Rivaxo Tablet 15mg 10 ‘S

Description

About

{{Product}} is an anticoagulant medication whose blood-thinning ability makes it an effective agent to minimize the risk of life-threatening cardiovascular diseases which occur due to the formation of blood clots. It works by inhibiting the factor Xa involved in the coagulation cascade, thereby reducing the likeliness of developing blood clots. Due to its anticoagulant properties, Rivaxo Tablet 15mg 10 ‘S is used for the treatment and prevention of Deep Vein thrombosis (DVT), Pulmonary Embolism (PE), atrial fibrillation, unstable angina, coronary and peripheral artery diseases, and stroke. 

{{Product}} is the first oral anticoagulant that directly causes the inhibition of factor Xa and hence ensures streamlined blood through the veins. Routine monitoring of INR (International normalized is not necessary as done in the case of other anticoagulants (Warfarin). {{Product}} is a prescription-only medicine and can only be administered upon the suggestion of a healthcare practitioner. 

Premature discontinuation of Rivaxo Tablet 15mg 10 ‘S should be avoided as it may put you at increased risk of thrombotic events such as spinal or epidural hematoma (blood accumulates in the epidural space, compressing the spinal cord). {{Product}} in low doses e.g. 10mg can be taken with or without food but the dose 15mg and 20mg of the tablet should be taken along with food for better absorption. 

Indications

{{Product}} is prescribed in the following clinical conditions:

• Prevention of thrombosis in people who have undergone hip or knee replacement surgery. 
• Chronic coronary artery disease
• Chronic peripheral artery disease
• Prevention of atherothrombosis in patients with raised cardiac biomarkers (along with other antiplatelets such as Acetyl Salicylic acid, ticlopidine, and Clopidogrel)
• Prevention of stroke in people with atrial fibrillation (irregular heartbeat that can create a clot that may travel to the brain and cause stroke)
• Treatment of recurrent Deep Vein Thrombosis (blood clot in the veins of legs) and Pulmonary embolism (Blood clot in the lung)
• Reduction of vascular thrombosis
• Reduction of the risk of major cardiovascular diseases
• A low dose of acetylsalicylic acid reduces the risk of life-threatening heart diseases such as stroke, heart attack, and coronary artery disease.
• In children (not younger than 2 years of age) for the treatment of congenital heart disease after the Fontan procedure (a type of open-heart surgery).
• For the prevention and treatment of VTE (Venous thromboembolism) in pediatrics and adolescents. 

How Does Rivaxo Tablet 15mg 10 ‘S Work

{{Product}} is a selective inhibitor of factor Xa which is involved in the intrinsic and extrinsic pathway of blood coagulation. Factor Xa is a blood clotting factor that is required for the activation of prothrombin (factor II) to thrombin (factor IIa) and also for the activation of fibrinogen into fibrin (a loose meshwork that makes up the clot). Clot formation cannot occur without the presence of these two major factors (thrombin and fibrin). So, by the inhibition of a catalyst of blood coagulation cascade i.e. factor Xa, Rivaxo Tablet 15mg 10 ‘S ceases the progression of clot formation and hence produces its anti-platelet effect.

How To Use Rivaxo Tablet 15mg 10 ‘S

{[Product}} is supposed to be taken orally (by mouth) with or without food, depending on the dose to be administered:

• If you have to take 2.5mg or 10mg tablets, you can take them irrespective of food. As the bioavailability is not significantly affected by the intake in an empty stomach. 
• 15 mg or 20mg tablets should be taken with food as their bioavailability is enhanced with food. 
• People who cannot swallow the whole tablet can take the crushed tablets with food such as apple puree (15 mg or 20mg) or without food. 
• The dose should not be changed unless the prescriber makes any changes. 

Dosage

Form and strength

The active agent “Rivaroxiban” comes as the film-coated tablet in the following strengths:

• 5mg
• 10mg
• 15mg
• 20mg

Adult Dose

Prevention Of Major Cardiovascular Events e.g. Stroke, Heart Attack in Chronic Coronary Artery Disease Or Pulmonary Artery Disease

2.5mg twice a day along with Aspirin (75 mg to 100mg) once a day. 

Prevention Of Stroke Associated With Atrial fibrillation 

• 20mg once daily along with evening meal
• 15mg once daily is recommended in case of renal impairment (Creatinine clearance less than 50ml/min)

Prevention Of Deep Vein Thrombosis After Hip or Knee Replacement Surgery

• Once hemostasis (the body’s natural reaction towards bleeding and injury) is achieved, the dose can be started after 6 to 10 hours of surgery. 
• If creatinine clearance is greater than 15ml/min, 10mg once daily can be given for 12 days in case of knee replacement or 10mg once daily for 35 days in case of Hip replacement. 

Deep Vein Thromboses (DVT) or Pulmonary Embolism (PE)

15mg twice daily (with 12 hours of the interval) for 21 days, followed by 20 mg once daily. 

Recommendations for After Surgical Invasive Interventions 

{{Product}} should be stopped 24 hours before the intervention if possible. If the delay in the surgery is not desirable, the risk of bleeding should be closely assessed. {{Product}} should be restarted as soon as hemostasis is established. 

Pediatric Dose

Treatment And Prevention Of Venous Thromboembolism (VTE)

In children and adolescents below 18 years of age and 30 to 50 kg of weight after a minimum of 5 days of parenteral anticoagulation therapy. 

• 30-49kg: 15 mg once daily 
• ≥50 kg: 20 mg once daily 

Treatment duration may extend from 3 months up to 12 months if needed (depending on the bleeding risks)

Thromboprophylaxis for Fontan Procedure

For thromboprophylaxis (to promote venous outflow), the dose in pediatrics greater than and equal to 2 years of age with congenital heart disease who have undergone (a type of open-heart surgery) depends on the weight of the child:

• 30-49 kg: 7.5 mg orally once a day 
• ≥50 kg: 10 mg orally once a day

Pregnancy And Lactation 

The risk of bleeding may increase during labor and delivery. There is also a potential for hemorrhage. {{Product}} is also known to secret in breast milk. The risk of thrombosis, as well as bleeding, should be balanced in special cases. 

Contraindications

The use of Rivaxo Tablet 15mg 10 ‘S is contraindicated in the following scenarios:

• Known allergies to the active components or any of the excipients
• Active bleeding
• Wound or lesion that may put you at the risk of bleeding such as ulceration of the G.I. tract, malignant tumors, recent brain or spinal injury, recent hemorrhage, or liver cirrhoses. 
• Pregnancy and breastfeeding or in women who are trying to get pregnant.
• Ophthalmic or spinal surgery 
• Concomitant therapy with other anticoagulants such enoxaparin, fondaparinux, warfarin, apixaban, etc unless switching of the treatment is not needed. 
• Antiphospholipid syndrome (a disease that affects the immune system rendering the body to make blood clots)
• Concomitant treatment with St. John’s Wort (a herbal remedy for depression)
• Severe renal impairment (Creatinine clearance less than 30ml/min).

Precautions

• You should avoid herbal remedies and supplements while taking Rivaxo Tablet 15mg 10 ‘S that are known to produce blood-thinning effects such as ginger and Ginkgo Biloba. 
• Complete the dose as per the doctor’s recommendation. If you make premature cessation in the dose of Rivaxo Tablet 15mg 10 ‘S, you put yourself at a higher risk of blood clot formation that may lead to stroke, deep vein thrombosis, or pulmonary edema. 
• People with deformed spines or who had an epidural puncture are at higher risk of bleeding. So Rivaxo Tablet 15mg 10 ‘S should be given with caution in such cases. 
• {{Product}} should either not be administered or taken with high caution in patients who are already on anti-platelets (e.g. Warfarin, Clopdogril), or NSAIDs (e.g. Ibuprofen). Such patients should be carefully monitored for any signs of bleeding as they are at risk of hemorrhage. 
• Long-term treatment with Rivaxo Tablet 15mg 10 ‘S may lead an individual to the risk of mucosal bleeding such as bleeding in the gums, epistaxis, gastrointestinal bleeding, genitourinary bleeding, increased menstrual bleeding, and also anemia. Lab tests related to hematocrit and hemoglobin help detect if a long–term user of {{product} is at enhanced risk of bleeding.
• The bleeding site should be searched if there is an unexplained drop in the hemoglobin level or blood pressure.

Interactions With Other Medications

• Mifepristone
• Antipletelet (clopidogrel, warferin, enoxaperin)
• SSRI Antidepressants (venlafaxine, fluoxetine)

The above medications may increase the risk of bleeding upon concomitant administration with Rivaxo Tablet 15mg 10 ‘S. 

Other interactions are seen with: 

• Antifungals (Itraconazole, Ketoconacole)
• Antivirals (Ritonavir, Lopinavir) 
• Antiepileptics (Carbamazepine, Phenytoin, Phenobarbital)
• St. John’s Wort
• Rifamycin

Adverse Effects

Common Adverse Effects

• Bleeding
• Inflammation in the gut wall
• Vomiting in children

Potential Adverse Effects 

• Secretion from the wound
• Dizziness and fainting 
• Pain in the legs and arms
• Hematoma
• Back and abdominal pain
• Pruritus (Itchy skin)
• Anemia
• Heavy menstrual flow
• Bloody stools 
• Numbness
• Cough with or without the presence of blood

Rare Adverse Effects

• A burning sensation upon urination
• Painful urination 
• Fatigue and muscle spasm
• Anxiety
• Anxiety (1.4%)
• Blister (1.4%)
• Fatigue (1.4%)
• Muscle spasm (1.3%)

How To Cope With Some Of The Adverse Effects

• Anemia – Pale skin, fatigue, weakness, and disturbed appetite are signs of anemia. Eat iron-rich food such as beef, salmon, cereals, liver, dry fruits, and leafy vegetables. Take a good night’s sleep, take rest when needed to avoid fainting, light exercise daily improves blood flow. 
• Dizziness – Do not get up or change your position immediately when you are feeling dizzy. Instead, get up slowly and steadily. Increase your fluid intake to stay energetic, refrain from coffee, smoking, alcohol, and addicting drugs.
• Nausea – Eat light and less spicy food and avoid food with high sugar content in it. Take frequent meals rather than taking a heavy one. Eat slowly and eat smaller, more frequent meals. Activity after eating should be avoided such as driving and playing. If there is vomit, take drink plenty of water in short intervals. 
• Heartburn – Take antacids such as magnesium hydroxide, sugar-free gum. Late eating and snacking before going to bed should be avoided. Take simple and less spicy food. 
• Chances Of Bleeding – Sports and other vigorous activities should be avoided until the treatment goes on as a little cut or injury may result in bleeding. Take safety measures while operating sharp objects such as gardening tools and knives. 

Key Facts About {{product}

• {{Product}} is a potent blood thinner that is used to significantly reduce the risk of thromboembolic diseases such as deep vein thrombosis (DVT), Pulmonary embolism (PE), Stroke, Myocardial Infarction (MI), and other life-threatening cardiovascular events.
• The tablet should be taken with a meal in high doses (15 mg or 20 mg) for better absorption and bioavailability. Low doses (2.5 mg or 10 mg) can be taken irrespective of food. 
• {{Product}} is likely to cause bleeding such as nose bleeding, heavy menstruation, and gum bleeding. You may observe these symptoms in the first week of treatment. 
• Your doctor should know that you are on this blood-thinning agent before having surgery.
• {{Product}} should not be taken by a pregnant or breastfeeding woman, or by a woman who is trying to get pregnant as Rivaxo Tablet 15mg 10 ‘S is associated with a high risk of bleeding and may cause harm to the fetus. 

FAQ’s

• CAN {{PRODUCT}} BE TAKEN WITH VITAMIN K?

There is no direct interaction between Rivaxo Tablet 15mg 10 ‘S and vitamin k, unlike warfarin. You can eat a vitamin k containing diet without the fear of developing dangerous interactions. 

• WHAT IF I MISS THE DOSE?

If you are on once-daily dosing, take the dose as soon as you remember any time of the day. If you are on a twice-daily dose, you can take the dose as soon as you remember. If the time for the second dose is near, skip the previous dose and take the next one. 

• WHAT IF I TAKE MORE THAN RECOMMENDED DOSE?

Overdose may put you at risk of bleeding. You should contact your doctor in that case. 

• FOR HOW LONG DO I NEED TO TAKE {{PRODUCT}}?

If you had a knee or hip joint replacement surgery, the usual duration of treatment is 2 to 5 weeks. However, 3 months is the duration of therapy for deep vein thrombosis or pulmonary embolism. The therapy may take longer. The treatment is long-term in case of serious cardiovascular events such as atrial fibrillation and heart attack.

• FOR HOW LONG DOES {{PRODUCT}} TAKE TO PRODUCE ITS EFFECT?

{{Product}} takes 2 to 4 hours to produce an anticoagulant effect and eliminates in 24 hours from the body. 

• CAN I CONSUME ALCOHOL DURING THE TREATMENT?

Alcohol intake is limited to not more than 2 units (175ml) a day while you are on Rivaxo Tablet 15mg 10 ‘S. Binge drinking of alcohol can increase the risk of bleeding associated with Rivaxo Tablet 15mg 10 ‘S. 

• DOES {{PRODUCT}} HAVE ANY INTERACTION WITH CONTRACEPTION?

{{Product}} doesn’t interrupt emergency contraception. However, it should be avoided if the contraceptive effect is not desired. 

• IS IT SAFE TO HAVE A TATTOO OR PIERCING WHILE TAKING {{PRODUCT}}?

As Rivaxo Tablet 15mg 10 ‘S is associated with the risk of bleeding, it is better not to have a tattoo or piercing. So that the chances of infection are minimized. If you want a tattoo during the course, talk to your doctor he might suggest some antibiotics in case of infections. Also, let your piercer know that you are taking blood-thinning medicine so that he may put some extra care in doing the procedure. 

• DOES LIFESTYLE CHANGES REDUCE THE RISK OF DEVELOPING BLOOD CLOTS?

Yes, changes in your habits and lifestyle impact your cardiovascular health significantly. There are fewer chances of developing blood clots if you stop smoking, take a healthy and bad cholesterol-free diet, and exercise regularly. 

• HOW TO STORE {{PRODUCT}}?

{{Product}} can be stored at room temperature away from moisture and light. The crushed mixture of the tablets should be discarded within 4 hours. 

• HOW LONG BEFORE SURGERY DO I NEED TO STOP RIVAROXABAN?

{{Product}} should be stopped at least 24 hours before the procedure to minimize the risk of bleeding which could be outweighed against the clinical urgency. 

• IS {{PRODUCT}} SAFE TO USE IN PREGNANCY AND BREASTFEEDING?    

{{Product}} is associated with the risk of bleeding and may render harm to the fetus, so it should be avoided in pregnancy unless the healthcare provider is not considering it in case of a life-threatening situation. {{Product}} is also released in breast milk. However, the clinical effects on the nursing infant are not significantly known.