Rivoxan: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Rivaroxaban

Indications/Uses

DVT & pulmonary embolism (PE). Prevention of recurrent DVT & PE. Prevention of stroke & systemic embolism in patients w/ nonvalvular atrial fibrillation.

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Dosage/Direction for Use

Prevention of stroke & systemic embolism 20 mg once daily. Max daily dose: 20 mg. DVT & PE Initially 15 mg bid for 21 days followed by 20 mg once daily. Recommended max daily dose: 30 mg during 1st 3 wk, then 20 mg in the following treatment phase. Prevention of recurrent DVT & PE 20 mg once daily. Non-valvular atrial fibrillation Renal impairment CrCl 15-50 mL/min 15 mg once daily.

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Overdosage

View Rivoxan overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: May be crushed & mixed in 50 mL of water for nasogastric/gastric feeding tube administration w/in 4 hr of preparation.

Contraindications

Hypersensitivity. Clinically significant active bleeding eg, intracranial & GI bleeding. Hepatic disease associated w/ coagulopathy leading to clinically relevant bleeding risk. Pregnancy & lactation.

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Special Precautions

Discontinue in patients who develop acute renal failure (CrCl <15 mL/min); if INR falls to <3; at least 24 hr prior to surgery/invasive procedures or 3 days prior in patients w/ CrCl ≥50 mL/min or 5 days prior if CrCl <50 mL/min. Major hemorrhages eg, intracranial, GI, epidural hematoma, adrenal bleeding. Spinal or epidural hematomas w/ neuraxial anesth (epidural or spinal anesth) or spinal puncture in patients who are anticoagulated; may result in long-term or permanent paralysis. Increased risk of thrombotic events including stroke. Avoid use in patient w/ CrCl <30 mL/min. Concomitant use w/ drug therapy known to increase systemic exposure & deteriorates renal function. Moderate to severe hepatic impairment (Child-Pugh class B & C) or hepatic disease associated w/ coagulopathy. Moderate renal impairment (CrCl 30-50 mL/min). Avoid use in severe renal impairment. Pregnancy & lactation. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Fatigue, syncope; pruritus, skin blister, wound secretion; abdominal pain, dyspepsia, nausea, toothache; UTI; hemorrhage, pulmonary hemorrhage; increased serum transaminases; back & limb pain, muscle spasm, OA; oropharyngeal pain, sinusitis. SJS.

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Drug Interactions

Increased exposure w/ systemic ketoconazole, clarithromycin, ritonavir, telaprevir, indinavir, lopinavir, idelalisib, conivaptan, cobicistat, darunavir, itraconazole, atazanavir. Reduced plasma conc w/ rifampin, nevirapine, primidone, carbamazepine, phenytoin, St. John's wort. Increased risk of bleeding w/ warfarin, enoxaparin, fondaparinux, acenocoumarol, dalteparin, phenprocoumon, dabigatran etexilate, argatroban, SNRIs & SSRIs, lepirudin, heparin, tinzaparin, bivalirudin, protein C, desirudin, danaparoid, drotrecogin α, phenindione, idelalisib, conivaptan. Decreased efficacy & possible subtherapeutic anticoagulation w/ oxcarbazepine.

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Storage

View Rivoxan storage conditions for details to ensure optimal shelf-life.

Description

View Rivoxan description for details of the chemical structure and excipients (inactive components).

Action

View Rivoxan mechanism of action for pharmacodynamics and pharmacokinetics details.

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.

Thai FDA Category

Presentation/Packing

Form

Rivoxan FC tab 15 mg

Packing/Price

3 × 10's

Form

Rivoxan FC tab 20 mg

Packing/Price

3 × 10's

Rivoxan

rivaroxaban

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma