Arixtra Dosage & Drug Information

Concise Prescribing Info Bahasa 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 Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Fondaparinux Na

Indications/Uses

Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs, abdominal surgery who are at risk of thromboembolic complications & in medical patients who are at risk of thromboembolic complications due to restricted mobility during acute illness. Treatment of acute DVT & pulmonary embolism (PE), unstable angina or non-ST segment elevation MI (UA/NSTEMI) in patients in whom urgent (<120 min) invasive management (percutaneous coronary intervention) is not indicated. Adjunctive treatment of ST segment elevation MI (STEMI) in patients managed w/ thrombolytics or who initially are to receive no other form of reperfusion therapy.

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Dosage/Direction for Use

SC Prevention of VTE for orthopaedic & abdominal surgery 2.5 mg once daily 6 hr post-op, continued for at least 5-9 days post-op. Prevention of VTE for the patients at risk of thromboembolic complications 2.5 mg once daily, to be given 6-14 days. Treatment of DVT & PE Patients weighing >100 kg 10 mg, 50-100 kg 7.5 mg, <50 kg 5 mg, continued for at least 5 days & until adequate oral anticoagulation is established (INR 2-3). Doses are to be taken once daily. Treatment of UA/NSTEMI 2.5 mg once daily continued for up to 8 days or until hospital discharge. Treatment of STEMI 2.5 mg once daily. The 1st dose is administered IV & subsequent doses are by SC inj, continued for up to 8 days or until hospital discharge.

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Overdosage

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Contraindications

Hypersensitivity. Active clinically significant bleeding, acute bacterial endocarditis, severe renal impairment (CrCl <20 mL/min).

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Special Precautions

Do not administer IM. Patients undergoing percutaneous coronary intervention & w/ history of heparin induced thrombocytopenia. Increased risk of guiding catheter thrombus & haemorrhage eg, congenital or acquired bleeding disorders, active ulcerative GI disease, recent intracranial hemorrhage; shortly after brain, spinal, or ophth surgery. Patients treated concomitantly w/ medicinal products that may increase the risk of haemorrhage (eg, GPIIb/IIIa inhibitors or thrombolytics). Current use of spinal/epidural anesth or spinal puncture. Patients <50 kg. Not to be used for patients w/ renal impairment (CrCl <30 mL/min). Severe hepatic impairment. Pregnancy & lactation. Childn <17 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anaemia, bleeding, purpura. Oedema.

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Drug Interactions

Co-administration of vit K enhance risk of haemorrhage. Increased bleeding risk w/ concomitant administration of agents that may enhance the risk of hemorrhage (eg, GP IIb/IIIa inhibitors or thrombolytics).

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Storage

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Description

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

Action

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MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

ATC Classification

B01AX05 - fondaparinux ; Belongs to the class of other antithrombotic agents.

Regulatory Classification

Presentation/Packing

Form

Arixtra inj 2.5 mg/0.4 mL

Packing/Price

(pre-filled syringe) 2 × 1's

Form

Arixtra inj 7.5 mg/0.6 mL

Packing/Price

(pre-filled syringe) 2 × 1's (Rp690,000/pak)

Arixtra

fondaparinux sodium

Manufacturer:

GlaxoSmithKline Indonesia