Trajenta duo 2.5mg/500mg Boehringerer treatment of type 2 diabetes (14 tablets)
Dosage form Box of 14 tablets
Specifications Metformin, linagliptin
Ingredient
| Composition information | Content |
| Metformin | 500mg |
| Linagliptin | 2.5mg |
Uses
Indications
trajenta duo 2.5mg/500mg indicated treatment in the following cases:
Pharmacy
linagliptin
is an enzyme inhibitor DPP - 4 (dipeptidyl peptidase 4), is an enzyme involved in the inactivating the hormone of Incretin GLP - 1 and GIP (peptide - 1 glucagon, polypeptide stimulating insulin -dependent glucose). These hormones are fastened by the enzyme DPP - 4.
Both Incretin hormones are related to the physiological regulation for glucose balance. Incretin is excreted at a low concentration throughout the day and this concentration increases immediately after eating. GLP - 1 và GIP làm tăng sinh tổng hợp insulin và bài tiết glucagon từ tế bào beta ở tụy khi đường huyết ở mức bình thường và tăng. Hơn nữa, GLP - 1 cũng làm giảm bài tiết glucagon từ các tế bào alpha ở tụy, dẫn đến làm giảm bài tiết đường ở gan.
Linagliptin gắn kết rất hiệu quả với DPP - 4 và có thể tách rời được nhờ đó làm tăng ổn định và kéo dài nồng độ incretin hoạt tính. Linagliptin increases the secretion of glucose depends on glucose and reduces the excretion of glucagon secretion, so it generally improves glucose balance. Linagliptin gắn kết một cách chọn lọc với DPP - 4 và có tính chọn lọc > 10.000 lần so với hoạt tính DPP - 8 hoặc DPP - 9 trên in vitro.
metformin hydrochloride
is a biguanide that has anti -hypertension effects, reducing both plasma sugar levels at a basic level as well as after meals. The drug does not stimulate insulin secretion so it does not cause hypoglycemia.
metformin hydrochloride can work through 3 mechanisms:
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 pharmacokinetics
lina
absorption
Absolutely bioavailability of Linagliptin is about 30%. Drinking Linagliptin along with a fat -rich meal that does not affect 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 strong inhibitor P - Glycoprotein and CYP3A4 increases the concentration of drugs (AUC) 2 times and used many times simultaneously Linagliptin with Rifampicin, a powerful induction for P - GP and CYP3A, leading to a decrease of about 40% of the AUC level of Linagliptin in a stable state, maybe due to Linagliptin's increased rise Application P - Glycoprotein.
Distribution
Due to tissue bonds, the average appsed distribution volume is in a stable state after using a single -dose of 5 mg of vein line of Linagliptin in healthy people at 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 the saturation associated with DPP - 4 when increasing the concentration of linagliptin. At high concentrations, when DPP - 4 is completely saturated, 70 - 80% of Linagliptin is linked to other plasma proteins other than DPP - 4, so 30-20% in non -binding form in plasma.
Metabolism
After taking a dose [14C] Linagliptin oral 10 mg, about 5% of radioactive substances are excreted into the urine. Metabolism plays a secondary role in the elimination of linagliptin. A main metabolite with a relatively 13.3% linagliptin dose in a stable state is detected as a substance without pharmacological activity and therefore does not contribute to the inhibition of DPP - 4 plasma inhibitors of Linagliptin.
Elimination
After giving healthy people oral orally [14C] Linagliptin, about 85%of the doses of radioactive activity are eliminated by fertilizer (80%) or urine (5%) within 4 days of taking the drug. The renal removal in a stable state is about 70 ml/min.
Hepatic failure: There is no need to adjust the linagliptin dose for patients with mild, moderate or severe liver failure.
metformin
absorption
After taking 1 oral metformin dose, TMAX is achieved after 2.5 hours. Absolute bioavailability of Metformin Hydrochloride 500 mg or 850 mg in healthy volunteers is about 50 - 60%.
After an oral dose, the non -absorbing drug is found in feces of 20 - 30%.
After oral use, Metformin Hydrochloride is absorbed in incomplete and saturated. Pharmacoderminium absorption of Metformin Hydrochloride is thought to be non -linear.
Distribution
drugs are negligible with 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 - 276 l.
Metabolism
metformin hydrochloride eliminates urine in a constant form. No metabolites in humans.
Elimination
The renal waste of the metformin hydrochloride> 400 ml/min shows that metformin hydrochloride is eliminated 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.
Before taking Trajenta duo 2.5mg/500mg Boehringerer treatment of type 2 diabetes (14 tablets)
How to use
Trajenta duo 2.5 mg/500 mg oral with meals with a slow dosage to reduce side effects on the gastrointestinal tract related to Metformin.
Dosage
recommended dose:
Patients who have not been well controlled with blood sugar with the maximum dose Metformin Single therapy: The starting dose of ordinary linagliptin is 2.5 mg x 2 times/day (total dose of 5 mg/day) and metformin with the dose of being used.
Patients transferred from combination of Linagliptin and Metformin separately into a fixed form of dosage: Patients should start using the drug at the dose of Linagliptin and Metformin in use.
Patients who have not been well controlled with metformin combination treatment and a sulphonylurea are at the maximum doses that can be tolerated:
Should use the dose of Trajenta Duo contains 2.5 mg of linagliptin 2 times daily (total daily dose 5mg) and a metformin dose similar to the dose of the patient in use. When combining Trajenta Duo with a sulphonylurea, the lower sulphonylurea dose of hypoglycemia.
Corresponding to different metformin doses, Trajenta Duo has the content of 2.5 mg of Linagliptin plus 500 mg of metformin hydrochloride, 850 mg of metformin hydrochloride or 1000 mg of metformin hydrochloride.
kidney failure
Can only use Trajenta Duo for patients with medium renal impairment, phase 3a (Creatinin clearance [CRCI] 45-59 ml/min or Estimated glomerular filtration [EGFR] 45-59 ml/min/1.73m3) If there is no factors that can increase the risk of increased lactic acidic acidosis and use as follows as follows: Maximum willow recommend Time every day.
Must closely monitor kidney function.
If CrCl or EGFR are below 45-59 ml/min and 45-59 ml/min/1.73m, must stop using Trajenta Duo immediately).
liver failure
Trajenta duo contraindicated in patients with liver failure due to drugs containing metformin ingredients.
Elderly
Due to the renal and elderly metformin, the elderly tends to impaired the kidney function, so monitoring the kidney function is often in the elderly patients treated with Trajenta Duo.
children and teenagers
Do not recommend the use of Trajenta Duo for children under 18 years of age due to lack of data on effectiveness and safety of drugs.
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?
In control clinical trials conducted on healthy volunteers, single dose up to 600mg of Linagliptin (equivalent to 120 recommended dose) is well tolerated. There is no experience using a dosage higher than 600mg in humans.
Hypoglycemia does not occur with Metformin Hydrochloride dose up to 85g despite lactic acidic acidosis. High doses of metformin hydrochloride or associated risk factors can lead to lactic acidic acidosis. Lactic acidic acidosis is a medical emergency and must be treated at the hospital.
Treatment
In case of overdose, it is advisable to take common supportive treatments, for example: removal of not being absorbed from the gastrointestinal tract, clinical monitoring and necessary treatment measures. The most effective measure to eliminate lactate and metformin hydrochloride is dialysis.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
The safety of Linagliptin 2.5 mg twice daily (or biological equivalent dose with 5 mg once a day) in combination with Metformin is assessed on 3500 patients with diabetes Typ 2.
In controls with placebo, more than 1300 patients are treated at a dose of 2.5 mg of linagliptin twice per day (or biological equivalent 5 mg linagliptin once a day) in combination with metformin in ≥ 12/24 weeks.
In gross analysis of fatal control tests, the proportion of all adverse events in patients with placebo and metformin is similar to the ratio in the 2.5 mg linagliptin and metformin (50.6% and 47.8%).
The rate of stopping drug use due to adverse events in groups of placebo combined with Metformin is similar to the Linagliptin and Metformin combination treatment group (2.6% and 2.3%).
Due to the effects of the initial available treatment on adverse events (for example, hypoglycemia), adverse events are analyzed and presented based on the corresponding treatment regime, added to Metformin treatment and added to Metformin treatment in combination sulphonylurea.
Business control studies include 4 studies in which Linagliptin is added to Metformin treatment and 1 study in which Linagliptin is added to Metformin + Sulphonylurea treatment.
The adverse reactions are reported in patients using Linagliptin + Metformin in combination (analysis of placebo -control studies):
1: Gastrointestinal disorders such as abdominal pain (see Table 2) and nausea, vomiting, diarrhea and reduce cravings that occur most often in the early stages of the treatment process with Metformin hydrochloride and self -recovery in most cases. For prevention, recommendations to use Trajenta Duo 2 times a day during or after eating.
*: Adultery effects are also reported in patients using single therapy linagliptin.
**: Adultery effects are also reported in patients using single Metformin therapy.
In the place of fatal control, the relevant adverse reaction is reported the most to Linagliptin + Metformin is diarrhea (0.9%) at a similar low rate in the metformin + fake group (1.2%).
Harmful reactions are reported when combining linagliptin and metformin with Su:
When Linagliptin and Metformin are combined with a sulphonylurea, hypoglycemia is the most common adverse event (22.9% in Linagliptin plus Metformin plus sulphonylurea compared to 14.8% in the placebo group) and is considered to be an additional adverse reaction. No hypoglycemic hypoglycemia has been ranked seriously.
Adultery reactions when combining linagliptin and metformin with insulin:
When Linagliptin and Metformin are used in combination with insulin, the most common adverse event is reported as hypoglycemia, but appears at the same ratio when the placebo and metformin are combined with insulin (Linagliptin in combination with Metformin and Insulin is 29.5% compared to 30.9% in the placebo group with Metformin and Insulin) with a serious low -ratio. 0.9%).
Additional information about each individual ingredient:
The adverse effects that were previously reported with each individual ingredient of the drug may be the potential adverse effect of Trajenta Duo even when not observed in clinical trials with this product.
All the adverse effects are reported in patients using the monochromatic linagliptin that has been recorded to Trajenta Duo and includes the adverse reactions listed above.
The adverse reactions are reported in patients using Metformin Single Treatment:
1: Long -term treatment with metformin related to reducing vitamin B12 absorption, which can lead to a clinical vitamin B12 deficiency in a rare case (such as a large red blood cell anemia).
2: Gastrointestinal disorders such as abdominal pain and nausea, vomiting, diarrhea, reducing cravings occur most often in the stage of arising and recovery in most cases. To prevent these disorders, Metformin Hydrochloride should be used 2 times daily during or after meals if used for monomers.
The adverse reactions are reported in patients with 5 mg linagliptin treatment daily to insulin*:
Notify the physician the unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
trajenta duo 2.5mg/500mg contraindicated in the following cases:
Be cautious when using
General warning
Do not use Trajenta Duo 2.5 mg/500 mg for patients with type 1 diabetes or patients with diabetes.
Used with known drugs that cause hypoglycemia
linagliptin
Insulin and insulin secretion stimulants are known to cause hypoglycemia. In a clinical study, the use of linagliptin combined with an insulin secretion (eg sulfonylurea) accompanied with a higher rate of hypoglycemia than a placebo group. The rate of hypoglycemia is higher when using linagliptin in combination with insulin in patients with severe renal impairment. Therefore, to reduce the risk of hypoglycemia when used in conjunction with Trajenta Duo, may request a lower dose than insulin or insulin secretion.
metformin
Hypoglycemia does not appear in patients using monon metformin when used in normal cases, but may appear when the calories are insufficient, when exercising too much without adequate calories, or when used simultaneously with other hypoglycemic drugs (eg su and insulin) or ethanol.
Elderly, weak, or malnutrition patients, and patients with pituitary or adrenal impairment or alcohol poisoning are especially sensitive to hypoglycemic effects. Hypoglycemia may be difficult to identify in the elderly, and in patients taking B-adreneric inhibitors.
Lactic acidic acidosis
Lactic acidic acidosis is a serious metabolic complication that can appear due to metformin accumulation during treatment with Trajenta Duo and death in about 50% of cases. Lactic acidic acidosis may appear along with a number of pathophysiological conditions, including diabetes, and whenever there is a significant reduction in reproduction to tissue and reducing blood oxygen.
Lactic acidic acidosis has the characteristics of increased blood levels in the blood (> 5 mmol/l), reduces blood pH, electrolyte disorders due to an increase in anion space, and increases lactate/pyruvate ratio. When Metformin is considered to be the cause of lactic acidic acidosis, the plasma metformin concentration is> 5 microg/ml.
The rate of lactic acidic acidosis in patients using metformin is about 0.03 cases/1000 patients/year, (with approximately 0.015 deaths/1000 patients/year). Of the more than 20,000 patients-Metformin used in clinical trials, no reports are related to lactic acid acidic acidosis. Cases that have been reported mainly in patients with diabetes with significant renal failure, including kidney disease and reduced renal perfusion, usually in cases where there are many medical/surgical problems simultaneously and at the same time taking a lot of drugs.
Patients with congestion heart failure need to control drugs, especially when accompanied by reduced perfusion and hypoxemia due to unstable or acute heart failure, which is likely to increase lactic acidic acidosis. The risk of lactic acidic acidosis increases with the level of renal failure and the age of patients. Therefore, the risk of lactic acidic acidosis can be significantly reduced by regular control of kidney function in patients using Metformin.
In particular, treatment in elderly patients should go along with tightening the renal function. Metformin treatment should not be started in any patient unless checking for creatinine clearance shows no impaired kidney function. In addition, Metformin should be stopped when there is any sign of hypoxemia, dehydration, or infection.
Due to the decline in liver function can seriously affect the ability to eliminate lactate, it is advisable to avoid using metformin in patients with clinical evidence or testing showing liver failure. Patients should be cautious when drinking a lot of alcohol while using Metformin, because alcohol can affect the metabolism of metformin.
In addition, temporarily stop using Metformin before participating in the internal contrast test and any surgery necessary to limit food and fluid. Using Topiramat, an anhydrase carbon inhibitor in the treatment of epilepsy and prevention of migraines can cause metabolic acidosis depends on the dose and can worsen the risk of metformin causing lactic acidic acidosis.
Lactic acidic acidosis is often difficult to see, and accompanied by nonspecific symptoms such as discomfort, muscle pain, respiratory failure, increased drowsiness, and nonspecific abdomen. A more severe acidosis comes with signs such as reducing body temperature, hypotension, and anti -treatment heart rate.
Patients should be instructed to identify and immediately report symptoms. If so, you should stop using Trajenta Duo until the lactic acidic acidosis is completely gone. Stomach disorders are a common report when starting treatment with Metformin and is observed with lower frequency in patients who have used long -term metformin with stable doses. Stomach disorders appear in patients using long -term metformin with stable doses that can be caused by lactic acidic acidosis or other serious pathology.
To eliminate lactic acidic acidosis, serum electrolyte, ketone, blood sugar, pH, lactate and metformin levels may be helpful. Venous plasma lactate concentration at the upper limit of normal levels is lower than 5 mmol/l in metformin -taking patients that do not necessarily indicate lactic acidic acidosis and may be caused by other mechanisms, such as poor diabetic control or obesity, excessive physical activity, or technical problems during blood tests.
Suspected lactic acidic acidosis in any patient with diabetes metabolic lack of evidence of keton acid infection (urinary tract and blood keton). Lactic acidic acidosis is an emergency medical condition so it must be treated in the hospital. Should stop using immediately and immediately transferred to replacement support measures in patients with lactic acidic acidosis which is using Metformin. Metformin can be separated (cleared up to 170 ml/minute in good hemodynamics) and recommended dialysis to remove Metformin storage and calibration of metabolic acidosis.Such control often leads to rapid and recovery reduction.
pancreatitis
There have been after -sales reports of acute pancreatitis, including dead 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 inflammation, though increasing or not the risk of inflammation while using Trajenta Duo.
Hypersensitivity reaction
There have been after -sales reports on serious hypersensitivity reactions in patients using linagliptin (a component of Trajenta Duo). The reactions include hypersensitivity shock, angioedema, and peeling. Signs of reactions that appear in the first 3 months after the beginning of treatment with Linagliptin, with a few reports appeared after the first dose. If a serious hypersensitivity reaction is suspected, stop using Trajenta Duo, assess other abilities that can cause events, and use another measure to treat diabetes.
Evaluation has been reported with other Dipeptidyl peptidase-4 (DPP-4) inhibitors. Use cautiously in patients with a history of angioedema due to the previous use of DPP-4 inhibitors because they do not know whether these patients may have angioed angels when treated with Trajenta Duo.
Vitamin B12 concentration
In a 29 -week control clinical study with Metformin, it was observed that approximately 7% of patients treated with Metformin fell below normal levels of vitamin B12 and no clinical manifestations. Reducing this vitamin B12 level may be due to the intervention in the absorption of vitamin B12 from the combination of internal factors of B12, however, it is very rare with anemia or neurological manifestation due to short time of use (
Reduce the concentration of vitamin B12 quickly reversed when stopping using metformin or supplementing with vitamin B12. It is recommended to control annual periodic hematology parameters in patients using Trajenta Duo and any abnormalities should be considered and processed. In some cases (for patients who lack or absorb incomplete vitamin B12 or calcium) seems to be easy to vitamin B12 levels below normal. In these patients, regular control of serum vitamin B12 in 2-3 years is beneficial.
alcohol
Wine is known to increase the effects of metformin on lactate metabolism. Therefore, patients should be warned not to drink excessive alcohol while using Trajenta Duo.
Lack of oxygen
Cardiovascular collapse (shock) due to any cause (for example, acute congestion, acute myocardial infarction, and other conditions are characterized by hypoxemia) is associated with lactic acidic acidosis and can also cause hyper urea hyperurize before the kidneys. The drug should be discontinued as soon as these events occur in patients who are being treated for Trajenta Duo.
Kidney function
Because metformin hydrochloride is eliminated through the kidney, serum creatinine levels should be determined before the beginning of treatment and periodic treatment:
At least annually in patients with normal renal function.
At least 2 to 4 times per year in patients with creatinine levels at the upper limit of normal levels and elderly patients.
Contraindicated Trajenta duo for patients with CrCl
A decrease in kidney function in the elderly is common and asymptomatic. It is necessary to be special in case the renal function may be impaired, for example, when dehydrated or when it is started to treat with anti -hypertension drugs, diuretics and when starting treatment with nonsteroidal anti -inflammatory drugs.
In the above cases, kidney function should be checked before starting treatment with metformin.
Heart function
Patients with heart failure are 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 heart failure is unstable because the drug contains metformin (see the contraindication section).
Using iodine contrast drugs
The use of intravenous iodine contrast drugs in X-rays can lead to renal failure, so it can lead to metformin accumulation and increase the risk of lactic acidic acidosis.
In patients with EGFR> 60 ml/min/1.73 m must stop metformin before or during the survey and do not use it at least for at least 48 hours later, only use after re -evaluation of kidney function and the results are not worse.
In patients with average renal impairment (EGFR between 45 and 60 ml/min/1.73 m), Metformin must be stopped 48 hours before using iodine contrast drugs and do not use at least 48 hours later, only use after reassessing kidney function and not deteriorated results.
Surgery
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.
Drug interaction
linagliptin
Assessment of In vitro interaction:
Linagliptin is a p - glycoprotein substrate and inhibits the transport of digoxin through intermediaries P - Glycoprotein with low activity. Based on these results and studies on Vivo, Linagliptin interactive drugs are considered to be less likely to cause interaction with other P -GP substrates.
Interaction assessment in vivo:
Linagliptin không có ảnh hưởng lâm sàng liên quan đến dược động học của metformin, glibenclamide, simvastatin, pioglitazone,warfarin, digoxin hay các thuốc tránh thai đường uống, điều này cung cấp bằng chứng in vivo cho thấy xu hướng ít gây tương tác thuốc với các cơ chất của CYP3A4, CYP2C9, CYP2C8, P - Glycoprotein and organic cation (OCT) Organic Cations (OCT).
metformin
The risk of lactic acidic acidosis increases in acute alcoholic poisoning patients (especially in the case of fasting, malnutrition or liver failure) due to the active ingredient Metformin of Trajenta Duo 2.5 mg/500 mg (see the cautious part when used). 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 to be transported by the renal tubules. 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 medications in patients treated with Trajenta Duo 2.5 mg/500 mg due to an increased risk of lactic acidic acidosis.
Injecting of the intravascular contrast in patients who are being treated for metformin can lead to impairment of renal function and cause lactic acidosis.
Stop using Metformin before or at the time of performing a scan using iodine -containing contrast drug 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 contrast drugs containing iodine by artery. Reassess EGFR 48 hours after screening and reuse Metformin if the kidney function is stable.
Storage
In a dry place, avoid light, temperatures below 30⁰C.
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