Xarelto (20mg) 14 Tablets

Xarelto (20mg) 14 Tablets

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  • Manufacturer BAYER PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Rivaroxaban

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • Dosage
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Quick Tips, if any
  • Laboratory Screening
  • Description

    Rivaroxaban is an oral anticoagulant that selectively inhibits factor Xa, a key enzyme in the coagulation cascade. Its mechanism of action involves blocking the active site of factor Xa, thereby preventing the conversion of prothrombin to thrombin and ultimately inhibiting the formation of fibrin clots. By specifically targeting factor Xa, rivaroxaban effectively interrupts the common pathway of coagulation, which is essential for the formation of both venous and arterial thrombi. This inhibition of factor Xa leads to a rapid and predictable anticoagulant response, helping to prevent the development or progression of blood clots in various therapeutic settings.

  • Ingredients

    Rivaroxaban
  • Drug Class

    Oral anticoagulant.

  • Dosage Form

    Tablet

  • Uses

    The following are the uses of Rivaroxaban 20mg Tablet:

    • Used for preventing blood clots after hip or knee replacement surgeries, reducing the risk of blood clots forming and traveling to the lungs.
    • Used for treating deep vein thrombosis (DVT), helping to dissolve existing clots and preventing new ones.
    • Used for managing pulmonary embolism (PE), reducing the risk of recurrent blood clots in the lungs.
    • Used for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
    • Used in certain heart conditions to lower the chances of blood clots forming and causing complications.
    • Used as an alternative to warfarin in patients who prefer a more convenient dosing regimen.
    • Used in patients with a history of blood clots to prevent future episodes and improve blood flow.
    • Used to stabilize the condition of patients with acute coronary syndrome, reducing the risk of cardiovascular events.
  • Dosage

    Tailoring Treatment for Optimal Health, Prescribed Medication Dosage is:

    • Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)- Initially, take 10 mg orally twice a day for 3 weeks, followed by 20 mg once daily.
    • Prevention of strokes and systemic embolisms in patients with non-valvular atrial fibrillation- 5 mg orally twice a day (may increase to 20 mg once daily if necessary).
  • In case of Overdose

    In the case of an overdose of Rivaroxaban 20mg Tablets, it is important to recognize the potential risks. The severity of symptoms may vary, but common signs include excessive bleeding, easy bruising, and prolonged bleeding from cuts. Prompt medical attention is essential to manage the overdose effectively. Treatment may involve supportive care, monitoring vital signs, and administering appropriate medications to control bleeding and support vital organ function. It is crucial to seek medical assistance immediately if an overdose is suspected.

  • Missed Dose

    In the case of a missed dose of Rivaroxaban 20mg Tablet, it is important to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss multiple doses, contact your healthcare provider for guidance, as they may advise you to adjust the timing of your next dose to ensure the medication's effectiveness. It is crucial to maintain a consistent dosing routine for optimal results.

  • How To Use

    To take Rivaroxaban 20mg Tablet, swallow the tablet whole with a glass of water, preferably at the same time each day, as directed by your healthcare professional, without crushing or chewing the medication.

  • When Not to Use

    Following are the conditions/situations when Rivaroxaban 20mg Tablet should not be used:

    • Should not be used in individuals with a known allergy to Rivaroxaban or any factor Xa inhibitors.
    • Contraindicated in patients with active pathological bleeding or a history of bleeding disorders.
    • Not recommended for individuals with severe liver impairment or active liver disease.
    • Should not be used in patients with mechanical prosthetic heart valves.
    • Contraindicated in patients with severe uncontrolled high blood pressure.
    • Not suitable for individuals with a history of spinal surgery or spinal deformity, as it may increase the risk of spinal hematoma.
    • Should not be used in patients with active gastrointestinal bleeding or a history of gastrointestinal lesions.
  • Side Effects

    The side effects of Rivaroxaban 20mg Tablet may include:

    • Increased risk of bleeding, including nosebleeds, bleeding gums, or easy bruising.
    • Headache and dizziness.
    • Nausea and vomiting.
    • Stomach pain or indigestion.
    • Skin rashes or itching.
    • Weakness or fatigue.
    • Increased liver enzymes (liver function tests may be affected).
    • In rare cases, severe allergic reactions.
  • Precautions & Warnings

    Following are the precautions and warnings for Rivaroxaban 20mg Tablet:

    • This medication should be used with caution in patients with a history of bleeding disorders or those currently experiencing active bleeding. Regular monitoring of blood clotting parameters may be necessary.
    • Patients with liver disease should exercise caution as Rivaroxaban is metabolized in the liver, and its effects may be altered.
    • Elderly patients may be more susceptible to bleeding risks, and regular monitoring is recommended.
    • Not recommended for individuals with prosthetic heart valves, as the safety and efficacy in this population have not been established.
    • May cause an increased risk of bleeding during surgical procedures, including dental surgeries. Inform your doctor or dentist about Rivaroxaban use before any procedure.
    • Not suitable for individuals with heparin-induced thrombocytopenia (HIT) or other conditions where heparin is contraindicated.
    • Patients with kidney problems should be monitored closely, as dosage adjustments may be required.
    • Seek immediate medical attention if signs of allergic reactions, such as rash, itching, swelling, or difficulty breathing, occur.
  • Drug Interactions

    Following are the drug interactions for Rivaroxaban 20mg Tablet:

    • Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or aspirin may increase bleeding risk when taken with Rivaroxaban.
    • Anticoagulants such as warfarin, heparin, or enoxaparin can elevate bleeding risks, requiring close monitoring.
    • Antiplatelet agents (e.g., clopidogrel, ticagrelor) may further enhance the risk of bleeding.
    • Drugs that induce or inhibit CYP3A4 and CYP2J2 enzymes, including rifampin, phenytoin, and carbamazepine, can reduce the effectiveness of Rivaroxaban.
    • Certain antifungal medications like ketoconazole and itraconazole may increase Rivaroxaban levels, potentially leading to bleeding.
    • Herbal supplements like St. John's Wort can decrease Rivaroxaban concentrations, reducing its efficacy.
    • Caution is advised with proton pump inhibitors (PPIs) like omeprazole, as they may decrease Rivaroxaban absorption.
  • Food Interactions

    Following are the food interactions for Rivaroxaban 20mg Tablet:

    • Grapefruit and grapefruit juice should be consumed with caution as they may influence the metabolism of Rivaroxaban, potentially leading to increased drug levels in the blood and an elevated risk of bleeding.
    • Avoid excessive alcohol consumption as it can increase the risk of bleeding and may also affect liver function, which is crucial for metabolizing the medication.
    • Green leafy vegetables rich in vitamin K, like spinach and kale, should be consumed consistently. Abrupt changes in vitamin K intake can affect blood clotting.
    • Cranberry juice and cranberry products may increase the risk of bleeding when taken with Rivaroxaban, especially in large amounts.
    • Fish oil supplements and omega-3 fatty acids may have a mild blood-thinning effect, so consult a healthcare provider for dosage adjustments if needed.
    • High-fat meals can affect the absorption of Rivaroxaban, so it is best to take the medication with a consistent and moderate-fat diet.
    • Herbal supplements like St. John's Wort can reduce Rivaroxaban levels, potentially making the medication less effective.
    • Consult a healthcare professional for personalized advice, especially if you have specific dietary preferences or medical conditions that might influence drug interactions.
  • Storage/Disposal

    Rivaroxaban 20mg Tablets should be stored in a cool, dry area, preferably in a medicine cabinet or a designated storage space at room temperature, maintaining a consistent temperature range between 68°F and 77°F (20°C and 25°C). Protect the tablets from light exposure by keeping them in their original packaging or a light-resistant container. Ensure the medication is out of reach of children and pets to prevent accidental ingestion. Do not store the tablets in the bathroom or near the kitchen sink to avoid exposure to moisture. When disposing of unused or expired tablets, do not throw them in the trash or flush them down the toilet. Instead, consult your pharmacist or local waste management guidelines for safe disposal methods to minimize environmental impact.

  • Quick Tips, if any

    Following are the quick tips for Rivaroxaban 20mg Tablet:

    • Take the tablet with a full glass of water at the same time each day as directed by your doctor.
    • It is important to swallow the tablet whole; do not break, crush, or chew it.
    • Rivaroxaban can be taken with or without food, but maintaining a consistent routine is advised.
    • Do not stop taking the medication without consulting your doctor to prevent blood clots.
    • Avoid activities that increase your risk of bleeding, and inform your doctor if you have any bleeding disorders.
    • Regular blood tests may be required to monitor your liver function and blood clotting ability.
    • Keep this medication in its original packaging to protect it from moisture.
  • Laboratory Screening

    Rivaroxaban is a novel, direct factor Xa inhibitor, used for the prevention of venous thromboembolism in acute medically ill patients and the treatment of deep vein thrombosis and pulmonary embolism. It is also used for the reduction of the risk of recurrence of deep vein thrombosis and pulmonary embolism. Lab tests that should be monitored when taking rivaroxaban include prothrombin time (PT) or international normalized ratio (INR) which should be monitored frequently in the first few days of treatment to confirm desired levels are obtained and to detect any evidence of over-anticoagulation. Renal function should also be monitored prior to starting rivaroxaban and periodically thereafter. Close monitoring of renal function is recommended in patients aged 65 and over, those with preconceived renal impairment or dehydration, and those undergoing concomitant nephrotoxic medication. In patients with severe renal impairment CrCl ≤15 mL/min), or with hepatic impairment, rivaroxaban should be used with caution and frequent monitoring of PT or INR is recommended. In patients with mild hepatic impairment, monitoring of PT or INR may be considered. If severe bleeding occurs in a patient receiving rivaroxaban, immediate laboratory assays to assess hemoglobin, hematocrit, and coagulation status are recommended. In case of over-anticoagulation, the dose should be reduced or discontinued dependent on the patient's clinical condition. Immediately intervene if the INR is elevated or if signs and symptoms of bleeding are present. In cases of suspected overdose, priority should be given to assessing and treating bleeding risk and establishing hemodynamic stability.

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