycemia In the studies of dapagliflozin, complementary coordination therapy with metformin, the frequency of mild hypoglycemia is similar between treatment groups with dapagliflozin 10 mg in combination with Metformin (6.9%) and (5.5%) in the placebo group. No severe hypoglycemia occurs. Similar observation occurred in patients who had not been treated with dapagliflozin and metformin. In an additional coordinated study with metformin and 1 sulfonylurea, up to 24 weeks, no severe hypoglycemic attacks. Mild hypoglycemia is recorded in 12.8 % of patients in the treatment group with dapagliflozin 10 mg in combination with Metformin and 1 sulfonylura drug and at 3.7 % of patients in the placebo group in combination with Metformin and 1 sulfonylurea. dapagliflozin Frequency of hypoglycemia depends on the foundation therapy used in each study. In dapagliflozin studies, additional coordination with metformin or additional coordination with sitagliptin (same or not with metformin) up to 102 weeks of treatment, the frequency of mild hypoglycemia ( In an additional coordinated study with insulin, at 24 and 104 weeks of severe hypoglycemia in the treatment group with dapagliflozin 10 mg in combination with insulin is 0.5% and 1.0% and in the placebo group combined with insulin is 0.5%. At week 24 and week 104, mild hypoglycemia in the treatment group with dapagliflozin 10 mg in combination with insulin respectively is 40.3% and 53.1% and in the placebo group in combination with insulin, respectively 34.0% and 41.6%. Reduce the volume of circulation Reactions related to volume reduction (including cooling, reducing blood volume or hypotension) were recorded in the group using dapagliflozin 10 mg and in the placebo group, respectively 1.1% and 0.7%; The serious reactions occur in Vaginitis - vulva, foreskin and genital tract infections Vaginitis - vulva, foreskin and genital tract infections are recorded in the group using dapagliflozin 10 mg and in the placebo group is 5.5% and 0.6% respectively. Most mild to medium infections and patients respond to the first round of standard treatment and rarely have to stop treating dapagliflozin. These infections are more common in women (equivalent to 8.4% and 1.2% for dapagliflozin and placebo) and patients with a history of often more often re -infected. Urinary tract infections The urinary tract infection is more often recorded for patients using 10 mg dapagliflozin compared to placebo (corresponding to 4.7% and 3.5%). Most mild to medium infections and patients respond to the first treatment with standard treatment regimen and rarely stop treatment with dapagliflozin. These infections often occur more often in women and patients with a history of disease often re -infected. Increase creatinine The adultery reactions of the drug are related to the increased creatinin (for example, reducing the evaporation of the kidneys in the kidneys, kidney failure, increased blood creatinine and reduced glomerular filtration). These groups of adultery reactions have been recorded in patients using dapagliflozin 10 mg and in patients with placebo, respectively 3.2% and 1.8%. In patients with normal kidney function or mild kidney failure (initial EGFR> 60 ml/min/1.73m2) The group of these adultery reactions has been recorded in patients using dapagliflozin 10 mg and patients with placebo are 1.3% and 0.8%. These reactions usually occur in patients with initial EGFR> 30 and Evaluation more in patients with adultery events related to the kidneys shows that most of the serum creatinine changes Hormonal hormone (PTH) Surprisely increased serum PTH concentration with a higher increase in patients with higher initial PTH concentrations. Bone density indicators in patients with normal kidney function or mild renal failure do not show bone loss during 2 years of treatment. Malignant tumor In clinical trials, the proportion of patients with malignant tumors or unknown tumors in the treatment group with dapagliflozin (1.50 %) is equivalent to the placebo group/comparative drug (1.50 %), and there is no sign of cancer or genetic mutations from animal data. When considering the cases of tumors appearing in different organs, the risk ratio is relatively for dapagliflozin greater than one of some types of tumors (bladder tumors, prostate tumors, breast tumors) and less than one of some other types of tumors (such as hematoma and lymphatic tumors, uterine tumors, urinary tract tumors), does not increase the overall risk of dipagloFlozin. No statistical significant differences in increased or decreasing risks in any organ system. Consider the lack of evidence of the appearance of tumors in preclinical trials as well as the short -term time from the use of the drug for the first time until the diagnosis of tumors, it is impossible to establish the causal relationship here. The significant difference in the number of tumors in the breast, bladder and prostate must be carefully considered and will be monitored in studies after circulation of the drug. For bladder cancer. Special subjects Elderly (≥ 65 years) In patients ≥ 65 years old, adultery reactions related to reduced kidney function or renal failure are recorded in the treatment group with dapagliflozin is 7.7% and in the placebo group is 3.8%. The most common adverse adverse reaction is serum increased. Most of the adverse reactions are transient and recovered. In patients ≥ 65 years old, adverse reactions reduce the volume of circulatory, most common are hypotension, recorded in the treatment group with dapagliflozin and the placebo groups are 1.7% and 0.8%. Report on suspicious adultery reactions Report suspected adultery reactions after pharmaceutical products are very important. This allows continuous monitoring of the balance between the benefits and the risk of pharmaceutical products. Medical experts are required to report any suspicious adverse reactions. Instructions on how to handle ADR When experiencing 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
Xigduo® XR 10 mg/500 mg contraindicated in the following cases:
Caution when using
Lactic acidosis
There are cases of lactic acidosis due to metformin recorded during the circulation of the drug, including deaths. These cases have a gentle onset and accompanied by nonspecific symptoms such as fatigue, muscle pain, abdominal pain, respiratory failure, or increased drowsiness; However, hypothermia, hypotension and slow heart rate occurred with severe acidic symptoms.
Metformin acidic acidosis is characterized by increased lactate levels in the blood (> 5 mmol/l), acidic infection with anion space (no evidence of ceturia or ceton blood) and increased lactate - pyruvat ratio; Normal plasma metformin levels> 5 mcg/ml. Metformin causes liver to slowly absorb lactate, increased lactate in the blood, thereby increasing the risk of lactic acidosis, especially in patients at high risk.
If lactic acidosis is suspected, it is necessary to immediately conduct common medical measures to support at the hospital, along with immediately stopping the Xigduo XR.
In patients with Xigduo XR treatment with diagnosis or certainly suspected lactic acidosis, should promptly dialysis to improve acidosis and remove cumulative metformin (metformin hydrochloride can be separated, with clearance of up to 170 ml/min in good dynamics). Hemorrhage often leads to the reversal of symptoms and recovery.
Instructions for patients and their families on signs of lactic acidosis and if these symptoms occur, it is required that the patient will stop the drug and report symptoms to the doctor.
For each risk factor known to occur lactic acidosis caused by metformin, it is recommended to reduce risk groups and control lactic acidosis due to metformin.
Patients with renal failure
Cases of lactic acidosis due to Metformin mainly occurs in patients with severe renal impairment. The risk of metformin accumulation and lactic acidosis due to increased metformin with renal failure because the metformin is excreted through the kidneys. Clinical recommendations based on the patient's kidney function include:
Contraindicated use of Xigduo XR in patients with EGFR
Drug interaction
Concomitance use of Xigduo XR with specific drugs may increase the risk of lactic acidosis due to metformin: These drugs reduce kidney function, leading to significant hemodynamic changes, interfere with acid -base balance or increase metformin accumulation (for example cation drugs). Therefore, it is advisable to consider monitoring patients more often.
Patients aged 65 and over
The risk of lactic acidosis is increased by Metformin with the age of patients because the elderly patients are more likely to have liver failure, kidney failure or heart failure than young patients. Should evaluate kidney function more often in elderly patients.
Diagnostic studies with contrast drugs
Iodine intravenous injection in patients being treated with metformin leads to acute renal failure and lactic acidosis occurs. Stop taking Xigduo XR at the time of iodine contrast or before taking iodine contrast in patients with a history of liver failure, alcoholism or heart failure; Or in patients will be injected with iodine contrast drugs into the artery. Re -evaluating EGFR about 48 hours after contrasting, and reusing Xigduo XR if the kidney function is stable.
Surgery and other processes
Fasting during surgery or other procedures may increase the risk of reducing the volume of body fluid, lowering blood pressure and kidney failure. Temporarily stop Xigduo XR while the patient is reducing the amount of food and liquid.
Oxygen shortage
Many reports during the circulation of drugs about lactic acidosis due to metformin occurs during acute congestive heart failure (especially when accompanied by reduced osical and hypoxemia). Stroke (shock), acute myocardial infarction, bacterial infections, and other conditions related to hypoxemia are associated with lactic acidosis and can also cause blood nitrogen hypercode syndrome before birth. Stop taking Xigduo XR when these events occur.
drink too much alcohol
The substance also increases the effects of metformin on lactate metabolism and this may increase the risk of lactic acidosis due to metformin. Warning the patient must not drink too much alcohol while taking Xigduo XR.
Hepatic failure
Patients with liver impairment progresses lactic acidosis due to metformin. This may be due to reduced lactate clearance leading to increased lactate concentration in the blood. Therefore, avoiding the use of Xigduo XR in patients with clinical or subclinical evidence with liver disease.
Hypotension
dapagliflozin causes a decrease in internal volume. Symptomic hypotension may occur after starting dapagliflozin, especially in patients with renal function impairment (EGFR Lactic acidosis
Reports of ketone acidosis, a serious life -threatening situation that requires emergency hospitalization, has been determined during monitoring after circulating drugs in patients with type 1 diabetes and type 2 using copper inhibitors of Sodium - Glucose 2 (SGLT2), including dapagliflozin.
Cases of kerosopen due to meton acidosis have been reported in patients using dapaghiflozin. Do not use Xigduo XR to treat type 1 diabetes patients. The patient treated with Xigduo XR shows signs and symptoms suitable for severe metabolic acidosis, so it is evaluated to be acidosis regardless of blood glucose level due to cetone acidosis of Xigduo XR can appear even when glucose levels in blood glucose under 250 mg /dl. If the metonic acidosis is suspected, Xigduo XR should be discontinued, patients need to be tested and treated promptly. Treatment of ketone acidosis may need insulin, transmission and carbohydrate replacement.
In many reports after the circulation of the drug, especially in patients with type 1 diabetes, presence of metonic acidosis is not recorded promptly and the treatment is delayed because the blood glucose level is lower than the normal level for diabetes acidosis due to diabetes (usually less than 250 mg/dl). Signs and symptoms suitable to dehydration and serious metabolic acidosis include nausea, vomiting, abdominal pain, shortness of breath and short breath.
In some cases but not all, factors that lead to metonic acidosis such as insulin dose, acute fever, calori tolerance due to disease or surgery, pancreatic disorders cause insulin deficiency (such as type 1 diabetes, history of pancreatitis or pancreatic surgery) and alcoholic has been identified.
Before starting the Xigduo XR, consider the patient history factors that may be expected to lead to keratical acidosis including pancreatic insul deficiency from any cause, calories and alcoholism.
In patients treated with Xigduo XR, consider monitoring of keton acidosis and suspending Xigduo XR in clinical situations known as expected ceton acidosis (for example, prolonged fasting due to acute or surgical diseases).
Acute kidney damage and renal function impairment
dapagliflozin causes a decrease in internal volume, and can cause kidney failure. There have been reports in the circulation of drugs on acute kidney damage, some cases need to be hospitalized and dialysis, in patients using dapagliflozin.
Before starting to use XIGDUO XR, consider factors that may cause patients with acute kidney damage including decreased volume, chronic kidney failure, congestive heart failure, and simultaneous medications (diuretics, angiotensin transferring enzymes, angiotensin receptor inhibitors, non -non -steroid anti -inflammatory drugs). Consider the suspension of Xigduo XR in any decrease in eating (such as acute or vegetarian diseases) or dehydration (gastrointestinal tract or high temperature exposure); Monitor patients on signs and symptoms of acute renal damage. If the acute kidney damage occurs, stop taking Xigduo XR and hospitalized.
dapagliflozin increases serum creatinine and reduces EGFR. Elderly patients and patients with impaired renal function may be more sensitive to these changes. Adultery reactions related to kidney function may occur after starting to use Xigduo XR. Kidney function should be evaluated before starting to take Xigduo XR and follow up later. Contraindicated to use Xigduo XR in patients with EGFR
Demonstration caused by urinary and pyelonephritis
There have been reports in the circulation of drugs for serious urinary tract infections including blood infections caused by urinary and pyelonephritis that need to be hospitalized for treatment in patients using SGLT2 inhibitors, including dapagliflozin. SGLT2 inhibitors treatment increases the risk of urinary tract infections. Check patients on signs and symptoms of urinary infections and conduct timely treatment if indicated.
Simultaneously used with hypoglycemic drugs
insulin and insulin secretion are known to cause hypoglycemia. Dapagtiflozin may increase the risk of hypoglycemia when combined with insulin or insulin secretion. Therefore, a low dose of insulin or insulin stimulants should be stimulated to minimize the risk of hypoglycemia when using these drugs in combination with Xigduo XR.
metformin hydrochloride
No hypoglycemia occurs in patients using Metformin merely in normal cases, but may occur without a calories, when exercising hard but not responding by supplementing calories or during use with other glucose drugs (such as sulfonylurea and insulin) or ethanol or ethanol. Elderly, depressed or malnutrition patients, and people with impaired adrenal or pituitary gland function or alcohol poisoning are especially sensitive to hypoglycemic effects. It may be difficult to recognize hypoglycemia in the elderly and in people who are taking beta - adrenergic blockers.
Vitamin B12 concentration
In Metformin's controlled clinical trials for 29 weeks, about 7% of patients reduce the level of vitamin B12 to lower levels compared to the previous level without clinical manifestations. This decline, may be due to the B12 absorption intervention from the B12 complex - internal factors, however, rarely due to anemia and seem to recover quickly when stopping metformin or vitamin B12 supplement. It is recommended to test the annual periodic hematology parameters in patients using Xigduo XR and any abnormal signs that need to be tested and treated appropriately.
Some specific individuals (people who are unwell or deficient in vitamin B12 or calcium) tend to develop vitamin B12 levels below normal levels. In these patients, the measurement of the serum vitamin B12 concentration periodically every 2 to 3 years is useful.
Skin fungal infections in the genitals
dapagliflozin increases the risk of fungal infections in the genitals. Patients with a history of genital fungal infections are more likely to develop genital fungal infections. Should monitor and treat appropriate treatment.
Increase low density lipoprotein (LDL - C)
dapagliflozin increases LDL - C. Monitoring LDL - C and treatment according to the degree of care after starting to take Xigduo XR.
Bladder cancer
In 22 clinical studies, cases of newly diagnosed bladder cancer were reported in 10/6045 patients (0.17%) treated with dapagliflozin and 1/3512 patients (0.03%) treated with placebo/control drugs. After eliminating patients with medications for less than one year at the time of diagnosis of bladder cancer, there are 4 cases of dapagliflozin and there are no place to use placebo/control drugs.
The risk factors for bladder and blood cancer (an existing tumor indicator) are evenly distributed between treatment groups at the beginning. There are too few cases to determine whether the appearance of these events is related to dapagliflozin.
There is not enough data to determine whether dapagliflozin affects the existing bladder tumors. Therefore, Xigduo XR should not be used in patients with active bladder cancer. In patients with a history of bladder cancer, the benefits of blood sugar control of Xigduo XR should be considered compared to the risk of unknown cancer recurrence.
Acting on large blood vessels
There has been no clinical research to evidence that the risk of reducing the risk of a large blood vessel when taking Xigduo XR.
lactose
Pills contain lactose (anhydrous). Patients with rare genetic disorders such as galactose tolerance disorders, Lapp Lactase deficiency or Glucose - Galactose abnormal abnormalities should not be used.
The ability to drive and operate machinery
dapagliflozin or metformin without or does not significantly affect the ability to drive and operate machinery. Patients should be warned of the risk of hypoglycemia when taking the drug in combination with other hypoglycemic drugs that have been known to have the risk of hypoglycemia.
During pregnancy
There is no full research and good control of Xigduo XR or the individual active ingredients of the drug performed in pregnant women. Based on the results of reproductive and developed toxicity on animal toxicity and development, dapagliflozin, an active ingredient of Xigduo XR, can affect the development and growth of the kidney. In a study in the child, the incidence and/or the severity of the renal and renal pelvis expansion increased clearly at the lowest test, which is about 15 times higher than the clinical use of clinical drugs from 10 mg.
These results occur when taking the drug during the development of animals correlated with the final stage of the second and third trimester in humans. During pregnancy, consider appropriate alternative therapies, especially in the second and third phase of the trimester. Xigduo XR should only be used during pregnancy when the benefits are clearer than the risk for the fetus.
dapagliflozin
In toxicity research on mice, when dapagliflozin is directly injected with young mice from the 21st day after birth until the 90th after birth at a dose of 1.15, or 75 mg/kg/day, increasing the weight of kidney and renal and renal tubules is reported at all the dose concentrations. Drug contact at the lowest dose is 15 times compared to the maximum clinical dose, based on AUC. The renal and renal expansion in the mouse has not completely recovered during the recovery period of about 1 month.
In the study of before and postpartum development, the mother mouse was injected from 6th to 21 days of milk secretion at a dose of 1.15 or 75 mg/kg/day, and the mice were indirectly exposed to the mother's uterus and during the dairy period. It is shown that the rate and severity of the renal pelvis of the adult mouse of the mother mouse use the dose of 75 mg/kg/day (Dapagliflozin exposure of mother and child mouse is 1415 times and 137 times, compared to the corresponding values in humans when using clinical dose level).
Reducing the weight of the mouse body depends on the dose recorded when taking the dose> 1 mg/kg/day (about> 19 times compared to the clinical dose). Noted that there is no adverse reaction to the ending points at 1 mg/kg/day, or about 19 times higher than the clinical dose. In the study of embryo-fetal development in rats and rabbits, dapagliflozin is used for the period corresponding to the first three months of the formation of human organs.
There is no toxicity for rabbits in any test. In mice, dapagliflozin does not cause embryo death and does not cause teratogenic at 75 mg/kg/day or 1441 clinical doses up to 10 mg. Higher doses in mice, blood vessel defects, ribs, vertebrae, breast hilts, and bone change in the fetus at a dose of> 150 mg/kg or 2344 times compared to the dose of 10 mg clinically recorded.
metformin hydrochloride
Metformin does not cause teratogen in mice and rabbits at a dose of up to 600 mg/kg/day. This shows about 2 times the exposure level and 6 times compared to the maximum recommended dose in 2000 mg based on the comparison of the body surface area for rats and rabbits. Determining the concentration in the fetus shows a partial placental barrier for Metformin.
Breastfeeding period
It is unknown whether the Xigduo XR is excreted through breast milk or not. In studies conducted with each active ingredient, dapagliflozin (reaching a concentration of 0.49 times compared to the mother's plasma concentration) and Metformin is excreted through the mother's milk.
Temorated mice data in direct contact with dapagliflozin shows the risk of kidney development (dilated renal and renal pelvis) in the process of adulthood. Since the adult of the kidneys in the mother's uterus and in the first 2 years of life when it is possible to contact the drug through breast milk, there may be a risk of kidney development in humans. Because many drugs are excreted through breast milk and because there is a possibility of serious adverse reactions in babies due to dapagliflozin, it is necessary to decide whether to stop breastfeeding or stop taking Xigduo XR, in which, considering the importance of the drug for the mother.
Drug interaction
positive test glucose in urine
Monitoring of blood sugar control by glucose test in urine is not recommended in patients being treated with SGLT2 inhibitors, due to SGLT2 channel inhibitors that increase glucose secretion through urine and lead to positive glucose tests in urine.
Interventions quantitative results 1, 5 - anhydroglucitol (1, 5 - Ag).
Monitoring of blood sugar control by quantitative tests 1, 5 - Ag is not recommended because the quantitative method 1, 5 - Ag is not reliable in blood sugar control assessment in patients using SGLT2 inhibitors. Should use other replacement methods to monitor blood sugar control.
ANHYDRASE CARBICDRAS
toamat or other carbon dioxide inhibitors (for example, zonisamid, acetazolamid or dichlophenamid) often reduce serum bicarbonate and cause anger space, acidosis increases blood chloride. The simultaneous use of these drugs with Xigduo XR may increase the risk of lactic acidosis. Consider monitoring more often than these patients.
Medication reduces the clearance of Metformin
Concentrated use of drugs that affect the regular renal tubular transportation systems related to the elimination of metformin in the kidneys (for example: Organic cation channel 2 [oct2]/multi -drug/toxin inhibitors such as Ranolazin, Vandetanib, Dolutegravir and Cimetidine) can increase the exposure of body drugs with Metformin and can increase the risk The benefits and risks of simultaneous use of these drugs.
alcohol
Alcohol is known to increase the effect of metformin on lactate metabolism. It is recommended that patients do not drink much alcohol while using Xigduo® XR.
Use with other drugs
Some drugs may increase blood sugar and may lose blood sugar control. These drugs include thiazid diuretics and other diuretics, corticosteroids, phenothiazin, thyroid treatment drugs, estrogen, oral contraceptives, phenytoin, nicotinic acid, sympathetic drugs, calcium channel blockers and isoniazid.
When these drugs are used for patients who are using Xigduo XR, they should closely monitor the loss of blood sugar control in patients. When stopping using these drugs in patients who are taking Xigduo XR, patients should be closely monitored by hypoglycemia. In healthy, pharmacokinetic volunteers of Metformin and Propranolol; Metformin and ibuprofen are not affected when used simultaneously in single -dose interactive studies.
Storage
Store drugs at temperatures not exceeding 30 ° C.
Other drugs
- ANDROCUR 50MG TABLETS
- Actraphane
- CETRIMIDE CREAM BP
- INTRATECT 50 G/L SOLUTION FOR INFUSION
- PABRINEX INTRAVENOUS HIGH POTENCY SOLUTION FOR INJECTION
- UTROGESTAN CAPSULES 200MG
Disclaimer
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The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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