Langitax 15 usarichpharm tablet prevents venous thrombosis (2 blisters x 7 tablets)

Dosage form Box of 2 blisters x 7 tablets
Specifications Rivaroxaban

Ingredient

Composition information	Content
Rivaroxaban	15mg

Uses

Indications

Langitax 15mg drug is indicated in the following cases:

Reduce the risk of stroke and body embolism in patients with atrial fibrillation without valve disease.

Pharmacokology

Mechanism of action

Rivaroxaban is a selective inhibitor of the distant factor without a factor (like antithrombin III). Rivaroxaban inhibits the activity of prothrombinase and freedom. Rivaroxaban does not work directly on platelet aggregation, but indirectly inhibit platelet aggregation caused by thrombin by the way of inhibiting thrombin.

Pharmaceutical effect

The inhibition of active factors depends on the dose of Rivaroxaban has been observed on humans. Prothrombin (PT) time is affected by the dose of rivaroxaban used to be closely correlated with plasma concentrations if using Neoplastin to try. Partial activation time of thromboplastin (APTT) and Heptest is 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. No need to monitor blood clotting parameters during treatment with Rivaroxaban.

pharmacokinetic

absorption

Rivaroxaban's bioavailability depends on the dose. At 10mg dose, oral bioavailability is about 80 - 100% and is not affected by food. At the dose of 20 mg with a non -fat meal, about 66%. The cohesion with food increases the bioavailability of a dose of 20mg (the average AUC increases by 39% and CMAX increases by about 76% when used with food).

Rivaroxaban's

TMAX is 2 - 4 hours later. The pharmacokinetics of Rivaroxaban are not affected by drugs that change the gastric pH.

Distribution

High -connected drugs with plasma proteins (92 - 95%), mainly with albumin. The integral distribution in a healthy state is about 50 liters.

Metabolism

about 51%of the dose of rivaroxaban taken into recalled in the form of inactive metabolites in urine (30%) and feces (21%), the rest is constant. Oxidation catalyzed by CYP3A4/5 and CYP2J2 and hydrolysis are the main paths of metabolism.

Elimination

About two -thirds of the rivaroxaban dose is eliminated in the form of non -activated metabolites through feces and urine, the remaining one -third of the dose is excreted directly through the kidneys in the form of unchanged urine, mainly through positive excretion in the kidneys.

Rivaroxaban is the substrate of transport protein P - GP and breast cancer antagonistic protein (BCRP). Rivaroxaban's affinity with unknown shipping proteins. Rivaroxaban has slow clearance (about 10 liters/hour). The half -life of Rivaroxaban is about 5 - 9 hours in young people, healthy and from 11 - 13 hours in the elderly.

Before taking Langitax 15 usarichpharm tablet prevents venous thrombosis (2 blisters x 7 tablets)

How to use

Do not chew, break or crush the pill. Should use medicine with food.

Dosage

Reducing the risk of stroke and body embolism in patients with atrial fibrillation without valve disease

CrCl> 50 ml/minute: 20 mg/time/day at dinner.

CrCl 15 - 50 ml/minute: 15 mg/time/day at dinner.

Treatment of deep vein thrombosis, pulmonary embolism

15 mg/time x 2 times/day for 21 days. Then take a dose of 10 mg/time/day for maintenance treatment.

Reduce the risk of deep static blood recurrence and pulmonary embolism

20 mg/day/day.

Deep venous thrombosis in patients conducting knee surgery or hip replacement

Hip replacement: 10 mg/day/day for 35 days.

Knee replacement: 10 mg/time/day for 12 days.

Patients who are taking warfarin when switching to Rivaroxaban must stop Warfarin and start Rivaroxaban as soon as the Inr index below 3.0 to avoid the incomplete anticoagulant period.

For patients who are taking another anticoagulant drug Warfarin (low molecular weight heparin or Warfarin oral anticoagulant drugs), start rivaroxaban 0-2 hours before the evening dose of the next schedule of the drug and abandon the dose of other anticoagulants. For heparin, there is no constant segmentation, stop transmission and immediately start Rivaroxaban.

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? Stop rivaroxaban and use appropriate treatments if bleeding complications are related to overdose. There is no specific antidote for Rivaroxaban.

Rivaroxaban concentration in the blood does not increase when taking the dose> 50mg due to absorption limitations. Activated carbon can be used to reduce absorption in the case of rivaroxaban overdose.

Due to the strong cohesion of rivaroxaban with plasma proteins, the separation is not recommended. Using plasma products that can reverse the anticoagulant parameters in vitro.

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 Langitax 15mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Body: Fatigue.

digestive: upper abdominal pain, digestive disorders, toothache, peritoneal bleeding.

Infections and parasites: sinusitis, urinary tract infections.

musculoskeletal: back pain, osteoarthritis, headache, muscle contraction.

Respiratory: throat pain.

Trauma, poisoning and complications after the procedure: Wound secretion.

nerve: fainting, cerebral hemorrhage, epidural hematoma, hemiplegia.

Skin and subcutaneous tissue: itching, urticaria, Stevens - Johnson syndrome. Blood and lymph: Losing leukocytes, platelets. liver: jaundice, cholestasis, hepatitis, liver cell damage.

Immune: Hypersensitivity, anaphylaxis, angioedema.

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

Langitax 15mg contraindications in the following cases:

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

Patients with pathological bleeding or at risk of clinical bleeding.

Patients with renal impairment with creatinine clearance

Patients with liver failure are severe or have any liver disease associated with coagulation disorders.

Pregnant women.

Caution when using

stop using early oral anticoagulant (rivaroxaban ...) increases the risk of thrombosis. Increasing the rate of stroke has been observed during the conversion from Rivaroxaban to Warfarin in clinical trials in patients with atrial fibrillation. If you stop using Rivaroxaban for a reason other than bleeding or completing the treatment process, it is necessary to consider the use of another anticoagulant.

Patients using Rivaroxaban should be carefully observed with signs of bleeding. Precautions and careful monitoring of signs and symptoms of hemorrhage, anemia after starting treatment in patients with increased risk of bleeding such as congenital bleeding disorders or suffering, serious arterial hypertension is uncontrolled, gastrointestinal disease without an active ulcer with potential bleeding (intestinal inflammation, esophagitis, gastritis, gastroesophagitis, esophagus) Need to find bleeding position if a hemoglobin or blood pressure is found.

In patients with severe renal impairment (CrCl

Stop rivaroxaban in patients with acute renal failure. Precautions in medium renal failure patients (CrCl 30 - 40 ml/minute) use simultaneously drugs that can increase Rivaroxaban level.

It is not recommended to use Rivaroxaban in patients with fake heart valves due to the safety and effectiveness of the drug that has not been studied.

Rivaroxaban is not recommended to replace heparin without segmentation in patients with pulmonary embolism with unstable blood dynamics or patients need to soluble thrombosis or open lungs because of the safety and effectiveness of the drug has not been set.

Spinal anesthesia (outside of the epidural/spinal cord):

When conducting spinal anesthesia (outer endometrial/ spinal cord) or spinal cord detection in patients using anti -thrombotic drugs to prevent venous thromboembolic complications, there will be a risk of hematoma in the spinal cord or exterior, leading to prolonged paralysis. The risk of these complications is even increased when placing an external catheter or used simultaneously with drugs that affect hemostasis.

The risk also increases during injury or fibromy spinal cord detection.

Need to regularly monitor signs and symptoms of neurological decline (numb or weak legs, bladder and colon dysfunction) for timely diagnosis and treatment.

Doctors should consider the benefits and risks before spinal anesthesia in patients who use anticoagulants or anticoagulants to prevent thrombosis. Do not withdraw the epidural catheter earlier than 18 hours from the last time using Rivaroxaban. Do not use rivaroxaban earlier 6 hours after withdrawing the catheter. If the damage is caused by a delay, the use of Rivaroxaban should be delayed until 24 hours later.

Caution in the elderly because it may increase the risk of bleeding.

The drug contains lactose. Patients with rare genetic problems are galactose intolerance, lapp lactase deficiency or malposure - Galactose should not take this drug.

The ability to drive and operate machinery

fainted and dizzy has been reported and can affect the ability to drive and control machinery. Patients with these adverse effects should not drive or control machines.

Pregnancy

Classification of pregnancy by FDA.

There is no safety and effectiveness of Rivaroxaban in pregnant women. In Vivo, Rivaroxaban through the placenta fence. So contraindicated use of rivaroxaban during pregnancy.

Breastfeeding period

There is no data on safety and effectiveness of rivaroxaban in breastfeeding women. In Vivo, Rivaroxaban excreted into breast milk. So only use Rivaroxaban when stopping breastfeeding.

Medicinal interaction

Induction drugs P - GP and CYP3A4 (Rifampicin, Phenytoin, Carbamazepin, Phenobarbital, St. John’s Wort) reduce Rivaroxaban concentration in the blood leading to reduced treatment effectiveness of the drug.

P - GP and CYP3A4 inhibitors (Ketoconazole, Itraconazole, Lopinavir/Ritonavir, Indinavir, Clarithromycin, Erythromycin) increase the level of Rivaroxaban in the blood, which can increase the risk of clinical bleeding on clinical.

Anticoagulants: In a drug interactive study, the single dose Enoxaparin (4 mg subcutaneously) and Rivaroxaban (10mg) is simultaneously leading to an increase in remote antagonistic effect. In another study, Warfarin's only dose (15mg) and Rivaroxaban (5 mg) led to an increase in the factor inhibitors and PT. Enoxaparin and warfarin do not affect the pharmacokinetics of rivaroxaban.

simultaneous use of aspirin (dose of 100mg or less) during the double blind period is identified as an independent risk factor for heavy bleeding. The risk of bleeding increases when NSAID is used simultaneously with Rivaroxaban. No pharmacological interactions or pharmaceuticals when using the only dose Naproxen or aspirin with rivaroxaban.

Simultaneous use Clopidogrel with Rivaroxaban may increase bleeding time by 2 times compared to single use of each drug. There is no change in pharmacokinetics of each drug.

Storage

In a dry place, avoid light, the temperature does not exceed 30 ° C.

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