Rivaroxaban

8 Drugs classified under this active ingredient

Direct Factor Xa Inhibitor. Rivaroxaban 2.5 mg, 10 mg, 15 mg, 20 mg.
FCTabs  56 X 2.5 mg, 30 X 10 mg, 28 X 15 mg, 328 X 20 mg
Dosage to be adjusted indiv. according to the ptt.’s medic. condit. See lit.
Rivaroxaban 2.5 mg:
co-admin. with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel, for the prevent. of atherothrombotic events in adults after an ac. coron. syndr. (ACS) with elevated card. biomarkers.
co-admin. with acetylsalicylic acid (ASA), for the prevent. of atherothrombotic events in adults with coronary artery dis. (CAD) or symptom. peripheral artery dis. (PAD) at high risk of ischaemic events.
Rivaroxaban 10 mg:
Prevent. of venous thromboembolism (VTE) in adults undergoing elective hip or knee replacement surgery.
Prevent. of recurrent deep vein thrombosis (DVT) and pulm. embolism (PE), in adults (following completion of at least 6 months ther. for DVT or PE).
Rivaroxaban 15 mg and 20 mg:
Prevent. of stroke and syst. embolism in adults with non-valvular atrial fibrillation with one or more risk factors, such as congestive HF, HT, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Tmt. of deep vein thrombosis (DVT), and pulm. embolism (PE), and prevent. of recurrent DVT and PE in adults
Paediatric pop.: Tmt. of venous thromboembolism (VTE) and prevent. of VTE recurrence in childr. and adolesc. aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoag. tmt.
C/I for 2.5, 10, 15 and 20 mg prod.:
 Hypersens./Active clin. signif.bleeding/
Lesion or condit. posing significant risk for major bleeding.: GI ulcer., neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, oesophageal varices, arteriovenous malformat./ vasc. aneurysms or major intraspinal or intracerebral vasc. abnormalities/
Concom. tmt. with any other anticoag. e.g. unfractionated heparin (UFH), low molec. weight heparins (enoxaparin, dalteparin, etc.), heparin derivat. (fondaparinux, etc.), oral anticoag. (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumst. of switching anticoag. ther. or when UFH is given at doses necessary to maintain an open ctral. venous or arterial catheter/ Hepatic dis. associated with coagulopathy and clinic. relevant bleeding risk includ. cirrhotic pts. with Child Pugh B and C/ Pregn. and breast feeding.
For 2.5 mg prod.: Concom. tmt. of ACS with antiplatelet ther. in pts with a prior stroke or a transient ischaemic attack (TIA).
* Concom. tmtt of CAD/PAD with ASA in pts with previous haemorrhagic or lacunar stroke, or any stroke within a month

Direct Factor Xa Inhibitor. Rivaroxaban 2.5, 10, 15, 20 mg.
FCTabs  60 X 2.5 mg, 30 X 10 mg, 30 X 15 mg, 30 X 20 mg
Dosage to be adjusted indiv. according to the ptt.’s medic. condit. See lit.
Rivaroxaban 2.5 mg:
co-admin. with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel, for the prevent. of atherothrombotic events in adults after an ac. coron. syndr. (ACS) with elevated card. biomarkers.
co-admin. with acetylsalicylic acid (ASA), for the prevent. of atherothrombotic events in adults with coronary artery dis. (CAD) or symptom. peripheral artery dis. (PAD) at high risk of ischaemic events.
Rivaroxaban 10 mg:
Prevent. of venous thromboembolism (VTE) in adults undergoing elective hip or knee replacement surgery.
Prevent. of recurrent deep vein thrombosis (DVT) and pulm. embolism (PE), in adults (following completion of at least 6 months ther. for DVT or PE).
Rivaroxaban 15 mg and 20 mg:
Prevent. of stroke and syst. embolism in adults with non-valvular atrial fibrillation with one or more risk factors, such as congestive HF, HT, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Tmt. of deep vein thrombosis (DVT), and pulm. embolism (PE), and prevent. of recurrent DVT and PE in adults
C/I for 2.5, 10, 15 and 20 mg prod.:
  Hypersens./Active clin. signif.bleeding/
Lesion or condit. posing significant risk for major bleeding.: GI ulcer., neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, oesophageal varices, arteriovenous malformat./ vasc. aneurysms or major intraspinal or intracerebral vasc. abnormalities/
Concom. tmt. with any other anticoag. e.g. unfractionated heparin (UFH), low molec. weight heparins (enoxaparin, dalteparin, etc.), heparin derivat. (fondaparinux, etc.), oral anticoag. (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumst. of switching anticoag. ther. or when UFH is given at doses necessary to maintain an open ctral. venous or arterial catheter/ Hepatic dis. associated with coagulopathy and clinic. relevant bleeding risk includ. cirrhotic pts. with Child Pugh B and C/ Pregn. and breast feeding.
for 2.5 mg prod.: Concom. tmt. of ACS with antiplatelet ther. in pts with a prior stroke or a transient ischaemic attack (TIA).
* Concom. tmtt of CAD/PAD with ASA in pts with previous haemorrhagic or lacunar stroke, or any stroke within a month

Rivaroxaban 1 mg/ml.
Gr. for oral susp. 1 X 2.625 g or 5.25 g
Dose and freq. of admin. are based on BW. See full prescription info.
Tmt. of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, childr., and adolesc. < 18 years after at least 5 days of initial parenteral anticoagul. tmt.
C/I:  Hypersens.

Factor Xa Inhibitor. Rivaroxaban 10 mg.
F.C. TABS: 30. Recommend. dose: 10 mg
orally 1 x dly, initial dose: 6-10 hrs aft. surg. Tmt. durat. acc. to type of surg.
See lit.
Prevent. VTE in adult pts. undergoing
elective hip/knee replace. surg.
C/I: Hypersens. to active substance or
any of the excips., clin. signif. active
bleed., hepat. dis. assoc. with
coagulopathy and clin. relevant bleed.
risk, pregnancy, lact.

Factor Xa Inhibitor. Rivaroxaban 15 mg.
F.C. TABS: 7, 14, 28, 42, 98, 100 x 15 mg. Dosage must be ajust individ. accord. to pt. med. cond.
Prevent. of stroke & system. embolism in
adult pts. with non-valvular AF with one
or more risk factor., such as CHF,
hypertens., age≥75 yrs., diab. mell., prior
stroke or TIA. Tmt. of DVT and PE, and
prevent. of recurrent DVT and PE in
adults. See.lit.
C/I: Hypersens. Active clinical. signific.
bleed. Lesion / cond., if considered to be
a signific. risk for major bleed. (e.g:
current/ recent GI ulcer., presence of
malign. neoplasms at high risk of bleed. ,
recent brain/ spinal inj., recent brain,
spinal or ophthal. surg., recent intracran.
haemorrhage, known/ suspect.
esophagi. varices, arterioven. malfor. ,
vasc. aneurysms/ major intraspinal or
intracereb. vasc. abnormalit. Concom.
tmt. with any other anticoagul. e.g.
unfraction. heparin, low molec. weight
heparins (enoxaparin, dalteparin, etc.),
heparin derivate.(fondaparinux, etc.),
oral anticoag. (warfarin, dabigatran
etexilate, apixaban, etc.) except under
specific circumst. of switch. anticoag.
ther. or when unfraction. heparin is
given at doses necessary to maint. an
open cent. venous/arter. catheter.
Hep. dis. assoc. with coagulopathy and
clinical. relevant bleed. risk include.
cirrhotic pts. with Child Pugh B and C.
Preg., lact.