Fragmin 5000 IU/0.2 ml

INDICATIONS

Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Unstable angina, Prophylaxis of venous thromboembolism during surgical procedures, Venous thromboembolism.

PHARMACOLOGY

Dalteparin Na is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate factor Xa inhibition than to prolong aPTT.

DOSAGE & ADMINISTRATION

Intravenous-

Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration: 30-40 U/kg IV inj, then 10-15 U/kg/hr as IV infusion.

Subcutaneous-

Venous thromboembolism: 200 U/kg/day as a single or in 2 divided doses in pregnant and high-risk patients. Max: 18,000 U/day.
Prophylaxis of venous thromboembolism during surgical procedures Moderate risk: 2,500 U given 1-2 hr pre-op then 2,500 U once daily for 5-7 days or until the patient is fully ambulant. High risk: 2,500 U given 1-2 hr before and 8-12 hr after the procedure then 5,000 U daily.
Unstable angina: 120 U/kg 12 hrly continued for 5-8 days w/ low-dose aspirin. Max: 10,000 U 12 hrly.

INTERACTION

Increased risk of haemorrhage with other anticoagulant/ antiplatelet agents (e.g. aspirin/ dipyridamole, glycoprotein IIb/ IIIa receptor antagonists, vit K antagonists, NSAIDs, cytostatics, dextran, thrombolytics, sulfinpyrazone, probenecid, etacrynic acid). Reduced anticoagulant effect with antihistamines, cardiac glycosides, tetracycline and ascorbic acid.

SIDE EFFECTS

Elevated serum transaminase levels (AST and ALT), allergic reactions (e.g. pruritus, rash, fever, inj site reaction, bullous eruption), pain on inj site. Epidural or spinal haematomas that may result in permanent paralysis, severe haemorrhage, thrombocytopenia.

PREGNANCY & LACTATION

Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

PRECAUTIONS & WARNINGS

Patient with increased risk of bleeding complications (e.g. following surgery or trauma, haemorrhagic stroke, thrombocytopenia or defective platelet function, uncontrolled HTN, hypertensive or diabetic retinopathy). Increased risk of spinal or epidural haematomas in patient undergoing neuraxial anaesth or spinal puncture esp with post-op use of indwelling epidural catheters. Hepatic and renal impairment. Pregnancy and lactation.

THERAPEUTIC CLASS

Parenteral anti-coagulants

STORAGE CONDITIONS

Store between 20-25°C.