Rivaflo 15mg Tab

RIVAFLO 15MG TAB is an anticoagulant medication manufactured by SUN PHARMA LABORATORIES LTD..

Name

• Brand Name: RIVAFLO 15MG TAB
• Common Name: Rivaroxaban (active ingredient)

Composition

Each tablet contains Rivaroxaban 15 mg as the active ingredient.

Uses

RIVAFLO 15MG TAB is primarily used as a blood thinner to prevent and treat blood clots. Its key applications include:

• Preventing stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
• Treating deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Preventing recurrence of DVT and PE.
• Reducing the risk of blood clot formation in patients who have undergone knee or hip replacement surgeries.
• Managing thrombosis in children (2 years and older) with congenital heart disease post-Fontan procedure.
• Reducing the risk of major cardiovascular events in patients with coronary artery disease (CAD) and major thrombotic vascular events in patients with peripheral artery disease (PAD).

Dosage and Administration

RIVAFLO 15MG TAB is taken orally, typically once daily, as prescribed by your doctor. It can be taken with or without food, but for doses of 15 mg or more, it is often recommended to take it with food for better absorption. It is important to take the tablet at the same time each day for maximum benefit. Do not chew, crush, or break the tablet; swallow it whole with water. Do not stop taking the medicine or change the dose without consulting your doctor, as this could increase the risk of blood clot formation.

Side Effects

Common side effects of RIVAFLO 15MG TAB include:

• Bleeding (e.g., nosebleeds, bleeding gums, heavy menstrual bleeding, bruising, gastrointestinal bleeding, blood in urine).
• Headache, dizziness, weakness, or fatigue.
• Nausea, vomiting, constipation, or diarrhea.
• Pain and swelling in the limbs.

Serious side effects, though less common, can include severe bleeding, allergic reactions, liver problems, and kidney dysfunction.

Precautions

• Bleeding Risk: RIVAFLO 15MG TAB increases the risk of bleeding. Be cautious with activities that may cause injury and immediately report any unusual or excessive bleeding to your doctor.
• Contraindications: This medicine should not be used in individuals with active pathological bleeding, severe liver disease associated with coagulopathy, or known allergy to rivaroxaban.
• Specific Conditions: Use with caution in patients with kidney disease, uncontrolled high blood pressure, stomach or intestine ulcers, or a history of bleeding disorders.
• Pregnancy and Breastfeeding: RIVAFLO 15MG TAB is generally not recommended during pregnancy or breastfeeding, as it may be unsafe and can increase the risk of bleeding in the mother or unborn baby.
• Alcohol and Food Interactions: Limit or avoid alcohol consumption as it can increase the risk of bleeding. Avoid grapefruit and grapefruit juice as they can increase the activity of rivaroxaban and thus bleeding risk.
• Drug Interactions: Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal products, and supplements. Concomitant use with other anticoagulants, antiplatelet agents (like aspirin), NSAIDs (like ibuprofen), some antifungal agents (e.g., fluconazole), and certain antivirals (e.g., ritonavir) can increase the risk of bleeding.

Storage

Store RIVAFLO 15MG TAB below 30°C. Keep it in a cool and dry place, away from direct sunlight and moisture, and out of the sight and reach of children.

RIVAFLO 15MG TAB contains Rivaroxaban, which is an anticoagulant (blood thinner) used to prevent and treat blood clots.

What is RIVAFLO 15MG TAB used for?

RIVAFLO 15MG TAB is primarily used to prevent and treat various conditions involving blood clots. These include treating and preventing deep vein thrombosis (DVT), which are blood clots in the legs, and pulmonary embolism (PE), which are blood clots in the lungs. It is also prescribed to reduce the risk of stroke and systemic embolism in individuals with non-valvular atrial fibrillation (an irregular heartbeat). Additionally, it can be used for the prevention of DVT after hip or knee replacement surgery and to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) or peripheral artery disease (PAD), often in combination with aspirin. In some pediatric cases, it is used for the treatment and prevention of venous thromboembolism.

How does RIVAFLO 15MG TAB work?

RIVAFLO 15MG TAB contains Rivaroxaban, which is a selective, direct Factor Xa inhibitor. Factor Xa is a crucial enzyme in the blood clotting cascade. By blocking the activity of Factor Xa, Rivaroxaban effectively interrupts the coagulation cascade, which prevents the formation of thrombin and the subsequent development of blood clots. It works without directly affecting thrombin or platelets, but indirectly inhibits platelet aggregation.

What is the usual dosage for RIVAFLO 15MG TAB?

The dosage of RIVAFLO 15MG TAB varies depending on the condition being treated. For the initial treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), the typical dose is 15mg twice daily with food for the first 21 days, followed by 20mg once daily with food. For preventing stroke in patients with non-valvular atrial fibrillation, it's usually 20mg once daily with food, with a lower dose of 15mg once daily with food considered for those with kidney problems. For prevention of DVT after hip or knee replacement surgery, the dosage is generally 10mg once daily. It is important to note that 15mg and 20mg tablets should always be taken with food to ensure proper absorption. If you have difficulty swallowing, the tablets can be crushed and mixed with applesauce or water and taken immediately.

What are the possible side effects of RIVAFLO 15MG TAB?

The most common and serious side effect of RIVAFLO 15MG TAB is bleeding, which can manifest as bleeding gums, nosebleeds, prolonged bleeding from cuts, unusually heavy or long menstrual periods, blood in urine or stools (which may appear black and tarry), or increased bruising. Other common side effects may include back pain, headache, dizziness, nausea, stomach pain, vomiting (particularly in children), fatigue, rash, itching, and anemia (low red blood cell count). Serious but less common side effects can include severe headache, stiff neck, confusion, changes in vision, or numbness/weakness in the legs or feet, which could indicate a spinal hematoma. Allergic reactions are also possible.

Is RIVAFLO 15MG TAB safe during pregnancy or breastfeeding?

Pregnancy: RIVAFLO 15MG TAB is not recommended during pregnancy and should not be taken. If you are planning to become pregnant or become pregnant while taking this medication, you should consult your doctor immediately as another medication will be necessary. Serious fetal side effects, such as bleeding, may occur.

Breastfeeding: Rivaroxaban, the active ingredient, passes into breast milk in very small amounts. While some studies suggest minimal infant exposure and no reported side effects, there is limited long-term data available. Therefore, while it may be considered compatible, your doctor might recommend a different medication with more established safety information for breastfeeding, or suggest monitoring your baby for any signs of bruising or bleeding.

Can RIVAFLO 15MG TAB be taken with other medications?

It is crucial to inform your doctor about all prescription and non-prescription medications, vitamins, and herbal supplements you are currently taking or plan to take. Taking RIVAFLO 15MG TAB with other blood thinners (like warfarin or enoxaparin), non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen, or certain antiplatelet agents (like clopidogrel) can significantly increase the risk of bleeding. There can also be interactions with certain antifungal medications (e.g., fluconazole), antivirals (e.g., ritonavir), and antiepileptic drugs (e.g., carbamazepine, phenytoin). The herbal remedy St. John's wort can increase the risk of side effects. Paracetamol is generally considered safe to take with Rivaroxaban. Rivaroxaban is noted to have fewer drug interactions compared to warfarin.

What precautions should be taken while taking RIVAFLO 15MG TAB?

Do not stop taking RIVAFLO 15MG TAB without first consulting your doctor, as discontinuing it prematurely can significantly increase your risk of blood clots or stroke. You are at an increased risk of bleeding while on this medication, especially if you have certain medical conditions such as liver or kidney problems, active bleeding, or a history of stomach/bowel ulcers or recent stroke. Always inform any doctor or dentist treating you that you are taking Rivaroxaban before any surgery, dental work, or other medical procedures, as the medication may need to be temporarily stopped. If you undergo a spinal procedure (e.g., epidural or spinal tap), there is a risk of a blood clot forming around the spine, which could lead to paralysis. Immediately report any pain, tingling, numbness, or weakness in your legs or feet. To minimize injury and bleeding, avoid contact sports, be careful with sharp tools, and consider using an electric razor and a soft-bristled toothbrush. It is also advisable to carry a medical ID card or bracelet. Avoid heavy alcohol consumption while on this medication, as it can increase bleeding risk.

What happens if a dose of RIVAFLO 15MG TAB is missed?

If you miss a dose of RIVAFLO 15MG TAB, what you should do depends on your prescribed dosing schedule:

• For a 15mg twice daily dosage: Take the missed dose as soon as you remember on the same day. You may take two 15mg tablets at the same time to ensure you get the total daily dose of 30mg. Then, continue with your regular twice-daily schedule the next day.
• For a once daily dosage (10mg, 15mg, or 20mg): Take the missed dose as soon as you remember on the same day. Do not take a double dose the next day to compensate for the missed one. Simply continue with your regularly scheduled dose the following day.
• If a child taking the oral liquid vomits or spits up within 30 minutes after taking the medicine, another dose should be given. If it's more than 30 minutes, the next dose should be given at the regular time.

How should RIVAFLO 15MG TAB be stored?

RIVAFLO 15MG TAB should be stored in its original packaging in a closed container at room temperature, typically below 25°C (or between 20°C to 25°C), away from excessive heat, moisture, and direct light. Always keep all medicines out of the sight and reach of children. If the tablet is crushed and mixed with applesauce or water, it must be consumed immediately, or within 4 hours. If you are using an oral liquid formulation of Rivaroxaban, it should be discarded 60 days after opening.