Xarelto 2.5mg Bayer prevents venous thrombosis (1 blister x 14 tablets)
Dosage form Box of 1 blister x 14 tablets
Specifications Rivaroxaban
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Rivaroxaban | 2.5mg |
Uses
indications
Xarelto 2.5mg indicated treatment in the following cases:
Xarelto, in combination with acetylsalicylic acid (ASA) mono therapy or with ASA with a combination of clopidogrel or ticlopidine, is indicated to prevent thrombosis in adult patients after acute coronary syndrome (ACS) with increased biological marks of the heart.
Pharmacokic
The inhibition of the activity of the distant factor depends on the dose that has been observed on humans. Prothrombin (PT) time is affected by the dose of rivaroxaban, which is closely correlated with plasma concentrations (the value of R is 0.98) if using Neoplastin to try. Other reagents can give different results.
The results for PT are calculated in seconds, because the INR (international standardization ratio) is only standard and valid for COMAARIN and cannot be used for any other anticoagulant drugs. In patients undergoing orthopedic surgery, the ratio of 5/95 for PT (Neoplastin) 2 - 4 hours after taking the pills (ie the maximum effect time) within the limit from 13 to 25 seconds.
Part part of thromboplastin (APTT) and Heptest are also prolonged depending on the dose; However, it is not recommended to use these indicators to evaluate the pharmaceutical effect of Rivaroxaban. The antagonistic activity is also affected by Rivaroxaban; However, there is no standard to evaluate.
There is no need to monitor blood clotting parameters during treatment with Xarelto.
Clinical studies on effectiveness and safety
Rivaroxaban's clinical research program is designed to prove the effectiveness of Xarelto in the provision of cardiovascular death (CV), myocardial infarction (MI), or stroke in new patients with recent ACS (Stema's myocardial infarction, [stemi], myocardial infarctionwithout ST difference [NSTEMEJ or unstable angina [UA]). Only a few patients with a history of stroke or rays are put into research.
Restricted data in patients with a history of stroke or rays does not show the use of 2.5 mg of xarelto twice a day in combination with ASA or ASA+ Clopidogrel/ Ticlopidin is fully effective in these patients. In the key trial of the Atlas ACS 2 Timi 51, 15,526 patients randomly divided in a ratio of 1: 1: 1 into one of the three treatment groups: Xarelto 2.5 mg, taken 2 times/day, 5 mg oral 2 times/day or Placebo orally oral 2 times/day. The median value of the treatment time is 13 months and the total treatment time is up to nearly 3 years.
93.2% of patients use Asa + Thienopyridin and 6.8% only use Asa. Among patients taking two anti -platelets, 98.8 % of patients use clopidogrel, 0.9 % ticlopidine and 0.3 % use prasugrel.
Compared to Placebo, Xarelto significantly reduces the main criteria for evaluation of the heart death, myocardial infarction or stroke. Benefits are gained by reducing cardiovascular death and myocardial infarction of statistical significance. Moreover, sub -assessment criteria 1 (death due to all causes, myocardial infarction or stroke) also decreased significantly (see Table 1). Patients with a history of blood failure (CHF) receive a significant benefit due to Rivaroxaban treatment (see Table 1).
Additional analysis shows the difference in the rate of patients with thrombosis due to the stent of the group using 2.5 mg twice a day (HR: 0.70, 95% CI: 0.51, 0.97) and 5 mg, twice a day (HR: 0.70, 95% CI: 0.51, 0.98) compared to the Placebo group (see table 1). The percentage of patients with events related to the main safety evaluation criteria (large bleeding events according to the criteria of Non Cabg Timi) in the higher Xarelto treatment group in the group using Placebo (see Table 2), the percentage of patients with bleeding threatening is similar to the above, but the balance between the Xarelto and Placebo groups for the components of the venous venous events need to be treated with blood vessels, which is needed to treat blood vessels with blood vessels that need to be treated with blood vessels causing muscle drugs with muscle lines And need surgical intervention to treat bleeding is active.
Patients taking the first dose of Xarelto at at least 24 hours to 7 days (an average of 4.7 days) after hospitalization and shortly after stabilization, among the ACS indicators, including rejuvenation procedure and when oral anticoagulants are often stopped.
Both doses of 2.5 mg, twice a day and 5 mg, twice the day of Rivaroxaban are effective in reducing the frequency of cardiovascular events on the background of standard anti -plateletic drug treatment.
The dose mode 2.5 mg, 2 times/day reduces the mortality rate and has evidence that the lower dosage mode is at a lower risk of bleeding, so Rivaroxaban 2.5 mg, 2 times/day with acetylsalicylic acid (ASA) merely or with ASA combined with clopidogrel or ticlopidine is recommended for large blood claims in patients with acute pulse (ACS) Biology of the heart.
Table 1: Effective evaluation results from phase test III atlas Timi 51
Total n = 10229 n (%) Hazard Ratio (95% CI) P-Value b) 626 (6.1%) 0.84 (0.74, 0.96) 0.83 321 (6.3%) 0.84 641 (6.3%) 0.84 (0.74, 0.95) 0.66 132 (2.6%) 0.94 226 (2.2%) 0.80 (0.65, 0.99) 245 (2.4%) 0.81 (0.66, 1.00) (0.86, 1.78) 0.58 64/574 (11.1%) 0.61
n = 5113
n (%) (6.1%)
0.85
(0.73, 0.98)
P = 0.028
P = 0.008
(0.72, 0.97)
P = 0.016
(0.73, 0.98)
P = 0.025
P = 0.006
(0.51, 0.86)
P = 0.002 **
(0.75, 1.20)
P = 0.633
P = 0.038 **
P = 0.044 **
1.13
(0.74, 1.73)
P = 0.562
1.34
(0.90, 2.02)
P = 0.151
P = 0.246
(0.42, 0.81)
P = 0.016 **
(0.44, 0.83)
p = 0.030 **
123/1136 (10.8%)
0.59
(0.45, 0.78)
P = 0.006 **
122 (1.2%)
0.70
(0.53, 0.92)
p = 0.011 **
Table 2: Safety evaluation results from phase test III ACS 2 timi 51
n = 5115
n (%)
(95% CI)
hazard ratio
p-value b)
Take oral 2 times/day
n = 5110
n (%)
hazard ratio
(95% CI)
P-Value b) Total
n = 10225
n (%)
hazard ratio
(95%CI)
p-value b)
n = 5125
n (%)
3.46
(2.08.5.77)
P =
82 (1.6%)
4.47
(2.71,7.36)
P =
147 (1.4%)
3.96
(2.46,6.38)
P =
Hematoplasty need to be treated b) Compared to plantbo; Log-Rank P-Value. * Statistical significance. absorption and bioavailability Rivaroxaban absorbs fast with a maximum concentration (cmax) about 2-4 hours after taking the pill. Rivaroxaban's oral absorption is almost completely and highly used by orally (80 - 100%) for a tablet dose of 10 mg, regardless of fasting conditions or eating. Simultaneously used with food does not affect the AUC or CMAX of Rivaroxaban at 10mg dose. Xarelto 2.5 mg and 10 mg tablets can be used or not with food. Rivaroxaban's pharmacokinetic variation is moderately moderate with variability between individuals (CV%) limited from 30%to 40%. distribution high -bound drugs with human plasma proteins, about 92% to 95%, mainly with albumin ingredients. The integral distribution is moderate with VSS value of about 50L. metabolism and elimination About 2/3 of the doses of Rivaroxaban taken into the divestment due to metabolism, then half will be eliminated through the kidneys and the rest through the feces. 1/3 of the dose is directly eliminated through the kidneys in the form of a constant active ingredient in the urine, mainly through positive excretion in the kidneys. Rivaroxaban is metabolized through CYP3A4, CYP2J2, and an independent mechanism for CYP. The divestment caused by half of Morpholinone oxidation and hydrolyzed amide bonds are the main transformer locations. Based on in vitro studies, Rivaroxaban is the substrate of P-GP transport protein (P-Glycoprotein) and BCRP (breast cancer protein). Rivaroxaban is not metabolized as the most important compound in a plasma without a major circulatory metabolitus or any activity. With the body clearance of about 10 l/h, Rivaroxaban can be arranged in a group of slow removal drugs. Rivaroxaban's excretion from plasma occurs with a half -life from 5 to 9 hours in young people and from 11 to 13 hours in the elderly. Old people The concentration of drugs in older plasma patients is higher than in young patients with average AUC values about 1.5 times higher than 1.5 times, mainly due to reduction in renal and total clearance. Sex There is no clinical pharmacokinetic difference between male and female patients. different types of weight Worlds received in different extreme body weights ( 120 kg) only have very little effect on the concentration of rivaroxaban in plasma ( children and teenagers The effectiveness and safety for children and teenagers have not been determined under the age of 18 (see the "dosage and usage" section). The difference between peoples There is no clinical difference between white, American - African, Spain and Portuguese peoples, Japan or China related to pharmacokinetics and pharmacokinetics. liver failure
muscle medications
venous sugar.
Activities 7 (0.1%) pharmacokinetics
Because this problem is only evaluated by one of the five clinical/biochemical indicators that constitute the Child Pugh classification system, the patient's risk of bleeding may not be closely correlated with this rating method. Therefore, the decision to treat anticoagulant treatment will be independent of the level of Child Pugh.
Xarelto 2.5mg Contraindicated in patients with liver disease comes with coagulation disorders leading to clinical bleeding risks.
Patients with cirrhosis with mild liver damage (Child Pugh A) has only been changed very little about the pharmacokinetics of Rivaroxaban (the average AUC of Rivaroxaban increases 1.2 times), almost comparable to a healthy evidence group. There is no difference in pharmacological properties between these groups.
In patients with cirrhosis with average liver damage (classification of Pugh B), the average AUC of Rivaroxaban increased significantly, 2.3 times higher than the healthy volunteer, due to the significant reduction of the drug's clearance, showing serious liver disease. The AUC of the free drug increased to 2.6 times. There is no data on patients with severe liver failure.
The inhibition of the activity of the remote factor increases with a factor of 2.6 when compared to a healthy volunteer, the extension of the PT time also increases similarly to the coefficient 2.1. Patients with average average liver failure with Rivaroxaban, leading to PK/PD correlation between drug concentration and PT more steep.
There is no data on patient Child Pugh c.
kidney failure
Increased rivaroxaban exposure, inversely correlation with impaired renal function, is evaluated through creatinine clearance.
In patients with mild renal failure (CRC from 80-50 ml/minute), average (CRC from 50-30 ml/min) or severe (CRC from 30-15 ml/minute), plasma rivaroxaban levels (AUC) increased by 1.4; 1.5 and 1.6 times compared to healthy volunteers.
The corresponding increase of pharmacological efficiency is more clear.
In patients with mild, moderate or severe renal failure, the factor inhibits the factor in general increases with the corresponding coefficient of 1.5; 1.9 and 2.0 when compared to healthy volunteers; Extending PT also increased similarly to the corresponding coefficient of 1.3; 2.2 and 2.4.
No data on patients with CRC
Do not recommend the use of drugs for patients with creatinine clearance
Due to the background diseases, patients with severe renal impairment are at high risk of both bleeding and thrombosis.
Before taking Xarelto 2.5mg Bayer prevents venous thrombosis (1 blister x 14 tablets)
How to use
Xarelto 2.5mg drug used orally. Can take Xarelto 2.5 mg tablets with or not accompanied by food.
Dosage
After the acute rim syndrome, the recommended dose is 1 tablet Xarelto content of 2.5 mg, 2 times/day.
Patients also need to take 1-dose daily ASA from 75-100 mg or daily dose 75-100 mg ASA combined with 1 daily dose of 75 mg clopidogrel or a daily dose of ticlopidin.
Treatment process
The treatment is recommended for at least 24 months.
Patients after acute rim syndrome continue to be at risk of cardiovascular events and therefore can be useful when prolonged treatment.
How to use and use
start treatment with Xarelto 2.5mg as soon as possible after stabilizing the indicators of the acute rim syndrome event (including reproductive reproduction procedure). Should start using Xarelto 2.5 mg right after stopping treatment with anticoagulant drugs.
Should take 1 Xarelto tablet 2.5mg twice a day.
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 using overdose?
What to do when forgetting 1 dose?
Add dose as soon as you remember. 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
When using Xarelto 2.5mg often has unwanted effects (ADR).
Table 3: All drug reactions during the treatment period are reported in patients in phase III studies (accumulated from Record 1–4, Einstein-DVT/PE, wide fat Einstein, Magellan, Atlas, Rocket, J Rocket).
platelet) A
digestive disorders
Pepper hemorrhage
(including rectal bleeding)
abdominal and stomach pain,
indigestion
Constipation A
diarrhea
vomit A
general disorders and topical diseases of oral medication
Peripheral edema
reduces strength and energy (including fatigue and weakness)
(including discomfort)
(including anemia after surgery, and hemorrhage
wounds)
crash
Increasing Lipase A
Increasing amylase A
Increasing GGT A
headache
unconscious (Including increased
blood, hyper urea
) A
School of
Systemic itching)
Bleeding under the skin
Hemorrhage in the skin and under the skin
ADR terms based on Meddra version 14.1.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Xarelto 2.5mg contraindications in the following cases:
Caution when using
Simultaneous drugs
Do not use Xarelto 2.5mg for patients who are using Azole antifungal drugs (for example, ketoconazole) or protease inhibitors (eg Ritonavir). These drugs strongly inhibit both CYP 3A4 and P-GP. Therefore, it can increase the level of rivaroxaban in plasma (an average of 2.6 times higher) to the point that can increase the risk of clinical bleeding.
Azole antifungal drugs, a moderate CYP3A4 inhibitor, but less effective on Rivaroxaban exposure and can be treated in combination.
kidney failure
Be cautious when using Xarelto for patients with medium renal failure used at the same time, the drugs may increase the level of rivaroxaban in plasma.
Plasma rivaroxaban levels may increase significantly in patients with severe renal impairment (1.6 times an average), leading to an increase in the risk of bleeding.
Due to not having enough clinical data, caution should be used when using Xarelto for patients with CRC
Safety and effectiveness of xarelto in breastfeeding women have not been set up.
Animal data shows that Rivaroxaban has excreted breast milk. Therefore, the mother only uses xarelto when stopping breastfeeding.
There is no clinical data on patients with severe renal impairment. Therefore, it is not recommended to use Xarelto for these patients.
Patients with severe renal impairment or increased risk of bleeding and patients who are simultaneously taking the body of Azole antifungal drugs or HIV -resistant Protease inhibitors should be closely monitored by signs of bleeding complications after the beginning of treatment.
regularly conduct patient physical examination, carefully observe the incision drainage and periodically quantify hemoglobin.
Patients with a history of stroke or transient ischemic anemia (transientischemic attack (ray).
Do not use Xarelto 2.5 mg, 2 times/day on ACS patients with a history of stroke or rays. Only a few ACS patients have a history of stroke or rays that are put into research, but with the data that has the effectiveness of treatment is limited to indicate that these patients may not benefit from treatment.
Risk of bleeding
Like other anti -thrombotic drugs, Xarelto needs to be used very carefully in patients with increased risk of bleeding such as:
Be cautious in patients with simultaneous use of drugs that affect hemostasis such as nonsteroidal anti -inflammatory drugs (NSAIDs), anti -plateletic or other anti -thrombotic drugs. Patients after acute rim syndrome are being treated with Xarelto and ASA or Xarelto and ASA + Clopidogrel/Ticlopidin should only be treated simultaneously with non-mineroid anti-inflammatory analgesics (NSAID), if the benefit is more than the risk of bleeding.
For patients at risk of gastrointestinal ulcer should consider appropriate preventive treatment.
any case of hemoglobin decrease or unexplained blood pressure, it is necessary to find a bleeding location.
The effectiveness and safety of Xarelto when used with anti -plateletic anti -platelets of Aspirin and Clopidogrel/Ticlopidine have been studied. The treatment combined with other anti -platelets, for example: prasugrel or ticagrelor, has not been researched and therefore, is not recommended shared.
Neurodoris anesthesia (outside of the epidural/spinal cord)
When conducting anesthesia anesthesia of the cerebrospinal axis (external/spinal cord) or the spinal cord detection in patients using anti -thrombotic drugs to prevent venous clogged complications will be at risk of hematoma in the spinal or exterior epidural, leading to prolonged paralysis.
The risk of these complications is even increasing when placing an external catheter or using simultaneously with drugs that affects hemostasis. The risk also increases when injured or repeated the spinal cord/external epidural.
Need to regularly monitor in patients with signs and symptoms of neurological decline (such as numbness or weak legs, bladder and colon dysfunction). If detected nerve impairment, need to be diagnosed and treated promptly for patients.
Doctors need to consider the benefits and risks before interfering with the cerebrospinal axis in patients with anticoagulants or anticoagulants to prevent thrombosis.
There is no clinical experience when using Xarelto 2.5mg along with ASA merely or with ASA in combination with clopidogrel or ticlopidine in cases like this. To reduce the risk of bleeding associated with simultaneous use of Rivaroxaban with cerebrospinal axis anesthesia (outermost/ spinal cord) or spinal cord detection, rivaroxaban pharmacokinetic properties should be considered. The placement or removal of epidural catheter or spinal cord detection should be done best at the time of Rivaroxaban's anticoagulant effects are considered low.
However, the exact determination of the time when the anticoagulant effect is low in each patient is unknown.
Simultaneous use and stopping anti -platelets should be considered appropriately.
surgery and interventions
If surgery or invasive procedure is required, Xarelto is needed 2.5mg before intervention for at least 12 hours, if possible and based on the clinical decision of the doctor.
If the patient will operate and do not desire to have anti -platelet effects, need to stop platelet aggregation inhibitors according to the instructions from the manufacturer's information.
If it is not possible to delay the procedure, it is necessary to assess the risk of increased bleeding compared to the emergency level of intervention.
After the invasive procedure or surgical intervention, it is necessary to continue using Xarelto as soon as possible when the clinical condition is allowed and hemodynamic is stable.
Women are likely to be pregnant
Only use Xarelto for pregnant women can apply effective contraception.
extends the range of qtc
Not observing that Xarelto has the effect of extending QTC.
Information about excipients
Because this drug contains lactose, patients with rare diseases are lactose or galactose intolerance (for example, lactase or glucose-galactose deficiency) should not be used xarelto.
The effect of the drug on the ability to drive and operate machinery
fainted and dizzy has been reported and may affect the ability to drive and control machinery. Patients with these adverse effects should not drive or control machines.
Using drugs for women during pregnancy and lactation
only using Rivaroxaban for pregnant women can apply effective contraception.
Pregnant women
There is no data on the safety and effectiveness of Xarelto in pregnant women.
In Rivaroxaban rabbits and rabbits showing significant toxicity to the mother with changes in fetal vegetables related to the mechanism of action of the drug, (for example, bleeding complications) leads to reproductive toxicity. It is not possible to determine the likelihood of causing primary monsters. Due to the risk of endogenous bleeding and evidence that Xarelto can be contraindicated, contraindicated use of xarelto for pregnant women.
breastfeeding women
There is no data on the safety and effectiveness of Xarelto in nursing women. In mice, Rivaroxaban is excreted in milk.
Therefore, only use xarelto after stopping breastfeeding.
Drug interaction
pharmacokinetic interaction
Rivaroxaban is excreted mainly through intermediaries of metabolic Cytochrome P450 (CYP 3A4, CYP 2J2) in the liver and excreted through the kidneys in a constant form, related to P-Glycoprotein (P-GP)/protein system (BCRP)
CYP inhibitors
Rivaroxaban does not inhibit CYP 3A4 or any other main CYP isomers.
CYP induction
Rivaroxaban does not cause CYP 3A4 or any other CYP isomers.
affect Rivaroxaban
Concomitance Xarelto with strong inhibitors CYP 3A4 and P-GP, which can lead to reducing the elimination of the drug through both the liver and the kidneys, thus significantly increasing the concentration and duration of the drug.
Concomitance Xarelto and antifungal drugs Azole is Ketoconazole (400 mg once a day), a strong CYP 3A4 and P-GP inhibitors, making the average AUC in the equilibrium state of Xarelto increased to 2.6 times and the average CMAX increased to 1.7 times, and the pharmacoturetic effect also increased significantly.
Simultaneous use of Xarelto with Ritonavir, HIV anti-HIV-inhibitors (600 mg, 2 times/day), a strong CYP 3A4 and P-GP inhibitor, increasing 2.5 times the average value of AUC and 1.6 times cmax of Xarelto, with increased pharmaceutical effects of the drug significantly.
Therefore, it is not recommended to use Xarelto for patients who are simultaneously using the whole body of Azole antifungal drugs or protease inhibitors.
Clarithromycin (500 mg, 2 times/day), is also considered a strong CYP 3A4 inhibitor and P-GP inhibitors at an average level, increasing the average AUC of Rivaroxaban to 1.5 times and CMAX increases 1.4 times. This increase is also close to the normal variation amplitude of AUC and CMAX values, so it is thought to have no clinical significance.
erythromycin (500 mg, 3 times/day), inhibit CYP 3A4 and P-GP at an average level, increasing the average value of AUC and CMAX of Rivaroxaban to 1.3 times. This increase is within the limit of the normal variable amplitude of AUC and CMAX, so it is thought to have no clinical significance.
fluconazole (400 mg once a day) is considered a moderate CYP 3A4 inhibitor, increasing 1.4 times the average AUC and an increase of 1.3 times cmax of Rivaroxaban's average. This increase is in the amplitude of normal variables of AUC, CMAX and is considered to have no clinical meaning.
Simultaneous use of Xarelto and Rifampicin, a strong CYP 3A4 and P-GP induction drugs, reduces about 50% of the average AUC of Rivaroxaban, while reducing the pharmacological effect of the drug. Simultaneous use of Rivaroxaban with other powerful CYP 3A4 induction drugs (e.g. Phenytoin, carbamazepine, phenobarbitone or St. John’s World) can also reduce rivaroxaban levels in plasma.
Caution must be used with strong CYP3A4 touch substances in patients with acute rim syndrome treated with Xarelto 2.5 mg, twice a day.
Pharmacological interaction
When used in combination with Enoxaparin (40 mg a single dose) with Rivaroxaban (10 mg a single dose), it has noticed that there is an additional effect on the anti -activity of the distant factor but there is no additional effect on blood clotting tests (PT, APTT). Enoxaparin does not affect the pharmacokinetics of rivaroxaban.
Clopidogrel (starting dose of 300 mg, then maintained at a dose of 75 mg) does not cause pharmacokinetic interaction (with Xarelto 15mg). However, on a group of patients, there is an increase in bleeding time not to the platelet aggregation, P-Selectin concentration or GPIIB / IIIA receptor levels.
There is no clinical evidence about prolonging bleeding time after simultaneous use of Xarelto (15mg) and 500 mg of Naproxen. However, there may be individuals who have a stronger pharmacological response than that.
The transfer of patients from Warfarin (INR 2,0-3,0) to Xarelto (20 mg) or from Xarelto (20 mg) to Warfarin (INR 2,0-3.0) increases prothrombin/ INR (Neoplastin) time rather than plus (single-in-single values that are detected to 12), while the effects on APTT are active, the inhibition of APTT, the inhibitory inhibitors The properties of the far and the potential of endogenous thrombin are plus.
If you want to check the Xarelto's pharmaceutical effects during the transition, the anti -factor activity, Pict, and the Heptest can be used because these tests are not affected by Warfarin. From the 4th day after stopping Warfarin onwards, all tests (including PT, APTT, inhibit the activity of the remote factor and ETP) only reflect the effects of Xarelto.
If you want to check Warfarin's pharmaceutical effects during the conversion, the Inr measurement can be used at the Crough concentration of Rivaroxaban (24 hours after taking the previous Rivaroxaban dose) because this test is very less affected by Rivaroxaban at this time.
There is no pharmacokinetic interaction that is discovered between Warfarin and Xarelto
Food and dairy products: Xarelto 2.5 mg can be used or not of the same food.
Interaction with test parameters: Blood coagulation tests (PT, APTT, HEP Test®) are expected to be affected by Xarelto's acting mechanism.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children.
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