GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Rivaroxaban Tablets (2.5mg)
B. Rivaroxaban Tablets (10mg)
C. Rivaroxaban Tablets (15mg)
D. Rivaroxaban Tablets (20mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Rivaroxaban Tablets (2.5mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………2.5mg
Excipients…………………………………. q.s.
Colours: Titanium Dioxide USP

B. Rivaroxaban Tablets (10mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………10mg
Excipients…………………………………. q.s.
Colours: Ferric Oxide Red USP-NF


C. Rivaroxaban Tablets (15mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………15mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Yellow

D. Rivaroxaban Tablets (20mg)
Composition:
Each film-coated tablet contains:
Rivaroxaban ………………………………20mg
Excipients…………………………………. q.s.
Colours: Iron Oxide Black

THERAPEUTIC INDICATIONS:

Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
PHARMACIST: Please dispense with medication guide provided separately.
WARNING: To be sold by retail on the prescription of a psychiatrist only.
Medicinal product subject to medical prescription.
Prescription medicines once daily.
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.

Rivaroxaban Tablets 10mg Technical Specification:

Product Name:Rivaroxaban Tablet 10mg
Brand Name:Ravetaj
Strength:2.5mg, 10mg, 15mg, 20mg
Dosage Form:Film-coated tablets
Packing:5s Blisters, 7s Blisters, 10s Blisters, 14s Blisters, 28s Blisters, 98s Blisters
Route of Administration:For Oral Use Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anticoagulants, Cardiovascular
Indication: Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.
Storage:Store protected from moisture at a temperature not exceeding 25°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Rivaroxaban Tablets (10mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rivaroxaban Tablets (10mg)
    Composition:
    Each film-coated tablet contains:
    Rivaroxaban ………………………………10mg
    Excipients…………………………………. q.s.
    Colours: Ferric Oxide Red USP-NF

THERAPEUTIC INDICATIONS:

Rivaroxaban Tablet is used to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after hip or knee replacement surgery. It is also used to prevent blood clots from forming in high-risk patients with limited mobility during their hospital stay and after discharge.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
PHARMACIST: Please dispense with medication guide provided separately.

WARNING: To be sold by retail on the prescription of a psychiatrist only.
Medicinal product subject to medical prescription.
Prescription medicines once daily.
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage:  Store protected from moisture at a temperature not exceeding 25°C.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

When it comes to Rivaroxaban Tablets, Taj Pharma stands out as your dependable partner. With a rich history of unwavering commitment to pharmaceutical excellence, Taj Pharma is the preferred choice for those seeking top-quality anticoagulant medications. Our Rivaroxaban Tablets are meticulously crafted to meet the highest industry standards, ensuring safety and efficacy for patients requiring anticoagulation therapy. At Taj Pharma, we prioritize your well-being and peace of mind. Our dedication to research and development guarantees that you receive the latest advancements in medication technology. Whether you’re a healthcare professional or a patient, you can trust Taj Pharma’s Rivaroxaban Tablets to provide consistent results and help manage conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AFib).

Join the countless individuals and healthcare providers who rely on Taj Pharma for their pharmaceutical needs. Choose Taj Pharma for Rivaroxaban Tablets and experience the difference of pharmaceutical excellence. Your health deserves nothing less than the best, and Taj Pharma delivers precisely that.

What is Rivaroxaban Tablets and its use?

Rivaroxaban tablets are a medication that belongs to a class of drugs known as direct oral anticoagulants (DOACs). Rivaroxaban is the active ingredient in these tablets, and it is used to prevent and treat various conditions related to abnormal blood clotting. Here’s an overview of Rivaroxaban Tablets and their uses:

  • Anticoagulation: Rivaroxaban is primarily prescribed as an anticoagulant, which means it helps prevent the formation of blood clots. It works by inhibiting a specific clotting factor called Factor Xa, which plays a crucial role in the blood clotting cascade.
  • Deep Vein Thrombosis (DVT): Rivaroxaban is often used to prevent and treat deep vein thrombosis (DVT). DVT is a condition in which blood clots form in the deep veins of the legs or other parts of the body. Left untreated, DVT can lead to serious complications, such as pulmonary embolism.
  • Pulmonary Embolism (PE): Rivaroxaban is also used to prevent and treat pulmonary embolism (PE), which occurs when a blood clot travels to the lungs. PE is a potentially life-threatening condition, and anticoagulant therapy can help prevent its recurrence.
  • Atrial Fibrillation (AFib): Rivaroxaban may be prescribed to individuals with atrial fibrillation (AFib), a heart rhythm disorder that can increase the risk of stroke due to blood clots forming in the heart’s chambers. It helps reduce the risk of stroke and systemic embolism in patients with AFib.
  • Post-Surgical Prophylaxis: In some cases, Rivaroxaban may be used for the prevention of blood clots following major orthopedic surgeries, such as hip or knee replacement surgery.
  • Other Uses: Rivaroxaban may be considered for other conditions or surgical procedures where blood clot prevention is necessary, as determined by a healthcare provider.

Rivaroxaban is a prescription medication, and its use should be carefully monitored by a healthcare professional. The dosage and duration of treatment will depend on the specific medical condition being treated, as well as individual patient factors. As with any anticoagulant, there is a risk of bleeding associated with Rivaroxaban, so it should be taken exactly as prescribed.

How does Rivaroxaban Tablets Work?

Rivaroxaban tablets work by inhibiting a specific clotting factor in the blood known as Factor Xa. Factor Xa is a crucial component of the coagulation cascade, the complex series of events that leads to the formation of blood clots. By blocking Factor Xa, Rivaroxaban interferes with this cascade and prevents the formation of blood clots. Here’s how it works:

  • Normal Blood Clotting: In response to injury or other triggers, the body initiates a process called blood clotting to stop bleeding. The coagulation cascade involves a series of steps that lead to the conversion of inactive proteins into active enzymes, ultimately forming a stable blood clot.
  • Role of Factor Xa: Factor Xa is one of the key enzymes in the coagulation cascade. It plays a pivotal role in converting prothrombin into thrombin, an enzyme that converts fibrinogen into fibrin. Fibrin is the protein that forms a mesh-like structure, reinforcing the blood clot.
  • Inhibition by Rivaroxaban: Rivaroxaban is a direct oral anticoagulant (DOAC) that specifically inhibits Factor Xa. It binds to Factor Xa in the bloodstream, preventing it from carrying out its role in the coagulation cascade.
  • Preventing Blood Clot Formation: By inhibiting Factor Xa, Rivaroxaban disrupts the formation of thrombin and, consequently, the conversion of fibrinogen to fibrin. This leads to a reduction in the formation of blood clots in the arteries and veins.
  • Anticoagulation: The anticoagulant effect of Rivaroxaban makes it useful in preventing and treating conditions associated with abnormal blood clot formation, such as deep vein thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation (AFib), and post-surgical clot prevention.

Rivaroxaban is a specific and targeted anticoagulant that primarily affects the clotting pathway in the bloodstream. Unlike older anticoagulants like warfarin, which require frequent monitoring and dosage adjustments, Rivaroxaban has a more predictable effect and often does not require regular blood tests. However, it should be taken as prescribed by a healthcare provider to maintain its therapeutic effect while minimizing the risk of bleeding complications. Patients taking Rivaroxaban should follow their healthcare provider’s guidance closely and report any unusual bleeding or side effects.

Benefits of Rivaroxaban Tablets:

  • Effective Anticoagulation: Rivaroxaban is an effective anticoagulant (blood thinner) that helps prevent and treat conditions associated with abnormal blood clotting, such as deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AFib). It reduces the risk of clot formation, potentially preventing serious complications.
  • Convenience: Unlike older anticoagulants like warfarin, Rivaroxaban does not require frequent monitoring of blood clotting parameters (INR), making it more convenient for patients. This allows for a more predictable dosing regimen.
  • Oral Administration: Rivaroxaban is taken orally (by mouth) as a tablet, eliminating the need for injections, which can be a significant advantage for patients.
  • Stroke Prevention: In patients with non-valvular atrial fibrillation (a type of irregular heart rhythm), Rivaroxaban helps reduce the risk of stroke and systemic embolism.
  • Post-Surgical Clot Prevention: Rivaroxaban may be used for post-surgical clot prevention after certain major orthopedic surgeries, such as hip or knee replacement surgery, reducing the risk of DVT and PE.

Side Effects of Rivaroxaban Tablets:

  • Bleeding: Anticoagulants like Rivaroxaban can increase the risk of bleeding. Common signs of bleeding include nosebleeds, bruising, prolonged bleeding from minor cuts, and gum bleeding. It’s important to promptly report any unusual bleeding to a healthcare provider.
  • Gastrointestinal Disturbances: Some individuals may experience gastrointestinal symptoms like nausea, indigestion, or abdominal pain while taking Rivaroxaban.
  • Headache: Headaches are a possible side effect but are typically mild and temporary.
  • Low Hemoglobin: Rivaroxaban may cause a slight decrease in hemoglobin levels in some patients.
  • Allergic Reactions: Allergic reactions to Rivaroxaban are rare but can include symptoms like rash, itching, swelling, severe dizziness, and difficulty breathing. Seek medical attention immediately if you experience these symptoms.
  • Liver Enzyme Changes: In some cases, Rivaroxaban may cause mild elevations in liver enzyme levels. Regular monitoring during treatment is recommended.
  • Kidney Function: Rivaroxaban can affect kidney function in certain individuals. Kidney function may be monitored during treatment.
  • Reduced Platelets: Rarely, Rivaroxaban may lead to a decrease in platelet counts (thrombocytopenia), which can affect blood clotting. Regular blood tests may be necessary to monitor platelet levels.

It’s important for individuals taking Rivaroxaban to adhere to their prescribed dosing regimen and to report any side effects or concerns to their healthcare provider promptly. Dosage adjustments or changes may be necessary based on individual factors and the specific medical condition being treated. While Rivaroxaban offers significant benefits in managing certain conditions, it should only be used under the guidance of a healthcare professional.

Frequently asked questions (FAQs) about Rivaroxaban Tablets:

  1. What is Rivaroxaban, and what is its primary use?

Rivaroxaban is a medication classified as a direct oral anticoagulant (DOAC). It is primarily used to prevent and treat conditions related to abnormal blood clotting, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AFib).

  1. How does Rivaroxaban differ from traditional anticoagulants like warfarin?

Unlike warfarin, Rivaroxaban does not require frequent blood testing (INR monitoring) to adjust the dosage. It has a more predictable effect and is often more convenient for patients.

  1. What should I do if I miss a dose of Rivaroxaban?

If you miss a dose, take it as soon as you remember on the same day. If it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double dose to make up for a missed dose.

  1. Are there dietary restrictions while taking Rivaroxaban?

Rivaroxaban does not have the same dietary restrictions as warfarin. However, it’s advisable to maintain a balanced diet and consult with your healthcare provider regarding specific dietary considerations.

  1. How can I recognize signs of bleeding while taking Rivaroxaban?

Common signs of bleeding include nosebleeds, bruising easily, prolonged bleeding from minor cuts, gum bleeding, blood in the urine or stool, and unusually heavy menstrual bleeding. Report any of these symptoms to your healthcare provider.

  1. Can I drink alcohol while on Rivaroxaban?

Moderate alcohol consumption is generally considered safe while taking Rivaroxaban. However, excessive alcohol intake can increase the risk of bleeding, so it’s best to consume alcohol in moderation.

  1. What should I do if I need surgery or dental work while taking Rivaroxaban?

It’s important to inform your surgeon or dentist about your Rivaroxaban use well in advance of any procedures. Your healthcare provider may recommend temporarily discontinuing the medication or adjusting the dosage to minimize bleeding risk.

  1. Can I take overthecounter medications or herbal supplements with Rivaroxaban?

It’s important to discuss any new medications, including overthecounter drugs and herbal supplements, with your healthcare provider. Some medications and supplements can interact with Rivaroxaban and affect its effectiveness or increase the risk of bleeding.

  1. How long will I need to take Rivaroxaban?

The duration of Rivaroxaban treatment depends on the specific medical condition being treated and individual factors. Your healthcare provider will determine the appropriate duration for your therapy.

  1. Are there any specific precautions for pregnant or breastfeeding individuals taking Rivaroxaban?

Pregnant and breastfeeding individuals should discuss the use of Rivaroxaban with their healthcare provider. The benefits and risks will be weighed carefully, and alternative treatments may be considered.

As Rivaroxaban Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Rivaroxaban Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Rivaroxaban Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Rivaroxaban Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274