Diviti

Diviti

fondaparinux sodium

Manufacturer:

Dexa Medica
Concise Prescribing Info
Contents
Fondaparinux Na
Indications/Uses
Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopedic surgery of the lower limbs eg, hip fracture including extended prophylaxis, knee & hip replacement surgery; abdominal surgery who are at risk of thromboembolic complications; who are at risk for VTE & thromboembolic complications due to restricted mobility in acute illness.
Dosage/Direction for Use
SC Orthopedic & abdominal surgery 2.5 mg once daily post-op for 5-9 days. Administer 1st dose no earlier than 6 hr following surgical closure. Patient at risk of thromboembolic complication 2.5 mg once daily for 6-14 days.
Contraindications
Hypersensitivity. Active clinically significant bleeding. Acute bacterial endocarditis. Severe renal impairment (CrCl <20 mL/min).
Special Precautions
Epidural or spinal hematomas may occur in patients who are anticoagulated w/ low molecular wt heparins (LMWH), heparinoids or fondaparinux Na & are receiving neuraxial anesth or undergoing spinal puncture. May result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that increase risk of developing hematomas include use of indwelling catheters; concomitant use w/ drugs affecting hemostasis eg, NSAIDs, platelet inhibitors, other anticoagulants; history of traumatic or repeated epidural or spinal puncture; history of spinal deformity or surgery. Monitor for signs & symptoms of impairment. Not for IM administration. Conditions w/ increased risk of intracranial hemorrhage eg, congenital or acquired bleeding disorders, active ulcerative GI disease, recent intracranial hemorrhage, shortly after brain, spinal or ophth surgery. Agents enhancing risk of hemorrhage should not be administered concomitantly eg, desirudin, fibrinolytics, glycoprotein IIb/IIIa receptor antagonists, heparin, heparinoids, LMWH, other antiplatelets eg, acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine, clopidogrel. Strictly adhere to timing of 1st inj. Heparin-induced thrombocytopenia. 1st inj of follow-up treatment w/ heparin or LMWH should be given 1 day after last fondaparinux inj. Continue fondaparinux treatment until target INR has been reached if follow-up treatment w/ vit K is required. Patient w/ low body wt (<50 kg). Renal & hepatic impairment. Pregnancy & lactation. Childn <17 yr. Elderly.
Adverse Reactions
Anemia, bleeding (various sites including rare cases of intracranial/intracerebral & retroperitoneal bleedings; hematoma, hematuria, hemoptysis, gingival bleeding), purpura; edema.
Drug Interactions
Increased bleeding risk w/ agents that may enhance risk of hemorrhage.
ATC Classification
B01AX05 - fondaparinux ; Belongs to the class of other antithrombotic agents.
Presentation/Packing
Form
Diviti inj 2.5 mg/0.5 mL
Packing/Price
2 × 1's
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