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Rivaxored

Rivaxored

rivaroxaban

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH
Concise Prescribing Info
Contents
Rivaroxaban
Indications/Uses
10 mg: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery. 15 & 20 mg: DVT & pulmonary embolism (PE) & prevention of recurrent DVT & PE in adults. Prevention of stroke & systemic embolism in adult patients w/ non-valvular atrial fibrillation w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack.
Dosage/Direction for Use
VTE prevention in hip or knee replacement surgery Initially 10 mg once daily 6-10 hr after surgery. Duration: 5 wk for major hip surgery, 2 wk for major knee surgery. Prevention of stroke & systemic embolism 20 mg once daily. Initial treatment of acute DVT or PE 15 mg bd for Day 1-21 followed by 20 mg once daily for Day 22 & onwards. Severe (CrCl 15-29 mL/min) or moderate (30-49 mL/min) renal impairment Prevention of stroke & systemic embolism w/ non-valvular atrial fibrillation 15 mg once daily. DVT & PE & prevention of recurrent DVT & PE 15 mg bd for 1st 3 wk.
Administration
10 mg: May be taken with or without food.. 15 & 20 mg: Should be taken with food.. For patients unable to swallow, may be crushed & mixed w/ water/apple puree immediately prior to taking. Crushed tab may also be mixed w/ small amount of water & administered via gastric tube. Flush tube w/ water after administration then immediately followed by enteral feeding.
Contraindications
Hypersensitivity. Clinically significant active bleeding; lesion or condition at significant risk for major bleeding. Concomitant treatment w/ other anticoagulants except switching therapy or use of unfractioned heparin (UFH) to maintain open central venous or arterial catheter. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk including cirrhotic patients w/ Child-Pugh B & C. Pregnancy & lactation.
Special Precautions
Discontinue use if severe haemorrhage occurs; at 1st appearance of severe skin rash or any other sign of hypersensitivity. Not to be used for thromboprophylaxis in patients having recently undergone transcatheter aortic valve replacement. Not recommended as alternative to UFH in haemodynamically unstable PE patients or patients requiring thrombolysis or pulmonary embolectomy. Serious skin reactions eg, SJS/TEN, DRESS syndrome. Not recommended in patients w/ increased bleeding risk eg, congenital or acquired bleeding disorders, uncontrolled severe arterial HTN; other GI disease w/o active ulceration potentially leading to bleeding complications; vascular retinopathy, bronchiectasis or history of pulmonary bleeding; prosthetic heart valves; history of thrombosis w/ triple +ve antiphospholipid syndrome. History of stroke/transient ischaemic attack; spinal/epidural anaesth or puncture. Patients w/ non-valvular atrial fibrillation undergoing percutaneous coronary intervention w/ stent placement; undergoing cardioversion. Discontinue use at least 24 hr prior to surgery & other interventions. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in concomitant use w/ azole-antimycotics, HIV PIs. Concomitant use w/ haemostasis-affecting medicinal products. May affect ability to drive & use machines. Not recommended in CrCl <15 mL/min. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential should avoid pregnancy during treatment. Not recommended in childn <18 yr. Elderly.
Adverse Reactions
Anaemia; dizziness, headache; eye haemorrhage; hypotension, haematoma; epistaxis, haemoptysis; gingival bleeding, GIT haemorrhage; GI & abdominal pains, dyspepsia, nausea, constipation, diarrhoea, vomiting; increased transaminases; pruritus, rash, ecchymosis, cutaneous & SC haemorrhage; pain in extremity; urogenital tract haemorrhage, renal impairment; fever, peripheral oedema, decreased general strength & energy; post-procedural haemorrhage, contusion, wound secretion.
Drug Interactions
Increased mean AUC & Cmax w/ CYP3A4 & P-gp inhibitors. Increased bleeding risk w/ other anticoagulants; NSAIDs & platelet aggregation inhibitors; SSRIs/SNRIs. Reduced plasma conc w/ strong CYP3A4 inducers. Avoid co-administration w/ dronedarone. Affected clotting parameters (eg, PT, aPTT, HepTest).
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF01 - rivaroxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Rivaxored FC tab 10 mg
Packing/Price
10's
Form
Rivaxored FC tab 15 mg
Packing/Price
28's
Form
Rivaxored FC tab 20 mg
Packing/Price
28's
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