Rivaroxaban

6 Drugs classified under this active ingredient

Direct Factor Xa Inhibitor. Rivaroxaban 2.5 mg, 10 mg, 15 mg, 20 mg.
FC Tab: 56x 2.5mg, 30 X 10 mg, 28 X 15 mg, 28 X 20 mg
Dosage to be adj. indiv. according to the pt’s. med. condit. See lit.
Rivaroxaban Dexcel 2.5 mg:
Co-admin. with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel, for t prevent. of atherothrombotic events in adult pts. after an acute coron. syndr. (ACS) with elev. cardiac biomarkers.
Co-admin. with acetylsalicylic acid (ASA), for the prevent. of atherothrombotic events in adult pts. with coron. artery dis. (CAD) or symptom. periph. artery dis. (PAD) at high risk of isch. events.
Rivaroxaban Dexcel 10 mg:
Prevent. of venous thromboembolism (VTE) in adult pts. undergoing elective hip or knee replacement surg.
Prevent. of recurrent deep vein thrombosis (DVT) and pulmon. embolism (PE), in adults (following complet. of at least 6 months ther. for DVT or PE).
Rivaroxaban Dexcel 15, 20 mg:
Prevent. of stroke and system. embolism in adult pts. with non-valv. atrial fibrill. with one or more risk factors, such as congestive HF, hypertension, age≥75, diabetes mell., prior stroke or transient isch. attack.
Tmt. of deep vein thrombosis (DVT) and pulmon. embolism (PE), and prevent. of recurr. DVT and PE in adults.
Paed. pop.: Tmt. of venous thromboembolism (VTE) and prevent. of VTE recurr. in children and adolesc. aged less than 18  and weighing from 30 kg to 50 kg after at least 5 days of init. parenteral anticoag. tmt..
C/I-Hypersens.
/Act. clinic. signif. bleeding.
/Lesion or condit., if considered to be a signif. risk for major bleeding. incl. current or recent GI ulcerat., presence of malign. neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surg., recent intracranial haemorrhage, known or suspect. oesophageal varices, arteriovenous malformat., vasc. aneurysms or major intraspin. or intracerebr. vasc. abnormalities.
/ Concomit. tmt. with any other anticoag. e.g. unfraction. heparin (UFH), low MW heparins (enoxaparin, dalteparin, etc.), heparin derivat. (fondaparinux, etc.), oral anticoag. (warfarin, dabigatran etexilate, apixaban, etc.) except under spec. circumst. of switching anticoag. ther. or when UFH is given at doses necess. to maintain an open ctral. venous or arterial catheter.
/Hepatic dis. assoc. with coagulopathy and clinic. relevant bleeding risk incl. cirrhotic p with Child Pugh B and C.
/Pregn. and breastfeed.
For Rivaroxaban Dexcel 2.5mg:
/Concom. tmt. of ACS with antiplatelet ther. in pts. with a prior stroke or a transient isch. attack (TIA).
/Concom. tmt. of CAD/PAD with ASA in pts. with prev. haemorrhagic or lacunar stroke, or any stroke within a month. See lit.

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.

Direct Factor Xa Inhibitor. Rivaroxaban 2.5 mg.
TABS.: 14, 56, 60, 168
The recomm. dose is 2.5 mg×2/d. Pts. should also take a daily dose of 75 - 100 mg ASA or a dly. dose of 75 - 100 mg ASA in addit. to either a dly. dose of 75 mg clopidogrel. Tmt. should be regularly evaluated in the individ. pt. weighing the risk for ischaem. events against the bleed. risks. Extens. of tmt. beyond 12 mnths. should be done on an individ.pt. Tmt. should be started as soon as possible after stabilisat. of the ACS event (includ. revascularisat. procedures); at the earliest 24 hrs. after admis.to hospital and at the time when parenteral anticoagul. ther. would normally be discont. If a dose is missed the pt. should cont. with the regular dose as recommend. at the next scheduled time. The dose
should not be doubled to make up for a missed dose.
Co-admin. with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel , is indic. for the prevent. atherothrombotic events in adult pts. after an acute coronary syndr. (ACS) with elevated card. biomarkers.
C/I: Hypersens. Active clinical. signific. bleed. Lesion or condit. , if consid. to be a signific. risk for major bleed. This may include current or recent GI ulcerat., presence of malignant neoplasm. at high
risk of bleed., recent brain or spinal injury, recent brain, spinal or ophthalmic surg., recent intracran. haemorrhage, known or suspected oesophageal varices, arterioven. malformat., vascular aneurysms or major intraspin. or intracereb. vascular abnormal. Concom. tmt. with any other anticoagulant.e.g. unfractionat. heparin, low MW hepar. (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux,
etc.), oral anticoag. (warfarin, dabigatran etexilate, apixaban, etc.) except under specific circumstan. of switching anticoag. ther. or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Concom. tmt. of ACS with antiplatelet ther. in pts. with a prior stroke or a TIA. Hep. dis. assoc. with coagulopathy and clinical. relevant bleed.risk include. cirrhotic pts. with Child Pugh B and C.
Pregnancy and breast feeding

Factor Xa Inhibitor. Rivaroxaban 20 mg.
F.C. TABS: 7, 14, 28, 98, 100 x 20 mg 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.