Xarelto 15mg Bayer prevents venous thrombosis (1 blister x 14 tablets)

Dosage form Box of 1 blister x 14 tablets
Specifications Rivaroxaban

Ingredient

Composition information	Content
Rivaroxaban	15mg

Uses

Indications

xarelto 15mg are indicated in case of:

Preventive stroke and body embolism in patients with atrial fibrillation due to heart valve disease have a risk factor or more such as: heart failure, hypertension, ≥ 75 years old, diabetes, a history of stroke or anemia is anemia.

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Rivaroxaban is a high selective direct inhibitor for long -term oral factors. The activation of factor X into a remote factor (FXA) through the endogenous and external pathway plays a central role in the blood clotting waterfall. FXA directly converts prothrombin into thrombin through prothrombinase complex and finally, leading to the formation of fibrin blood clots and platelet activation by thrombin. A FXA molecule is capable of creating over 1,000 thrombin molecules due to the amplified nature of the blood clotting waterfall.

Pharmacological effect

The inhibition of remote factors depends on the dosage recorded on humans. Prothrombin time (PT), prothrombin time is partially activated (APTT) and Heptest® are also prolonged depending on the dose depends on the dose. No need to monitor blood coagulation parameters during treatment with Xarelto.

Dynamic pharmacokinetics

absorption and bioavailability

Rivaroxaban absorbs oral and oral bioavailability (80 - 100%). Maximum concentration (cmax) after 2-4 hours of taking medicine.

Distribution

Conducting protein in plasma is approximately 92% to 95%. VSS distribution volume is about 50 L.

Metabolism and elimination

Rivaroxaban is metabolized through CYP 3A4, CYP 2J2 mechanisms and non -dependent CYP mechanisms. The sale time is about 5 - 9 hours in young people and about 11 - 13 hours in the elderly.

Before taking Xarelto 15mg Bayer prevents venous thrombosis (1 blister x 14 tablets)

How to use

use orally, should be taken with food.

can grind Xarelto pills and mix with water or soft food like apple juice right before use and be used by oral. After taking Xarelto tablets, it should be followed immediately with food.

The crushed Xarelto tablet can be given through the gastric catheter, the crushed drug must be used with a small amount of water through the gastric catheter and then added water. After taking Xarelto tablet is crushed, it should be followed immediately with feeding through the intestinal tract.

Dosage

adults

Prevention of stroke and body embolism in the atrial fibrillation patient (Spaf)

recommended dose is 20 mg x 1 time/day.

The treatment with Xarelto should be continued for a long time provided that the benefits of stroke prevention and body embolism are superior to the risk of bleeding.

Treatment and prevent relapse DVT and PE

Day 1 to 21: dose 15 mg x 2 times/day, maximum 30 mg/day.

Day 22 and day later: dose 20 mg x 1 time/day, maximum 20 mg/day.

Treatment time should be carefully evaluated for the benefits of treatment compared to the risk of bleeding depending on individual.

Short treatment time (at least 3 months) should be based on temporary risk factors (for example, surgery, injury, recent immobile) and longer treatment time, based on permanent risk factors or patients with DVT or PE patients with no onset factors.

Transferring from vitamin K (VKA) to Xarelto.

For patients with preventive treatment stroke and body embolism, should stop VKA treatment and start with Xarelto when the INR ≤ 3.

For patients for treatment and prevent relapse DVT, PE, should stop treatment with VKA and start with Xarelto when the index Inr ≤ 2.5.

Switch from Xarelto to vitamin K anti -vitamin drugs

In patients who move from Xarelto to VKA, should use simultaneously Xarelto and VKA until the index Inr ≥ 2.0. In the first two days of the drug conversion phase, VKA dose adjusted according to Test Inr used after the VKA standard dose. When patients use simultaneously Xarelto and VKA, should check the Inr number before the next dose of Xarelto but after 24 hours compared to the previous dose. When stopping using Xarelto, conducting Inr 24 hours after the last dose.

Switch from anticoagulants to Xarelto.

Stop using anticoagulants and start taking Xarelto 0 - 2 hours before the next use of the injection or at the time of stopping intravenous drugs.

Transferring from Xarelto to anticoagulant drugs

Stop taking Xarelto and start the first dose of the anticoagulant drug at the time of the next xarelto dose.

Special subjects

kidney failure

Patients with average renal impairment (crCl = 30 - 49 ml/minute) or severe (crCC = 15 - 29 ml/minute):

In the prevention of stroke and body embolism in patients with atrial fibrillation due to the heart valve (spaf), the recommended dose is 15 mg once a day.

In treatment and prevent recurrence of DVT and PE: Patients should be treated 15 mg x 2 times/day for the first 3 weeks. Then, when the recommended dose is 20 mg x 1 time/day, it is advisable to consider reducing the dose from 20 mg x 1 time/day to 15 mg x 1 time/day if the risk of bleeding is assessed to be more than the risk of DVT and PE recurrence.

Older people

No dose adjustment.

Children

Xarelto 15mg is not recommended for children under 18 years of age.

Patients need rhythm

For patients with rhythms based on ultrasound through the esophagus without previous anticoagulant treatment, Xarelto should be started at least 4 hours before the rhythm to ensure adequate anticoagulant effect.

Patients who have been pci (coronary artery intervention) with stent

Patients with atrial fibrillation are not caused by valve disease, people who are performed PCI have stent should be used by a dose of 15 mg xarelto x 1 time/day (or 10 mg xarelto x 1 time/day for patients with average renal impairment [CrCl: heart valve disease .

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?

There is no specific detoxification substance against the pharmacological effect of Rivaroxaban.

Bleeding treatment

In patients with Rivaroxaban if a bleeding complication occurs, the next treatment should be temporarily suspended or stopped completely if appropriate, using symptomatic treatments if necessary.

What to do when forgetting a dose?

If the patient forgets to take a dose of the drug, you should take xarelto as soon as you remember and continue to drink once a day as recommended on the following days. Do not use twice the same day to compensate for the forgotten dose.

Treatment and prevention of recurrence DVT and PE

If the patient forgets to take a dose of 15 mg in the diet 2 times/day (1 - 21), should take Xarelto immediately to ensure enough 30 mg of xarelto per day. In this case, you can take 2 tablets of Xarelto 15 mg at the same time.

Patients should continue at a dose of 15 mg x 2 times/day as recommended for the following days.

If the patient forgets to take the drug in the dosage 1 time/day (from the 22nd onwards), should take Xarelto immediately and continue in the following days with a dose 1 time/day as recommended. Do not double the dose in the same day to compensate for the forgotten dose.

Side Effects

When using Xarelto 15mg , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Blood, hematology: Anemia .

Eyes: Eye bleeding.

Gastrointestinal: Bleeding gums, gastrointestinal bleeding, abdominal pain, indigestion, nausea, constipation, diarrhea, vomiting.

Hand limbs: Pain in Chi.

Damage, toxicity, postoperative complications: postoperative bleeding, stamping.

Neurology: headache, dizziness.

Other disorders: fever, peripheral edema, decreased strength, general energy, nosebleeds, itching, skin hemorrhage, skin hematoma, ...

Uncommon, 1/1000

Blood, hematology: platelet increase.

heart: tachycardia.

Digestive: dry mouth.

Damage, toxicity, postoperative complications: hemorrhage wounds.

Neurology: brain bleeding and endoscopy, fainting.

GOODS: Hematoma.

Other disorders: discomfort, reduced liver function, urticaria ...

Rare, 1/10000

Body: edema, jaundice.

Cardiovascular: bulge.

Metabolism: Increased conjugated bilirubin levels (with or not increased by ALT).

skeletal muscle: muscle bleeding.

Unknown frequency

Systemic: Evaluation, allergies.

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

Xarelto 15mg contraindicated in the following cases:

Patients with hypersensitivity to rivaroxaban or any ingredients of the drug.

Patients with clinical bleeding (such as intracranial bleeding, gastrointestinal bleeding).

Patients are being treated with other anticoagulants, except for specific cases during the transition from one anticoagulant to another anticoagulant or when heparin is not segmented to maintain the opening of the artery or central vein.

Patients with liver disease are associated with coagulation disorders and the risk of clinical bleeding, including patients with cirrhosis with Child Pugh B and C.

Pregnant women and during breastfeeding.

Caution when using

Hemorrhage risk

Recommendations should be used carefully in diseases that increase the risk of bleeding:

congenital or suffering bleeding disorders.

serious arterial hypertension is uncontrolled.

Gastrointestinal ulcer is progressing.

Recent gastrointestinal ulcers.

Retinal disease caused by blood vessels.

Recent intracranial bleeding or brain bleeding.

Vascular abnormalities in the spinal cord or in the brain.

Surgery for brain, spinal cord or recent ophthalmology.

bronchodilator or a history of pulmonary bleeding.

Stop using xarelto if bleeding. During Rivaroxaban treatment, mucosal bleeding (nosebleeds, gums, gastrointestinal, genital anur) and anemia are more common than VKA treatment. Haemoglobin/Haematocrit tests may have covered bleeding value.

Need to monitor patients who are simultaneously taking medications that affect the hemostasis - coagulation such as nonsteroidal anti -inflammatory drugs (NSAID), platelet or other anti -thrombotypes inhibitors.

surgery and intervention

Should stop treatment with Xarelto at least 24 hours before the intervention if possible and based on the clinical assessment of the doctors. If it is not possible to delay the procedure, it is advisable to assess the increased risk of bleeding with the urgency of intervention. Should start using Xarelto after surgery or intervention as soon as the clinical condition is allowed and the wound has been stopped.

Neurotic anesthesia (outer endometrial/spinal cord)

Consider risks and benefits before neurotransmit intervention in patients who have or are about to use anticoagulant to prevent thrombosis. Do not withdraw the epidural catheter sooner than 18 hours after the last xarelto. Should drink xarelto earliest 6 hours after removing the catheter. If there is a injury due to poke, should drink xarelto slow down 24 hours.

Patients with artificial valve replacement, DVT and PE treatment in patients with pulmonary embolism with unstable hemodynamics or patients need to soluble thrombosis or procedures for removal of pulmonary embolism, patients who are performed PCI have stent

Clinical data is limited, so be cautious when using xarelto for the above objects.

Renal function impairment

Be cautious when using Xarelto simultaneously with other drugs in patients with average renal function because it can increase plasma rivaroxaban levels.

Be cautious when indicating xarelto for patients with CrCl

Women of reproductive age

Only use Xarelto 15mg for women of reproductive age while using contraception.

The ability to drive and operate machinery

There have been reports on cases of fainting and dizziness and can affect the ability to drive and operate machinery. Patients encountering these harmful reactions should not drive or use machines.

Pregnancy

Contraindicated Xarelto in pregnant women.

Breastfeeding period

Contraindications for Xarelto during breastfeeding.

Drug interaction

pharmacokinetic interaction

Rivaroxaban is excreted mainly through metabolism in the liver thanks to the intermediary Cytocrom P450 (CYP3A4, CYP2J2) and excreted through the kidneys in a constant form, related to P -Glycoprotein transportation system (P - GP)/Breast cancer protein (BCRP).

Use Xarelto simultaneously with strong CYP 3A4 and P - GP inhibitors such as antifungal groups of Azole Sugar Sugar (Ketoconazole, Itraconazole, Voriconazole and Posaconazole ), HIV Protase Inhibitors (Ritonavir), Erythromycin antibiotic increase Rivaroxa in Rivaroxa concentration Tuong.

In contrast, when using Xarelto simultaneously with CYP3A4 and P - GP induction substances such as Rifampicin, Phenytoin, Carbamazepin, Phenobarbital or St. John's Wort will lead to reduced plasma rivaroxaban levels.

Pharmacological interaction

Due to the risk of increasing the risk of bleeding, it is important to pay attention when treated simultaneously with any other blood clotting drugs such as Enoxaparin, NSAIDs, platelet aggregation inhibitors, warfarin, ...

Food and dairy foods

Xarelto 15mg tablets can be taken with food.

Testing parameters

Blood coagulation test parameters (PT, APTT, Heptest ®) may be affected by Xarelto's action mechanism.

Storage

Do not leave the drug at a temperature of over 30 ° C.

Other drugs

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