Rivaxored 10mg Dr. R.Deddy's prevents vein thrombosis (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications Dr.Reddy

Uses

indications

Rivaxored drugs are indicated in the case of preventing venous thromboembolism (VTE) in adult patients with surgical surgery under the hip replacement program or knee joint.

Pharmacokology

There is no reported information.

pharmacokinetics

There is no reported information.

Before taking Rivaxored 10mg Dr. R.Deddy's prevents vein thrombosis (1 blister x 10 tablets)

How to use

Rivaxored 10mg drug tablets for oral. The drug can be used or not with food.

In case the patient cannot swallow the pills, can be ground and mixed with water or soft food like apple sauce right before eating or drinking.

In addition, the crushed Rivaroxaban can be placed through the gastric catheter after determining the location of the catheter in the stomach. The crushed pill must be put into a small amount of water pouring through the catheter, then added water.

Dosage

The usual dose in the prevention of venous thrombosis (VTE) in adult patients:

The recommended dose is 10 mg of Rivaroxaban taken once a day. The starting dose should be used within 6-10 hours after the surgery, provided that the hemostasis has been established. Week.

The recommended dose is 20 mg once a day, this is also the maximum dose recommended. PE:

recommended dose for the initial treatment of acute or PE DVT is 15 mg twice daily for the first three weeks, then 20 mg once a day for continued treatment and prevention of relapses DVT and PE, indicated in the table below.

Dosage Maximum dose 20mg Short treatment time (at least 3 months) should be based on temporary risk factors (for example, recent surgery, injury, motion) and longer time should be based on permanent risk factors or idiopathic or PE DVTs.

If you forget a dose during the treatment period twice a day of 15 mg (1-21), patients should take Rivaroxaban as soon as they remember to ensure the amount of 30 mg of rivaroxaban per day. In this case, two tablets can be taken at 15 mg at the same time. Patients should continue taking regularly twice a day to dose 15 mg on the next day as recommended.

If you forget a dose during the treatment once a day (on the 22nd day onwards), patients should take Rivaroxaban as soon as they remember and continue drinking once a day the next day as recommended. Do not doubling the same dose in the same day to compensate for a forgotten dose.

Cases of conversion from vitamin K (VKA) to Rivaroxaban:

When the patient converts from VKA to Rivaroxaban, the Inr values will increase artificially after taking Rivaroxaban.
During the conversion from Rivaroxaban to VKA, there may be incomplete anticoagulants. It is necessary to ensure adequate and continuous anticoagulants in any conversion process to anticoagulants instead. It should be noted that Rivaroxaban may contribute to the increase in the Inr value.
For patients converting from Rivaroxaban to VKA, VKA should be used simultaneously until INR ≥ 2.0. In the first two days of conversion time, the standard VKA dose should be used, followed by the VKA dose based on Inr test.
In case the patient uses both Rivaroxaban and VKA, the Inr should not be tested before 24 h after the previous Rivaroxaban dose but before the next rivaroxaban dose. Once Rivaroxaban is interrupted, the Inr test can be conducted with a reliable level of 24 h after the last dose.
Cases of conversion from anticoagulants injected to rivaroxaban:
For patients currently taking anticoagulant drugs, starting to use Rivaroxaban 0 to 2 hours before the time of use of the next injection (such as low molecular weight heparin) or at the stop of a continuous injection drug (such as non -segmented heparin intravenous injection).
In case of conversion from rivaroxaban to anticoagulant drugs:
The first dose of anticoagulant drugs in the time that will have the next dose of Rivaroxaban.
Dosage for special patients:
Patients with renal function impairment:
Restricted clinical data in patients with severe renal impairment (Creatinine clearance 15 - 29 ml/minute) shows that plasma rivaroxaban levels increase significantly. Therefore, caution should be used for rivaroxaban for these patients. It is not recommended to use in patients with creatinine clearance
In patients with average renal impairment (the clearance of creatinine 30-49 ml/min) or severe (clearine clearance 15-29 ml/min), recommend the application of the following doses:

To prevent stroke and blockage systems in patients with atrial fibrillation due to heart valve disease, the recommended dose is 15 mg once a day. The dose should be considered from 20 mg once daily to 15 mg once a day if the patient's risk of bleeding is not higher than the risk of recurrence DVT and PE. The recommendation of 15 mg is based on the PK model and has not been studied in this clinical context.

No dose adjustments in patients with mild renal impairment (Creatinine clearance 50 - 80 ml/min).

Patients with liver function impairment:

Contraindicated Rivaroxaban in patients with liver disease is accompanied by blood clotting and the risk of clinical bleeding, including cirrhosis patients with Child Pugh B and C.

Children:

The effectiveness and safety of Rivaroxaban has not been determined for children under 18 years old. No data. Therefore, rivaroxaban should not be used for children under 18 years old.

Patients undergo heart rate

Rivaroxaban can be started or continued in patients undergoing heart rate.

For echocardiography through the esophagus (TEE) instructing heart rate in patients who have not been treated for anticoagulants before, Rivaroxaban treatment should be started at least 4 hours before the heart rate to ensure adequate anticoagulants.

For all patients, it must be confirmed before the heart rate that the patient used Rivaroxaban as prescribed.

The decision on the beginning and the duration of treatment should consider the recommendation in the instructions that have been set for anticoagulant treatment in patients undergoing heart rate.

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 you forget 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

When using Rivaxored drugs, you may experience unwanted effects (ADRS).

The frequency of ADRS reports to Rivaroxaban below according to the classification of the organ system (Meddra) and the frequency.

The frequency is determined as follows: Very popular (≥ 1/10), popular (≥ 1/100 to Blood and lymphatic disorders:

Popular: Anemia (including corresponding test parameters).

Unpopular: allergic reactions, atopic dermatitis.

Nervous system disorders:

Popular: Dizziness, headache.

Popular: Eye bleeding (including conjunctiva).

Heart disorders:

Not common: tachycardia.

Popular: Hypotension, hematoma.

Popular: Nosebleeds, coughing up blood.

Gastrointestinal disorders:

Popular: gum bleeding, gastrointestinal bleeding (including rectal bleeding), abdominal pain and stomach, indigestion, nausea, constipation, diarrhea, vomiting.

Uncompleted: Unusual liver function.

Rare: Jaundice.

Popular: itching (including non -common cases of systemic itching), rash, minced bleeding under the skin, skin bleeding and under the skin.

common: Divide headache.

Commonly: Hemorrhagic hemorrhage (including blood and menstrual bleeding), kidney failure (including hypercemosis of blood, hyper uremia) a.

Popular: Fever, peripheral edema, reduce strength and energy (including fatigue and weakness).

Popular: Increasing transaminase. Complications after procedure:

Popular: Bleeding after the procedure (including anemia after surgery and hemorrhage wound) used, secreted from wounds.

B: Observing for the treatment of DVT, PE and prevent recurrence very popular in women

C: Non -frequent observation in patients in blood thrombosis due to atherosclerosis after an ACS therapy (after skin intervention).

When experiencing side effects of the drug, patients need 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

Rivaxored 10mg drug contraindicated in the following cases:

Patients with hypersensitivity to Rivaroxaban or any excipients of the drug. This may include existing gastrointestinal ulcers or recently, a malignant tumor appears with a high risk of bleeding, recently with brain or spine damage, recently surgery for brain, spine or eye, recent intracranial hemorrhage, known or suspected of esophageal varicose veins, venous deformities, vascular aneurysms or large blood vessels in the spine or intracellular. (UFH), low molecular weight heparin (Enoxaparin, Dalteparin, etc.), Heparin derivatives (fondaparinux, etc.), oral anticoagulant (Warfarin, Dabigatran Etexalate, Apixaban, etc ...), except for special cases in the conversion of antipigan drugs or when UFH is used in the UFH to be used to be used to be used to be the dose necessary Aortic or central vein catheter.

Caution when using

should be very cautious when taking the drug for patients in the following cases:

The safety and effectiveness of Rivaroxaban has been studied in combination with anti -platelet drugs, Aspirin and Clopidogrel or Ticlopidine. Treatment combined with other platelet anti -platelets, such as prasugrel or ticagrelor, has not been researched and not recommended.

Clinical monitoring in accordance with the practice of anticoagulants is recommended during treatment.

Risk of bleeding:

Like other anti -thrombotic drugs, Rivaroxaban needs to be used cautiously in patients with signs of bleeding. Recommendation is cautious if there is an increased risk of bleeding. Rivaroxaban should be discontinued if serious bleeding occurs.

In clinical studies on mucosal bleeding (meaning nosebleeds, gums, digestive, urinary-sex) and anemia has appeared more often during long-term Rivaroxaban treatment at the beginning of single or double platelet anti-platelet therapy. Therefore, in addition to appropriate clinical monitoring, hemoglobin/hematocrit testing may have hidden bleeding value, which is considered appropriate.

Some patient subgroups, such as details below, have many risks of bleeding. Therefore, the use of Rivaroxaban combined with dual platelet resistance treatment in patients at high risk of bleeding has been known to be balanced with the prevention of blood thrombosis due to atherosclerosis.

In addition to patients, they must be carefully monitored with signs and symptoms of bleeding and anemia after starting treatment.

Any drop in hemoglobin or blood pressure does not explain it is necessary to think about finding a bleeding position.

Despite treatment with Rivaroxaban does not require regular exposure monitoring, Rivaroxaban level is measured with a remote quantitative calibration test that can be useful in special situations, when knowledge of Rivaroxaban exposure can help clinical decisions, for example, overdose and emergency surgery.

Patients with renal failure:

In patients with severe renal impairment (creatinine clearance

Use rivaroxaban caution in patients with medium renal failure (Creatinine clearance 30 - 49 ml/min) simultaneously with other drugs that increase the level of rivaroxaban in plasma.

interact with other drugs:

It is not recommended to use Rivaroxaban for patients who are using Azole antifungal drugs (such as ketoconazole, iTraconazole, Voriconazole and Posaconazole) or protease inhibitors (eg Ritonavir). These drugs strongly inhibit both CYP3A4 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.

Be cautious in patients with simultaneous use of drugs that affect hemostasis such as nonsteroidal anti -inflammatory drugs (NSAID), acetylsalicylic acid (ASA) and anti -platelets. For patients at risk of gastrointestinal ulcers, they should consider appropriate preventive treatment.

Other bleeding risk factors:

Like other anti -thrombotic drugs, Rivaroxaban needs to be used cautiously in patients with increased risk of bleeding such as:

congenital or suffering bleeding disorders. lungs.

Hirgonary fracture surgery:

Rivaroxaban has not been studied in clinical trials intervention in patients undergoing hip fracture surgery to evaluate safety and effectiveness.

Patients with fake heart valves:

The safety and effectiveness of Rivaroxaban has not been studied in patients with fake heart valves; Therefore, there is no data to prove that Rivaroxaban 20 mg (15 mg in patients with medium or severe renal failure) provides adequate anticoagulant drugs in this patient group. Do not recommend Rivaroxaban treatment for these patients.

PE patients with hemodynamics are unstable or patients need to soluble thrombosis or tricks to remove pulmonary obstruction:

Rivaroxaban is not recommended as an alternative to non -segmented heparin in patients with pulmonary embolism that is unstable in hemodynamics or can be dissolved in thrombosis or a procedure for lung obstruction removal because of the safety and effectiveness of rivaroxaban has not been set in clinical situations.

epidural anesthesia/spinal cord or spinal removal:

When conducting anesthesia of the cerebrospinal axis (external/spinal cord) or spinal cord detection in patients using anti -thrombotic drugs to prevent venous thrombolytic complications, there will be a 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.

To reduce the potential risk of bleeding in combination with simultaneous use of Rivaroxaban and cerebrospinal axis anesthesia (external/spinal cord) or spinal removal, consider Rivaroxaban's pharmacokinetic records.

Placing or withdrawal of epidural catheter or spinal cathematics is best done when Rivaroxaban's anticoagulant effect is estimated to be low. However, the exact time to achieve a low enough anticoagulant effect in each patient is not known.

Do not withdraw the epidural catheter earlier 18 hours earlier since the last time using Rivaroxaban. The next dose of rivaroxaban should be used at the earliest 6 hours after withdrawing the catheter.

If damage caused by poke, it is necessary to delay the use of rivaroxaban until 24 hours later.

recommended dose before and after invasive procedures and surgical intervention:

If surgery or invasive procedure is required, Rivaroxaban is needed to stop rivaroxaban 15 mg before intervention for at least 24 hours, if possible and based on the clinical decision of the doctor.

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 Rivaroxaban as soon as possible when the clinical condition is allowed and when the bleeding is set under the decision of the treating doctor.

Elderly: The risk of bleeding may increase with age.

Information about excipients:

Rivaroxaban contains lactose. Patients with rare genetic problems are galactose intolerance, lactase lactase deficiency, or malposure of glucose-galactose should not use this drug.

Use drugs for pregnant and lactating women

contraindicated Rivaxored for pregnant and lactating women.

The ability to drive and operate machinery

Rivaroxaban has a small impact on the ability to drive and operate machinery. Adverse reactions such as fainting (frequency: not common) and dizziness (frequency: common) have been reported.

Patients with these adverse effects should not drive or control machines.

Drug interaction

drug interactions may affect the activity of the drug or cause side effects. Should notify the doctor or pharmacist a list of drugs and functional foods you are using. Do not use or increase or decrease the dose of the drug without the guidance of a doctor.

CYP3A4 and P-GP inhibitors:

Simultaneously use rivaroxaban with ketoconazole (400 mg once a day) or ritonavir (600 mg twice a day) causes the average AUC of rivaroxaban to increase to 2.5 times/2.6 times and the average CMAX of Rivaroxaban increases to 1.6 times/1.7 times, and the pharmaceutical force also increases significantly, resulting in increased blood bleeding risk.

Therefore, it is not recommended to use Rivaroxaban for patients who are simultaneously using the body of Azole-Etimycotics such as Ketoconazole, Itraconazole, Voriconazole and Posaconazole or HIV Protease inhibitors. These active ingredients are strong inhibitors both CYP3A4 and P-GP.

substances that only inhibit one of the rivaroxaban excretion lines, either CYP3A4 or P-GP, will increase rivaroxaban concentration in plasma to a lesser level. Clarithromycin (500 mg twice a day), for example, is also considered a strong CYP3A4 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 not considered 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 not considered clinical significance.

On those with mild renal impaired patients, erythromycin (500 mg, 3 times/day) increased by 1.8 times the average AUC value of Rivaroxaban and 1.6 times cmax when compared to patients with normal kidney function. On medium -sized patients with patients, erythromycin increases 2 times the average AUC and 1.6 cmax values when compared to the patient with normal kidney function.

Effects of erythromycin are added to the impact of renal failure.

fluconazole (400 mg once a day) is considered a moderate CYP3A4 inhibitor, increasing 1.4 times the average AUC and an increase of 1.3 times cmax of Rivaroxaban's average. This increase is not considered clinical significance.

With limited clinical data with droneedaron, should be avoided simultaneously with rivaroxaban.

Antibiotic drug group:

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.

Due to the increased risk of bleeding, closely monitored if the patient is treated simultaneously with any other anticoagulant drugs.

nsaids/platelet inhibitors:

Do not prolong clinical bleeding time after simultaneous use of rivaroxaban (15 mg) and 500 mg of Naproxen. However, there may be individuals who have a stronger pharmacological response than that.

No observations of pharmacokinetics or pharmacodynamics are clinically significant when using rivaroxaban with 500 mg of acetylsalicylic acid.

Clopidogrel (starting dose of 300 mg, then maintained at a dose of 75 mg) does not cause pharmacokinetic interaction with Rivaroxaban (15 mg). 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.

Need to closely monitor if the patient is treated simultaneously with NSAIDs (including acetylsalicylic acid) and platelet aggregation inhibitors because these are typical drugs that increase the risk of bleeding.

warfarin:

The transfer of patients from vitamin K-resistant warfarin (INR 2,0-3,0) to Rivaroxaban (20 mg) or from Rivaroxaban (20 mg) to Warfarin (INR 2.0-3.0) increases the time of prothrombin/ INR (Neoplastin) rather than added (the single Inr values are detected to 12), while the effects APTT, the active inhibition of far and endogenous factors is plus.

If you want to check the pharmaceutical effects of Rivaroxaban 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 Rivaroxaban.

If you want to check Warfarin's pharmaceutical effects during the conversion, the Inr measurement can be used at Rivaroxaban's CTRough concentration (24 hours after the previous Rivaroxaban dose) because this test is very little affected by Rivaroxaban at this time.

There is no pharmacokinetic interaction that is detected between warfarin and rivaroxaban.

CYP3A4 induction substances:

Simultaneous use of Rivaroxaban with Rifampicin is a strong CYP3A4 induction drug, resulting in a nearly 50% reduction of Rivaroxaban's average AUC, while reducing its pharmacological effect.

The simultaneous use of rivaroxaban with other strong CYP3A4 induction drugs (for example: phenytoin, carbamazepine, phenobarbital or st. John's (Hypericum Perforatum) can also lead to plasma concentrations of rivaroxaban decreasing. Symptoms of thrombosis.

Other simultaneous treatments:

Do not observe any pharmacokinetic or pharmacokinetic interaction with significant significant clinical significance when using a combination of rivaroxaban with Midazolam (the substrate of CYP3A4), digoxin (the substrate of P-GP), Atorvastatin (the substrate of CYP3A4 and P-GP) or Omeprazole (Proton pump inhibitors).

Rivaroxaban does not inhibit nor generating any large CYP isomers like CYP3A4.

Not observing the interaction with food related to clinical.

interact with test parameters:

Lessonic measurement tests (PT, APTT, HEP Test) are expected to be affected by the mechanism of action of rivaroxaban.

Storage

Leave a cool place, avoid light, temperature below 30⁰C.

To be out of reach of children.

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